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Sample records for assay performance demonstration

  1. Performance in the WIPP nondestructive assay performance demonstration program

    Energy Technology Data Exchange (ETDEWEB)

    Marcinkiewicz, C.J. [Consolidated Technical Services, Inc., Frederick, MD (United States); Connolly, M.J.; Becker, G.K. [Lockheed Martin Idaho Technologies Company, Idaho Falls, ID (United States)

    1997-11-01

    Measurement facilities performing nondestructive assay (NDA) of wastes intended for disposal at the United States Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) are required to demonstrate their ability to meet specific Quality Assurance Objectives (QAOs). This demonstration is performed, in part, by participation in the NDA Performance Demonstration Program (PDP). The PDP is funded and managed by the Carlsbad Area Office (CAO) of DOE and is conducted by the Idaho National Engineering Laboratory. It tests the characteristics of precision, system bias and/or total uncertainty through the measurement of variable, blind combinations of simulated waste drums and certified radioactive standards. Each facility must successfully participate in the PDP using each different type of measurement system planned for use in waste characterization. The first cycle of the PDP using each different type of measurement system planned for use in waste characterization. The first cycle of the PDP was completed in July 1996 and the second is scheduled for completion by December 1996. Seven sites reported data in cycle 1 for 11 different measurement systems. This paper describes the design and operation of the PDP and provides the performance data from cycle 1. It also describes the preliminary results from cycle 2 and updates the status and future plans for the NDA PDP. 4 refs., 9 figs., 11 tabs.

  2. Performance Demonstration Program Plan for Nondestructive Assay for the TRU Waste Characterization Program. Revision 1

    International Nuclear Information System (INIS)

    1997-01-01

    The Performance Demonstration Program (PDP) for Nondestructive Assay (NDA) consists of a series of tests conducted on a regular frequency to evaluate the capability for nondestructive assay of transuranic (TRU) waste throughout the Department of Energy (DOE) complex. Each test is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed with TRU waste characterization systems. Measurement facility performance will be demonstrated by the successful analysis of blind audit samples according to the criteria set by this Program Plan. Intercomparison between measurement groups of the DOE complex will be achieved by comparing the results of measurements on similar or identical blind samples reported by the different measurement facilities. Blind audit samples (hereinafter referred to as PDP samples) will be used as an independent means to assess the performance of measurement groups regarding compliance with established Quality Assurance Objectives (QAOs). As defined for this program, a PDP sample consists of a 55-gallon matrix drum emplaced with radioactive standards and fabricated matrix inserts. These PDP sample components, once manufactured, will be secured and stored at each participating measurement facility designated and authorized by Carlsbad Area Office (CAO) under secure conditions to protect them from loss, tampering, or accidental damage

  3. Performance Demonstration Program Plan for Nondestructive Assay of Drummed Wastes for the TRU Waste Characterization Program

    International Nuclear Information System (INIS)

    2009-01-01

    Each testing and analytical facility performing waste characterization activities for the Waste Isolation Pilot Plant (WIPP) participates in the Performance Demonstration Program (PDP) to comply with the Transuranic Waste Acceptance Criteria for the Waste Isolation Pilot Plant (WAC) (DOE/WIPP-02-3122) and the Quality Assurance Program Document (QAPD) (CBFO-94-1012). The PDP serves as a quality control check for data generated in the characterization of waste destined for WIPP. Single blind audit samples are prepared and distributed to each of the facilities participating in the PDP. The PDP evaluates analyses of simulated headspace gases, constituents of the Resource Conservation and Recovery Act (RCRA), and transuranic (TRU) radionuclides using nondestructive assay (NDA) techniques.

  4. Performance Demonstration Program Plan for Nondestructive Assay of Drummed Wastes for the TRU Waste Characterization Program

    International Nuclear Information System (INIS)

    DOE Carlsbad Field Office

    2001-01-01

    The Performance Demonstration Program (PDP) for nondestructive assay (NDA) consists of a series of tests to evaluate the capability for NDA of transuranic (TRU) waste throughout the Department of Energy (DOE) complex. Each test is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements obtained from NDA systems used to characterize the radiological constituents of TRU waste. The primary documents governing the conduct of the PDP are the Waste Acceptance Criteria for the Waste Isolation Pilot Plant (WAC; DOE 1999a) and the Quality Assurance Program Document (QAPD; DOE 1999b). The WAC requires participation in the PDP; the PDP must comply with the QAPD and the WAC. The WAC contains technical and quality requirements for acceptable NDA. This plan implements the general requirements of the QAPD and applicable requirements of the WAC for the NDA PDP. Measurement facilities demonstrate acceptable performance by the successful testing of simulated waste containers according to the criteria set by this PDP Plan. Comparison among DOE measurement groups and commercial assay services is achieved by comparing the results of measurements on similar simulated waste containers reported by the different measurement facilities. These tests are used as an independent means to assess the performance of measurement groups regarding compliance with established quality assurance objectives (QAO's). Measurement facilities must analyze the simulated waste containers using the same procedures used for normal waste characterization activities. For the drummed waste PDP, a simulated waste container consists of a 55-gallon matrix drum emplaced with radioactive standards and fabricated matrix inserts. These PDP sample components are distributed to the participating measurement facilities that have been designated and authorized by the Carlsbad Field Office (CBFO). The NDA Drum PDP materials are stored at these sites under secure conditions to

  5. Performance Demonstration Program Plan for Nondestructive Assay of Boxed Wastes for the TRU Waste Characterization Program

    International Nuclear Information System (INIS)

    2001-01-01

    The Performance Demonstration Program (PDP) for nondestructive assay (NDA) consists of a series of tests to evaluate the capability for NDA of transuranic (TRU) waste throughout the Department of Energy (DOE) complex. Each test is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements obtained from NDA systems used to characterize the radiological constituents of TRU waste. The primary documents governing the conduct of the PDP are the Waste Acceptance Criteria for the Waste Isolation Pilot Plant (WAC; DOE 1999a) and the Quality Assurance Program Document (QAPD; DOE 1999b). The WAC requires participation in the PDP; the PDP must comply with the QAPD and the WAC. The WAC contains technical and quality requirements for acceptable NDA. This plan implements the general requirements of the QAPD and applicable requirements of the WAC for the NDA PDP for boxed waste assay systems. Measurement facilities demonstrate acceptable performance by the successful testing of simulated waste containers according to the criteria set by this PDP Plan. Comparison among DOE measurement groups and commercial assay services is achieved by comparing the results of measurements on similar simulated waste containers reported by the different measurement facilities. These tests are used as an independent means to assess the performance of measurement groups regarding compliance with established quality assurance objectives (QAO's). Measurement facilities must analyze the simulated waste containers using the same procedures used for normal waste characterization activities. For the boxed waste PDP, a simulated waste container consists of a modified standard waste box (SWB) emplaced with radioactive standards and fabricated matrix inserts. An SWB is a waste box with ends designed specifically to fit the TRUPACT-II shipping container. SWB's will be used to package a substantial volume of the TRU waste for disposal. These PDP sample components

  6. Performance Demonstration Program Plan for Nondestructive Assay of Drummed Wastes for the TRU Waste Characterization Program

    International Nuclear Information System (INIS)

    2005-01-01

    The Performance Demonstration Program (PDP) for Nondestructive Assay (NDA) is a test program designed to yield data on measurement system capability to characterize drummed transuranic (TRU) waste generated throughout the Department of Energy (DOE) complex. The tests are conducted periodically and provide a mechanism for the independent and objective assessment of NDA system performance and capability relative to the radiological characterization objectives and criteria of the Office of Characterization and Transportation (OCT). The primary documents requiring an NDA PDP are the Waste Acceptance Criteria for the Waste Isolation Pilot Plant (WAC), which requires annual characterization facility participation in the PDP, and the Quality Assurance Program Document (QAPD). This NDA PDP implements the general requirements of the QAPD and applicable requirements of the WAC. Measurement facilities must demonstrate acceptable radiological characterization performance through measurement of test samples comprised of pre-specified PDP matrix drum/radioactive source configurations. Measurement facilities are required to analyze the NDA PDP drum samples using the same procedures approved and implemented for routine operational waste characterization activities. The test samples provide an independent means to assess NDA measurement system performance and compliance per criteria delineated in the NDA PDP Plan. General inter-comparison of NDA measurement system performance among DOE measurement facilities and commercial NDA services can also be evaluated using measurement results on similar NDA PDP test samples. A PDP test sample consists of a 55-gallon matrix drum containing a waste matrix type representative of a particular category of the DOE waste inventory and nuclear material standards of known radionuclide and isotopic composition typical of DOE radioactive material. The PDP sample components are made available to participating measurement facilities as designated by the

  7. Design of benign matrix drums for the non-destructive assay performance demonstration program for the National TRU Program

    International Nuclear Information System (INIS)

    Becker, G.K.

    1996-09-01

    Regulatory compliance programs associated with the Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) Transuranic (TRU) Waste Characterization Program (the Program) require the collection of waste characterization data of known quality to support repository performance assessment, permitting, and associated activities. Blind audit samples, referred to as PDP (performance demonstration program) samples, are devices used in the NDA PDP program to acquire waste NDA system performance data per defined measurement routines. As defined under the current NDA PDP Program Plan, a PDP sample consists of a DOT 17C 55-gallon PDP matrix drum configured with insertable radioactive standards, working reference materials (WRMs). The particular manner in which the matrix drum and PDP standard(s) are combined is a function of the waste NDA system performance test objectives of a given cycle. The scope of this document is confined to the design of the PDP drum radioactive standard internal support structure, the matrix type and the as installed configuration. The term benign is used to designate a matrix possessing properties which are nominally non-interfering to waste NDA measurement techniques. Measurement interference sources are technique specific but include attributes such as: high matrix density, heterogeneous matrix distributions, matrix compositions containing high moderator/high Z element concentrations, etc. To the extent practicable the matrix drum design should not unduly bias one NDA modality over another due to the manner in which the matrix drum configuration manifests itself to the measurement system. To this end the PDP matrix drum configuration and composition detailed below is driven primarily by the intent to minimize the incorporation of matrix attributes known to interfere with fundamental waste NDA modalities, i.e. neutron and gamma based techniques

  8. Radiometric measurements on the fabrication of non-destructive assay standards for WIPP-Performance Demonstration Program

    International Nuclear Information System (INIS)

    Wong, A.S.; Marshall, R.S.

    1997-04-01

    The Inorganic Elemental Analysis Group of LANL has prepared several different sets of working reference materials (WRMs). These WRMs are prepared by blending quantities of nuclear materials (plutonium, americium, and enriched uranium) with diatomaceous earth. The blends are encapsulated in stainless steel cylinders. These WRMs are being measured as blind controls in neutron and gamma based non-destructive assay (NDA) instruments. Radiometric measurements on the blending homogeneity and verification on a set of sixty three plutonium based WRMs are discussed in this paper

  9. Performance Demonstration Program Management Plan

    International Nuclear Information System (INIS)

    2005-01-01

    To demonstrate compliance with the Waste Isolation Pilot Plant (WIPP) waste characterization program, each testing and analytical facility performing waste characterization activities participates in the Performance Demonstration Program (PDP). The PDP serves as a quality control check against expected results and provides information about the quality of data generated in the characterization of waste destined for WIPP. Single blind audit samples are prepared and distributed by an independent organization to each of the facilities participating in the PDP. There are three elements within the PDP: analysis of simulated headspace gases, analysis of solids for Resource Conservation and Recovery Act (RCRA) constituents, and analysis for transuranic (TRU) radionuclides using nondestructive assay (NDA) techniques. Because the analysis for TRU radionuclides using NDA techniques involves both the counting of drums and standard waste boxes, four PDP plans are required to describe the activities of the three PDP elements. In accordance with these PDP plans, the reviewing and approving authority for PDP results and for the overall program is the CBFO PDP Appointee. The CBFO PDP Appointee is responsible for ensuring the implementation of each of these plans by concurring with the designation of the Program Coordinator and by providing technical oversight and coordination for the program. The Program Coordinator will designate the PDP Manager, who will coordinate the three elements of the PDP. The purpose of this management plan is to identify how the requirements applicable to the PDP are implemented during the management and coordination of PDP activities. The other participants in the program (organizations that perform site implementation and activities under CBFO contracts or interoffice work orders) are not covered under this management plan. Those activities are governed by the organization's quality assurance (QA) program and procedures or as otherwise directed by CBFO.

  10. NDT performance demonstration in Spain

    International Nuclear Information System (INIS)

    Bollini, G.J.

    1994-01-01

    The experience obtained from the in-service inspection of reactor pressure vessels (RPV) of Spanish nuclear power plants and the participation in several international programs, such as PISC, has shown the need for a performance demonstration, not only for the ultrasonic inspection techniques of RPV, but also for other ISI non-destructive techniques as in the case of eddy current inspection of steam generator tubing. Section XI of the ASME Code, which is applied in Spain for ISI, has incorporated recently the Appendix VIII for performance demonstration of ultrasonic inspection techniques. As a direct consequence of this, a Spanish project for performance demonstration of ultrasonic inspection techniques has been launched recently, which includes the manufacturing of full-scale mock-ups of nozzle to vessel welds, reactor vessel welds, wrought austenitic piping welds and ferritic piping welds of PWR and BWR nuclear power plants from different suppliers. This considerable technical effort will let the different Spanish organizations which are part of the project to participate and colaborate with similar international projects and in particular with a European initiative for performance demonstration. (Author)

  11. Performance of a Multiplex Serological Helicobacter pylori Assay on a Novel Microfluidic Assay Platform

    Directory of Open Access Journals (Sweden)

    Angela Filomena

    2017-10-01

    Full Text Available Infection with Helicobacter pylori (H. pylori occurs in 50% of the world population, and is associated with the development of ulcer and gastric cancer. Serological diagnostic tests indicate an H. pylori infection by detecting antibodies directed against H. pylori proteins. In addition to line blots, multiplex assay platforms provide smart solutions for the simultaneous analysis of antibody responses towards several H. pylori proteins. We used seven H. pylori proteins (FliD, gGT, GroEL, HpaA, CagA, VacA, and HP0231 and an H. pylori lysate for the development of a multiplex serological assay on a novel microfluidic platform. The reaction limited binding regime in the microfluidic channels allows for a short incubation time of 35 min. The developed assay showed very high sensitivity (99% and specificity (100%. Besides sensitivity and specificity, the technical validation (intra-assay CV = 3.7 ± 1.2% and inter-assay CV = 5.5 ± 1.2% demonstrates that our assay is also a robust tool for the analysis of the H. pylori-specific antibody response. The integration of the virulence factors CagA and VacA allow for the assessment of the risk for gastric cancer development. The short assay time and the performance of the platform shows the potential for implementation of such assays in a clinical setting.

  12. Performance characteristics of the ARCHITECT anti-HCV assay.

    Science.gov (United States)

    Jonas, Gesa; Pelzer, Claudia; Beckert, Christian; Hausmann, Michael; Kapprell, Hans-Peter

    2005-10-01

    The ARCHITECT Anti-HCV assay is a fully automated high throughput chemiluminescent microparticle immunoassay (CMIA) for the detection of antibodies to structural and nonstructural proteins of the hepatitis C virus (HCV). To further enhance the performance of this test, the assay was modified to improve the specificity for blood donor specimens. The specificity of the enhanced ARCHITECT Anti-HCV assay was evaluated by screening blood donor samples randomly collected from various German blood banks, as well as hospitalized patient samples derived from Germany and the US. Additionally, antibody sensitivity was determined on commercially available anti-HCV seroconversion panels and on a commercially available worldwide anti-HCV genotype performance panel. Apparent specificity of the modified ARCHITECT Anti-HCV assay in a blood donor population consisting of 3811 specimens was 99.92%, compared to 99.76% for the current on-market assay. Additionally, antibody sensitivity was determined on commercially available anti-HCV seroconversion panels. Seroconversion sensitivity equivalent to or better than the current on-market product was observed by testing 33 seroconversion panels. This study demonstrates that the modified version of the ARCHITECT Anti-HCV assay shows improved specificity for blood donor specimens compared to the current assay on market without compromising sensitivity. With the availability of the improved ARCHITECT Anti-HCV assay and the recent launch of the ARCHITECT HIV Ag/Ab Combo assay, the ARCHITECT system now offers a full hepatitis/retrovirus menu with excellent performance on a high throughput, random access, automated analyzer, ideally suited for blood screening and diagnostic applications.

  13. ARIES nondestructive assay system operation and performance

    International Nuclear Information System (INIS)

    Cremers, Teresa L.; Hansen, Walter J.; Herrera, Gary D.; Nelson, David C.; Sampson, Thomas E.; Scheer, Nancy L.

    2000-01-01

    The ARIES (Advanced Recovery and Integrated Extraction System) Project is an integrated system at the Los Alamos Plutonium Facility for the dismantlement of nuclear weapons. The plutonium produced by the ARIES process was measured by an integrated nondestructive assay (NDA) system. The performance of the NDA systems was monitored by a measurement control program which is a part of a nuclear material control and accountability system. In this paper we will report the results of the measurements of the measurement control standards as well as an overview of the measurement of the ARIES process materials

  14. The status of performance demonstration in Taiwan

    International Nuclear Information System (INIS)

    Shyu, H.F.; Shong, W.J.

    2004-01-01

    The nuclear authority in Taiwan adopts the ASME Code Section XI, Appendix VIII as a mandatory requirement for the in-service inspection of importance nuclear components. To fulfill this requirement, the ultrasonic testing (UT) Level II of nuclear power plants have to go abroad for the qualification of performance demonstration (PD) hosted by the EPRI, USA. It is time consuming and costs much money. In order to set up domestic PD capability, this project planned and purchased test pieces, prepared qualification procedures and arranged examination site. A prototype PD system for carbon steel piping weld and stainless steel piping weld manual UT has been established from 2002. Until January 2004, five PD qualification sections have been held. The detection accuracy and uncertainty of flaw length sizing of UT were calculated according to the data provided by the examinees. Based on the available data, the flaw detection accuracy was about 89% for both stainless steel and carbon steel. However, the uncertainty of flaw length sizing varied with test piece material and flaw orientation. This analysis can be a reference for related organizations to gain more insight information of UT results. (author)

  15. Demonstrating Interactions of Transcription Factors with DNA by Electrophoretic Mobility Shift Assay.

    Science.gov (United States)

    Yousaf, Nasim; Gould, David

    2017-01-01

    Confirming the binding of a transcription factor with a particular DNA sequence may be important in characterizing interactions with a synthetic promoter. Electrophoretic mobility shift assay is a powerful approach to demonstrate the specific DNA sequence that is bound by a transcription factor and also to confirm the specific transcription factor involved in the interaction. In this chapter we describe a method we have successfully used to demonstrate interactions of endogenous transcription factors with sequences derived from endogenous and synthetic promoters.

  16. Phase 1: ISOCELL demonstration test performance review

    International Nuclear Information System (INIS)

    Chatwin, T.D.

    1991-04-01

    This document consolidates and organizes information available concerning cryogenic retrieval of hazardous, radioactive, and mixed wastes and is mainly derived from a report on the ISOCELL Demonstration Project prepared by Concept RKK, Ltd. ISOCELL cryogenic technology is designed to immobilize hazardous, radioactive, and mixed waste by creating a block of frozen waste and soil that can be safely retrieved, stored, transported, and treated with a minimum of dust. A test of the ISOCELL process was conducted in Carnation, Washington by Concept RKK, Ltd. Test conditions were compared to possible testing conditions at Idaho National Engineering Laboratory. Results indicate ISOCELL technology successfully froze wet soil into a soil block capable of being lifted. 5 refs., 6 figs., 1 tab

  17. SWATH Mass Spectrometry Performance Using Extended Peptide MS/MS Assay Libraries*

    Science.gov (United States)

    Wu, Jemma X.; Song, Xiaomin; Pascovici, Dana; Zaw, Thiri; Care, Natasha; Krisp, Christoph; Molloy, Mark P.

    2016-01-01

    The use of data-independent acquisition methods such as SWATH for mass spectrometry based proteomics is usually performed with peptide MS/MS assay libraries which enable identification and quantitation of peptide peak areas. Reference assay libraries can be generated locally through information dependent acquisition, or obtained from community data repositories for commonly studied organisms. However, there have been no studies performed to systematically evaluate how locally generated or repository-based assay libraries affect SWATH performance for proteomic studies. To undertake this analysis, we developed a software workflow, SwathXtend, which generates extended peptide assay libraries by integration with a local seed library and delivers statistical analysis of SWATH-quantitative comparisons. We designed test samples using peptides from a yeast extract spiked into peptides from human K562 cell lysates at three different ratios to simulate protein abundance change comparisons. SWATH-MS performance was assessed using local and external assay libraries of varying complexities and proteome compositions. These experiments demonstrated that local seed libraries integrated with external assay libraries achieve better performance than local assay libraries alone, in terms of the number of identified peptides and proteins and the specificity to detect differentially abundant proteins. Our findings show that the performance of extended assay libraries is influenced by the MS/MS feature similarity of the seed and external libraries, while statistical analysis using multiple testing corrections increases the statistical rigor needed when searching against large extended assay libraries. PMID:27161445

  18. Analytical performances of the Diazyme ADA assay on the Cobas® 6000 system.

    Science.gov (United States)

    Delacour, Hervé; Sauvanet, Christophe; Ceppa, Franck; Burnat, Pascal

    2010-12-01

    To evaluate the analytical performance of the Diazyme ADA assay on the Cobas® 6000 system for pleural fluid samples analysis. Imprecision, linearity, calibration curve stability, interference, and correlation studies were completed. The Diazyme ADA assay demonstrated excellent precision (CVADA assay correlated well with the Giusti method (r(2)=0.93) but exhibited a negative bias (~ -30%). The Diazyme ADA assay on the Cobas® 6000 system represents a rapid, accurate, precise and reliable method for determination of ADA activity in pleural fluid samples. Copyright © 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  19. How-to-do-it: Immunological Assays for the Classroom 1. Enzyme Linked Immunosorbent Assay (ELISA): A Laboratory Tool for Demonstration of Antibody-Antigen Interaction.

    Science.gov (United States)

    Russo, A. J.; And Others

    1984-01-01

    Background information, list of required materials, and procedures are provided for an immunological assay which has been modified for use as a classroom/laboratory demonstration of antigen-antibody reaction. The assay is designed for a two and one-half hour laboratory period but may be modified for one hour laboratories. (JN)

  20. Clinical performance of a new hepatitis B surface antigen quantitative assay with automatic dilution

    Directory of Open Access Journals (Sweden)

    Ta-Wei Liu

    2015-01-01

    Full Text Available Hepatitis B virus surface antigen (HBsAg levels reflect disease status and can predict the clinical response to antiviral treatment; however, the emergence of HBsAg mutant strains has become a challenge. The Abbott HBsAg quantification assay provides enhanced detection of HBsAg and HBsAg mutants. We aimed to evaluate the performance of the Abbott HBsAg quantification assay with automatic sample dilutions (shortened as automatic Architect assay, compared with the Abbott HBsAg quantification assay with manual sample dilutions (shortened as manual Architect assay and the Roche HBsAg quantification assay with automatic sample dilutions (shortened as Elecsys. A total of 130 sera samples obtained from 87 hepatitis B virus (HBV-infected patients were collected to assess the correlation between the automatic and manual Architect assays. Among the 87 patients, 41 provided 42 sera samples to confirm the linearity and reproducibility of the automatic Architect assay, and find out the correlation among the Elecsys and two Architect assays. The coefficients of variation (0.44–9.53% and R2 = 0.996–1, which were both determined using values obtained from the automatic Architect assay, showed good reproducibility and linearity. Results of the two Architect assays demonstrated a feasible correlation (n = 130 samples; R = 0.898, p  0.93 in all cases. In conclusion, the correlation between the automatic and manual dilution Architect assays was feasible, particularly in the HBeAg-negative and low DNA groups. With lower labor costs and less human error than the manual version, the Abbott automatic dilution Architect assay provided a good clinical performance with regard to the HBsAg levels.

  1. A European multicenter study on the analytical performance of the VERIS HBV assay.

    Science.gov (United States)

    Braun, Patrick; Delgado, Rafael; Drago, Monica; Fanti, Diana; Fleury, Hervé; Izopet, Jacques; Lombardi, Alessandra; Mancon, Alessandro; Marcos, Maria Angeles; Sauné, Karine; O Shea, Siobhan; Pérez-Rivilla, Alfredo; Ramble, John; Trimoulet, Pascale; Vila, Jordi; Whittaker, Duncan; Artus, Alain; Rhodes, Daniel

    Hepatitis B viral load monitoring is an essential part of managing patients with chronic Hepatits B infection. Beckman Coulter has developed the VERIS HBV Assay for use on the fully automated Beckman Coulter DxN VERIS Molecular Diagnostics System. 1 OBJECTIVES: To evaluate the analytical performance of the VERIS HBV Assay at multiple European virology laboratories. Precision, analytical sensitivity, negative sample performance, linearity and performance with major HBV genotypes/subtypes for the VERIS HBV Assay was evaluated. Precision showed an SD of 0.15 log 10 IU/mL or less for each level tested. Analytical sensitivity determined by probit analysis was between 6.8-8.0 IU/mL. Clinical specificity on 90 unique patient samples was 100.0%. Performance with 754 negative samples demonstrated 100.0% not detected results, and a carryover study showed no cross contamination. Linearity using clinical samples was shown from 1.23-8.23 log 10 IU/mL and the assay detected and showed linearity with major HBV genotypes/subtypes. The VERIS HBV Assay demonstrated comparable analytical performance to other currently marketed assays for HBV DNA monitoring. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Performance of hepatitis B assays on the Bayer ADVIA Centaur Immunoassay System.

    Science.gov (United States)

    van Helden, Josef; Denoyel, Gérard; Karwowska, Sylwia; Reamer, Randy; Schmalz, John; Wright, Ted; Preisel-Simmons, Barbara

    2004-01-01

    Centaur HBV assays resulted in no change in interpretation of the results. Assay performance was further evaluated using HBV seroconversion panels with comparable or better results when compared to the comparison assays. The performance evaluation data demonstrate that the ADVIA Centaur HBV assays are specific and sensitive automated immunoassays for detection of antigens and antibodies to hepatitis B virus with performance that is comparable to those of currently marketed assays. Additionally, these assays have the advantage of being available on the ADVIA Centaur immunoassay system, which provides for the flexibility of high throughput and full automation.

  3. European Multicenter Study on Analytical Performance of Veris HIV-1 Assay.

    Science.gov (United States)

    Braun, Patrick; Delgado, Rafael; Drago, Monica; Fanti, Diana; Fleury, Hervé; Hofmann, Jörg; Izopet, Jacques; Kalus, Ulrich; Lombardi, Alessandra; Marcos, Maria Angeles; Mileto, Davide; Sauné, Karine; O'Shea, Siobhan; Pérez-Rivilla, Alfredo; Ramble, John; Trimoulet, Pascale; Vila, Jordi; Whittaker, Duncan; Artus, Alain; Rhodes, Daniel W

    2017-07-01

    The analytical performance of the Veris HIV-1 assay for use on the new, fully automated Beckman Coulter DxN Veris molecular diagnostics system was evaluated at 10 European virology laboratories. The precision, analytical sensitivity, performance with negative samples, linearity, and performance with HIV-1 groups/subtypes were evaluated. The precision for the 1-ml assay showed a standard deviation (SD) of 0.14 log 10 copies/ml or less and a coefficient of variation (CV) of ≤6.1% for each level tested. The 0.175-ml assay showed an SD of 0.17 log 10 copies/ml or less and a CV of ≤5.2% for each level tested. The analytical sensitivities determined by probit analysis were 19.3 copies/ml for the 1-ml assay and 126 copies/ml for the 0.175-ml assay. The performance with 1,357 negative samples demonstrated 99.2% with not detected results. Linearity using patient samples was shown from 1.54 to 6.93 log 10 copies/ml. The assay performed well, detecting and showing linearity with all HIV-1 genotypes tested. The Veris HIV-1 assay demonstrated analytical performance comparable to that of currently marketed HIV-1 assays. (DxN Veris products are Conformité Européenne [CE]-marked in vitro diagnostic products. The DxN Veris product line has not been submitted to the U.S. FDA and is not available in the U.S. market. The DxN Veris molecular diagnostics system is also known as the Veris MDx molecular diagnostics system and the Veris MDx system.). Copyright © 2017 American Society for Microbiology.

  4. Pu-238 assay performance with the Canberra IQ3 system

    Energy Technology Data Exchange (ETDEWEB)

    Booth, L.; Gillespie, B.; Seaman, G.

    1997-11-01

    Canberra Industries has recently completed a demonstration project at the Westinghouse Savannah River Site (WSRC) to characterize 55-gallon drums containing Pu-238 contaminated waste. The goal of this project was to detect and quantify Pu-238 contaminated waste. The goal of this project was to detect and quantify Pu-238 waste to detection limits of less than 50 nCi/g using gamma assay techniques. This would permit reclassification of these drums from transuranic (TRU) waste to low-level waste (LLW). The instrument used for this assay was a Canberra IQ3 high sensitivity gamma assay system, mounted in a trailer. The results of the measurements demonstrate achievement of detection levels as low as 1 nCi/g for low density waste drums, and good correlation with known concentrations in several test drums. In addition, the data demonstrates significant advantages for using large area low-energy germanium detectors for achieving the lowest possible MDAs for gamma rays in the 80-250 keV range. 1 fig., 2 tabs.

  5. Evaluation of the Thermo Scientific SureTect Listeria species assay. AOAC Performance Tested Method 071304.

    Science.gov (United States)

    Cloke, Jonathan; Evans, Katharine; Crabtree, David; Hughes, Annette; Simpson, Helen; Holopainen, Jani; Wickstrand, Nina; Kauppinen, Mikko; Leon-Velarde, Carlos; Larson, Nathan; Dave, Keron

    2014-01-01

    The Thermo Scientific SureTect Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested Methods program to validate the SureTect Listeria species Assay in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996 including amendment 1:2004 in a variety of foods plus plastic and stainless steel. The food matrixes validated were smoked salmon, processed cheese, fresh bagged spinach, cantaloupe, cooked prawns, cooked sliced turkey meat, cooked sliced ham, salami, pork frankfurters, and raw ground beef. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, fresh bagged spinach, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled independent laboratory study by the University ofGuelph, Canada. Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. Accelerated stability testing was additionally conducted, validating the assay

  6. Evaluation of the Clinical Performance of the HPV-Risk Assay Using the VALGENT-3 Panel.

    Science.gov (United States)

    Polman, N J; Oštrbenk, A; Xu, L; Snijders, P J F; Meijer, C J L M; Poljak, M; Heideman, D A M; Arbyn, M

    2017-12-01

    Human papillomavirus (HPV) testing is increasingly being incorporated into cervical cancer screening. The Validation of HPV Genotyping Tests (VALGENT) is a framework designed to evaluate the clinical performance of various HPV tests relative to that of the validated and accepted comparator test in a formalized and uniform manner. The aim of this study was to evaluate the clinical performance of the HPV-Risk assay with samples from the VALGENT-3 panel and to compare its performance to that of the clinically validated Hybrid Capture 2 assay (HC2). The VALGENT-3 panel comprises 1,300 consecutive samples from women participating in routine cervical cancer screening and is enriched with 300 samples from women with abnormal cytology. DNA was extracted from original ThinPrep PreservCyt medium aliquots, and HPV testing was performed using the HPV-Risk assay by investigators blind to the clinical data. HPV prevalence was analyzed, and the clinical performance of the HPV-Risk assay for the detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) and CIN2 or worse (CIN2+) relative to the performance of HC2 was assessed. The sensitivity of the HPV-Risk assay for the detection of CIN3+ was similar to that of HC2 (relative sensitivity, 1.00; 95% confidence interval [CI], 0.95 to 1.05; P = 1.000), but the specificity of the HPV-Risk assay was significantly higher than that of HC2 (relative specificity, 1.02; 95% CI, 1.01 to 1.04; P performance of the HPV-Risk assay for the detection of CIN3+ and CIN2+ was noninferior to that of HC2, with all P values being ≤0.006. In conclusion, the HPV-Risk assay demonstrated noninferiority to the clinically validated HC2 by the use of samples from the VALGENT-3 panel for test validation and comparison. Copyright © 2017 Polman et al.

  7. Performance demonstration requirements for eddy current steam generator tube inspection

    International Nuclear Information System (INIS)

    Kurtz, R.J.; Heasler, P.G.; Anderson, C.M.

    1992-10-01

    This paper describes the methodology used for developing performance demonstration tests for steam generator tube eddy current (ET) inspection systems. The methodology is based on statistical design principles. Implementation of a performance demonstration test based on these design principles will help to ensure that field inspection systems have a high probability of detecting and correctly sizing tube degradation. The technical basis for the ET system performance thresholds is presented. Probability of detection and flaw sizing tests are described

  8. Safety analysis report for packaging (onsite) transuranic performance demonstration program sample packaging

    International Nuclear Information System (INIS)

    Mccoy, J.C.

    1997-01-01

    The Transuranic Performance Demonstration Program (TPDP) sample packaging is used to transport highway route controlled quantities of weapons grade (WG) plutonium samples from the Plutonium Finishing Plant (PFP) to the Waste Receiving and Processing (WRAP) facility and back. The purpose of these shipments is to test the nondestructive assay equipment in the WRAP facility as part of the Nondestructive Waste Assay PDP. The PDP is part of the U. S. Department of Energy (DOE) National TRU Program managed by the U. S. Department of Energy, Carlsbad Area Office, Carlsbad, New Mexico. Details of this program are found in CAO-94-1045, Performance Demonstration Program Plan for Nondestructive Assay for the TRU Waste Characterization Program (CAO 1994); INEL-96/0129, Design of Benign Matrix Drums for the Non-Destructive Assay Performance Demonstration Program for the National TRU Program (INEL 1996a); and INEL-96/0245, Design of Phase 1 Radioactive Working Reference Materials for the Nondestructive Assay Performance Demonstration Program for the National TRU Program (INEL 1996b). Other program documentation is maintained by the national TRU program and each DOE site participating in the program. This safety analysis report for packaging (SARP) provides the analyses and evaluations necessary to demonstrate that the TRU PDP sample packaging meets the onsite transportation safety requirements of WHC-CM-2-14, Hazardous Material Packaging and Shipping, for an onsite Transportation Hazard Indicator (THI) 2 packaging. This SARP, however, does not include evaluation of any operations within the PFP or WRAP facilities, including handling, maintenance, storage, or operating requirements, except as they apply directly to transportation between the gate of PFP and the gate of the WRAP facility. All other activities are subject to the requirements of the facility safety analysis reports (FSAR) of the PFP or WRAP facility and requirements of the PDP

  9. West Valley Demonstration Project low-level and transuranic waste assay and methodology

    International Nuclear Information System (INIS)

    McVay, C.W.

    1987-03-01

    In the decontamination and decommissioning of the West Valley Nuclear Facility, waste materials are being removed and packaged in a variety of waste containers which require classification in accordance with USNRC 10 CFR 61 and DOE 5820.2 criteria. Low-Level and Transuranic waste assay systems have been developed to efficiently assay and classify the waste packages. The waste is assayed by segmented gamma scanning, passive neutron techniques, dose rate conversion, and/or radiochemical laboratory analysis. The systems are capable of handling all the waste forms currently packaged as part of the Project. The above systems produce a list of nuclides present with their concentrations and determines the classification of the waste packages based on criteria outlined in DOE Order 5820.2 and USNRC 10 CFR 61.55. 9 refs., 12 figs., 8 tabs

  10. Probe colorimeter for quantitating enzyme-linked immunosorbent assays and other colorimetric assays performed with microplates.

    Science.gov (United States)

    Ackerman, S B; Kelley, E A

    1983-03-01

    The performance of a fiberoptic probe colorimeter (model PC800; Brinkmann Instruments, Inc., Westbury, N.Y.) for quantitating enzymatic or colorimetric assays in 96-well microtiter plates was compared with the performances of a spectrophotometer (model 240; Gilford Instrument Laboratories, Inc., Oberlin, Ohio) and a commercially available enzyme immunoassay reader (model MR590; Dynatech Laboratories, Inc., Alexandria, Va.). Alkaline phosphatase-p-nitrophenyl phosphate in 3 M NaOH was used as the chromophore source. Six types of plates were evaluated for use with the probe colorimeter; they generated reproducibility values (100% coefficient of variation) ranging from 91 to 98% when one individual made 24 independent measurements on the same dilution of chromophore on each plate. Eleven individuals each performed 24 measurements with the colorimeter on either a visually light (absorbance of 0.10 at 420 nm) or a dark (absorbance of 0.80 at 420 nm) dilution of chromophore; reproducibilities averaged 87% for the light dilution and 97% for the dark dilution. When one individual measured the same chromophore sample at least 20 times in the colorimeter, in the spectrophotometer or in the enzyme immunoassay reader, reproducibility for each instrument was greater than 99%. Measurements of a dilution series of chromophore in a fixed volume indicated that the optical responses of each instrument were linear in a range of 0.05 to 1.10 absorbance units.

  11. Performance demonstration experience for reactor pressure vessel shell ultrasonic testing

    International Nuclear Information System (INIS)

    Zado, V.

    1998-01-01

    The most ultrasonic testing techniques used by many vendors for pressurized water reactor (PWR) examinations were based on American Society of Mechanical Engineers 'Boiler and Pressurized Vessel Code' (ASME B and PV Code) Sections XI and V. The Addenda of ASME B and PV Code Section XI, Edition 1989 introduced Appendix VIII - 'Performance Demonstration for Ultrasonic Examination Systems'. In an effort to increase confidence in performance of ultrasonic testing of the operating nuclear power plants in United States, the ultrasonic testing performance demonstration examination of reactor vessel welds is performed in accordance with Performance Demonstration Initiative (PDI) program which is based on ASME Code Section XI, Appendix VIII requirements. This article provides information regarding extensive qualification preparation works performed prior EPRI guided performance demonstration exam of reactor vessel shell welds accomplished in January 1997 for the scope of Appendix VIII, Supplements IV and VI. Additionally, an overview of the procedures based on requirements of ASME Code Section XI and V in comparison to procedure prepared for Appendix VIII examination is given and discussed. The samples of ultrasonic signals obtained from artificial flaws implanted in vessel material are presented and results of ultrasonic testing are compared to actual flaw sizes. (author)

  12. Performance demonstration program plan for analysis of simulated headspace gases

    International Nuclear Information System (INIS)

    1995-06-01

    The Performance Demonstration Program (PDP) for analysis of headspace gases will consist of regular distribution and analyses of test standards to evaluate the capability for analyzing VOCs, hydrogen, and methane in the headspace of transuranic (TRU) waste throughout the Department of Energy (DOE) complex. Each distribution is termed a PDP cycle. These evaluation cycles will provide an objective measure of the reliability of measurements performed for TRU waste characterization. Laboratory performance will be demonstrated by the successful analysis of blind audit samples of simulated TRU waste drum headspace gases according to the criteria set within the text of this Program Plan. Blind audit samples (hereinafter referred to as PDP samples) will be used as an independent means to assess laboratory performance regarding compliance with the QAPP QAOs. The concentration of analytes in the PDP samples will encompass the range of concentrations anticipated in actual waste characterization gas samples. Analyses which are required by the WIPP to demonstrate compliance with various regulatory requirements and which are included in the PDP must be performed by laboratories which have demonstrated acceptable performance in the PDP

  13. High-performance liquid chromatographic radioenzymatic assay for plasma catecyholamines

    International Nuclear Information System (INIS)

    Klaniecki, T.S.; Corder, C.N.; McDonald, R.H. Jr.; Feldman, J.A.

    1977-01-01

    A new assay method for plasma catecholamimes (CA) requiring only 50 μl has been developed, which uses high performance liquid chromatography (HPLC). The norepinephrine (NE), dopamine (D), and epinephrine (E) compounds found in plasma are radioactively o-methylated with S-[methyl- 3 H]-adenosyl-L-methionine ( 3 H-SAM) 3 H-SAM by the reaction of catechol-o-methyl transferase (COMT). The reaction is terminated and a standard mixture of nonradioactive o-methylated analogues of NE, D, and E is added to act as a carrier. Following separation by HPLC, the D,L-normetanephrine (NMN), 3-methoxy-4-hydroxyphenylethyl-amine or 3-methoxytyramine (3-MOT), and metanephrine (MN) radioactive peaks are collected which represent NE, D, and E, respectively. Then MNM and MN are oxidized to vanillin, and 3-MOT is acetylated. The products are subsequently separated by solvent extraction. This is necessary in order to avoid high radioactive blanks and to allow quantitation of the radioactivity by liquid scintillation spectrometry. The mean supine levels of NE, D, and E in normal subjects were respectively 182, 33, and 87 pg/ml of plasma. Similar assays on patients with pheochromocytoma revealed 797, 80, and 470 pg/ml

  14. The Beckman DxI 800 prolactin assay demonstrates superior specificity for monomeric prolactin.

    LENUS (Irish Health Repository)

    Byrne, Brendan

    2010-02-01

    Commercially available prolactin immunoassays detect macroprolactin to variable degrees. Best practice requires laboratories to assess the cross-reactivity of their prolactin assay with macroprolactin, and where appropriate, introduce a screen for the presence of macroprolactin. Our policy has been to reanalyse hyperprolactinaemic samples following polyethylene glycol (PEG) precipitation and to report the resultant value as the monomeric prolactin content of the sample. The goal of this study was to determine the need to continue PEG precipitation when prolactin measurements with the Wallac AutoDELFIA were replaced by the Beckman DxI 800.

  15. Low cut-off values increase diagnostic performance of protein S assays

    NARCIS (Netherlands)

    Mulder, Rene; ten Kate, Min Ki; Kluin-Nelemans, Hanneke C.; Mulder, Andre B.

    Conflicting data have been reported on the accuracy of protein S (PS) assays for detection of hereditary PS deficiency. In this study we assessed the diagnostic performance of two total PS antigen assays, four free PS assays and three PS activity assays in a group of 28 heterozygous carriers of

  16. Evaluation of the Thermo Scientific SureTect Salmonella species assay. AOAC Performance Tested Method 051303.

    Science.gov (United States)

    Cloke, Jonathan; Clark, Dorn; Radcliff, Roy; Leon-Velarde, Carlos; Larson, Nathan; Dave, Keron; Evans, Katharine; Crabtree, David; Hughes, Annette; Simpson, Helen; Holopainen, Jani; Wickstrand, Nina; Kauppinen, Mikko

    2014-01-01

    The Thermo Scientific SureTect Salmonella species Assay is a new real-time PCR assay for the detection of Salmonellae in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested Methods program to validate the SureTect Salmonella species Assay in comparison to the reference method detailed in International Organization for Standardization 6579:2002 in a variety of food matrixes, namely, raw ground beef, raw chicken breast, raw ground pork, fresh bagged lettuce, pork frankfurters, nonfat dried milk powder, cooked peeled shrimp, pasteurized liquid whole egg, ready-to-eat meal containing beef, and stainless steel surface samples. With the exception of liquid whole egg and fresh bagged lettuce, which were tested in-house, all matrixes were tested by Marshfield Food Safety, Marshfield, WI, on behalf of Thermo Fisher Scientific. In addition, three matrixes (pork frankfurters, lettuce, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled laboratory study by the University of Guelph, Canada. No significant difference by probability of detection or McNemars Chi-squared statistical analysis was found between the candidate or reference methods for any of the food matrixes or environmental surface samples tested during the validation study. Inclusivity and exclusivity testing was conducted with 117 and 36 isolates, respectively, which demonstrated that the SureTect Salmonella species Assay was able to detect all the major groups of Salmonella enterica subspecies enterica (e.g., Typhimurium) and the less common subspecies of S. enterica (e.g., arizoniae) and the rarely encountered S. bongori. None of the exclusivity isolates analyzed were detected by the SureTect Salmonella species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation (enrichment time

  17. Performance Demonstration Program Plan for Analysis of Simulated Headspace Gases

    International Nuclear Information System (INIS)

    2006-01-01

    The Performance Demonstration Program (PDP) for headspace gases distributes sample gases of volatile organic compounds (VOCs) for analysis. Participating measurement facilities (i.e., fixed laboratories, mobile analysis systems, and on-line analytical systems) are located across the United States. Each sample distribution is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD) (DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardous Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department (NMED). The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the Headspace Gas (HSG) PDP. Participating measurement facilities analyze blind audit samples of simulated TRU waste package headspace gases according to the criteria set by this PDP Plan. Blind audit samples (hereafter referred to as PDP samples) are used as an independent means to assess each measurement facility's compliance with the WAP quality assurance objectives (QAOs). To the extent possible, the concentrations of VOC analytes in the PDP samples encompass the range of concentrations anticipated in actual TRU waste package headspace gas samples. Analyses of headspace gases are required by the WIPP to demonstrate compliance with regulatory requirements. These analyses must be performed by measurement facilities that have demonstrated acceptable performance in this PDP. These analyses are referred to as WIPP analyses and the TRU waste package headspace gas samples on which they are performed are referred to as WIPP samples in this document. Participating measurement

  18. Performance Demonstration Program Plan for Analysis of Simulated Headspace Gases

    International Nuclear Information System (INIS)

    2007-01-01

    The Performance Demonstration Program (PDP) for headspace gases distributes blind audit samples in a gas matrix for analysis of volatile organic compounds (VOCs). Participating measurement facilities (i.e., fixed laboratories, mobile analysis systems, and on-line analytical systems) are located across the United States. Each sample distribution is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD) (DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardous Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department (NMED). The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the Headspace Gas (HSG) PDP. Participating measurement facilities analyze blind audit samples of simulated TRU waste package headspace gases according to the criteria set by this PDP Plan. Blind audit samples (hereafter referred to as PDP samples) are used as an independent means to assess each measurement facility's compliance with the WAP quality assurance objectives (QAOs). To the extent possible, the concentrations of VOC analytes in the PDP samples encompass the range of concentrations anticipated in actual TRU waste package headspace gas samples. Analyses of headspace gases are required by the WIPP to demonstrate compliance with regulatory requirements. These analyses must be performed by measurement facilities that have demonstrated acceptable performance in this PDP. These analyses are referred to as WIPP analyses and the TRU waste package headspace gas samples on which they are performed are referred to as WIPP samples in this document

  19. Performance Assessment of a Trypanosoma cruzi Chimeric Antigen in Multiplex Liquid Microarray Assays.

    Science.gov (United States)

    Santos, Fred Luciano Neves; Celedon, Paola Alejandra Fiorani; Zanchin, Nilson Ivo Tonin; Leitolis, Amanda; Crestani, Sandra; Foti, Leonardo; de Souza, Wayner Vieira; Gomes, Yara de Miranda; Krieger, Marco Aurélio

    2017-10-01

    Diagnosing chronic Chagas disease (CD) requires antibody-antigen detection methods, which are traditionally based on enzymatic assay techniques whose performance depend on the type and quality of antigen used. Previously, 4 recombinant chimeric proteins from the Instituto de Biologia Molecular do Paraná (IBMP-8.1 to 8.4) comprising immuno-dominant regions of diverse Trypanosoma cruzi antigens showed excellent diagnostic performance in enzyme-linked immunosorbent assays. Considering that next-generation platforms offer improved CD diagnostic accuracy with different T. cruzi -specific recombinant antigens, we assessed the performance of these chimeras in liquid microarrays (LMAs). The chimeric proteins were expressed in Escherichia coli and purified by chromatography. Sera from 653 chagasic and 680 healthy individuals were used to assess the performance of these chimeras in detecting specific anti- T. cruzi antibodies. Accuracies ranged from 98.1 to 99.3%, and diagnostic odds ratio values were 3,548 for IBMP-8.3, 4,826 for IBMP-8.1, 7,882 for IBMP-8.2, and 25,000 for IBMP-8.4. A separate sera bank (851 samples) was employed to assess cross-reactivity with other tropical diseases. Leishmania , a pathogen with high similarity to T. cruzi , showed cross-reactivity rates ranging from 0 to 2.17%. Inconclusive results were negligible (0 to 0.71%). Bland-Altman and Deming regression analysis based on 200 randomly selected CD-positive and negative samples demonstrated interchangeability with respect to CD diagnostic performance in both singleplex and multiplex assays. Our results suggested that these chimeras can potentially replace antigens currently used in commercially available assay kits. Moreover, the use of multiplex platforms, such as LMA assays employing 2 or more IBMP antigens, would abrogate the need for 2 different testing techniques when diagnosing CD. Copyright © 2017 American Society for Microbiology.

  20. Validation of Sizewell ''B'' ultrasonic inspections -- Messages for performance demonstration

    International Nuclear Information System (INIS)

    Conroy, P.J.; Leyland, K.S.; Waites, C.

    1994-01-01

    At the time that the decisions leading to the construction of the Sizewell ''B'' plant were being made, public concern over the potential hazards of nuclear power was increasing. This concern was heightened by the accident at USA's Three Mile Island plant. The result of this and public pressure was that an extensive public inquiry was held in addition to the UK's normal licensing process. Part of the evidence to the inquiry supporting the safety case relied upon the ability of ultrasonic inspections to demonstrate that the Reactor Pressure Vessel (RPV) and other key components were free from defects that could threaten structural integrity. Evidence from a variety of trials designed to investigate the performance capability of ultrasonic inspection revealed that although ultrasonic inspection had the potential to satisfy this requirement its performance in practice was heavily dependent upon the details of application. It was therefore generally recognized that some form of inspection validation was required to provide assurance that the equipment, procedures and operators to be employed were adequate for purpose. The concept of inspection validation was therefore included in the safety case for the licensing of Sizewell ''B''. The UK validation trials covering the ultrasonic inspections of the Sizewell ''B'' PWR Reactor Pressure Vessel are now nearing completion. This paper summarizes the results of the RPV validations and considers some of the implications for ASME 11 Appendix 8 the US code covering performance demonstration

  1. Eddy current NDE performance demonstrations using simulation tools

    International Nuclear Information System (INIS)

    Maurice, L.; Costan, V.; Guillot, E.; Thomas, P.

    2013-01-01

    To carry out performance demonstrations of the Eddy-Current NDE processes applied on French nuclear power plants, EDF studies the possibility of using simulation tools as an alternative to measurements on steam generator tube mocks-up. This paper focuses on the strategy led by EDF to assess and use code C armel3D and Civa, on the case of Eddy-Current NDE on wears problem which may appear in the U-shape region of steam generator tubes due to the rubbing of anti-vibration bars.

  2. One gigasample per second transient recorder: a performance demonstration

    International Nuclear Information System (INIS)

    Linnenbrink, T.E.; Gradl, D.A.; Ritt, D.M.; DeWitte, G.J.; Hutton, J.D.

    1982-01-01

    The performance demonstrated by a one gigasample per second (1 Gs/s) transient recorder currently in advanced development portends an important new instrument for recording single transient data. A Charge-Coupled Device (CCD) is used to sample a continuous analog signal. Samples acquired at the full sampling rate (1 Gs/s) are temporarily stored in the CCD, then read out at a slow rate (e.g., 250 Ks/s) into a conventional analog-to-digital converter prior to storage in nonvolatile, digital memory. Enhanced circuitry and techniques developed over the past three years have yielded higher performance than originally anticipated. Accordingly, the target specification has been revised to reflect higher expectations

  3. Performance Evaluation of a Novel Chemiluminescence Assay Detecting Treponema Pallidum Antibody as a Syphilis Screening Method.

    Science.gov (United States)

    Chen, Qixia; An, Jingna; Rao, Chenli; Wang, Tingting; Li, Dongdong; Feng, Shu; Tao, Chuanmin

    2016-01-01

    Syphilis is a major concern to global public health with increasing incidence. So its screening test should have sufficient sensitivity and specificity. We evaluated the performance of the Lumipulse G TP-N assay detection for syphilis screening and compared it with the InTec ELISA test kit for TP, which is widely used. Samples of several patient groups including 133 clinical and serologically characterized syphilitic sera, 175 samples containing potentially interfering agents, and 2290 unselected samples submitted for routine screening were detected by both the Lumipulse G TP-N assay and the InTec ELISA test kit for TP. Inconsistent samples were confirmed by RecomLine Treponema IgG, IgM immunoblot. Coefficient of variations of the Lumipulseo G TP-N assay at both levels were below 5% and of the InTec ELISA test kit for TP both over 5%. The sensitivity of the Lumipulse G TP-N assay and the InTec ELISA test kit for TP were 100% for all stages of syphilis. The two methods had consistent analytical specificity of 100% (95% CI: 97.21 - 100.00), while the clinical specificity was 100% (95% CI: 99.79 - 100.00) and 99.82% (95% CI: 99.51 - 99.94), respectively. Between them, Spearman's correlation coefficient was 0.455 and kappa value was 0.986. The overall sensitivity and specificity of the Lumipulse G TP-N assay was higher than the InTec ELISA test kit for TP (sensitivity: 100.0 versus 99.5, specificity: 100.0 versus 99.8). The automated Lumipulse G TP-N assay demonstrated excellent diagnostic sensitivity and specificity when evaluated as a screening test for syphilis. Thus, it can be an alternative to the treponemal screening test.

  4. Pecan Street Grid Demonstration Program. Final technology performance report

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2015-02-10

    This document represents the final Regional Demonstration Project Technical Performance Report (TPR) for Pecan Street Inc.’s (Pecan Street) Smart Grid Demonstration Program, DE-OE-0000219. Pecan Street is a 501(c)(3) smart grid/clean energy research and development organization headquartered at The University of Texas at Austin (UT). Pecan Street worked in collaboration with Austin Energy, UT, Environmental Defense Fund (EDF), the City of Austin, the Austin Chamber of Commerce and selected consultants, contractors, and vendors to take a more detailed look at the energy load of residential and small commercial properties while the power industry is undergoing modernization. The Pecan Street Smart Grid Demonstration Program signed-up over 1,000 participants who are sharing their home or businesses’s electricity consumption data with the project via green button protocols, smart meters, and/or a home energy monitoring system (HEMS). Pecan Street completed the installation of HEMS in 750 homes and 25 commercial properties. The program provided incentives to increase the installed base of roof-top solar photovoltaic (PV) systems, plug-in electric vehicles with Level 2 charging, and smart appliances. Over 200 participants within a one square mile area took advantage of Austin Energy and Pecan Street’s joint PV incentive program and installed roof-top PV as part of this project. Of these homes, 69 purchased or leased an electric vehicle through Pecan Street’s PV rebate program and received a Level 2 charger from Pecan Street. Pecan Street studied the impacts of these technologies along with a variety of consumer behavior interventions, including pricing models, real-time feedback on energy use, incentive programs, and messaging, as well as the corresponding impacts on Austin Energy’s distribution assets.The primary demonstration site was the Mueller community in Austin, Texas. The Mueller development, located less than three miles from the Texas State Capitol

  5. High Input Voltage, Silicon Carbide Power Processing Unit Performance Demonstration

    Science.gov (United States)

    Bozak, Karin E.; Pinero, Luis R.; Scheidegger, Robert J.; Aulisio, Michael V.; Gonzalez, Marcelo C.; Birchenough, Arthur G.

    2015-01-01

    A silicon carbide brassboard power processing unit has been developed by the NASA Glenn Research Center in Cleveland, Ohio. The power processing unit operates from two sources: a nominal 300 Volt high voltage input bus and a nominal 28 Volt low voltage input bus. The design of the power processing unit includes four low voltage, low power auxiliary supplies, and two parallel 7.5 kilowatt (kW) discharge power supplies that are capable of providing up to 15 kilowatts of total power at 300 to 500 Volts (V) to the thruster. Additionally, the unit contains a housekeeping supply, high voltage input filter, low voltage input filter, and master control board, such that the complete brassboard unit is capable of operating a 12.5 kilowatt Hall effect thruster. The performance of the unit was characterized under both ambient and thermal vacuum test conditions, and the results demonstrate exceptional performance with full power efficiencies exceeding 97%. The unit was also tested with a 12.5kW Hall effect thruster to verify compatibility and output filter specifications. With space-qualified silicon carbide or similar high voltage, high efficiency power devices, this would provide a design solution to address the need for high power electric propulsion systems.

  6. Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX® Colon Cancer Assay

    International Nuclear Information System (INIS)

    Clark-Langone, Kim M; Sangli, Chithra; Krishnakumar, Jayadevi; Watson, Drew

    2010-01-01

    The Oncotype DX ® Colon Cancer Assay is a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection using fixed paraffin embedded (FPE) primary colon tumor tissue. Like the Oncotype DX Breast Cancer Assay, this is a high complexity, multi-analyte, reverse transcription (RT) polymerase chain reaction (PCR) assay that measures the expression levels of specific cancer-related genes. By capturing the biology underlying each patient's tumor, the Oncotype DX Colon Cancer Assay provides a Recurrence Score (RS) that reflects an individualized risk of disease recurrence. Here we describe its analytical performance using pre-determined performance criteria, which is a critical component of molecular diagnostic test validation. All analytical measurements met pre-specified performance criteria. PCR amplification efficiency for all 12 assays was high, ranging from 96% to 107%, while linearity was demonstrated over an 11 log 2 concentration range for all assays. Based on estimated components of variance for FPE RNA pools, analytical reproducibility and precision demonstrated low SDs for individual genes (0.16 to 0.32 C T s), gene groups (≤0.05 normalized/aggregate C T s) and RS (≤1.38 RS units). Analytical performance characteristics shown here for both individual genes and gene groups in the Oncotype DX Colon Cancer Assay demonstrate consistent translation of specific biology of individual tumors into clinically useful diagnostic information. The results of these studies illustrate how the analytical capability of the Oncotype DX Colon Cancer Assay has enabled clinical validation of a test to determine individualized recurrence risk after colon cancer surgery

  7. Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX® Colon Cancer Assay

    Directory of Open Access Journals (Sweden)

    Krishnakumar Jayadevi

    2010-12-01

    Full Text Available Abstract Background The Oncotype DX® Colon Cancer Assay is a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection using fixed paraffin embedded (FPE primary colon tumor tissue. Like the Oncotype DX Breast Cancer Assay, this is a high complexity, multi-analyte, reverse transcription (RT polymerase chain reaction (PCR assay that measures the expression levels of specific cancer-related genes. By capturing the biology underlying each patient's tumor, the Oncotype DX Colon Cancer Assay provides a Recurrence Score (RS that reflects an individualized risk of disease recurrence. Here we describe its analytical performance using pre-determined performance criteria, which is a critical component of molecular diagnostic test validation. Results All analytical measurements met pre-specified performance criteria. PCR amplification efficiency for all 12 assays was high, ranging from 96% to 107%, while linearity was demonstrated over an 11 log2 concentration range for all assays. Based on estimated components of variance for FPE RNA pools, analytical reproducibility and precision demonstrated low SDs for individual genes (0.16 to 0.32 CTs, gene groups (≤0.05 normalized/aggregate CTs and RS (≤1.38 RS units. Conclusions Analytical performance characteristics shown here for both individual genes and gene groups in the Oncotype DX Colon Cancer Assay demonstrate consistent translation of specific biology of individual tumors into clinically useful diagnostic information. The results of these studies illustrate how the analytical capability of the Oncotype DX Colon Cancer Assay has enabled clinical validation of a test to determine individualized recurrence risk after colon cancer surgery.

  8. Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX Colon Cancer Assay.

    Science.gov (United States)

    Clark-Langone, Kim M; Sangli, Chithra; Krishnakumar, Jayadevi; Watson, Drew

    2010-12-23

    The Oncotype DX Colon Cancer Assay is a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection using fixed paraffin embedded (FPE) primary colon tumor tissue. Like the Oncotype DX Breast Cancer Assay, this is a high complexity, multi-analyte, reverse transcription (RT) polymerase chain reaction (PCR) assay that measures the expression levels of specific cancer-related genes. By capturing the biology underlying each patient's tumor, the Oncotype DX Colon Cancer Assay provides a Recurrence Score (RS) that reflects an individualized risk of disease recurrence. Here we describe its analytical performance using pre-determined performance criteria, which is a critical component of molecular diagnostic test validation. All analytical measurements met pre-specified performance criteria. PCR amplification efficiency for all 12 assays was high, ranging from 96% to 107%, while linearity was demonstrated over an 11 log2 concentration range for all assays. Based on estimated components of variance for FPE RNA pools, analytical reproducibility and precision demonstrated low SDs for individual genes (0.16 to 0.32 CTs), gene groups (≤ 0.05 normalized/aggregate CTs) and RS (≤ 1.38 RS units). Analytical performance characteristics shown here for both individual genes and gene groups in the Oncotype DX Colon Cancer Assay demonstrate consistent translation of specific biology of individual tumors into clinically useful diagnostic information. The results of these studies illustrate how the analytical capability of the Oncotype DX Colon Cancer Assay has enabled clinical validation of a test to determine individualized recurrence risk after colon cancer surgery.

  9. Performance of seven serological assays for diagnosing tularemia

    Science.gov (United States)

    2014-01-01

    Background Tularemia is a rare zoonotic disease caused by the Gram-negative bacterium Francisella tularensis. Serology is frequently the preferred diagnostic approach, because the pathogen is highly infectious and difficult to cultivate. The aim of this retrospective study was to determine the diagnostic accuracy of tularemia specific tests. Methods The Serazym®Anti-Francisella tularensis ELISA, Serion ELISA classic Francisella tularensis IgG/IgM, an in-house ELISA, the VIRapid® Tularemia immunochromatographic test, an in-house antigen microarray, and a Western Blot (WB) assay were evaluated. The diagnosis tularemia was established using a standard micro-agglutination assay. In total, 135 sera from a series of 110 consecutive tularemia patients were tested. Results The diagnostic sensitivity and diagnostic specificity of the tests were VIRapid (97.0% and 84.0%), Serion IgG (96.3% and 96.8%), Serion IgM (94.8% and 96.8%), Serazym (97.0% and 91.5%), in-house ELISA (95.6% and 76.6%), WB (93.3% and 83.0%), microarray (91.1% and 97.9%). Conclusions The diagnostic value of the commercial assays was proven, because the diagnostic accuracy was >90%. The diagnostic sensitivity of the in-house ELISA and the WB were acceptable, but the diagnostic accuracy was <90%. Interestingly, the antigen microarray test was very specific and had a very good positive predictive value. PMID:24885274

  10. Subsurface barrier demonstration test strategy and performance specification

    International Nuclear Information System (INIS)

    Treat, R.L.; Cruse, J.M.

    1994-05-01

    This document was developed to help specify a major demonstration test project of subsurface barrier systems supporting the Tank Waste Remediation System (TWRS) Program. The document focuses discussion on requirements applicable to demonstration of three subsurface barrier concepts: (1) Injected Material, (2) Cryogenic, and (3) Desiccant. Detailed requirements are provided for initial qualification of a technology proposal followed by the pre-demonstration and demonstration test requirements and specifications. Each requirement and specification is accompanied by a discussion of the rationale for it. The document also includes information on the Hanford Site tank farms and related data; the related and currently active technology development projects within the DOE's EM-50 Program; and the overall demonstration test strategy. Procurement activities and other preparations for actual demonstration testing are on hold until a decision is made regarding further development of subsurface barriers. Accordingly, this document is being issued for information only

  11. Technology Performance Report: Duke Energy Notrees Wind Storage Demonstration Project

    Energy Technology Data Exchange (ETDEWEB)

    Wehner, Jeff [Duke Energy Renewables, Charlotte, NC (United States); Mohler, David [Duke Energy Renewables, Charlotte, NC (United States); Gibson, Stuart [Duke Energy Renewables, Charlotte, NC (United States); Clanin, Jason [Duke Energy Renewables, Charlotte, NC (United States); Faris, Don [Duke Energy Renewables, Charlotte, NC (United States); Hooker, Kevin [Duke Energy Renewables, Charlotte, NC (United States); Rowand, Michael [Duke Energy Renewables, Charlotte, NC (United States)

    2015-11-01

    Duke Energy Renewables owns and operates the Notrees Wind Farm in west Texas’s Ector and Winkler counties. The wind farm, which was commissioned in April 2009, has a total capacity of 152.6 MW generated by 55 Vestas V82 turbines, one Vestas 1-V90 experimental turbine, and 40 GE 1.5-MW turbines. The Vestas V82 turbines have a generating capacity of 1.65 MW each, the Vestas V90 turbine has a generating capacity of 1.86 MW, and the GE turbines have a generating capacity of 1.5 MW each. The objective of the Notrees Wind Storage Demonstration Project is to validate that energy storage increases the value and practical application of intermittent wind generation and is commercially viable at utility scale. The project incorporates both new and existing technologies and techniques to evaluate the performance and potential of wind energy storage. In addition, it could serve as a model for others to adopt and replicate. Wind power resources are expected to play a significant part in reducing greenhouse gas emissions from electric power generation by 2030. However, the large variability and intermittent nature of wind presents a barrier to integrating it within electric markets, particularly when competing against conventional generation that is more reliable. In addition, wind power production often peaks at night or other times when demand and electricity prices are lowest. Energy storage systems can overcome those barriers and enable wind to become a valuable asset and equal competitor to conventional fossil fuel generation.

  12. Performance characteristics of bioassay, radioenzymatic assay, homogeneous enzyme immunoassay, and high-performance liquid chromatographic determination of serum gentamicin

    International Nuclear Information System (INIS)

    Delaney, C.J.; Opheim, K.E.; Smith, A.L.; Plorde, J.J.

    1982-01-01

    We compared the accuracy, precision, and between-method error of the microbiological assay, the radioenzymatic assay, the homogeneous enzyme immunoassay, and the high-performance liquid chromatographic assay for the quantitation of gentamicin in serum. Precision and accuracy were evaluated by reference samples prepared to contain 0.0 to 32.7 micrograms of gentamicin per ml. Correlations between the methods utilized patient sera with gentamicin concentrations ranging from 0.6 to 13.3 micrograms/ml. All methods were reliable within acceptable limits for routine clinical use; intermethod correlation coefficients exceeded 0.96. Relative to the microbiological assay, the alternative methods offer the advantage of rapid analysis. The elapsed times for acquiring data on a set of 10 specimens under routine operating conditions were 0.5 h by the enzyme immunoassay, 4 h by the radioenzymatic assay, 5 h by the high-performance liquid chromatographic assay, and 10 h by the microbiological assay

  13. Thermal Performance of ATLAS Laser Thermal Control System Demonstration Unit

    Science.gov (United States)

    Ku, Jentung; Robinson, Franklin; Patel, Deepak; Ottenstein, Laura

    2013-01-01

    than 135 watts of heater power. 4) The LHP reservoir control heater power is limited to 15 watts with a 70 percent duty cycle. 5) The voltage of the power supply can vary between 26 volts direct current and 34 volts direct current during the spacecraft lifetime. A design analysis shows that a single LTCS can satisfy these requirements. However, shutdown of· the LHP is particularly challenging and the shutdown heater must be wired in series with two reservoir thermostats and two CCHP thermostats at different set points. An LTCS demonstration unit has been tested to verify these performance characteristics experimentally prior to proceeding to the final LTCS design and fabrication. Test results showed that the LHP shutdown scheme would be able to shut down the LHP as designed and the reservoir control heater can maintain the ATLAS mass simulator within the plus or minus 1 degrees Centigrade accuracy under various combinations of the heat load, sink temperature, and power supply voltage.

  14. The optimal condition of performing MTT assay for the determination of radiation sensitivity

    International Nuclear Information System (INIS)

    Hong, Semie; Kim, Il Han

    2001-01-01

    The measurement of radiation survival using a clonogenic assay, the established standard, can be difficult and time consuming. In this study, We have used the MTT assay, based on the reduction of a tetrazolium salt to a purple formazan precipitate by living cells, as a substitution for clonogenic assay and have examined the optimal condition for performing this assay in determination of radiation sensitivity. Four human cancer cell lines - PCI-1, SNU-1066, NCI-H63O and RKO cells have been used. For each cell line, a clonogenic assay and a MTT assay using Premix WST-1 solution, which is one of the tetrazolium salts and does not require washing or solubilization of the precipitate were carried out after irradiation of 0, 2, 4, 6, 8, 10 Gy, For clonogenic assay, cells in 25 cm 2 flasks were irradiated after overnight incubation and the resultant colonies containing more than 50 cells were scored after culturing the cells for 10-14 days, For MTT assay, the relationship between absorbance and cell number, optimal seeding cell number, and optimal timing of assay was determined. Then, MTT assay was performed when the irradiated cells had regained exponential growth or when the non-irradiated cells had undergone four or more doubling times. There was minimal variation in the values gained from these two methods with the standard deviation generally less than 5%, and there were no statistically significant differences between two methods according to t-test in low radiation dose (below 6 Gy). The regression analyses showed high linear correlation with the R 2 value of 0.975-0.992 between data from the two different methods. The optimal cell numbers for MTT assay were found to be dependent on plating efficiency of used cell line. Less than 300 cells/well were appropriate for cells with high plating efficiency (more than 30%). For cells with low plating efficiency (less than 30%), 500 cells/well or more were appropriate for assay. The optimal time for MTT assay was alter 6

  15. Analytical and Clinical Performance Evaluation of the Abbott Architect PIVKA Assay.

    Science.gov (United States)

    Ko, Dae-Hyun; Hyun, Jungwon; Kim, Hyun Soo; Park, Min-Jeong; Kim, Jae-Seok; Park, Ji-Young; Shin, Dong Hoon; Cho, Hyoun Chan

    2018-01-01

    Protein induced by vitamin K absence (PIVKA) is measured using various assays and is used to help diagnose hepatocellular carcinoma. The present study evaluated the analytical and clinical performances of the recently released Abbott Architect PIVKA assay. Precision, linearity, and correlation tests were performed in accordance with the Clinical Laboratory Standardization Institute guidelines. Sample type suitability was assessed using serum and plasma samples from the same patients, and the reference interval was established using sera from 204 healthy individuals. The assay had coefficients of variation of 3.2-3.5% and intra-laboratory variation of 3.6-5.5%. Linearity was confirmed across the entire measurable range. The Architect PIVKA assay was comparable to the Lumipulse PIVKA assay, and the plasma and serum samples provided similar results. The lower reference limit was 13.0 mAU/mL and the upper reference limit was 37.4 mAU/mL. The ability of the Architect PIVKA assay to detect hepatocellular carcinoma was comparable to that of the alpha-fetoprotein test and the Lumipulse PIVKA assay. The Architect PIVKA assay provides excellent analytical and clinical performance, is simple for clinical laboratories to adopt, and has improved sample type suitability that could broaden the assay's utility. © 2018 by the Association of Clinical Scientists, Inc.

  16. Complete validation of a unique digestion assay to detect Trichinella larvae in horse meat demonstrates the reliability of this assay for meeting food safety and trade requirements.

    Science.gov (United States)

    Forbes, L B; Hill, D E; Parker, S; Tessaro, S V; Gamble, H R; Gajadhar, A A

    2008-03-01

    A tissue digestion assay using a double separatory funnel procedure for the detection of Trichinella larvae in horse meat was validated for application in food safety programs and trade. The assay consisted of a pepsin-HCl digestion step to release larvae from muscle tissue and two sequential sedimentation steps in separatory funnels to recover and concentrate larvae for detection with a stereomicroscope. With defined critical control points, the assay was conducted within a quality assurance system compliant with International Organization for Standardization-International Electrotechnical Commission (ISO/IEC) 17025 guidelines. Samples used in the validation were obtained from horses experimentally infected with Trichinella spiralis to obtain a range of muscle larvae densities. One-, 5-, and 10-g samples of infected tissue were combined with 99, 95, and 90 g, respectively, of known negative horse tissue to create a 100-g sample for testing. Samples of 5 and 10 g were more likely to be positive than were 1-g samples when larval densities were less than three larvae per gram (lpg). This difference is important because ingested meat with 1 lpg is considered the threshold for clinical disease in humans. Using a 5-g sample size, all samples containing 1.3 to 2 lpg were detected, and 60 to 100% of samples with infected horse meat containing 0.1 to 0.7 lpg were detected. In this study, the double separatory funnel digestion assay was efficient and reliable for its intended use in food safety and trade. This procedure is the only digestion assay for Trichinella in horse meat that has been validated as consistent and effective at critical levels of sensitivity.

  17. Performance Analysis of XCPC Powered Solar Cooling Demonstration Project

    Science.gov (United States)

    Widyolar, Bennett K.

    A solar thermal cooling system using novel non-tracking External Compound Parabolic Concentrators (XCPC) has been built at the University of California, Merced and operated for two cooling seasons. Its performance in providing power for space cooling has been analyzed. This solar cooling system is comprised of 53.3 m2 of XCPC trough collectors which are used to power a 23 kW double effect (LiBr) absorption chiller. This is the first system that combines both XCPC and absorption chilling technologies. Performance of the system was measured in both sunny and cloudy conditions, with both clean and dirty collectors. It was found that these collectors are well suited at providing thermal power to drive absorption cooling systems and that both the coinciding of available thermal power with cooling demand and the simplicity of the XCPC collectors compared to other solar thermal collectors makes them a highly attractive candidate for cooling projects.

  18. Performance validation of commercially available mobile waste-assay systems: Preliminary report

    Energy Technology Data Exchange (ETDEWEB)

    Schanfein, M.; Bonner, C.; Maez, R. [Los Alamos National Lab., NM (United States)] [and others

    1997-11-01

    Prior to disposal, nuclear waste must be accurately characterized to identify and quantify the radioactive content to reduce the radioactive hazard to the public. Validation of the waste-assay systems` performance is critical for establishing the credibility of the assay results for storage and disposal purposes. Canberra Nuclear has evaluated regulations worldwide and identified standard, modular, neutron- and gamma-waste-assay systems that can be used to characterize a large portion of existing and newly generated transuranic (TRU) and low-level waste. Before making claims of guaranteeing any system`s performance for specific waste types, the standardized systems` performance be evaluated. 7 figs., 11 tabs.

  19. Performance validation of commercially available mobile waste-assay systems: Preliminary report

    International Nuclear Information System (INIS)

    Schanfein, M.; Bonner, C.; Maez, R.

    1997-01-01

    Prior to disposal, nuclear waste must be accurately characterized to identify and quantify the radioactive content to reduce the radioactive hazard to the public. Validation of the waste-assay systems' performance is critical for establishing the credibility of the assay results for storage and disposal purposes. Canberra Nuclear has evaluated regulations worldwide and identified standard, modular, neutron- and gamma-waste-assay systems that can be used to characterize a large portion of existing and newly generated transuranic (TRU) and low-level waste. Before making claims of guaranteeing any system's performance for specific waste types, the standardized systems' performance be evaluated. 7 figs., 11 tabs

  20. Performance of 9 x 9 demonstration assemblies in Dresden-2

    International Nuclear Information System (INIS)

    Bain, G.M.

    1992-06-01

    The Electric Power Research Institute, Empire State Electric energy Research Corporation and Siemens Nuclear Power corporation jointly sponsored a program to monitor the in-reactor performance of 9x9 BWR fuel. The program was conducted in Dresden-2, with four 9x9 lead assemblies and one 8x8 reference assembly. These assemblies were loaded at the beginning of reactor Cycle 9 and completed four cycles of operation. All five assemblies were discharged after reactor Cycle 12 (EOC12) in September 1990. the 9x9 assemblies reached an average exposure of 35.7 GWd/MTU and the 8x8 reference assembly reached a burnup of 34.2 GWd/MTU. This final program report evaluates the performance of the 9x9 and 8x8 fuel assemblies, based on results from all four poolside examinations, analysis of the operating histories, and ramp tests conducted on rod segments under another program. Overall, both 9x9 and 8x assemblies performed well during the four cycles of irradiation

  1. Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens.

    Science.gov (United States)

    Chen, J H K; She, K K K; Kwong, T-C; Wong, O-Y; Siu, G K H; Leung, C-C; Chang, K-C; Tam, C-M; Ho, P-L; Cheng, V C C; Yuen, K-Y; Yam, W-C

    2015-09-01

    The automated high-throughput Abbott RealTime MTB real-time PCR assay has been recently launched for Mycobacterium tuberculosis complex (MTBC) clinical diagnosis. This study would like to evaluate its performance. We first compared its diagnostic performance with the Roche Cobas TaqMan MTB assay on 214 clinical respiratory specimens. Prospective analysis of a total 520 specimens was then performed to further evaluate the Abbott assay. The Abbott assay showed a lower limit of detection at 22.5 AFB/ml, which was more sensitive than the Cobas assay (167.5 AFB/ml). The two assays demonstrated a significant difference in diagnostic performance (McNemar's test; P = 0.0034), in which the Abbott assay presented significantly higher area under curve (AUC) than the Cobas assay (1.000 vs 0.880; P = 0.0002). The Abbott assay demonstrated extremely low PCR inhibition on clinical respiratory specimens. The automated Abbott assay required only very short manual handling time (0.5 h), which could help to improve the laboratory management. In the prospective analysis, the overall estimates for sensitivity and specificity of the Abbott assay were both 100 % among smear-positive specimens, whereas the smear-negative specimens were 96.7 and 96.1 %, respectively. No cross-reactivity with non-tuberculosis mycobacterial species was observed. The superiority in sensitivity of the Abbott assay for detecting MTBC in smear-negative specimens could further minimize the risk in MTBC false-negative detection. The new Abbott RealTime MTB assay has good diagnostic performance which can be a useful diagnostic tool for rapid MTBC detection in clinical laboratories.

  2. Evaluation of reproductive performance using milk progesterone assay

    International Nuclear Information System (INIS)

    Reimers, T.J.

    1990-01-01

    Dairy herds (472) in the northeastern United States of America were surveyed to evaluate reproductive performance. Error of oestrus detection (>> 1 ng/mL of milk progesterone) on the day of insemination was 5.1% for 4558 cows. 'Standing' and 'riding other cows' were the most accurate signs of oestrus. Of cows in or near oestrus when inseminated, 28.1% were open three weeks later, 12.9% were probably open, and 59% were probably pregnant according to milk progesterone analysis. Post-partum days to first insemination and conception rates showed positive correlation. Concentrations of progesterone in milk samples collected 21 to 24 days after service allowed prediction with 88.6% accuracy that a cow was pregnant and with 93.9% accuracy that she was not. By rectal palpation, veterinarians predicted with 92.5% accuracy that a cow was pregnant. (author). 12 refs, 4 tabs

  3. Assay for dihydroorotase using high-performance liquid chromatography with radioactivity detection

    International Nuclear Information System (INIS)

    Mehdi, S.; Wiseman, J.S.

    1989-01-01

    An assay for measuring dihydroorotase activity was devised. Radiolabeled substrate and product were separated by high-performance liquid chromatography using a reverse-phase column with ion-pairing, and the radioactivity was quantitated by flow detection

  4. Assay of fluconazole by high-performance liquid chromatography with a mixed-phase column.

    OpenAIRE

    Wallace, J E; Harris, S C; Gallegos, J; Foulds, G; Chen, T J; Rinaldi, M G

    1992-01-01

    A mixed-phase liquid chromatographic column was used to assay fluconazole in plasma, serum, and cerebrospinal fluid. The assay was linear from 0.2 to 20 micrograms/ml, with an average coefficient of variation of less than 5%. The partitioning of the drug between serum and cerebrospinal fluid was determined for 34 patients. The method was demonstrated to be suitable for both pharmacokinetic studies and monitoring of patients receiving treatment with this antifungal agent.

  5. Evaluation of performance of human immunodeficiency virus antigen/antibody combination assays in Taiwan.

    Science.gov (United States)

    Chang, Chun-Kai; Kao, Cheng-Feng; Lin, Pi-Han; Huang, Hui-Lin; Ho, Shu-Yuan; Wong, Kuo-Chen; Lin, Bo-Chang; Yeh, Chang-Ching; Lee, Chia-Yeh; Kao, Chuan-Liang; Lee, Chun-Nan; Chang, Sui-Yuan; Yang, Jyh-Yuan

    2017-08-01

    The fourth-generation human immunodeficiency virus (HIV) combination assay, which can simultaneously detect the presence of anti-HIV antibody and HIV antigen, has been shown to shorten the window period in HIV diagnosis compared with the third-generation HIV antibody immunoassay. This study was aimed to determine the performance of HIV combination assays in Taiwan, where the HIV-1 seroprevalence is 0.007% and HIV-2 infection has never been reported. Performance of three fourth-generation HIV Ag/Ab combination assays (Dia.Pro, Wantai, and Bio-Rad) and one third-generation HIV Ab immunoassay (AxSYM HIV 1/2 gO) was assessed. A total of 152 specimens, including 86 confirmed HIV-seropositive and 66 HIV-seronegative samples, were used in the study. The sensitivity of four assays varied from 98.8% to 100%, and specificity varied from 98.5% to 100%. Performance of the 75 equivocal samples, the HIV status of which was confirmed later, in terms of negative prediction varied from 81.8% to 87.5%. The Bio-Rad and Dia.Pro assays exhibited higher sensitivity for the detection of p24 antigen among the three fourth-generation HIV combination assays. The three fourth-generation HIV Ag/Ab combination assays exhibited better sensitivity, specificity, and negative prediction than the third-generation HIV Ab immunoassay. Copyright © 2015. Published by Elsevier B.V.

  6. Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays.

    Science.gov (United States)

    Saleh, Lanja; Mueller, Daniel; von Eckardstein, Arnold

    2016-04-01

    We evaluated the analytical and clinical performance of the new Lumipulse® G 25-OH vitamin D assay from Fujirebio, and compared it to a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and three other commercial automated assays. Total 25 hydroxy vitamin D (25(OH)D) levels were measured in 100 selected serum samples from our routine analysis with Fujirebio 25(OH)D assay. The results were compared with those obtained with LC-MS/MS and three other automated 25(OH)D assays (Abbott, Beckman, and Roche). The accuracy of each assay tested was evaluated against a Labquality reference serum panel for 25(OH)D (Ref!25OHD; University of Ghent). Intra- and inter-day imprecision of the Fujirebio 25(OH)D assay was Lumipulse G 25-OH vitamin D assay from Fujirebio demonstrated a good correlation with LC-MS/MS and some immunoassays. The performance of the assay is well-suited for routine 25(OH)D measurement in clinical serum samples. A correction for the observed negative bias vs. LC-MS/MS could be considered.

  7. [Comparison of the clinical performance of the ECLusys HIV combi assay with the Lumipulse f and HISCL 2000-i HIV-1/2 ab screening assays].

    Science.gov (United States)

    Sugiura, Aya; Iwahara, Kunihiro; Suga, Yasuyuki; Uchiyama, Sachinori; Maekawa, Masato

    2012-04-01

    We compared the ECLusys HIV combi assay (ECL HIV Ag/Ab) to the Lumipulse Forte (LPf HIV 1/2 Ab) and HISCL (HIS HIV 1/2 Ab) assays. In a dilution sensitivity test using dilution panels of WHO HIV antibody international reference panel (HIV-1 Subtype A, B, C, E, HIV-1 Group O, HIV-2) and HIV-1/2 Ab CE marked material(HIV-1, HIV-2) parent specimens, the ECL assay enabled detection at a higher level of sensitivity than either the LPf assay or the HIS assay for all dilution panels. In an early detection test in the early phase of infection in which a BBI HIV seroconversion panel was used, the ECL assay enabled detection 7 days after initial blood sample collection, whereas the LPf and HIS assays enabled detection after 27 days. In a specificity test using high RF positive specimens (n=33), pregnancy specimens (n=35), cytomegalovirus antibody positive specimens (n=36), and high M protein positive specimens (n=21) that were confirmed negative for HIV-1/2 antibodies by the LPf assay, negative results were obtained for all specimens on both the ECL assay and the HIS assay. In a correlation test using routinely collected clinical specimens (n=121), including positive stock specimens, the ECL and HIS assays demonstrated the highest agreement rate 98.3%. The above results confirmed that the fourth-generation reagent ECL assay, which simultaneously detects both HIV-1/2 antibodies and p24 antigens, is both highly sensitive and specific, and is a suitable assay for use in routine testing.

  8. Anticoagulants Influence the Performance of In Vitro Assays Intended for Characterization of Nanotechnology-Based Formulations

    Directory of Open Access Journals (Sweden)

    Edward Cedrone

    2017-12-01

    Full Text Available The preclinical safety assessment of novel nanotechnology-based drug products frequently relies on in vitro assays, especially during the early stages of product development, due to the limited quantities of nanomaterials available for such studies. The majority of immunological tests require donor blood. To enable such tests one has to prevent the blood from coagulating, which is usually achieved by the addition of an anticoagulant into blood collection tubes. Heparin, ethylene diamine tetraacetic acid (EDTA, and citrate are the most commonly used anticoagulants. Novel anticoagulants such as hirudin are also available but are not broadly used. Despite the notion that certain anticoagulants may influence assay performance, a systematic comparison between traditional and novel anticoagulants in the in vitro assays intended for immunological characterization of nanotechnology-based formulations is currently not available. We compared hirudin-anticoagulated blood with its traditional counterparts in the standardized immunological assay cascade, and found that the type of anticoagulant did not influence the performance of the hemolysis assay. However, hirudin was more optimal for the complement activation and leukocyte proliferation assays, while traditional anticoagulants citrate and heparin were more appropriate for the coagulation and cytokine secretion assays. The results also suggest that traditional immunological controls such as lipopolysaccharide (LPS are not reliable for understanding the role of anticoagulant in the assay performance. We observed differences in the test results between hirudin and traditional anticoagulant-prepared blood for nanomaterials at the time when no such effects were seen with traditional controls. It is, therefore, important to recognize the advantages and limitations of each anticoagulant and consider individual nanoparticles on a case-by-case basis.

  9. Californium interrogation prompt neutron (CIPN) instrument for non-destructive assay of spent nuclear fuel—Design concept and experimental demonstration

    Energy Technology Data Exchange (ETDEWEB)

    Henzlova, D., E-mail: henzlova@lanl.gov [Los Alamos National Laboratory, Los Alamos, NM 87545 (United States); Menlove, H.O.; Rael, C.D.; Trellue, H.R.; Tobin, S.J. [Los Alamos National Laboratory, Los Alamos, NM 87545 (United States); Park, Se-Hwan; Oh, Jong-Myeong; Lee, Seung-Kyu; Ahn, Seong-Kyu; Kwon, In-Chan; Kim, Ho-Dong [Korea Atomic Energy Research Institute, Daejeong (Korea, Republic of)

    2016-01-11

    This paper presents results of the first experimental demonstration of the Californium Interrogation Prompt Neutron (CIPN) instrument developed within a multi-year effort launched by the Next Generation Safeguards Initiative Spent Fuel Project of the United States Department of Energy. The goals of this project focused on developing viable non-destructive assay techniques with capabilities to improve an independent verification of spent fuel assembly characteristics. For this purpose, the CIPN instrument combines active and passive neutron interrogation, along with passive gamma-ray measurements, to provide three independent observables. This paper describes the initial feasibility demonstration of the CIPN instrument, which involved measurements of four pressurized-water-reactor spent fuel assemblies with different levels of burnup and two initial enrichments. The measurements were performed at the Post-Irradiation Examination Facility at the Korea Atomic Energy Institute in the Republic of Korea. The key aim of the demonstration was to evaluate CIPN instrument performance under realistic deployment conditions, with the focus on a detailed assessment of systematic uncertainties that are best evaluated experimentally. The measurements revealed good positioning reproducibility, as well as a high degree of insensitivity of the CIPN instrument's response to irregularities in a radial burnup profile. Systematic uncertainty of individual CIPN instrument signals due to assembly rotation was found to be <4.5%, even for assemblies with fairly extreme gradients in the radial burnup profile. These features suggest that the CIPN instrument is capable of providing a good representation of assembly average characteristics, independent of assembly orientation in the instrument.

  10. Californium interrogation prompt neutron (CIPN) instrument for non-destructive assay of spent nuclear fuel—Design concept and experimental demonstration

    International Nuclear Information System (INIS)

    Henzlova, D.; Menlove, H.O.; Rael, C.D.; Trellue, H.R.; Tobin, S.J.; Park, Se-Hwan; Oh, Jong-Myeong; Lee, Seung-Kyu; Ahn, Seong-Kyu; Kwon, In-Chan; Kim, Ho-Dong

    2016-01-01

    This paper presents results of the first experimental demonstration of the Californium Interrogation Prompt Neutron (CIPN) instrument developed within a multi-year effort launched by the Next Generation Safeguards Initiative Spent Fuel Project of the United States Department of Energy. The goals of this project focused on developing viable non-destructive assay techniques with capabilities to improve an independent verification of spent fuel assembly characteristics. For this purpose, the CIPN instrument combines active and passive neutron interrogation, along with passive gamma-ray measurements, to provide three independent observables. This paper describes the initial feasibility demonstration of the CIPN instrument, which involved measurements of four pressurized-water-reactor spent fuel assemblies with different levels of burnup and two initial enrichments. The measurements were performed at the Post-Irradiation Examination Facility at the Korea Atomic Energy Institute in the Republic of Korea. The key aim of the demonstration was to evaluate CIPN instrument performance under realistic deployment conditions, with the focus on a detailed assessment of systematic uncertainties that are best evaluated experimentally. The measurements revealed good positioning reproducibility, as well as a high degree of insensitivity of the CIPN instrument's response to irregularities in a radial burnup profile. Systematic uncertainty of individual CIPN instrument signals due to assembly rotation was found to be <4.5%, even for assemblies with fairly extreme gradients in the radial burnup profile. These features suggest that the CIPN instrument is capable of providing a good representation of assembly average characteristics, independent of assembly orientation in the instrument.

  11. Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis.

    Science.gov (United States)

    Nash, Madlen; Huddart, Sophie; Badar, Sayema; Baliga, Shrikala; Saravu, Kavitha; Pai, Madhukar

    2018-04-01

    Viral load (VL) is the preferred treatment-monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale, CA) is a new, automated molecular test, and it can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of 12 articles (13 studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified. Study quality was generally high, but substantial variability was observed in the number and type of agreement measures reported. Correlation coefficients between Xpert and reference assays were high, with a pooled Pearson correlation ( n = 8) of 0.94 (95% confidence interval [CI], 0.89, 0.97) and Spearman correlation ( n = 3) of 0.96 (95% CI, 0.86, 0.99). Bland-Altman metrics ( n = 11) all were within 0.35 log copies/ml of perfect agreement. Overall, Xpert HIV-1 VL performed well compared to current reference tests. The minimal training and infrastructure requirements for the Xpert HIV-1 VL assay make it attractive for use in resource-constrained settings, where point-of-care VL testing is most needed. Copyright © 2018 Nash et al.

  12. A sensitive high performance liquid chromatography assay for the quantification of doxorubicin associated with DNA in tumor and tissues.

    Science.gov (United States)

    Lucas, Andrew T; O'Neal, Sara K; Santos, Charlene M; White, Taylor F; Zamboni, William C

    2016-02-05

    Doxorubicin, a widely used anticancer agent, exhibits antitumor activity against a wide variety of malignancies. The drug exerts its cytotoxic effects by binding to and intercalating within the DNA of tumor and tissue cells. However, current assays are unable to accurately determine the concentration of the intracellular active form of doxorubicin. Thus, the development of a sample processing method and a high-performance liquid chromatography (HPLC) methodology was performed in order to quantify doxorubicin that is associated with DNA in tumors and tissues, which provided an intracellular cytotoxic measure of doxorubicin exposure after administration of small molecule and nanoparticle formulations of doxorubicin. The assay uses daunorubicin as an internal standard; liquid-liquid phase extraction to isolate drug associated with DNA; a Shimadzu HPLC with fluorescence detection equipped with a Phenomenex Luna C18 (2μm, 2.0×100mm) analytical column and a gradient mobile phase of 0.1% formic acid in water or acetonitrile for separation and quantification. The assay has a lower limit of detection (LLOQ) of 10ng/mL and is shown to be linear up to 3000ng/mL. The intra- and inter-day precision of the assay expressed as a coefficient of variation (CV%) ranged from 4.01 to 8.81%. Furthermore, the suitability of this assay for measuring doxorubicin associated with DNA in vivo was demonstrated by using it to quantify the doxorubicin concentration within tumor samples from SKOV3 and HEC1A mice obtained 72h after administration of PEGylated liposomal doxorubicin (Doxil(®); PLD) at 6mg/kg IV x 1. This HPLC assay allows for sensitive intracellular quantification of doxorubicin and will be an important tool for future studies evaluating intracellular pharmacokinetics of doxorubicin and various nanoparticle formulations of doxorubicin. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Performance evaluation of new automated hepatitis B viral markers in the clinical laboratory: two quantitative hepatitis B surface antigen assays and an HBV core-related antigen assay.

    Science.gov (United States)

    Park, Yongjung; Hong, Duck Jin; Shin, Saeam; Cho, Yonggeun; Kim, Hyon-Suk

    2012-05-01

    We evaluated quantitative hepatitis B surface antigen (qHBsAg) assays and a hepatitis B virus (HBV) core-related antigen (HBcrAg) assay. A total of 529 serum samples from patients with hepatitis B were tested. HBsAg levels were determined by using the Elecsys (Roche Diagnostics, Indianapolis, IN) and Architect (Abbott Laboratories, Abbott Park, IL) qHBsAg assays. HBcrAg was measured by using Lumipulse HBcrAg assay (Fujirebio, Tokyo, Japan). Serum aminotransferases and HBV DNA were respectively quantified by using the Hitachi 7600 analyzer (Hitachi High-Technologies, Tokyo, Japan) and the Cobas AmpliPrep/Cobas TaqMan test (Roche). Precision of the qHBsAg and HBcrAg assays was assessed, and linearity of the qHBsAg assays was verified. All assays showed good precision performance with coefficients of variation between 4.5% and 5.3% except for some levels. Both qHBsAg assays showed linearity from 0.1 to 12,000.0 IU/mL and correlated well (r = 0.9934). HBsAg levels correlated with HBV DNA (r = 0.3373) and with HBcrAg (r = 0.5164), and HBcrAg also correlated with HBV DNA (r = 0.5198; P < .0001). This observation could provide impetus for further research to elucidate the clinical usefulness of the qHBsAg and HBcrAg assays.

  14. An improved behavioural assay demonstrates that ultrasound vocalizations constitute a reliable indicator of chronic cancer pain and neuropathic pain

    Directory of Open Access Journals (Sweden)

    Selvaraj Deepitha

    2010-03-01

    Full Text Available Abstract Background On-going pain is one of the most debilitating symptoms associated with a variety of chronic pain disorders. An understanding of mechanisms underlying on-going pain, i.e. stimulus-independent pain has been hampered so far by a lack of behavioural parameters which enable studying it in experimental animals. Ultrasound vocalizations (USVs have been proposed to correlate with pain evoked by an acute activation of nociceptors. However, literature on the utility of USVs as an indicator of chronic pain is very controversial. A majority of these inconsistencies arise from parameters confounding behavioural experiments, which include novelty, fear and stress due to restrain, amongst others. Results We have developed an improved assay which overcomes these confounding factors and enables studying USVs in freely moving mice repetitively over several weeks. Using this improved assay, we report here that USVs increase significantly in mice with bone metastases-induced cancer pain or neuropathic pain for several weeks, in comparison to sham-treated mice. Importantly, analgesic drugs which are known to alleviate tumour pain or neuropathic pain in human patients significantly reduce USVs as well as mechanical allodynia in corresponding mouse models. Conclusions We show that studying USVs and mechanical allodynia in the same cohort of mice enables comparing the temporal progression of on-going pain (i.e. stimulus-independent pain and stimulus-evoked pain in these clinically highly-relevant forms of chronic pain.

  15. The Davies-Gray titration for the assay of uranium in nuclear materials: a performance study

    International Nuclear Information System (INIS)

    Bickel, M.

    1997-01-01

    An interlaboratory comparison in two phases was organized to assess the precision and accuracy concerning the assay of uranium in nuclear materials by the potentiometric titration method. This contribution presents the results of this exercise in terms of method performance. Variations to be expected between different laboratories and within a single laboratory are estimated. In general, the method proved again very reliable. (orig.)

  16. How to best freeze liver samples to perform the in vivo mammalian alkaline comet assay

    Directory of Open Access Journals (Sweden)

    José Manuel Enciso Gadea

    2015-06-01

    None of the different methods used was capable of giving good results, except immersing the liver samples in liquid nitrogen, followed by Jackson’s et al. (2013 thawing protocol, suggesting that the thawing process may be as critical as the freezing process. To sum up, these results highlight the importance of deepening the possibility to perform the comet assay with frozen tissue.

  17. Short Communication: Comparison of Maxim and Sedia Limiting Antigen Assay Performance for Measuring HIV Incidence.

    Science.gov (United States)

    Schlusser, Katherine E; Konikoff, Jacob; Kirkpatrick, Allison R; Morrison, Charles; Chipato, Tsungai; Chen, Pai-Lien; Munjoma, Marshall; Eshleman, Susan H; Laeyendecker, Oliver

    2017-06-01

    Accurate methods for cross-sectional incidence estimation are needed for HIV prevention research. The Limiting Antigen Avidity (LAg-Avidity) assay has been marketed by two vendors, Maxim Biomedical and Sedia BioSciences Corporation. Performance differences between the two versions of the assay are unknown. We tested a total 1,410 treatment-naive samples with both versions of the assay. The samples came from 176 seroconverters from the Zimbabwe Hormonal Contraception and HIV Study. The correlation between the two versions of the assay was 0.93 for the optical density (OD) and 0.86 for the normalized OD. As the difference was more pronounced for the normalized OD, the difference in assays can be attributed to the calibrators. The mean duration of recent infection (MDRI), the average time individuals infected 1,000 copies/ml. The MDRI was 137 days for Sedia and 157 days for Maxim, with a difference of 20 days (95% CI 11-30). The MDRIs decreased to 102 and 120 days with the inclusion of a viral load cutoff of >1,000 copies/ml. These results imply that use of the Sedia LAg-Avidity will result in estimates of incidence ∼13% lower than those using the Maxim LAg-Avidity.

  18. Improved assay for thymine base damage in E. coli using high performance liquid chromatography

    International Nuclear Information System (INIS)

    Claycamp, H.G.

    1985-01-01

    A simple high performance liquid chromatography (HPLC) technique has been established for the simultaneous assay of thymine and thymidine radiation damage products. The HPLC procedure uses an isocratic mobile phase of 4% acetonitrile in 0.2 M ammonium dihydrogen phosphate (pH 5.0), a reversed-phase octadecylsilicate (5 micro-spherical packing) 0.45 x 25 cm column, and a variable wavelength UV detector. This procedure affords much better resolution than other published procedures that use 10 micron columns or separate assays for bases and nucleosides. For example, irradiation of 5 x 10 -3 M thymidine solutions have been performed to calibrate the system for base damage assays in E. coli. This yields up to 15 resolvable residues within 20 minutes. Sensitivity of the system (at 2210 nm) for 5,6- dihydrothymine (DHT) is about 10 -10 moles. Preliminary results show that this translates to about 0.4 DHT residues per 10 6 daltons of E. coli DNA. This is comparable to the sensitivities of monoclonal assays to thymine damage products that have recently been reported by others. Since it is feasible that the sensitivity of this system can be improved by 2-3 times, this HPLC technique should provide a simple and rapid means of detecting E. coli base damage release and base damage in nucleoside hydrolysates of DNA

  19. Point of Care Cardiac Troponin Assay Analytical Performances for their Use in Clinical Routine.

    Science.gov (United States)

    Dupuy, Anne M; Baillet, Solenne; Dumont, Richard; Giraud, Isabelle; Badiou, Stephanie; Bargnoux, Anne S; Kuster, Nils; Roubille, Francois; Cristol, Jean Paul

    2017-04-01

    We report the analytical and clinical performances of the Alere Triage Cardiac3© Panel on the Triage MeterPro© instrument, comparing concordance with hs-cTnT results from central laboratory above the respective 99th percentiles and determining the clinical sensitivity within the framework of AMI. The concordance was obtained with these two methods among unselected patients admitted to both the emergency and cardiology departments. The LoD of the assay is 0.010 µg/L. At 99th percentile (0.02 µg/L) the CV was found to be 18%, below the clinically acceptable cutoff of 20%. In the overall population, ROC AUC was not significantly different between the central laboratory assay and POC assay, with 0.952 (95% CI, 0.918 - 0.952) for hs-cTnT concentrations at presentation and 0.953 (95% CI, 0.912 - 0.953) for cTnI. Sensitivity and specificity of hs-cTnT vs. cTnI for AMI (n = 32) were 97% and 78% vs. 91% and 86%, respectively. Our results indicated 90.4% concordance between the two methods using the 99th percentile specific for each assay. The Kappa coefficient was higher than 0.75, and the strength of agreement could be considered to be good. The results of cTnI Alere assays provide similar clinical classification of patients, particularly for the AMI group as compared to the central laboratory hs-cTnT assay and could be suitable for clinical in accordance with the recommendations of Global Task Force guidelines.

  20. Performance evaluation of a particle-enhanced turbidimetric cystatin C assay on the Abbott ci8200 analyzer.

    Science.gov (United States)

    Flodin, Mats; Larsson, Anders

    2009-06-01

    Glomerular filtration rate (GFR) is widely accepted as the best overall measure of kidney function. Cystatin C is a novel endogenous GFR marker that has been shown to be superior to creatinine for estimation of GFR in several studies. There is a need for cystatin C assays adapted to routine chemistry instrument to minimize turnaround times and allowing 24 h/day availability. We have evaluated a new cystatin C assay developed for Architect cSystem (Abbott Laboratories, Abbott Park, IL, USA). The cystatin C assay showed good agreement with the corresponding assay from Dade Behring (Deerfield, IL, USA). The assay has a very low total imprecision and a good linearity. The new cystatin C assay is an interesting alternative to current cystatin C assays. On an Architect cSystem the assay can be performed with the same turnaround times and availability as creatinine.

  1. 40 CFR 450.24 - New source performance standards reflecting the best available demonstrated control technology...

    Science.gov (United States)

    2010-07-01

    ... performance standards reflecting the best available demonstrated control technology (NSPS). Any new source... 40 Protection of Environment 29 2010-07-01 2010-07-01 false New source performance standards reflecting the best available demonstrated control technology (NSPS). 450.24 Section 450.24 Protection of...

  2. High performance liquid chromatographic assay for the quantitation of total glutathione in plasma

    Science.gov (United States)

    Abukhalaf, Imad K.; Silvestrov, Natalia A.; Menter, Julian M.; von Deutsch, Daniel A.; Bayorh, Mohamed A.; Socci, Robin R.; Ganafa, Agaba A.

    2002-01-01

    A simple and widely used homocysteine HPLC procedure was applied for the HPLC identification and quantitation of glutathione in plasma. The method, which utilizes SBDF as a derivatizing agent utilizes only 50 microl of sample volume. Linear quantitative response curve was generated for glutathione over a concentration range of 0.3125-62.50 micromol/l. Linear regression analysis of the standard curve exhibited correlation coefficient of 0.999. Limit of detection (LOD) and limit of quantitation (LOQ) values were 5.0 and 15 pmol, respectively. Glutathione recovery using this method was nearly complete (above 96%). Intra-assay and inter-assay precision studies reflected a high level of reliability and reproducibility of the method. The applicability of the method for the quantitation of glutathione was demonstrated successfully using human and rat plasma samples.

  3. Repeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials.

    Science.gov (United States)

    White, Kirsten; Garner, Will; Wei, Lilian; Eron, Joseph J; Zhong, Lijie; Miller, Michael D; Martin, Hal; Plummer, Andrew; Tran-Muchowski, Cecilia; Lindstrom, Kim; Porter, James; Piontkowsky, David; Light, Angela; Reiske, Heinz; Quirk, Erin

    2018-05-15

    Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. Prospective and retrospective analysis of randomized clinical trial samples and reference standards. To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of ≥ 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50-200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50-200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested ≥ 50 copies/ml. The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source of viremia

  4. Highly sensitive assay for tyrosine hydroxylase activity by high-performance liquid chromatography.

    Science.gov (United States)

    Nagatsu, T; Oka, K; Kato, T

    1979-07-21

    A highly sensitive assay for tyrosine hydroxylase (TH) activity by high-performance liquid chromatography (HPLC) with amperometric detection was devised based on the rapid isolation of enzymatically formed DOPA by a double-column procedure, the columns fitted together sequentially (the top column of Amberlite CG-50 and the bottom column of aluminium oxide). DOPA was adsorbed on the second aluminium oxide column, then eluted with 0.5 M hydrochloric acid, and assayed by HPLC with amperometric detection. D-Tyrosine was used for the control. alpha-Methyldopa was added to the incubation mixture as an internal standard after incubation. This assay was more sensitive than radioassays and 5 pmol of DOPA formed enzymatically could be measured in the presence of saturating concentrations of tyrosine and 6-methyltetrahydropterin. The TH activity in 2 mg of human putamen could be easily measured, and this method was found to be particularly suitable for the assay of TH activity in a small number of nuclei from animal and human brain.

  5. Performance of the Xpert HPV assay in women attending for cervical screening

    Directory of Open Access Journals (Sweden)

    Jack Cuzick

    2015-12-01

    Full Text Available Objectives: This study evaluated the Xpert HPV Assay in women attending screening in general practice by comparing Xpert with two established HPV tests, cytology and histology. Methods: A prospective study in women aged 20–60 years attending screening in Bristol, Edinburgh and London using residual Preservcyt cytology samples. Sample order was randomised between Roche cobas4800 and Cepheid Xpert assays with Qiagen hc2 third. Results: 3408 cases were included in the primary analysis. Positivity for Xpert was 19.6%, cobas 19.2% and hc2 19.9% with high concordance (kappa=86.8% vs cobas, 81.55 vs hc2. Xpert, cobas and hc2 showed similar sensitivity (98.7%, 97.5%, 98.7% for CIN2+. All pairwise comparisons had high concordance (Kappa ≥0.78 with any abnormal cytology. Xpert and hc2 were positive for all cases of ≥moderate dyskaryosis (N=63, cobas was negative in two. Histology was available for 172 participants. 79 reported CIN2+, 47 CIN3+. All CIN3+ was positive on Xpert and hc2 and one case negative for cobas. One case of CIN2 was negative for all assays. Conclusions: The performance of Xpert HPV Assay in a general screening population is comparable to established HPV tests. It offers simplicity of testing, flexibility with non-batching of individual samples and rapid turnaround time. Keywords: Human papillomavirus, Xpert, Cervical screening, HPV testing

  6. Combined high-performance liquid chromatography/32P-postlabeling assay of N7-methyldeoxyguanosine

    International Nuclear Information System (INIS)

    Shields, P.G.; Povey, A.C.; Wilson, V.L.; Weston, A.; Harris, C.C.

    1990-01-01

    A highly sensitive and specific assay for the detection of N7-methyl-2'-deoxyguanosine (N7methyldG) has been developed by combining high-performance liquid chromatography, 32 P-postlabeling, and nucleotide chromatography. Separation of normal nucleotides and adducts by high-performance liquid chromatography and then combining a portion of 2'-deoxyguanosine to the N7methyldG allows for quantitation using an internal standard. The directly determined molar ratio is not subject to errors in digestion, variable ATP-specific activity, or assumptions in relative adduct-labeling efficiency. The detection limit was one N7methyldG adduct in 10(7) unmodified 2'-deoxyguanosine bases. N7methyldG adducts have been detected in 5 human lung samples in which O6-methyl-2'-deoxyguanosine adducts had been previously determined. The mean ratio of N7methyldG to O6-methyl-2'-deoxyguanosine was determined to be approximately 10. The current assay complements the high-performance liquid chromatography/ 32 P-postlabeling assay for O6-methyl-2'-deoxyguanosine and increases the detection sensitivity of DNA methylated by exogenous alkylating agents

  7. Demonstration of extracellular peptidylarginine deiminase (PAD) activity in synovial fluid of patients with rheumatoid arthritis using a novel assay for citrullination of fibrinogen

    DEFF Research Database (Denmark)

    Damgaard, Dres; Senolt, Ladislav; Nielsen, Michael Friberg

    2014-01-01

    INTRODUCTION: Members of the peptidylarginine deiminase (PAD) family catalyse the posttranslational conversion of peptidylarginine to peptidylcitrulline. Citrullination of proteins is well described in rheumatoid arthritis (RA), and hypercitrullination of proteins may be related to inflammation...... in general. PAD activity has been demonstrated in various cell lysates, but so far not in synovial fluid. We aimed to develop an assay for detection of PAD activity, if any, in synovial fluid from RA patients. METHODS: An enzyme-linked immunosorbent assay using human fibrinogen as the immobilized substrate...... for citrullination and anti-citrullinated fibrinogen antibody as the detecting agent were used for measurement of PAD activity in synovial fluid samples from five RA patients. The concentrations of PAD2 and calcium were also determined. RESULTS: Approximately 150 times lower levels of recombinant human PAD2 (rhPAD2...

  8. Pacific Northwest Smart Grid Demonstration Project Technology Performance Report Volume 1: Technology Performance

    Energy Technology Data Exchange (ETDEWEB)

    Melton, Ron [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-06-01

    The Pacific Northwest Smart Grid Demonstration (PNWSGD), a $179 million project that was co-funded by the U.S. Department of Energy (DOE) in late 2009, was one of the largest and most comprehensive demonstrations of electricity grid modernization ever completed. The project was one of 16 regional smart grid demonstrations funded by the American Recovery and Reinvestment Act. It was the only demonstration that included multiple states and cooperation from multiple electric utilities, including rural electric co-ops, investor-owned, municipal, and other public utilities. No fewer than 55 unique instantiations of distinct smart grid systems were demonstrated at the projects’ sites. The local objectives for these systems included improved reliability, energy conservation, improved efficiency, and demand responsiveness. The demonstration developed and deployed an innovative transactive system, unique in the world, that coordinated many of the project’s distributed energy resources and demand-responsive components. With the transactive system, additional regional objectives were also addressed, including the mitigation of renewable energy intermittency and the flattening of system load. Using the transactive system, the project coordinated a regional response across the 11 utilities. This region-wide connection from the transmission system down to individual premises equipment was one of the major successes of the project. The project showed that this can be done and assets at the end points can respond dynamically on a wide scale. In principle, a transactive system of this type might eventually help coordinate electricity supply, transmission, distribution, and end uses by distributing mostly automated control responsibilities among the many distributed smart grid domain members and their smart devices.

  9. Performance demonstration tests for eddy current inspection of steam generator tubing

    International Nuclear Information System (INIS)

    Kurtz, R.J.; Heasler, P.G.; Anderson, C.M.

    1996-05-01

    This report describes the methodology and results for development of performance demonstration tests for eddy current (ET) inspection of steam generator tubes. Statistical test design principles were used to develop the performance demonstration tests. Thresholds on ET system inspection performance were selected to ensure that field inspection systems would have a high probability of detecting and and correctly sizing tube degradation. The technical basis for the ET system performance thresholds is presented in detail. Statistical test design calculations for probability of detection and flaw sizing tests are described. A recommended performance demonstration test based on the design calculations is presented. A computer program for grading the probability of detection portion of the performance demonstration test is given

  10. Performance demonstration tests for eddy current inspection of steam generator tubing

    Energy Technology Data Exchange (ETDEWEB)

    Kurtz, R.J.; Heasler, P.G.; Anderson, C.M.

    1996-05-01

    This report describes the methodology and results for development of performance demonstration tests for eddy current (ET) inspection of steam generator tubes. Statistical test design principles were used to develop the performance demonstration tests. Thresholds on ET system inspection performance were selected to ensure that field inspection systems would have a high probability of detecting and and correctly sizing tube degradation. The technical basis for the ET system performance thresholds is presented in detail. Statistical test design calculations for probability of detection and flaw sizing tests are described. A recommended performance demonstration test based on the design calculations is presented. A computer program for grading the probability of detection portion of the performance demonstration test is given.

  11. Stereospecific high-performance liquid chromatographic assay of sotalol in plasma.

    Science.gov (United States)

    Carr, R A; Foster, R T; Bhanji, N H

    1991-09-01

    A convenient high-performance liquid chromatographic (HPLC) assay was developed for determination of sotalol (STL) enantiomers in plasma. Following addition of the internal standard (IS; racemic atenolol), enantiomers of STL and IS were extracted using ethyl acetate. After evaporation of the organic layer, samples were derivatized with a solution of S-(+)-1-(1-naphthyl)ethyl isocyanate (NEIC). The resulting diastereomers were chromatographed with normal-phase HPLC with chloroform:hexane:methanol [65:33:2 (v/v)] as the mobile phase at a flow rate of 2 ml/min. The fluorescence detection wavelength was set at 220 nm for excitation with no emission filter. The suitability of the assay for pharmacokinetic studies was determined by measuring STL enantiomers in the plasma of a healthy subject after administration of a single 160-mg oral, racemic dose of STL.

  12. Practical experience and lessons learned through implementation of Appendix VIII performance demonstration requirements

    International Nuclear Information System (INIS)

    Ashwin, P.J.; Becker, F.L.; Latiolais, C.L.; Spanner, J.C.

    1996-01-01

    To provide the US nuclear industry with a uniform implementation of the Performance Demonstration requirements within the 1989 edition of ASME Section XI, Appendix VIII, representatives from all US nuclear utilities formed the Performance Demonstration Initiative (PDI). The PDI recognized the potential benefits that Appendix VIII offered the nuclear industry and initiated a proactive approach to implement the requirements. In doing so it was expected that performance demonstration of ultrasonic examination procedures would allow for improvement in the efficiency and credibility of inservice inspection to be realized. Explicit within the performance demonstration requirements of Appendix VIII is the need for a Performance Demonstration Administrator, a difficult requirement to fulfill. Not only must the administrator exhibit the attributes of understanding the demonstration requirements, but also have solid technical knowledge, integrity and be able to interface with the industry at all levels, from operations to regulatory. For the nuclear industry, the EPRI NDE Center is an obvious choice to fulfill this position. This paper provides a brief background of the PDI, a nuclear industry-wide initiative to implement the performance demonstration requirements of Appendix VIII. Even though the consensus approach adopted by the PDI is discussed, the paper's primary objective is to provide examples of the lessons learned by the Center through the specific requirements of Appendix VIII

  13. Assessment of a robust model protocol with accelerated throughput for a human recombinant full length estrogen receptor-alpha binding assay: protocol optimization and intralaboratory assay performance as initial steps towards validation.

    Science.gov (United States)

    Freyberger, Alexius; Wilson, Vickie; Weimer, Marc; Tan, Shirlee; Tran, Hoai-Son; Ahr, Hans-Jürgen

    2010-08-01

    Despite about two decades of research in the field of endocrine active compounds, still no validated human recombinant (hr) estrogen receptor-alpha (ERalpha) binding assay is available, although hr-ERalpha is available from several sources. In a joint effort, US EPA and Bayer Schering Pharma with funding from the EU-sponsored 6th framework project, ReProTect, developed a model protocol for such a binding assay. Important features of this assay are the use of a full length hr-ERalpha and performance in a 96-well plate format. A full length hr-ERalpha was chosen, as it was considered to provide the most accurate and human-relevant results, whereas truncated receptors could perform differently. Besides three reference compounds [17beta-estradiol, norethynodrel, dibutylphthalate] nine test compounds with different affinities for the ERalpha [diethylstilbestrol (DES), ethynylestradiol, meso-hexestrol, equol, genistein, o,p'-DDT, nonylphenol, n-butylparaben, and corticosterone] were used to explore the performance of the assay. Three independent experiments per compound were performed on different days, and dilutions of test compounds from deep-frozen stocks, solutions of radiolabeled ligand and receptor preparation were freshly prepared for each experiment. The ERalpha binding properties of reference and test compounds were well detected. As expected dibutylphthalate and corticosterone were non-binders in this assay. In terms of the relative ranking of binding affinities, there was good agreement with published data obtained from experiments using a human recombinant ERalpha ligand binding domain. Irrespective of the chemical nature of the compound, individual IC(50)-values for a given compound varied by not more than a factor of 2.5. Our data demonstrate that the assay was robust and reliably ranked compounds with strong, weak, and no affinity for the ERalpha with high accuracy. It avoids the manipulation and use of animals, i.e., the preparation of uterine cytosol as

  14. Performance of the BioPlex 2200 HIV Ag-Ab assay for identifying acute HIV infection.

    Science.gov (United States)

    Eshleman, Susan H; Piwowar-Manning, Estelle; Sivay, Mariya V; Debevec, Barbara; Veater, Stephanie; McKinstry, Laura; Bekker, Linda-Gail; Mannheimer, Sharon; Grant, Robert M; Chesney, Margaret A; Coates, Thomas J; Koblin, Beryl A; Fogel, Jessica M

    Assays that detect HIV antigen (Ag) and antibody (Ab) can be used to screen for HIV infection. To compare the performance of the BioPlex 2200 HIV Ag-Ab assay and two other Ag/Ab combination assays for detection of acute HIV infection. Samples were obtained from 24 individuals (18 from the US, 6 from South Africa); these individuals were classified as having acute infection based on the following criteria: positive qualitative RNA assay; two negative rapid tests; negative discriminatory test. The samples were tested with the BioPlex assay, the ARCHITECT HIV Ag/Ab Combo test, the Bio-Rad GS HIV Combo Ag-Ab EIA test, and a viral load assay. Twelve (50.0%) of 24 samples had RNA detected only ( > 40 to 13,476 copies/mL). Ten (43.5%) samples had reactive results with all three Ag/Ab assays, one sample was reactive with the ARCHITECT and Bio-Rad assays, and one sample was reactive with the Bio-Rad and BioPlex assays. The 11 samples that were reactive with the BioPlex assay had viral loads from 83,010 to >750,000 copies/mL; 9/11 samples were classified as Ag positive/Ab negative by the BioPlex assay. Detection of acute HIV infection was similar for the BioPlex assay and two other Ag/Ab assays. All three tests were less sensitive than a qualitative RNA assay and only detected HIV Ag when the viral load was high. The BioPlex assay detected acute infection in about half of the cases, and identified most of those infections as Ag positive/Ab negative. Copyright © 2018 Elsevier B.V. All rights reserved.

  15. Association of Biotin Ingestion With Performance of Hormone and Nonhormone Assays in Healthy Adults.

    Science.gov (United States)

    Li, Danni; Radulescu, Angela; Shrestha, Rupendra T; Root, Matthew; Karger, Amy B; Killeen, Anthony A; Hodges, James S; Fan, Shu-Ling; Ferguson, Angela; Garg, Uttam; Sokoll, Lori J; Burmeister, Lynn A

    2017-09-26

    Biotinylated antibodies and analogues, with their strong binding to streptavidin, are used in many clinical laboratory tests. Excess biotin in blood due to supplemental biotin ingestion may affect biotin-streptavidin binding, leading to potential clinical misinterpretation. However, the degree of interference remains undefined in healthy adults. To assess performance of specific biotinylated immunoassays after 7 days of ingesting 10 mg/d of biotin, a dose common in over-the-counter supplements for healthy adults. Nonrandomized crossover trial involving 6 healthy adults who were treated at an academic medical center research laboratory. Administration of 10 mg/d of biotin supplementation for 7 days. Analyte concentrations were compared with baseline (day 0) measures on the seventh day of biotin treatment and 7 days after treatment had stopped (day 14). The 11 analytes included 9 hormones (ie, thyroid-stimulating hormone, total thyroxine, total triiodothyronine, free thyroxine, free triiodothyronine, parathyroid hormone, prolactin, N-terminal pro-brain natriuretic peptide, 25-hydroxyvitamin D) and 2 nonhormones (prostate-specific antigen and ferritin). A total of 37 immunoassays for the 11 analytes were evaluated on 4 diagnostic systems, including 23 assays that incorporated biotin and streptavidin components and 14 assays that did not include biotin and streptavidin components and served as negative controls. Among the 2 women and 4 men (mean age, 38 years [range, 31-45 years]) who took 10 mg/d of biotin for 7 days, biotin ingestion-associated interference was found in 9 of the 23 (39%) biotinylated assays compared with none of the 14 nonbiotinylated assays (P = .007). Results from 5 of 8 biotinylated (63%) competitive immunoassays tested falsely high and results from 4 out of 15 (27%) biotinylated sandwich immunoassays tested falsely low. In this preliminary study of 6 healthy adult participants and 11 hormone and nonhormone analytes measured by 37 immunoassays

  16. Relative performance of a TGS for the assay of drummed waste as function of collimator opening

    International Nuclear Information System (INIS)

    Kane, S.C.; Croft, S.; McClay, P.; Venkataraman, R.; Villani, M.F.

    2007-01-01

    Improving the safety, accuracy and overall cost effectiveness of the processes and methods used to characterize and handle radioactive waste is an on-going mission for the nuclear industry. An important contributor to this goal is the development of superior non-destructive assay instruments. The Tomographic Gamma Scanner (TGS) is a case in point. The TGS applies low spatial resolution experimental computed tomography (CT) linear attenuation coefficient maps with three-dimensional high-energy resolution single photon emission reconstructions. The results are presented as quantitative matrix attenuation corrected images and assay values for gamma-emitting radionuclides. Depending on a number of operational factors, this extends the diversity of waste forms that can be assayed, to a given accuracy, to items containing more heterogeneous matrix distributions and less uniform emission activity distributions. Recent advances have significantly extended the capability to a broader range of matrix density and to a wider dynamic range of surface dose rate. Automated systems sense the operational conditions, including the container type, and configure themselves accordingly. The TGS also provides a flexible data acquisition platform and can be used to perform far-field style measurements, classical segmented gamma scanner measurements, or to implement hybrid methods, such as reconstructions that use a priori knowledge to constrain the image reconstruction or the underlying energy dependence of the attenuation. A single, yet flexible, general purpose instrument of this kind adds several tiers of strategic and tactical value to facilities challenged by a diverse and difficult to assay waste streams. The TGS is still in the early phase of industrial uptake. There are only a small number of general purpose TGS systems operating worldwide, most being configured to automatically select between a few configurations appropriate for routine operations. For special investigations

  17. Utility and diagnostic performance of Mycobacterium tuberculosis complex by two immunochromatographic assays as compared with the molecular Genotype assay in Nigeria

    Directory of Open Access Journals (Sweden)

    Benjamin Thumamo Pokam

    2013-01-01

    Full Text Available Among the disadvantages of smear microscopy for detection of tuberculosis cases is its inability to differentiate between Mycobacterium tuberculosis (MTB and non-tuberculous mycobacteria (NTM. This study evaluated two, new immunochromatographic assays – Capilia TB-Neo and SD Bioline – on unheated and heated cultures at 80 °C for 30 min respectively for their ability to discriminate between MTB complex and NTM as compared with the molecular Genotype assay. Mycobacteria used in the study were obtained from smear-positive specimens collected from patients at four major hospitals in Cross River State, Nigeria. Capilia TB-Neo and SD Bioline showed sensitivities of 98.8% and 93.8% respectively and 100% specificity for both assays. Heating the isolates did not significantly impact the test performance. Both tests are recommended for use in rapid differentiation of strains isolated in Nigeria.

  18. Analytical and clinical performances of immunoradiometric assay of total and free PSA developed locally

    International Nuclear Information System (INIS)

    Boucekkine, N.; Korso, R.; Bellazoug, K.; Ferd, N.; Bouyoucef, S.E.; Boudjemai, S.; Benzaid, A.; Bouhila, Z.

    2002-01-01

    A specific assay was developed for total and free PSA (PSAt, PSAf). Both assay use a two site IRMA with polyclonal anti PSA antibodies coated on tubes. Polyclonal antibodies were obtained after rabbit's immunisation using an under skin injection of pure PSA in multiple site. For quantification, two monoclonal antibodies were selected, the first highly specific to free PSA and the second recognising both free and bound PSA. A correlation study was performed comparatively with two commercial kits from CIS Bio and Immunotech. For that purpose, 464 serums samples ranging from 0.5 ng/ml to 3399 ng/ml were used to characterise the analytical performance of the new test. The analytical detection limit of the new test was equal to 0.05 ng/ml for the total PSA and 0.02ng/ml for the free PSA. The within run and between-day coefficients of variation were to 20 ng/ml. For BPH, no significant difference was found between the three test for the ratio PSAf/PSAt using a cut off of 14% (all were>to 14%). For the 120 patients with PC, all PSAt were > to 2 ng/ml. However the mean value of PSAt was higher for the commercial kits (14.74 ng/ml against 12.48ng/ml for the new test) but all ratio of PSAf/PSAt for the 120 newly diagnosed cancer were <14%. In conclusion, our immunoradiometric assay developed locally has a good analytical performance and its outputs are well correlated to clinical findings in prostate disease. Furthermore, a cut off of 14% for the ratio PSAf/PSAt appears to be the most accurate tools to depict a prostate cancer

  19. Survey of EEC solid waste arisings and performance of non-destructive assay systems

    International Nuclear Information System (INIS)

    Bremner, W.B.; Adaway, D.W.; Yates, A.

    1992-01-01

    This report covers the work carried out during an one-year contract which surveyed the radioactive solid waste arisings in EEC Member States and also tabulated information on the performance of the non-destructive assay (NDA) system used. The work was jointly carried out with CEA partners at Cadarache and Paris. The tabulated data give information on types, packaging, associated activity, and NDA capability of the utilities or research organisations. Some short comings in NDA capabilities are identified and possible solutions are given

  20. Performance standard-based validation study for local lymph node assay: 5-bromo-2-deoxyuridine-flow cytometry method.

    Science.gov (United States)

    Ahn, Ilyoung; Kim, Tae-Sung; Jung, Eun-Sun; Yi, Jung-Sun; Jang, Won-Hee; Jung, Kyoung-Mi; Park, Miyoung; Jung, Mi-Sook; Jeon, Eun-Young; Yeo, Kyeong-Uk; Jo, Ji-Hoon; Park, Jung-Eun; Kim, Chang-Yul; Park, Yeong-Chul; Seong, Won-Keun; Lee, Ai-Young; Chun, Young Jin; Jeong, Tae Cheon; Jeung, Eui Bae; Lim, Kyung-Min; Bae, SeungJin; Sohn, Soojung; Heo, Yong

    2016-10-01

    Local lymph node assay: 5-bromo-2-deoxyuridine-flow cytometry method (LLNA: BrdU-FCM) is a modified non-radioisotopic technique with the additional advantages of accommodating multiple endpoints with the introduction of FCM, and refinement and reduction of animal use by using a sophisticated prescreening scheme. Reliability and accuracy of the LLNA: BrdU-FCM was determined according to OECD Test Guideline (TG) No. 429 (Skin Sensitization: Local Lymph Node Assay) performance standards (PS), with the participation of four laboratories. Transferability was demonstrated through successfully producing stimulation index (SI) values for 25% hexyl cinnamic aldehyde (HCA) consistently greater than 3, a predetermined threshold, by all participating laboratories. Within- and between-laboratory reproducibility was shown using HCA and 2,4-dinitrochlorobenzene, in which EC2.7 values (the estimated concentrations eliciting an SI of 2.7, the threshold for LLNA: BrdU-FCM) fell consistently within the acceptance ranges, 0.025-0.1% and 5-20%, respectively. Predictive capacity was tested using the final protocol version 1.3 for the 18 reference chemicals listed in OECD TG 429, of which results showed 84.6% sensitivity, 100% specificity, and 88.9% accuracy compared with the original LLNA. The data presented are considered to meet the performance criteria for the PS, and its predictive capacity was also sufficiently validated. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Performance of the Tile PreProcessor Demonstrator for the ATLAS Tile Calorimeter Phase II Upgrade

    OpenAIRE

    Carrio Argos, Fernando; Valero, Alberto

    2015-01-01

    The Tile Calorimeter PreProcessor (TilePPr) demonstrator is a high performance double AMC board based on FPGA resources and QSFP modules. This board has been designed in the framework of the ATLAS Tile Calorimeter (TileCal) Demonstrator Project for the Phase II Upgrade as the first stage of the back-end electronics. The TilePPr demonstrator has been conceived for receiving and processing the data coming from the front-end electronics of the TileCal Demonstrator module, as well as for configur...

  2. Environmental assessment for the electric and hybrid vehicle demonstration project, performance standards and financial incentives

    Energy Technology Data Exchange (ETDEWEB)

    LaBelle, S. J.

    1978-10-01

    The assessment is concerned with the impacts of the demonstration of electric and hybrid vehicles acquired to fulfill certain requirements of the Electric and Hybrid Vehicle Research, Development, and Demonstration Act, PL 94-413 as amended. The financial incentives programs and vehicle performance standards associated with the demonstration are also covered. Not included is an assessment of the long term effects of EHV commercialization and of the research and development program being carried out simultaneously with the demonstration, also in response to PL 94-413. These federal actions will be included in a programmatic environmental assessment scheduled for completion in FY 79.

  3. Designing Scholarships to Improve College Success: Final Report on the Performance-Based Scholarship Demonstration

    Science.gov (United States)

    Mayer, Alexander K.; Patel, Reshma; Rudd, Timothy; Ratledge, Alyssa

    2015-01-01

    Performance-based scholarships have two main goals: (1) to give students more money for college; and (2) to provide incentives for academic progress. MDRC launched the Performance-Based Scholarship (PBS) Demonstration in 2008 to evaluate the effectiveness of these scholarships in a diverse set of states, institutions, and low-income student…

  4. Performance demonstration program plan for RCRA constituent analysis of solidified wastes

    International Nuclear Information System (INIS)

    1995-06-01

    Performance Demonstration Programs (PDPS) are designed to help ensure compliance with the Quality Assurance Objectives (QAOs) for the Waste Isolation Pilot Plant (WIPP). The PDPs are intended for use by the Department of Energy (DOE) Carlsbad Area Office (CAO) to assess and approve the laboratories and other measurement facilities supplying services for the characterization of WIPP TRU waste. The PDPs may also be used by CAO in qualifying laboratories proposing to supply additional analytical services that are required for other than waste characterization, such as WIPP site operations. The purpose of this PDP is to test laboratory performance for the analysis of solidified waste samples for TRU waste characterization. This performance will be demonstrated by the successful analysis of blind audit samples of simulated, solidified TRU waste according to the criteria established in this plan. Blind audit samples (hereinafter referred to as PDP samples) will be used as an independent means to assess laboratory performance regarding compliance with the QAOs. The concentration of analytes in the PDP samples will address levels of regulatory concern and will encompass the range of concentrations anticipated in actual waste characterization samples. Analyses that are required by the WIPP to demonstrate compliance with various regulatory requirements and which are included in the PDP must be performed by laboratories that demonstrate acceptable performance in the PDP. These analyses are referred to as WIPP analyses and the samples on which they are performed are referred to as WIPP samples for the balance of this document

  5. SRTC Spreadsheet to Determine Relative Percent Difference (RPD) for Duplicate Waste Assay Results and to Perform the RPD Acceptance Test

    International Nuclear Information System (INIS)

    Casella, V.R.

    2002-01-01

    This report documents the calculations and logic used for the Microsoft(R) Excel spreadsheet that is used at the 773-A Solid Waste Assay Facility for evaluating duplicate analyses, and validates that the spreadsheet is performing these functions correctly

  6. Performance of an ELISA and Indirect Immunofluorescence Assay in Serological Diagnosis of Zoonotic Cutaneous Leishmaniasis in Iran

    Directory of Open Access Journals (Sweden)

    Bahador Sarkari

    2014-01-01

    Full Text Available Serological assays have been extensively evaluated for diagnosis of visceral leishmaniasis (VL and considered as a routine method for diagnosis of VL while these methods are not properly evaluated for diagnosis of cutaneous leishmaniasis (CL. This study aimed to assess the performance of indirect immunofluorescent-antibody test (IFA and enzyme-linked immunosorbent assay (ELISA for serodiagnosis of cutaneous leishmaniasis in Iran. Sixty-one sera samples from parasitologically confirmed CL patients and 50 sera from healthy controls along with 50 sera from non-CL patients were collected. Antigen was prepared from promastigotes and amastigotes of Leishmania major. IFA was used to detect anti-Leishmania IgG while ELISA was used to detect anti-Leishmania IgM, total IgG, or IgG subclasses (IgG1 and 4. ELISA, for detection of total IgG and IgM, showed sensitivity of 83.6% and 84.7% and specificity of 62.7% and 54.6%, respectively. Sensitivity and specificity of ELISA for detecting IgG1 and IgG4 were 64%, 75% and 85%, 49%, respectively. Sensitivity and specificity of IFA were 91.6% and 81%. Conclusion. Findings of this study demonstrated that serological test, especially IFA, can be used for proper diagnosis of CL.

  7. Evaluation of the performance of the reduced local lymph node assay for skin sensitization testing.

    Science.gov (United States)

    Ezendam, Janine; Muller, Andre; Hakkert, Betty C; van Loveren, Henk

    2013-06-01

    The local lymph node assay (LLNA) is the preferred method for classification of sensitizers within REACH. To reduce the number of mice for the identification of sensitizers the reduced LLNA was proposed, which uses only the high dose group of the LLNA. To evaluate the performance of this method for classification, LLNA data from REACH registrations were used and classification based on all dose groups was compared to classification based on the high dose group. We confirmed previous examinations of the reduced LLNA showing that this method is less sensitive compared to the LLNA. The reduced LLNA misclassified 3.3% of the sensitizers identified in the LLNA and misclassification occurred in all potency classes and that there was no clear association with irritant properties. It is therefore not possible to predict beforehand which substances might be misclassified. Another limitation of the reduced LLNA is that skin sensitizing potency cannot be assessed. For these reasons, it is not recommended to use the reduced LLNA as a stand-alone assay for skin sensitization testing within REACH. In the future, the reduced LLNA might be of added value in a weight of evidence approach to confirm negative results obtained with non-animal approaches. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Performance Values for Non-Destructive Assay (NDA) Technique Applied to Wastes: Evaluation by the ESARDA NDA Working Group

    International Nuclear Information System (INIS)

    Rackham, Jamie; Weber, Anne-Laure; Chard, Patrick

    2012-01-01

    The first evaluation of NDA performance values was undertaken by the ESARDA Working Group for Standards and Non Destructive Assay Techniques and was published in 1993. Almost ten years later in 2002 the Working Group reviewed those values and reported on improvements in performance values and new measurement techniques that had emerged since the original assessment. The 2002 evaluation of NDA performance values did not include waste measurements (although these had been incorporated into the 1993 exercise), because although the same measurement techniques are generally applied, the performance is significantly different compared to the assay of conventional Safeguarded special nuclear material. It was therefore considered more appropriate to perform a separate evaluation of performance values for waste assay. Waste assay is becoming increasingly important within the Safeguards community, particularly since the implementation of the Additional Protocol, which calls for declaration of plutonium and HEU bearing waste in addition to information on existing declared material or facilities. Improvements in the measurement performance in recent years, in particular the accuracy, mean that special nuclear materials can now be accounted for in wastes with greater certainty. This paper presents an evaluation of performance values for the NDA techniques in common usage for the assay of waste containing special nuclear material. The main topics covered by the document are: 1- Techniques for plutonium bearing solid wastes 2- Techniques for uranium bearing solid wastes 3 - Techniques for assay of fissile material in spent fuel wastes. Originally it was intended to include performance values for measurements of uranium and plutonium in liquid wastes; however, as no performance data for liquid waste measurements was obtained it was decided to exclude liquid wastes from this report. This issue of the performance values for waste assay has been evaluated and discussed by the ESARDA

  9. Performance Values for Non-Destructive Assay (NDA) Technique Applied to Wastes: Evaluation by the ESARDA NDA Working Group

    Energy Technology Data Exchange (ETDEWEB)

    Rackham, Jamie [Babcock International Group, Sellafield, Seascale, Cumbria, (United Kingdom); Weber, Anne-Laure [Institut de Radioprotection et de Surete Nucleaire Fontenay-Aux-Roses (France); Chard, Patrick [Canberra, Forss Business and Technology park, Thurso, Caithness (United Kingdom)

    2012-12-15

    The first evaluation of NDA performance values was undertaken by the ESARDA Working Group for Standards and Non Destructive Assay Techniques and was published in 1993. Almost ten years later in 2002 the Working Group reviewed those values and reported on improvements in performance values and new measurement techniques that had emerged since the original assessment. The 2002 evaluation of NDA performance values did not include waste measurements (although these had been incorporated into the 1993 exercise), because although the same measurement techniques are generally applied, the performance is significantly different compared to the assay of conventional Safeguarded special nuclear material. It was therefore considered more appropriate to perform a separate evaluation of performance values for waste assay. Waste assay is becoming increasingly important within the Safeguards community, particularly since the implementation of the Additional Protocol, which calls for declaration of plutonium and HEU bearing waste in addition to information on existing declared material or facilities. Improvements in the measurement performance in recent years, in particular the accuracy, mean that special nuclear materials can now be accounted for in wastes with greater certainty. This paper presents an evaluation of performance values for the NDA techniques in common usage for the assay of waste containing special nuclear material. The main topics covered by the document are: 1- Techniques for plutonium bearing solid wastes 2- Techniques for uranium bearing solid wastes 3 - Techniques for assay of fissile material in spent fuel wastes. Originally it was intended to include performance values for measurements of uranium and plutonium in liquid wastes; however, as no performance data for liquid waste measurements was obtained it was decided to exclude liquid wastes from this report. This issue of the performance values for waste assay has been evaluated and discussed by the ESARDA

  10. Performance Demonstration Program Plan for RCRA Constituent Analysis of Solidified Wastes

    International Nuclear Information System (INIS)

    2006-01-01

    The Performance Demonstration Program (PDP) for Resource Conservation and Recovery Act (RCRA) constituents distributes test samples for analysis of volatile organic compounds (VOCs), semivolatile organic compounds (SVOCs), and metals in solid matrices. Each distribution of test samples is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD; DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardous Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department. The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the RCRA PDP. Participating laboratories demonstrate acceptable performance by successfully analyzing single-blind performance evaluation samples (subsequently referred to as PDP samples) according to the criteria established in this plan. PDP samples are used as an independent means to assess laboratory performance regarding compliance with the WAP quality assurance objectives (QAOs). The concentrations of analytes in the PDP samples address levels of regulatory concern and encompass the range of concentrations anticipated in waste characterization samples. The WIPP requires analyses of homogeneous solid wastes to demonstrate compliance with regulatory requirements. These analyses must be performed by laboratories that demonstrate acceptable performance in this PDP. These analyses are referred to as WIPP analyses, and the samples on which they are performed are referred to as WIPP samples. Participating laboratories must analyze PDP samples using the same procedures used for WIPP samples.

  11. An interferon-gamma release assay test performs well in routine screening for tuberculosis

    DEFF Research Database (Denmark)

    Vestergaard Danielsen, Allan; Fløe, Andreas; Lillebæk, Troels

    2014-01-01

    Introduction: A positive interferon-gamma release assay (IGRA) is regarded as proof of latent Mycobacterium tuberculosis infection. We conducted an evaluation of the IGRA test “T-SPOT.TB” to test its performance during clinical routine use by analysing the positivity rate and odds, effect of season...... and sensitivity. Material and methods: Data from T-SPOT.TB testing together with age and test indications (anti-tumour necrosis factor alpha (TNFα) candidate, contact investigation or suspicion of tuberculosis (TB)) were combined with mycobac­teria culture results. Results: A total of 1,809 patients were tested....... Conclusive results were achieved for 1,780 patients (98.4%). Among these, 4.6% of anti-TNFα candidates, 19.3% of contacts and 24.4% of TB suspects tested positive. Compared with anti-TNFα candidates, the odds for a positive result were significantly higher for contact investigations (odds ratio (OR), mean...

  12. High-performance liquid chromatographic assay for the determination of Aloe Emodin in mouse plasma.

    Science.gov (United States)

    Zaffaroni, M; Mucignat, C; Pecere, T; Zagotto, G; Frapolli, R; D'Incalci, M; Zucchetti, M

    2003-10-25

    An isocratic high-performance liquid chromatography (HPLC) method was developed and validated to determine Aloe Emodin (AE) in mouse plasma. The analysis required 0.3 ml of plasma and involves extraction with dichloromethane. The HPLC separation was carried out on Symmetry Shield RP18, a mobile phase of methanol-water-acetic acid (65:35:0.2) and fluorescence detection at lambda(ex)=410 nm and lambda(em)=510 nm. The retention time of AE was 11.7 min. The assay was linear from 10 to 1,000 ng/ml (r2 > or = 0.999), showed intra- and inter-day precision within 7.8 and 4.7%, and accuracy of 87.3-105.7%. Detection limit (LOD) and quantification limit (LOQ) were 4.5 and 5 ng/ml, respectively. The method was applied to determine for the first time the pharmacokinetic of AE in mice.

  13. Establishment and implementation of performance demonstration system for ultrasonic examination in Korea

    International Nuclear Information System (INIS)

    Kim, Yong-sik

    2007-01-01

    Korea Electric Power Research Institute (KEPRI) and Korea Hydro and Nuclear Power Company (KHNP) developed Korean Performance Demonstration (KPD) system for ultrasonic examination applicable to pressurized light-water reactor and pressurized heavy-water reactor power plants in accordance with ASME Sec. XI App. VIII. In order to develop the KPD system following works were completed. 1) Surveying the welds on piping of all nuclear power plants in Korea, 2) Surveying the bolting configuration of all nuclear power plant in Korea, 3) Determining the number and type of test specimens, 4)Designing the test and the practice specimens, 5) Developing quality assurance procedures for the fabrication of test specimens and system management, 6) Developing generic procedures for manual ultrasonic test, 7) Fabrication and fingerprint of test specimen. After establishing the KPD system, round robin tests were conducted to evaluate the accuracy and reliability of examination results by comparing traditional ASME code and performance demonstration method. KEPRI/KHNP had successfully developed the KPD system to fulfill the performance demonstration requirements of ASME Sec. XI, Appendix VIII, and are executing the performance demonstration test for ultrasonic examination system. (author)

  14. Effects of β-glucan polysaccharide revealed by the dominant lethal assay and micronucleus assays, and reproductive performance of male mice exposed to cyclophosphamide

    Directory of Open Access Journals (Sweden)

    Rodrigo Juliano Oliveira

    2014-01-01

    Full Text Available β-glucan is a well-known polysaccharide for its chemopreventive effect. This study aimed to evaluate the chemopreventive ability of β-glucan in somatic and germ cells through the dominant lethal and micronucleus assays, and its influence on the reproductive performance of male mice exposed to cyclophosphamide. The results indicate that β-glucan is capable of preventing changes in DNA in both germ cells and somatic ones. Changes in germ cells were evaluated by the dominant lethal assay and showed damage reduction percentages of 46.46% and 43.79% for the doses of 100 and 150 mg/kg. For the somatic changes, evaluated by micronucleus assay in peripheral blood cells in the first week of treatment, damage reduction percentages from 80.63-116.32% were found. In the fifth and sixth weeks, the percentage ranged from 10.20-52.54% and -0.95-62.35%, respectively. Besides the chemopreventive efficiency it appears that the β-glucan, when combined with cyclophosphamide, is able to improve the reproductive performance of males verified by the significant reduction in rates of post-implantation losses and reabsorption in the mating of nulliparous females with males treated with cyclophosphamide.

  15. Performance Demonstration Program Plan for the WIPP Experimental-Waste Characterization Program

    International Nuclear Information System (INIS)

    1991-02-01

    The Performance Demonstration Program is designed to ensure that compliance with the Quality Assurance Objective, identified in the Quality Assurance Program Plan for the WIPP Experimental-Waste Characterization Program (QAPP), is achieved. This Program Plan is intended for use by the WPO to assess the laboratory support provided for the characterization of WIPP TRU waste by the storage/generator sites. Phase 0 of the Performance Demonstration Program encompasses the analysis of headspace gas samples for inorganic and organic components. The WPO will ensure the implementation of this plan by designating an independent organization to coordinate and provide technical oversight for the program (Program Coordinator). Initial program support, regarding the technical oversight and coordination functions, shall be provided by the USEPA-ORP. This plan identifies the criteria that will be used for the evaluation of laboratory performance, the responsibilities of the Program Coordinator, and the responsibilities of the participating laboratories. 5 tabs

  16. Performance characteristics of SCC radioimmunoassay and clinical significance serum SCC Ag assay in patients with malignancy

    International Nuclear Information System (INIS)

    Kim, Dong Youn

    1986-01-01

    To evaluate the performance characteristics of SCC RIV and the clinical significance of serum SCC Ag assay in patients with malignancy, serum SCC Ag levels were measured by SCC RIV kit in 40 normal controls and 35 percents with various untreated malignancy, who visited Chonju Presbyterian Medical Center. The results were as follows; 1. The SCC RIA was simple to perform and can be completed in two workday. And the standard curve and reproducibility were both good. 2. The mean serum SCC Ag level in normal controls was 1.64 ± 0.93 ng/mL and normal upper limit of serum SCC Ag was defined as 2.6 ng/mL. 3 out of 40 (7.5%) normal controls showed elevated SCC Ag levels above the normal upper limit. 3. In 35 patients with various untreated malignancy, 18 patients (51.4%) showed elevated serum SCC Ag levels, 59.1% of 22 patients with cervical cancer, 80% of 5 patients with lung cancer, 33% of 3 patients with esophageal cancer, 0% of 2 patients with rectal cancer and 0% of 3 patients with breast cancer showed elevated serum SCC Ag levels. Above results represent that SCC RIV is simple method to perform followed by good standard curve and reproducibility, and may be a useful indicator reflecting diagnostic data of patients with cervical cancer and lung cancer

  17. Basic Evaluation of Analytical Performance and Clinical Utility of Immunoradiometric TSH Assay

    International Nuclear Information System (INIS)

    Suhy, Il Kyo; Cho, Bo Youn; Lee, Hong Kyu; Koh, Chang Soon; Min, Hun Ki; Lee, Mun Ho

    1987-01-01

    To assess the analytic performance of immunoradiometric TSH assay (IRMA TSH), assay precision determined by intra and interassay variance, assay accuracy determined by dilution and recovery study, were evaluated by using two commercial kit (Abott and Daichi). Normal range of basal serum TSH and TRH stimulated TSH increment were also determined in 234 healthy subjects (male 110, female 124; age 20-70) and 30 volunteers (male 10, female 20; age 21-26). In addition, basal TSH levels of 70 patients with untreated hyperthyroidism, 50 untreated hypothyroidism, and 60 euthyroidism were measured to assess the clinical utility of IRMA TSH. The detection limit of IRMA TSH was 0.04 mU/l and 0.08 mU/l by Abott Kit and Daichi kit respectively. Using Abott kit, intraassay variance were 2.0, 3.1 and 1.4% in mean TSH concentration 2.4, 31.6 and 98.2 mU/l repectively and interassay variance were 2.0 and 3.2% in mean TSH concentration 2.3 and 31.3 mU/l. Mean recovery rate was 92.5% and dilution study showed nearly straight line. When Daichi kit was used, intrasssay variance were 5.6, 5.2 and 6.2% in mean TSH concentration of 2.4, 31.6 and 98.2 mU/1 respectively and interassay variance were 7.1 and 7.4% in mean TSH of 2.3 and 31.3 mU,/l. Mean recovery rate was 89.9%. Normal range of basal TSH and TRH stimulated peak TSH were 0.38-4.02 mU/1 and 2.85-30.8 mU/1 repectively (95% confidence interval, Abott kit used). Sensitivity and specificity of basal TSH levels for diagnosing hypothyroidism as well as specificity for diagnosing hyperthyroidism were 100% by using both kit. Sensitivity of basal TSH level for diagnosing hyperthyroidism was 100% when TSH levels were measured by Abott kit while that was 80.9% when measured by Daichi kit. These results suggest that IRMA TSH was very precise and accurate method and might be used as a first line test in the evaluation of thyroid function

  18. Summary performance assessment of in situ remediation technologies demonstrated at Savannah River

    International Nuclear Information System (INIS)

    Rosenberg, N.D.; Robinson, B.A.; Birdsell, K.H.; Travis, B.J.

    1994-06-01

    The Office of Technology Development (OTD) in the Department of Energy's (DOE) Office of Environmental Restoration and Waste Management is investigating new technologies for ''better, faster, cheaper, safer'' environmental remediation. A program at DOE's Savannah River site was designed to demonstrate innovative technologies for the remediation of volatile organic compounds (VOCs) at nonarid sites. Two remediation technologies, in situ air stripping and in situ bioremediation--both using horizontal wells, were demonstrated at the site between 1990--1993. This brief report summarizes the conclusions from three separate modeling studies on the performance of these technologies

  19. Experience with local lymph node assay performance standards using standard radioactivity and nonradioactive cell count measurements.

    Science.gov (United States)

    Basketter, David; Kolle, Susanne N; Schrage, Arnhild; Honarvar, Naveed; Gamer, Armin O; van Ravenzwaay, Bennard; Landsiedel, Robert

    2012-08-01

    The local lymph node assay (LLNA) is the preferred test for identification of skin-sensitizing substances by measuring radioactive thymidine incorporation into the lymph node. To facilitate acceptance of nonradioactive variants, validation authorities have published harmonized minimum performance standards (PS) that the alternative endpoint assay must meet. In the present work, these standards were applied to a variant of the LLNA based on lymph node cell counts (LNCC) run in parallel as a control with the standard LLNA with radioactivity measurements, with threshold concentrations (EC3) being determined for the sensitizers. Of the 22 PS chemicals tested in this study, 21 yielded the same results from standard radioactivity and cell count measurements; only 2-mercaptobenzothiazole was positive by LLNA but negative by LNCC. Of the 16 PS positives, 15 were positive by LLNA and 14 by LNCC; methylmethacrylate was not identified as sensitizer by either of the measurements. Two of the six PS negatives tested negative in our study by both LLNA and LNCC. Of the four PS negatives which were positive in our study, chlorobenzene and methyl salicylate were tested at higher concentrations than the published PS, whereas the corresponding concentrations resulted in consistent negative results. Methylmethacrylate and nickel chloride tested positive within the concentration range used for the published PS. The results indicate cell counts and radioactive measurements are in good accordance within the same LLNA using the 22 PS test substances. Comparisons with the published PS results may, however, require balanced analysis rather than a simple checklist approach. Copyright © 2011 John Wiley & Sons, Ltd.

  20. Design and Demonstration of Emergency Control Modes for Enhanced Engine Performance

    Science.gov (United States)

    Liu, Yuan; Litt, Jonathan S.; Guo, Ten-Huei

    2013-01-01

    A design concept is presented for developing control modes that enhance aircraft engine performance during emergency flight scenarios. The benefits of increased engine performance to overall vehicle survivability during these situations may outweigh the accompanied elevated risk of engine failure. The objective involves building control logic that can consistently increase engine performance beyond designed maximum levels based on an allowable heightened probability of failure. This concept is applied to two previously developed control modes: an overthrust mode that increases maximum engine thrust output and a faster response mode that improves thrust response to dynamic throttle commands. This paper describes the redesign of these control modes and presents simulation results demonstrating both enhanced engine performance and robust maintenance of the desired elevated risk level.

  1. E-ELT M5 field stabilisation unit scale 1 demonstrator design and performances evaluation

    Science.gov (United States)

    Casalta, J. M.; Barriga, J.; Ariño, J.; Mercader, J.; San Andrés, M.; Serra, J.; Kjelberg, I.; Hubin, N.; Jochum, L.; Vernet, E.; Dimmler, M.; Müller, M.

    2010-07-01

    The M5 Field stabilization Unit (M5FU) for European Extremely Large Telescope (E-ELT) is a fast correcting optical system that shall provide tip-tilt corrections for the telescope dynamic pointing errors and the effect of atmospheric tiptilt and wind disturbances. A M5FU scale 1 demonstrator (M5FU1D) is being built to assess the feasibility of the key elements (actuators, sensors, mirror, mirror interfaces) and the real-time control algorithm. The strict constraints (e.g. tip-tilt control frequency range 100Hz, 3m ellipse mirror size, mirror first Eigen frequency 300Hz, maximum tip/tilt range +/- 30 arcsec, maximum tiptilt error < 40 marcsec) have been a big challenge for developing the M5FU Conceptual Design and its scale 1 demonstrator. The paper summarises the proposed design for the final unit and demonstrator and the measured performances compared to the applicable specifications.

  2. Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays.

    Science.gov (United States)

    Fogel, Jessica M; Piwowar-Manning, Estelle; Debevec, Barbara; Walsky, Tamara; Schlusser, Katherine; Laeyendecker, Oliver; Wilson, Ethan A; McCauley, Marybeth; Gamble, Theresa; Tegha, Gerald; Soko, Dean; Kumwenda, Johnstone; Hosseinipour, Mina C; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

    2017-08-01

    Antiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays. Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm (early ART arm, N = 180) or ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result). Ten (4.8%) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection. False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.

  3. Demonstration of a repository performance assessment capability at the US Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Codell, R.; Eisenberg, N.; McCartin, T.; Park, J.

    1991-01-01

    In order to better review licensing submittals for a High-Level Waste Repository, the US Nuclear Regulatory Commission staff has expanded and improved its capability to conduct performance assessments. A demonstration of this capability used the limited data from Yucca Mountain, Nevada to investigate a small set of scenario classes. Models of release and transport of radionuclides from a repository via the groundwater and direct release pathways provided preliminary estimates of releases to the accessible environment for a 10,000 year simulation time. Latin hypercube sampling of input parameters was used to express results as distributions and to investigate model sensitivities. This methodology demonstration should not be interpreted as an estimate of performance of the proposed repository at Yucca Mountain, Nevada

  4. Analyses to demonstrate the thermal performance of the CASTOR KN12

    International Nuclear Information System (INIS)

    Diersch, R.; Weiss, M.; Tso, C.F.; Powell, D.; Choy, B.I.; Lee, H.Y.

    2004-01-01

    The CASTOR registered KN-12 is a new cask design of GNB for dry and wet transportation of up to 12 PWR spent nuclear fuel assemblies in Korea. It complies with the requirements of 10 CFR 71 [1] and IAEA ST-1 [2] for TYPE B(U)F packages. It received its transport license from the Korean Competent Authority KINS in July 2002 and is now in use in South Korea. Demonstration of the cask's compliance with the regulatory requirements in the area of thermal performance has been carried out by a combination of testing carried out by Korea Atomic Energy Research Institute and analyses carried out by Arup. This paper describes the analyses to demonstrate the thermal performance of the cask and compliance with regulatory requirements under normal and hypothetical accident conditions of transport. Other aspects of the design of the CASTOR registered KN12 are presented in other papers at this conference

  5. Performance of a daylight redirecting glass shading system demonstration in an office building

    DEFF Research Database (Denmark)

    Appelfeld, David; Svendsen, Svend; Traberg-Borup, Steen

    2011-01-01

    This paper evaluates the daylighting performance of a prototype external dynamic integrated shading and light redirecting system. The demonstration project was carried out on a building with an open-plan office. The prototype and original façades were placed on the same floor with the same...... orientation and similar surroundings. The existing façade was used as the reference for measurements and simulations. The focus of this research project was to employ available simulation tools for the system performance evaluation. This was accompanied by measurements of the daylight conditions...... in the investigated space. The prototype system improved daylighting conditions compared to the existing shading system....

  6. Performance-Based Technology Selection Filter description report. INEL Buried Waste Integrated Demonstration System Analysis project

    Energy Technology Data Exchange (ETDEWEB)

    O`Brien, M.C.; Morrison, J.L.; Morneau, R.A.; Rudin, M.J.; Richardson, J.G.

    1992-05-01

    A formal methodology has been developed for identifying technology gaps and assessing innovative or postulated technologies for inclusion in proposed Buried Waste Integrated Demonstration (BWID) remediation systems. Called the Performance-Based Technology Selection Filter, the methodology provides a formalized selection process where technologies and systems are rated and assessments made based on performance measures, and regulatory and technical requirements. The results are auditable, and can be validated with field data. This analysis methodology will be applied to the remedial action of transuranic contaminated waste pits and trenches buried at the Idaho National Engineering Laboratory (INEL).

  7. Demonstrated high performance of gas-filled rugby-shaped hohlraums on Omega

    Energy Technology Data Exchange (ETDEWEB)

    Philippe, F.; Villette, B. [CEA, DAM, DIF, F-91297 Arpajon (France); Michel, P. [Lawrence Livermore National Laboratory, Livermore, California 94550 (United States); Petrasso, R. [Plasma Science and Fusion Center, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139 (United States); Stoeckl, C. [Laboratory for Laser Energetics, University of Rochester, Rochester, New York 14623 (United States); Giraldez, E. [General Atomics, P.O. Box 85608, San Diego, California 92186-5608 (United States); Tassin, V.; Depierreux, S.; Gauthier, P.; Masson-Laborde, P. E.; Monteil, M. C.; Seytor, P.; Lasinski, B.; Park, H. S.; Ross, J. S.; Amendt, P.; Döppner, T.; Hinkel, D. E.; Wallace, R.; Williams, E.; and others

    2014-07-15

    A direct experimental comparison of rugby-shaped and cylindrical shaped gas-filled hohlraums on the Omega laser facility demonstrates that higher coupling and minimal backscatter can be achieved in the rugby geometry, leading to significantly enhanced implosion performance. A nearly 50% increase of x-ray drive is associated with earlier bangtime and increase of neutron production. The observed drive enhancement from rugby geometry in this study is almost twice stronger than in previously published results.

  8. Demonstrated high performance of gas-filled rugby-shaped hohlraums on Omega

    Science.gov (United States)

    Philippe, F.; Tassin, V.; Depierreux, S.; Gauthier, P.; Masson-Laborde, P. E.; Monteil, M. C.; Seytor, P.; Villette, B.; Lasinski, B.; Park, H. S.; Ross, J. S.; Amendt, P.; Döppner, T.; Hinkel, D. E.; Wallace, R.; Williams, E.; Michel, P.; Frenje, J.; Gatu-Johnson, M.; Li, C. K.; Petrasso, R.; Glebov, V.; Sorce, C.; Stoeckl, C.; Nikroo, A.; Giraldez, E.

    2014-07-01

    A direct experimental comparison of rugby-shaped and cylindrical shaped gas-filled hohlraums on the Omega laser facility demonstrates that higher coupling and minimal backscatter can be achieved in the rugby geometry, leading to significantly enhanced implosion performance. A nearly 50% increase of x-ray drive is associated with earlier bangtime and increase of neutron production. The observed drive enhancement from rugby geometry in this study is almost twice stronger than in previously published results.

  9. Demonstrated high performance of gas-filled rugby-shaped hohlraums on Omega

    International Nuclear Information System (INIS)

    Philippe, F.; Villette, B.; Michel, P.; Petrasso, R.; Stoeckl, C.; Giraldez, E.; Tassin, V.; Depierreux, S.; Gauthier, P.; Masson-Laborde, P. E.; Monteil, M. C.; Seytor, P.; Lasinski, B.; Park, H. S.; Ross, J. S.; Amendt, P.; Döppner, T.; Hinkel, D. E.; Wallace, R.; Williams, E.

    2014-01-01

    A direct experimental comparison of rugby-shaped and cylindrical shaped gas-filled hohlraums on the Omega laser facility demonstrates that higher coupling and minimal backscatter can be achieved in the rugby geometry, leading to significantly enhanced implosion performance. A nearly 50% increase of x-ray drive is associated with earlier bangtime and increase of neutron production. The observed drive enhancement from rugby geometry in this study is almost twice stronger than in previously published results

  10. Demonstrated high performance of gas-filled rugby-shaped hohlraums on Omega

    Energy Technology Data Exchange (ETDEWEB)

    Philippe, F. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Tassin, V. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Depierreux, S. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Gauthier, P. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Masson-Laborde, P. E. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Monteil, M. C. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Seytor, P. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Villette, B. [Commissariat a l' Energie Atomique et aux Energies Alternatives (CEA), Arpajon (France); Lasinski, B. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Park, H. S. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Ross, J. S. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Amendt, P. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Doeppner, T. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Hinkel, D. E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wallace, R. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Williams, E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Michel, P. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Frenje, J. [Massachusetts Inst. of Technology (MIT), Cambridge, MA (United States). Plasma Science and Fusion Center; Gatu-Johnson, M. [Massachusetts Inst. of Technology (MIT), Cambridge, MA (United States). Plasma Science and Fusion Center; Li, C. K. [Massachusetts Inst. of Technology (MIT), Cambridge, MA (United States). Plasma Science and Fusion Center; Petrasso, R. [Massachusetts Inst. of Technology (MIT), Cambridge, MA (United States). Plasma Science and Fusion Center; Glebov, V. [Univ. of Rochester, NY (United States). Lab. for Laser Energetics; Sorce, C. [Univ. of Rochester, NY (United States). Lab. for Laser Energetics; Stoeckl, C. [Univ. of Rochester, NY (United States). Lab. for Laser Energetics; Nikroo, A. [General Atomics, San Diego, CA (United States); Giraldez, E. [General Atomics, San Diego, CA (United States)

    2014-07-25

    A direct experimental comparison of rugby-shaped and cylindrical shaped gas-filled hohlraums on the Omega laser facility demonstrates that higher coupling and minimal backscatter can be achieved in the rugby geometry, leading to significantly enhanced implosion performance. A nearly 50% increase of x-ray drive is associated with earlier bangtime and increase of neutron production. The observed drive enhancement from rugby geometry in this study is almost twice stronger than in previously published results.

  11. Implementation status of performance demonstration program for steam generator tubing analysts in Korea

    International Nuclear Information System (INIS)

    Cho, Chan Hee; Lee, Hee Jong; Yoo, Hyun Ju; Nam, Min Woo; Hong, Sung Yull

    2013-01-01

    Some essential components in nuclear power plants are periodically inspected using non destructive examinations, for example ultrasonic, eddy current and radiographic examinations, in order to determine their integrity. These components include nuclear power plant items such as vessels, containments, piping systems, pumps, valves, tubes and core support structure. Steam generator tubes have an important safety role because they constitute one of the primary barriers between the radioactive and non radioactive sides of the nuclear power plant. There is potential that if a tube bursts while a plant is operating, radioactivity from the primary coolant system could escape directly to the atmosphere. Therefore, in service inspections are critical in maintaining steam generator tube integrity. In general, the eddy current testing is widely used for the inspection of steam generator tubes due tube integrity. In general, the eddy current testing is widely used for the inspection of steam generator tubes due to its high inspection speed and flaw detectability on non magnetic tubes. However, it is not easy to analyze correctly eddy current signals because they are influenced by many factors. Therefore, the performance of eddy current data analysts for steam generator tubing should be demonstrated comprehensively. In Korea, the performance of steam generator tubing analysts has been demonstrated using the Qualified Data Analyst program. This paper describes the performance demonstration program for steam generator tubing analysts and its implementation results in Korea. The pass rate of domestic analysts for this program was 71.4%

  12. Implementation status of performance demonstration program for steam generator tubing analysts in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Chan Hee; Lee, Hee Jong; Yoo, Hyun Ju; Nam, Min Woo [KHNP Central Research Institute, Daejeon (Korea, Republic of); Hong, Sung Yull [Yeungnam Univ., Gyeongsan (Korea, Republic of)

    2013-02-15

    Some essential components in nuclear power plants are periodically inspected using non destructive examinations, for example ultrasonic, eddy current and radiographic examinations, in order to determine their integrity. These components include nuclear power plant items such as vessels, containments, piping systems, pumps, valves, tubes and core support structure. Steam generator tubes have an important safety role because they constitute one of the primary barriers between the radioactive and non radioactive sides of the nuclear power plant. There is potential that if a tube bursts while a plant is operating, radioactivity from the primary coolant system could escape directly to the atmosphere. Therefore, in service inspections are critical in maintaining steam generator tube integrity. In general, the eddy current testing is widely used for the inspection of steam generator tubes due tube integrity. In general, the eddy current testing is widely used for the inspection of steam generator tubes due to its high inspection speed and flaw detectability on non magnetic tubes. However, it is not easy to analyze correctly eddy current signals because they are influenced by many factors. Therefore, the performance of eddy current data analysts for steam generator tubing should be demonstrated comprehensively. In Korea, the performance of steam generator tubing analysts has been demonstrated using the Qualified Data Analyst program. This paper describes the performance demonstration program for steam generator tubing analysts and its implementation results in Korea. The pass rate of domestic analysts for this program was 71.4%.

  13. Comparison of the performance of IFA, CFA, and ELISA assays for the serodiagnosis of acute Q fever by quality assessment.

    Science.gov (United States)

    Herremans, Tineke; Hogema, Boris M; Nabuurs, Marrigje; Peeters, Marcel; Wegdam-Blans, Marjolijn; Schneeberger, Peter; Nijhuis, Carla; Notermans, Daan W; Galama, Joep; Horrevorts, Anton; van Loo, Inge H M; Vlaminckx, Bart; Zaaijer, Hans L; Koopmans, Marion P; Berkhout, Hanneke; Socolovschi, Cristina; Raoult, Didier; Stenos, John; Nicholson, William; Bijlmer, Henk

    2013-01-01

    The indirect immunofluorescence assay (IFA) is considered the reference method for diagnosing Q fever, but serology is also performed by complement fixation assay (CFA) or enzyme-linked immunosorbent assay (ELISA). However, comparability between these assays is not clear, and therefore a quality assessment was performed. A total of 25 serum samples from negative controls, Q fever patients, and a serial diluted high-positive sample were analyzed in 10 Dutch laboratories. Six laboratories performed CFA, 5 performed IFA, and 5 performed ELISAs. Three international reference laboratories from Australia, France, and the USA also participated in this study. Qualitative values between laboratories using the same methods were within close range, and all 3 methods correctly identified acute Q fever patients. The IFA, ELISA, and CFA are all suitable serodiagnostic assays to diagnose acute Q fever, but the IFA remains an important tool in the follow-up of patients and in identifying patients at risk for developing chronic Q fever. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Spent nuclear fuel integrity during dry storage - performance tests and demonstrations

    International Nuclear Information System (INIS)

    McKinnon, M.A.; Doherty, A.L.

    1997-06-01

    This report summarizes the results of fuel integrity surveillance determined from gas sampling during and after performance tests and demonstrations conducted from 1983 through 1996 by or in cooperation with the US DOE Office of Commercial Radioactive Waste Management (OCRWM). The cask performance tests were conducted at Idaho National Engineering Laboratory (INEL) between 1984 and 1991 and included visual observation and ultrasonic examination of the condition of the cladding, fuel rods, and fuel assembly hardware before dry storage and consolidation of fuel, and a qualitative determination of the effects of dry storage and fuel consolidation on fission gas release from the spent fuel rods. The performance tests consisted of 6 to 14 runs involving one or two loading, usually three backfill environments (helium, nitrogen, and vacuum backfills), and one or two storage system orientations. The nitrogen and helium backfills were sampled and analyzed to detect leaking spent fuel rods. At the end of each performance test, periodic gas sampling was conducted on each cask. A spent fuel behavior project (i.e., enhanced surveillance, monitoring, and gas sampling activities) was initiated by DOE in 1994 for intact fuel in a CASTOR V/21 cask and for consolidated fuel in a VSC-17 cask. The results of the gas sampling activities are included in this report. Information on spent fuel integrity is of interest in evaluating the impact of long-term dry storage on the behavior of spent fuel rods. Spent fuel used during cask performance tests at INEL offers significant opportunities for confirmation of the benign nature of long-term dry storage. Supporting cask demonstration included licensing and operation of an independent spent fuel storage installation (ISFSI) at the Virginia Power (VP) Surry reactor site. A CASTOR V/21, an MC-10, and a Nuclear Assurance NAC-I28 have been loaded and placed at the VP ISFSI as part of the demonstration program. 13 refs., 14 figs., 9 tabs

  15. Analytical and clinical performance of thyroglobulin autoantibody assays in thyroid cancer follow-up.

    Science.gov (United States)

    Katrangi, Waddah; Grebe, Stephan K G; Algeciras-Schimnich, Alicia

    2017-10-26

    While thyroglobulin autoantibodies (TgAb) can result in false low serum thyroglobulin (Tg) immunoassay (IA) measurements, they might also be indicators of disease persistence/recurrence. Hence, accurate TgAb measurement, in addition to Tg quantification, is crucial for thyroid cancer monitoring. We compared the analytical and clinical performance of four commonly used TgAb IAs. We measured Tg by mass spectrometry (Tg-MS) and by four pairs of Tg and TgAb IAs (Beckman, Roche, Siemens, Thermo) in 576 samples. Limit of quantitation (LOQ) and manufacturers' upper reference interval cut-off (URI) were used for comparisons. Clinical performance was assessed by receiving operator characteristics (ROC) curve analysis. Quantitative and qualitative agreement between TgAb-IAs was moderate with R2 of 0.20-0.70 and κ from 0.41-0.66 using LOQ and 0.47-0.71 using URI. In samples with TgAb interference, detection rates of TgAb were similar using LOQ and URI for Beckman, Siemens, and Thermo, but much lower for the Roche TgAb-IA when the URI was used. In TgAb positive cases, the ROC areas under the curve (AUC) for the TgAb-IAs were 0.59 (Beckman), 0.62 (Siemens), 0.59 (Roche), and 0.59 (Thermo), similar to ROC AUCs achieved with Tg. Combining Tg and TgAb measurements improved the ROC AUCs compared to Tg or TgAb alone. TgAb-IAs show significant qualitative and quantitative differences. For 2 of the 4 TgAb-IAs, using the LOQ improves the detection of interfering TgAbs. All assays showed suboptimal clinical performance when used as surrogate markers of disease, with modest improvements when Tg and TgAb were combined.

  16. Round Robin Test for Performance Demonstration System of Ultrasound Examination Personnel in Nuclear Power Plants

    International Nuclear Information System (INIS)

    Kim, Young Ho; Yang, Seung Han; Kim, Yong Sik; Yoon, Byung Sik; Lee, Hee Jong

    2005-01-01

    Ultrasound testing performance during in-service inspection for the main components of NPPs is strongly affected by each examination person. Therefore, ASME established a more strict qualification requirement in Sec. XI Appendix VIII for the ultrasound testing personnel in nuclear power plants. The Korean Performance Demonstration (KPD) System according to the ASME code for the ultrasonic testing personnel, equipments, and procedures to apply to the Class 1 and 2 piping ultrasound examination of nuclear power plants in Korea was established. And a round robin test was conducted in order to verify the effectiveness of PD method by comparing the examination results from the method of Performance Demonstration (PD) and a traditional ASME code dB-drop method. The round robin test shows that the reliability of the PD method is better than that of the dB-drop method. As a result, application of the PD method to the in-service inspection of the nuclear power plants will improve the performance of ultrasound testing

  17. Site-Specific Analyses for Demonstrating Compliance with 10 CFR 61 Performance Objectives - 12179

    Energy Technology Data Exchange (ETDEWEB)

    Grossman, C.J.; Esh, D.W.; Yadav, P.; Carrera, A.G. [U.S. Nuclear Regulatory Commission, 11545 Rockville Pike, Rockville, MD 20852 (United States)

    2012-07-01

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations at 10 CFR Part 61 to require low-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance with the performance objectives in Subpart C. The amendments would require licensees to conduct site-specific analyses for protection of the public and inadvertent intruders as well as analyses for long-lived waste. The amendments would ensure protection of public health and safety, while providing flexibility to demonstrate compliance with the performance objectives, for current and potential future waste streams. NRC staff intends to submit proposed rule language and associated regulatory basis to the Commission for its approval in early 2012. The NRC staff also intends to develop associated guidance to accompany any proposed amendments. The guidance is intended to supplement existing low-level radioactive waste guidance on issues pertinent to conducting site-specific analyses to demonstrate compliance with the performance objectives. The guidance will facilitate implementation of the proposed amendments by licensees and assist competent regulatory authorities in reviewing the site-specific analyses. Specifically, the guidance provides staff recommendations on general considerations for the site-specific analyses, modeling issues for assessments to demonstrate compliance with the performance objectives including the performance assessment, intruder assessment, stability assessment, and analyses for long-lived waste. This paper describes the technical basis for changes to the rule language and the proposed guidance associated with implementation of the rule language. The NRC staff, per Commission direction, intends to propose amendments to 10 CFR Part 61 to require licensees to conduct site-specific analyses to demonstrate compliance with performance objectives for the protection of public health and the environment. The amendments would require a

  18. Performance and cost results from a DOE Micro-CHP demonstration facility at Mississippi State University

    International Nuclear Information System (INIS)

    Giffin, Paxton K.

    2013-01-01

    Highlights: ► We examine the cost and performance results of a Micro-CHP demonstration facility. ► Evaluation includes both summer and winter performance. ► Evaluation in comparison to a conventional HVAC system using grid power. ► Influence of improperly sized equipment. ► Influence of natural gas prices on the viability of CHP projects using that fuel. - Abstract: Cooling, Heating, and Power (CHP) systems have been around for decades, but systems that utilize 20 kW or less, designated as Micro-CHP, are relatively new. A demonstration site has been constructed at Mississippi State University (MSU) to show the advantages of these micro scale systems. This study is designed to evaluate the performance of a Micro-CHP system as opposed to a conventional high-efficiency Heating, Ventilation, and Air Conditioning (HVAC) system that utilizes electrical power from the existing power grid. Raw data was collected for 7 months to present the following results. The combined cycle efficiency from the demonstration site was averaged at 29%. The average combined boiler and engine cost was $1.8 h −1 of operation for heating season and $3.9 h −1 of operation for cooling season. The cooling technology used, an absorption chiller exhibited an average Coefficient of Performance (COP) of 0.27. The conventional high-efficiency system, during cooling season, had a COP of 4.7 with a combined cooling and building cost of $0.2 h −1 of operation. During heating mode, the conventional system had an efficiency of 47% with a fuel and building electrical cost of $0.28 h −1 of operation.

  19. Analytical evaluation of Lumipulse® BRAHMS PCT CLEIA assay and clinical performances in an unselected population as compared with central lab PCT assay.

    Science.gov (United States)

    Dupuy, Anne Marie; Né, Maxence; Bargnoux, Anne Sophie; Badiou, Stéphanie; Cristol, Jean Paul

    2017-03-01

    We report the analytical performances of the Lumipulse®G BRAHMS PCT assay (Fujirebio, Courteboeuf, France) and the concordance with BRAHMS PCT Kryptor CompactPlus© results from central laboratory. Lumipulse®G BRAHMS PCT immunoassay on Lumipulse®G600II instrument is a chemiluminescence enzyme immunoassay (CLEIA). Analytical performances included imprecision study, linearity, limit of detection and comparison study on 138 plasma specimen on Lumipulse®G600II vs plasma on Kryptor CompactPlus©. The intra and inter assay imprecision of Lumipulse®G BRAHMS PCT was between 2 and 5%. The LoD in our condition was 0.0029ng/mL in accordance with the LoD provided by the manufacturer (0.0048ng/mL). The linear equation of linearity was y=1,001×-0,052 with r 2 =0.99, with a mean recovery (SD) percentage of 1.8% (8%). Correlation studies showed a good correlation (r=0.99) between plasma on Kryptor and Lumipulse, with a bias of 0.02 in the range from 0.12 to 1ng/mL. The new adaptation developed from Fujirebio on quantification of PCT with CLEIA technology from monoclonal antibodies from ThermoFisher appears to be acceptable for clinical use. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  20. Diagnostic performance of a commercial immunoblot assay for myositis antibody testing.

    Science.gov (United States)

    Bundell, Chris; Rojana-Udomsart, Arada; Mastaglia, Frank; Hollingsworth, Peter; McLean-Tooke, Andrew

    2016-06-01

    The objective of this study was to establish a population based reference range for a commercial immunoblot assay detecting myositis specific autoantibodies (MSAs) and myositis associated autoantibodies (MAAs), and to assess the diagnostic performance of this reference range against the manufacturer's recommended ranges in a myositis patient cohort. A total of 124 patients from a myositis cohort and 197 healthy controls were serologically assessed using a commercial immunoblot containing eleven autoantigens (Jo-1, EJ, OJ, PL7, PL12, Mi-2, SRP, Ku, PMScl75, PMScl100 and Ro52) according to the manufacturer's instructions. Use of the manufacturer's reference ranges resulted in detection of MSAs in 19.4% of myositis patients and 9.1% of controls; MAAs were detected in 41.1% of myositis patients and 14.2% of controls. Reference values derived from the healthy control population resulted in significant differences in cut-off values for some autoantibodies, particularly Ro52 and PMScl75. Use of local reference ranges reduced detection of MSAs to 16.9% of myositis patients and 3% of healthy controls, with MAAs 23.4% of patients and 2% of healthy controls. Application of population based reference ranges resulted in significant differences in detection of MSAs and MAAs compared to the manufacturer's recommended ranges. Cut-off levels should be assessed to ensure suitability for the population tested. Copyright © 2016. Published by Elsevier B.V.

  1. Demonstration of a performance assessment methodology for nuclear waste isolation in basalt formations

    International Nuclear Information System (INIS)

    Bonano, E.J.; Davis, P.A.

    1988-01-01

    This paper summarizes the results of the demonstration of a performance assessment methodology developed by Sandia National Laboratories, Albuquerque for the US Nuclear Regulatory Commission for use in the analysis of high-level radioactive waste disposal in deep basalts. Seven scenarios that could affect the performance of a repository in basalts were analyzed. One of these scenarios, normal ground-water flow, was called the base-case scenario. This was used to demonstrate the modeling capabilities in the methodology necessary to assess compliance with the ground-water travel time criterion. The scenario analysis consisted of both scenario screening and consequence modeling. Preliminary analyses of scenarios considering heat released from the waste and the alteration of the hydraulic properties of the rock mass due to loads created by a glacier suggested that these effects would not be significant. The analysis of other scenarios indicated that those changing the flow field in the vicinity of the repository would have an impact on radionuclide discharges, while changes far from the repository may not be significant. The analysis of the base-case scenario was used to show the importance of matrix diffusion as a radionuclide retardation mechanism in fractured media. The demonstration of the methodology also included an overall sensitivity analysis to identify important parameters and/or processes. 15 refs., 13 figs., 2 tabs

  2. STATISTICAL EVALUATION OF SMALL SCALE MIXING DEMONSTRATION SAMPLING AND BATCH TRANSFER PERFORMANCE - 12093

    Energy Technology Data Exchange (ETDEWEB)

    GREER DA; THIEN MG

    2012-01-12

    The ability to effectively mix, sample, certify, and deliver consistent batches of High Level Waste (HLW) feed from the Hanford Double Shell Tanks (DST) to the Waste Treatment and Immobilization Plant (WTP) presents a significant mission risk with potential to impact mission length and the quantity of HLW glass produced. DOE's Tank Operations Contractor, Washington River Protection Solutions (WRPS) has previously presented the results of mixing performance in two different sizes of small scale DSTs to support scale up estimates of full scale DST mixing performance. Currently, sufficient sampling of DSTs is one of the largest programmatic risks that could prevent timely delivery of high level waste to the WTP. WRPS has performed small scale mixing and sampling demonstrations to study the ability to sufficiently sample the tanks. The statistical evaluation of the demonstration results which lead to the conclusion that the two scales of small DST are behaving similarly and that full scale performance is predictable will be presented. This work is essential to reduce the risk of requiring a new dedicated feed sampling facility and will guide future optimization work to ensure the waste feed delivery mission will be accomplished successfully. This paper will focus on the analytical data collected from mixing, sampling, and batch transfer testing from the small scale mixing demonstration tanks and how those data are being interpreted to begin to understand the relationship between samples taken prior to transfer and samples from the subsequent batches transferred. An overview of the types of data collected and examples of typical raw data will be provided. The paper will then discuss the processing and manipulation of the data which is necessary to begin evaluating sampling and batch transfer performance. This discussion will also include the evaluation of the analytical measurement capability with regard to the simulant material used in the demonstration tests. The

  3. Selecting the correct weighting factors for linear and quadratic calibration curves with least-squares regression algorithm in bioanalytical LC-MS/MS assays and impacts of using incorrect weighting factors on curve stability, data quality, and assay performance.

    Science.gov (United States)

    Gu, Huidong; Liu, Guowen; Wang, Jian; Aubry, Anne-Françoise; Arnold, Mark E

    2014-09-16

    A simple procedure for selecting the correct weighting factors for linear and quadratic calibration curves with least-squares regression algorithm in bioanalytical LC-MS/MS assays is reported. The correct weighting factor is determined by the relationship between the standard deviation of instrument responses (σ) and the concentrations (x). The weighting factor of 1, 1/x, or 1/x(2) should be selected if, over the entire concentration range, σ is a constant, σ(2) is proportional to x, or σ is proportional to x, respectively. For the first time, we demonstrated with detailed scientific reasoning, solid historical data, and convincing justification that 1/x(2) should always be used as the weighting factor for all bioanalytical LC-MS/MS assays. The impacts of using incorrect weighting factors on curve stability, data quality, and assay performance were thoroughly investigated. It was found that the most stable curve could be obtained when the correct weighting factor was used, whereas other curves using incorrect weighting factors were unstable. It was also found that there was a very insignificant impact on the concentrations reported with calibration curves using incorrect weighting factors as the concentrations were always reported with the passing curves which actually overlapped with or were very close to the curves using the correct weighting factor. However, the use of incorrect weighting factors did impact the assay performance significantly. Finally, the difference between the weighting factors of 1/x(2) and 1/y(2) was discussed. All of the findings can be generalized and applied into other quantitative analysis techniques using calibration curves with weighted least-squares regression algorithm.

  4. High-performance liquid chromatographic assay for genistein in biological fluids.

    Science.gov (United States)

    Supko, J G; Phillips, L R

    1995-04-07

    A specific, sensitive and technically convenient HPLC method for assaying genistein in biological fluids has been developed. The compound and 4-hydroxybenzophenone, added as an internal standard, were efficiently isolated from both plasma and urine by extraction with tert-butyl methyl ether. Following evaporation of the organic solvent, the extract was reconstituted with methanol-0.05 M ammonium acetate buffer, pH 4.7 (30:70, v/v), and loaded onto a 4 microns Nova-Pak C8 column (15 cm x 3.9 mm I.D.). Chromatography was performed at ambient temperature using a mobile phase of acetonitrile-0.05 M ammonium formate buffer, pH 4.0 (27:73, v/v), at a flow-rate of 1.0 ml/min, with UV detection at 260 nm. Mean values of the tR for the drug and internal standard, determined from chromatograms of the 1 microgram/ml plasma standard during a 6 month period, were 8.27 +/- 0.55 and 11.92 +/- 0.71 min, respectively (S.D., n = 29). With a sample volume of 50 microliters, the lowest concentration of genistein included in the plasma standard curve, 0.020 microgram/ml, was quantified with a 10.7% R.S.D. over a 5 month period. Plasma standards having concentrations of 0.050 to 1.02 micrograms/ml exhibited R.S.D. values ranging from 2.3 to 6.1%. The drug was quantified in urine with similar reproducibility. The sensitivity of the assay was adequate for characterizing the plasma pharmacokinetics of genistein in the mouse and dog. However, a 10-fold improvement in sensitivity was afforded by increasing the sample size to 250 microliters, without otherwise modifying the method. Thus, this procedure may prove suitable for determining plasma and urine levels of genistein in humans consuming dietary isoflavonoids in a much more convenient manner than permitted by existing methodology.

  5. Nondestructive examinations performance demonstration standpoint of the BCCN (Nuclear Construction Inspection Office)

    International Nuclear Information System (INIS)

    Deschamps, J.; Novat, J.

    1994-01-01

    The part played by in service non-destructive examinations (NDE) in the safety assessment of French nuclear power plants has developed considerably since startup of the first PWR unit 15 years ago. In 15 years of operation and continued plant construction, defects came to light, revealed either by a non-destructive examination or a leak occurring in operation or during hydrostatic test. It is consequently necessary to operate reactors affected by defects already detected or liable to develop according to a known mechanism. This practice is only acceptable if it can be proved that the defects will remain harmless in all situations. This implies that they can be detected without fail beyond a certain threshold, that they can be characterized and that their propensity to develop can be measured. In some cases, only NDE data can justify the continued operation of a reactor. Maximum guarantees as to the performances and reliability of these examinations are consequently indispensable, since plant safety conclusions will be based on their results. This paper discusses: the advantages of an NDE performance demonstration program; practical assessments role; and NDE performance demonstration stages

  6. The impact of initiation: Early onset marijuana smokers demonstrate altered Stroop performance and brain activation

    Directory of Open Access Journals (Sweden)

    K.A. Sagar

    2015-12-01

    Full Text Available Marijuana (MJ use is on the rise, particularly among teens and emerging adults. This poses serious public health concern, given the potential deleterious effects of MJ on the developing brain. We examined 50 chronic MJ smokers divided into early onset (regular MJ use prior to age 16; n = 24 and late onset (age 16 or later; n = 26, and 34 healthy control participants (HCs. All completed a modified Stroop Color Word Test during fMRI. Results demonstrated that MJ smokers exhibited significantly poorer performance on the Interference subtest of the Stroop, as well as altered patterns of activation in the cingulate cortex relative to HCs. Further, early onset MJ smokers exhibited significantly poorer performance relative to both HCs and late onset smokers. Additionally, earlier age of MJ onset as well as increased frequency and magnitude (grams/week of MJ use were predictive of poorer Stroop performance. fMRI results revealed that while late onset smokers demonstrated a more similar pattern of activation to the control group, a different pattern was evident in the early onset group. These findings underscore the importance of assessing age of onset and patterns of MJ use and support the need for widespread education and intervention efforts among youth.

  7. Noise Performance Evaluation of the Candidate Digitizers for the MAJORANA DEMONSTRATOR

    Energy Technology Data Exchange (ETDEWEB)

    Aguayo Navarrete, Estanislao

    2011-03-16

    The noise performance evaluation of the two digitizer cards being considered for the MAJORANA DEMONSTRATOR (MJD) is presented in this document. The procurement of the data acquisition electronics for the MJD is scheduled to happen this year. At the time of writing this document, there are two candidate digitizer electronic boards. One aspect that is being considered by the collaboration is the feasibility of using the MJD for dark matter searches. The feasibility of using the MJD for this application is going to be dictated by the ability of the demonstrator to reach sub-keV energy resolution. One of the potential sources of noise in the MJD is the data acquisition system. This document will is concluded with a recommendation for the final digitizer board by comparing the noise performance of the two electronics systems. Noise parameters such as the effective number of bits, input range linearity and signal to noise ratio are experimentally determined. The two digitizer cards feature different on-board digital signal processing and these features are compared. The experimental set-up was also used to identify sources of noise. This paper describes these sources of noise in the data acquisition system, along with mitigation strategies. Issues such as grounding and wiring scheme have an impact in the overall data acquisition system performance and are discussed in detail. As a conclusion, the suitability of each one of the cards to become the back bone of the data acquisition system of the MJD is discussed.

  8. Technical Bases to Consider for Performance and Demonstration Testing of Space Fission Reactors

    International Nuclear Information System (INIS)

    Hixson, Laurie L.; Houts, Michael G.; Clement, Steven D.

    2004-01-01

    Performance and demonstration testing are critical to the success of a space fission reactor program. However, the type and extent to which testing of space reactors should be performed has been a point of discussion within the industry for many years. With regard to full power ground nuclear tests, questions such as 'Do the benefits outweigh the risks? Are there equivalent alternatives? Can a test facility be constructed (or modified) in a reasonable amount of time? Will the test article accurately represent the flight system? Are the costs too restrictive?' have been debated for decades. There are obvious benefits of full power ground nuclear testing such as obtaining systems integrated reliability data on a full-scale, complete end-to-end system. But these benefits come at some programmatic risk. In addition, this type of testing does not address safety related issues. This paper will discuss and assess these and other technical considerations essential in deciding which type of performance and demonstration testing to conduct on space fission reactor systems. (authors)

  9. Comparative Evaluation of the Diagnostic Performance of the Prototype Cepheid GeneXpert Ebola Assay

    Science.gov (United States)

    Jansen van Vuren, Petrus; Grobbelaar, Antoinette; Storm, Nadia; Conteh, Ousman; Konneh, Kelfala; Kamara, Abdul; Sanne, Ian

    2015-01-01

    The Ebola virus disease (EVD) outbreak in West Africa has highlighted an urgent need for point-of-care (POC) assays for the diagnosis of this devastating disease in resource-limited African countries. The diagnostic performance characteristics of a prototype Cepheid GeneXpert Ebola POC used to detect Ebola virus (EBOV) in stored serum and plasma samples collected from suspected EVD cases in Sierra Leone in 2014 and 2015 was evaluated. The GeneXpert Ebola POC is a self-contained single-cartridge automated system that targets the glycoprotein (GP) and nucleoprotein (NP) genes of EBOV and yields results within 90 min. Results from 281 patient samples were compared to the results of a TaqMan real-time reverse transcription-PCR (RT-PCR) targeting the polymerase gene and performed on two real-time PCR machines. Agreement between the three platforms was 100% at cycle threshold (CT) values of ≤34.99, but discordant results were noted between CT values of 35 and 45.The diagnostic sensitivity of the three platforms was 100% in 91 patient samples that were confirmed to be infectious by virus isolation. All three molecular platforms detected viral EBOV RNA in additional samples that did not contain viable EBOV. The analytical sensitivity of the GeneXpert Ebola POC for the detection of NP was higher, and comparable to that of polymerase gene detection, than that for the detection of GP when using a titrated laboratory stock of EBOV. There was no detectable cross-reactivity with other hemorrhagic fever viruses or arboviruses. The GeneXpert Ebola POC offers an easy to operate and sensitive diagnostic tool that can be used for the rapid screening of suspected EVD cases in treatment or in holding centers during EVD outbreaks. PMID:26637383

  10. Construction and performance tests of Helium Engineering Demonstration Loop (HENDEL) for VHTR

    International Nuclear Information System (INIS)

    Hishida, M.; Tanaka, T.; Shimomura, H.; Sanokawa, K.

    1984-01-01

    A helium engineering demonstration loop (HENDEL) was constructed and operated in JAERI in order to develop the high-temperature key components of an experimental very high temperature gas cooled reactor, like fuel stack, in-core reactor structure, hot gas duct, intermediate heat exchanger. Performance tests as well as demonstration of integrity are carried out with large-size or actual-size models of key components. The key components to be tested in HENDEL are: fuel stack and control rod; core supporting structure, or bottom structure of rector core exposed to direct impingement of high temperature core outlet flow; reactor internal components and structure; high temperature components in heat removal system (primary and secondary cooling systems)

  11. Higs-instrument: design and demonstration of a high performance gas concentration imager

    Science.gov (United States)

    Verlaan, A. L.; Klop, W. A.; Visser, H.; van Brug, H.; Human, J.

    2017-09-01

    Climate change and environmental conditions are high on the political agenda of international governments. Laws and regulations are being setup all around the world to improve the air quality and to reduce the impact. The growth of a number of trace gasses, including CO2, Methane and NOx are especially interesting due to their environmental impact. The regulations made are being based on both models and measurements of the trend of those trace gases over the years. Now the regulations are in place also enforcement and therewith measurements become more and more important. Instruments enabling high spectral and spatial resolution as well as high accurate measurements of trace gases are required to deliver the necessary inputs. Nowadays those measurements are usually performed by space based spectrometers. The requirement for high spectral resolution and measurement accuracy significantly increases the size of the instruments. As a result the instrument and satellite becomes very expensive to develop and to launch. Specialized instruments with a small volume and the required performance will offer significant advantages in both cost and performance. Huib's Innovative Gas Sensor (HIGS, named after its inventor Huib Visser), currently being developed at TNO is an instrument that achieves exactly that. Designed to measure only a single gas concentration, opposed to deriving it from a spectrum, it achieves high performance within a small design volume. The instrument enables instantaneous imaging of the gas distribution of the selected gas. An instrument demonstrator has been developed for NO2 detection. Laboratory measurements proved the measurement technique to be successful. An on-sky measurement campaign is in preparation. This paper addresses both the instrument design as well as the demonstrated performances.

  12. Performance Characteristics of qPCR Assays Targeting Human- and Ruminant-Associated Bacteroidetes for Microbial Source Tracking across Sixteen Countries on Six Continents

    Science.gov (United States)

    2013-01-01

    Numerous quantitative PCR assays for microbial fecal source tracking (MST) have been developed and evaluated in recent years. Widespread application has been hindered by a lack of knowledge regarding the geographical stability and hence applicability of such methods beyond the regional level. This study assessed the performance of five previously reported quantitative PCR assays targeting human-, cattle-, or ruminant-associated Bacteroidetes populations on 280 human and animal fecal samples from 16 countries across six continents. The tested cattle-associated markers were shown to be ruminant-associated. The quantitative distributions of marker concentrations in target and nontarget samples proved to be essential for the assessment of assay performance and were used to establish a new metric for quantitative source-specificity. In general, this study demonstrates that stable target populations required for marker-based MST occur around the globe. Ruminant-associated marker concentrations were strongly correlated with total intestinal Bacteroidetes populations and with each other, indicating that the detected ruminant-associated populations seem to be part of the intestinal core microbiome of ruminants worldwide. Consequently tested ruminant-targeted assays appear to be suitable quantitative MST tools beyond the regional level while the targeted human-associated populations seem to be less prevalent and stable, suggesting potential for improvements in human-targeted methods. PMID:23755882

  13. Performance values for non destructive assay (NDA) techniques applied to safeguards: the 2002 evaluation by the ESARDA NDA Working Group

    International Nuclear Information System (INIS)

    Guardini, S.

    2003-01-01

    The first evaluation of NDA performance values undertaken by the ESARDA Working Group for Standards and Non Destructive Assay Techniques (WGNDA) was published in 1993. Almost 10 years later the Working Group decided to review those values, to report about improvements and to issue new performance values for techniques which were not applied in the early nineties, or were at that time only emerging. Non-Destructive Assay techniques have become more and more important in recent years, and they are used to a large extent in nuclear material accountancy and control both by operators and control authorities. As a consequence, the performance evaluation for NDA techniques is of particular relevance to safeguards authorities in optimising Safeguards operations and reducing costs. Performance values are important also for NMAC regulators, to define detection levels, limits for anomalies, goal quantities and to negotiate basic audit rules. This paper presents the latest evaluation of ESARDA Performance Values (EPVs) for the most common NDA techniques currently used for the assay of nuclear materials for Safeguards purposes. The main topics covered by the document are: techniques for plutonium bearing materials: PuO 2 and MOX; techniques for U-bearing materials; techniques for U and Pu in liquid form; techniques for spent fuel assay. This issue of the performance values is the result of specific international round robin exercises, field measurements and ad hoc experiments, evaluated and discussed in the ESARDA NDA Working Group. (author)

  14. In-Space Demonstration of High Performance Green Propulsion and its Impact on Small Satellites

    OpenAIRE

    Anflo, Kjell; Crowe, Ben

    2011-01-01

    This paper summarizes the pre-launch activities and the results from the in-space demonstration of a novel propulsion system on the PRISMA main satellite, using a “Green” monopropellant. This propellant is a storable ADN-based monopropellant blend (i.e. LMP-103S). The basic mission for the High Performance Green Propulsion System (HPGP) has been successfully completed and all primary objectives of TRL 7 have been met. The HPGP technology is now flight proven and ready for implementation on fu...

  15. Normalized performance and load data for the deepwind demonstrator in controlled conditions

    DEFF Research Database (Denmark)

    Battisti, L.; Benini, E.; Brighenti, A.

    2016-01-01

    , derived from real scale measurements on a three-bladed Troposkien vertical-axis wind turbine, are manipulated in a convenient form to be easily compared with the typical outputs provided by simulation codes. The here proposed data complement and support the measurements already presented in "Wind Tunnel......Performance and load normalized coefficients, deriving from an experimental campaign of measurements conducted at the large scale wind tunnel of the Politecnico di Milano (Italy), are presented with the aim of providing useful benchmark data for the validation of numerical codes. Rough data...... Testing of the DeepWind Demonstrator in Design and Tilted Operating Conditions" (Battisti et al., 2016) [1]....

  16. Experimental demonstration of H∞ filter performance for dynamic compensation of rhodium neutron detectors

    International Nuclear Information System (INIS)

    Park, Moon-Ghu; Choi, Yu-Sun; Lee, Kwang-Dae

    2008-01-01

    This paper describes the experimental demonstration of the theoretical result of the previous work on LMI (linear matrix inequality) based H ∞ filter for time-delay compensation of self-powered neutron detectors. The filter gains are optimized in the sense of noise attenuation level of H ∞ setting. By introducing bounded real lemma, the conventional algebraic Riccati inequalities are converted into linear matrix inequalities (LMIs). Finally, the filter design problem is solved via the convex optimization framework using LMIs. The experimental measurements of rhodium detector signal from a research reactor show that the predicted theoretical filter performance is verified by showing successful reconstruction of the reference power signal

  17. Advanced Flue Gas Desulfurization (AFGD) demonstration project: Volume 2, Project performance and economics. Final technical report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-04-30

    The project objective is to demonstrate removal of 90--95% or more of the SO{sub 2} at approximately one-half the cost of conventional scrubbing technology; and to demonstrate significant reduction of space requirements. In this project, Pure Air has built a single SO{sub 2} absorber for a 528-MWe power plant. The absorber performs three functions in a single vessel: prequencher, absorber, and oxidation of sludge to gypsum. Additionally, the absorber is of a co- current design, in which the flue gas and scrubbing slurry move in the same direction and at a relatively high velocity compared to conventional scrubbers. These features all combine to yield a state- of-the-art SO{sub 2} absorber that is more compact and less expensive than conventional scrubbers. The project incorporated a number of technical features including the injection of pulverized limestone directly into the absorber, a device called an air rotary sparger located within the base of the absorber, and a novel wastewater evaporation system. The air rotary sparger combines the functions of agitation and air distribution into one piece of equipment to facilitate the oxidation of calcium sulfite to gypsum. Additionally, wastewater treatment is being demonstrated to minimize water disposal problems inherent in many high-chloride coals. Bituminous coals primarily from the Indiana, Illinois coal basin containing 2--4.5% sulfur were tested during the demonstration. The Advanced Flue Gas Desulfurization (AFGD) process has demonstrated removal of 95% or more of the SO{sub 2} while providing a commercial gypsum by-product in lieu of solid waste. A portion of the commercial gypsum is being agglomerated into a product known as PowerChip{reg_sign} gypsum which exhibits improved physical properties, easier flowability and more user friendly handling characteristics to enhance its transportation and marketability to gypsum end-users.

  18. Quality Improvement to Demonstrate the Lack of Reliability of the Human Papillomavirus mRNA Assay to Identify Women With Latent Human Papillomavirus Infections.

    Science.gov (United States)

    Cotton, Sarah; Brown, Robert E; Nugent, Elizabeth K; Robazetti, Sonia C; Berens, Pamela D; Smith, Judith A

    2018-04-01

    To assess the consistency between human papillomavirus (HPV) mRNA testing in women with a history of previous HPV infections diagnosed by HPV DNA assay and the potential effects on follow-up HPV screening. This was a quality improvement study that used data from a pathology laboratory software database reviewed from November 2014 to June 2016 to identify female patients aged 30 years or older with greater than one HPV-positive result, including one or more HPV mRNA assay results and one or more documented HPV DNA assay results for comparison. Previous correlative cytology and colposcopic histopathology were also documented. American College of Obstetricians and Gynecologists' cervical cancer screening guidelines were used to compare potential differences in follow-up recommendations. Four hundred twenty-five charts for female patients 30 years of age or older were identified with one or more prior high-risk HPV infections by DNA assay. There was a 69.3% difference in HPV mRNA results compared with previous HPV DNA-positive results. There was a potential change in follow-up for 71.7% of patients with one prior high-risk-HPV-positive result and 60.0% of patients with two or more prior high-risk HPV-positive results. There were 231 colposcopy reports evaluated in this study. Of these, 62 (26.8%) were abnormal colposcopy reports, including 45 low-grade squamous intraepithelial lesions, 15 high-grade squamous intraepithelial lesions, and two cancers. Twenty-five (40.3%) abnormal colposcopy findings were in patients with a history of at least than two prior HPV DNA-positive results and a report of currently being HPV-negative with the mRNA assay. The HPV mRNA assays are less sensitive for detection of latent HPV infections compared with HPV DNA assays. Based on these data and the potential change in follow-up care, the HPV mRNA assay should not be used for a primary screening tool for cervical cancer. Many pathology laboratories have shifted to using the HPV mRNA assay

  19. Draft plan for the Waste Isolation Pilot Plant test phase: Performance assessment and operations demonstration

    International Nuclear Information System (INIS)

    1989-04-01

    The mission of the Waste Isolation Pilot Plant (WIPP) Project is to provide a research and development facility to demonstrate the safe disposal of transuranic (TRU) radioactive wastes resulting from United States defense programs. With the Construction Phase of the WIPP facility nearing completion, WIPP is ready to initiate the next phase in its development, the Test Phase. The purpose of the Test Phase is to collect the necessary scientific and operational data to support a determination whether to proceed to the Disposal Phase and thereby designate WIPP a demonstration facility for the disposal of TRU wastes. This decision to proceed to the Disposal Phase is scheduled for consideration by September 1994. Development of the WIPP facility is the responsibility of the United States Department of Energy (DOE), whose Albuquerque Operations Office has designated the WIPP Project Office as Project Manager. This document describes the two major programs to be conducted during the Test Phase of WIPP: (1) Performance Assessment for determination of compliance with the Environmental Protection Agency Standard and (2) Operations Demonstration for evaluation of the safety and effectiveness of the DOE TRU waste management system's ability to emplace design throughput quantities of TRU waste in the WIPP facility. 42 refs., 38 figs., 14 tabs

  20. LIFAC sorbent injection desulfurization demonstration project. Final report, volume II: Project performance and economics

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-01

    This publication discusses the demonstration of the LIFAC sorbent injection technology at Richmond Power and Light`s Whitewater Valley Unit No. 2, performed under the auspices of the U.S. Department of Energy`s (DOE) Clean Coal Technology Program. LIFAC is a sorbent injection technology capable of removing 75 to 85 percent of a power plant`s SO{sub 2} emissions using limestone at calcium to sulfur molar ratios of between 2 and 2.5 to 1. The site of the demonstration is a coal-fired electric utility power plant located in Richmond, Indiana. The project is being conducted by LIFAC North America (LIFAC NA), a joint venture partnership of Tampella Power Corporation and ICF Kaiser Engineers, in cooperation with DOE, RP&L, and Research Institute (EPRI), the State of Indiana, and Black Beauty Coal Company. The purpose of Public Design Report Volume 2: Project Performance and Economics is to consolidate, for public use, the technical efficiency and economy of the LIFAC Process. The report has been prepared pursuant to the Cooperative Agreement No. DE-FC22-90PC90548 between LIFAC NA and the U.S. Department of Energy.

  1. Comparison of Hemoglobin A1c assay performance on two different commercial systems

    Directory of Open Access Journals (Sweden)

    Jozo Ćorić

    2015-04-01

    Full Text Available Introduction: Glycated hemoglobin (HbA1c is formed by non-enzymatic binding of glucose to the free amino group of the N-terminal end of the ß-chain of hemoglobin A. HbA1c is representative of the mean blood glucose level over three months. The aim of the study was to evaluate the Hemoglobin A1c immunoturbidimetric assay performance on two different commercial systems.Methods: We evaluated the precision and trueness for determination of HbA1c in whole blood. Concentrations of total hemoglobin and HbA1c were evaluated on Dimension Xpand (Siemens and Cobas 501 (Roche analyzers. HbA1c was measured in a latex agglutination inhibition test. Commercial controls Liquichek Diabetes Control Level 1 and Liquichek Diabetes Control Level 2 (Bio Rad at two levels were used for quality control. Analytical validation of HbA1c included: within-run imprecision, between-day imprecision, inaccuracy and comparison determination on the human samples on 2 systems: Dimension Xpand and Cobas 501 analyzers. Results: Within-run imprecision on the commercially controls for Level 1 is 4.5% and Level 2 is 3.2% between-day imprecision on commercially controls is 6.1% Level 1 and 5.1% Level 2 for respectively inac- curacy on commercially controls for Level 1 is 1.8% and Level 2 is 4.8%. Method comparison on human samples shows the correlation coefficient of 0.99.Conclusion: The presented results of the analytical evaluation methods for the determination of HbA1c showed an acceptable accuracy and precision.

  2. Small Scale Mixing Demonstration Batch Transfer and Sampling Performance of Simulated HLW - 12307

    Energy Technology Data Exchange (ETDEWEB)

    Jensen, Jesse; Townson, Paul; Vanatta, Matt [EnergySolutions, Engineering and Technology Group, Richland, WA, 99354 (United States)

    2012-07-01

    The ability to effectively mix, sample, certify, and deliver consistent batches of High Level Waste (HLW) feed from the Hanford Double Shell Tanks (DST) to the Waste treatment Plant (WTP) has been recognized as a significant mission risk with potential to impact mission length and the quantity of HLW glass produced. At the end of 2009 DOE's Tank Operations Contractor, Washington River Protection Solutions (WRPS), awarded a contract to EnergySolutions to design, fabricate and operate a demonstration platform called the Small Scale Mixing Demonstration (SSMD) to establish pre-transfer sampling capacity, and batch transfer performance data at two different scales. This data will be used to examine the baseline capacity for a tank mixed via rotational jet mixers to transfer consistent or bounding batches, and provide scale up information to predict full scale operational performance. This information will then in turn be used to define the baseline capacity of such a system to transfer and sample batches sent to WTP. The Small Scale Mixing Demonstration (SSMD) platform consists of 43'' and 120'' diameter clear acrylic test vessels, each equipped with two scaled jet mixer pump assemblies, and all supporting vessels, controls, services, and simulant make up facilities. All tank internals have been modeled including the air lift circulators (ALCs), the steam heating coil, and the radius between the wall and floor. The test vessels are set up to simulate the transfer of HLW out of a mixed tank, and collect a pre-transfer sample in a manner similar to the proposed baseline configuration. The collected material is submitted to an NQA-1 laboratory for chemical analysis. Previous work has been done to assess tank mixing performance at both scales. This work involved a combination of unique instruments to understand the three dimensional distribution of solids using a combination of Coriolis meter measurements, in situ chord length distribution

  3. Performance evaluation of the Cobas TaqMan MTB assay on respiratory specimens according to clinical application

    Directory of Open Access Journals (Sweden)

    Jong Eun Park

    2017-11-01

    Full Text Available Objective: To evaluate the performance of the Cobas TaqMan MTB assay (Cobas assay with respect to its clinical application. Methods: This was a retrospective analysis of 1154 results from 1034 patients for whom mycobacterial cultures and the Cobas assay were performed simultaneously. Based on the patient medical records, two categories of clinical application were defined: (1 the diagnosis of patients with a high probability of pulmonary tuberculosis according to clinical and radiological features (n = 128, and (2 the exclusion of tuberculosis in clinically indeterminate patients (n = 1026. Standard culture was used as the reference method. Results: The sensitivity of the Cobas assay for the detection of Mycobacterium tuberculosis was 70.4% (95% confidence interval (CI 49.7–85.5% for category 1, but only 25.0% (95% CI 4.5–64.4% for category 2. The specificity was ≥95.0% for both categories. The positive predictive value was 79.2% (95% CI 57.3–92.1% for category 1 and 33.3% (95% CI 6.0–75.9% for category 2, while the negative predictive value was 92.3% (95% CI 85.0–96.4% for category 1 and 99.4% (95% CI 98.7–99.8% for category 2. Conclusions: The results of this study indicate that Cobas assay results must be interpreted carefully according to the clinical purpose of the assay. Keywords: Mycobacterium tuberculosis, Pulmonary tuberculosis, Cobas TaqMan MTB assay, Korea

  4. Demonstration of a performance assessment methodology for high-level radioactive waste disposal in basalt formations

    International Nuclear Information System (INIS)

    Bonano, E.J.; Davis, P.A.; Shipers, L.R.; Brinster, K.F.; Beyler, W.E.; Updegraff, C.D.; Shepherd, E.R.; Tilton, L.M.; Wahi, K.K.

    1989-06-01

    This document describes a performance assessment methodology developed for a high-level radioactive waste repository mined in deep basalt formations. This methodology is an extension of an earlier one applicable to bedded salt. The differences between the two methodologies arise primarily in the modeling of round-water flow and radionuclide transport. Bedded salt was assumed to be a porous medium, whereas basalt formations contain fractured zones. Therefore, mathematical models and associated computer codes were developed to simulate the aforementioned phenomena in fractured media. The use of the methodology is demonstrated at a hypothetical basalt site by analyzing seven scenarios: (1) thermohydrological effects caused by heat released from the repository, (2) mechanohydrological effects caused by an advancing and receding glacier, (3) normal ground-water flow, (4) pumping of ground water from a confined aquifer, (5) rerouting of a river near the repository, (6) drilling of a borehole through the repository, and (7) formation of a new fault intersecting the repository. The normal ground-water flow was considered the base-case scenario. This scenario was used to perform uncertainty and sensitivity analyses and to demonstrate the existing capabilities for assessing compliance with the ground-water travel time criterion and the containment requirements. Most of the other scenarios were considered perturbations of the base case, and a few were studied in terms of changes with respect to initial conditions. The potential impact of these scenarios on the long-term performance of the disposal system was ascertained through comparison with the base-case scenario or the undisturbed initial conditions. 66 refs., 106 figs., 27 tabs

  5. Performing in the surgical amphitheater of today: perception of urologists conducting live case demonstrations.

    Science.gov (United States)

    Salami, Simpa S; Elsamra, Sammy E; Motato, Hector; Leavitt, David A; Friedlander, Justin I; Paoli, Michele A; Duty, Brian; Okeke, Zeph; Smith, Arthur D

    2014-09-01

    To evaluate the perception of urologists who have participated in live case demonstrations (LCDs) regarding safety, educational value/benefits, and ethics. A 19-question anonymous survey was sent to urologists who performed and/or moderated LCDs at the World Congress of Endourology meetings from 2008 to 2012. E-survey was distributed via e-mail, and automatic reminders were sent 2 weeks after original distribution if no response was obtained. Eighty-one percent (92/113) of the urologists responded to the survey of whom 75% practice full time in an academic setting. Only 48.0% were fellowship trained, however. More than 60% had performed more than five LCDs at their home and/or away institutions. Performing LCD at an away institution was associated with a higher level of anxiety when compared with performing LCDs at a home institution (79.8% vs 34.6%; Pfilm equipment and crew; audience and moderator discussions; unfamiliar team, instruments and tools; language barrier; and having to narrate the procedure, as distractors. Seventy-nine percent considered LCD as an ethical practice, and 90.5% regarded LCDs as a "beneficial" and a "great way" to educate. Similarly, considering the various factors and conditions associated with LCDs, 95% would agree to participate in another LCD. LCDs are perceived to be an effective mode of education by performers and moderators of LCDs. Standard guidelines and policies are needed, however, for the selection of patient, surgeon and team, equipment, and facility. Studies are needed to evaluate the impact of this education process.

  6. CRP on Demonstrating Performance of Spent Fuel and Related Storage Systems beyond the Long Term

    International Nuclear Information System (INIS)

    Bevilacqua, Arturo

    2014-01-01

    At the initial Coordinated Research Project (CRP) planning meeting held in August 2011, international experts in spent fuel performance confirmed the value of further coordination and development of international efforts to demonstrate the performance of spent fuel and related storage system components as durations extend. Furthermore, in recognition that the Extended Storage Collaboration Program (ESCP) managed by the Electric Power Research Institute (EPRI) in the USA, from now on ESCP, provided a broad context for the research and development work to be performed in the frame of this CRP, it was agreed that its objectives should target specific ESCP needs in order to make a relevant contribution. Accordingly, the experts examined on-going gap analyses - gaps between anticipated technical needs and existing technical data - for identify the specific research objectives. Additionally, during the planning meeting it was pointed out the need to coordinate and cooperate with the OECD/NEA counterparts involved in the organization of the International Workshop planned in autumn 2013 and with the on-going third phase of the CRP on Spent Fuel Performance Assessment and Research (SPAR-III). Given the importance to assess the performance of spent fuel and related important storage system components in order to confirm the viability of very long term storage for supporting the need to extend or renew licenses for storage facilities the CRP was approved by the IAEA in November 2011. While a full range of spent fuel types and storage conditions are deployed around the world, this CRP is focused on existing systems and, more specifically, water reactor fuel in dry storage with the overall research objective to support the technical basis for water reactor spent fuel management as dry storage durations extend. In March 2012 the group of international experts who participated at the initial CRP planning meeting in August 2011 evaluated and recommended for approval 9 research

  7. High-performance liquid chromatography-mass spectrometry-based acetylcholinesterase assay for the screening of inhibitors in natural extracts

    NARCIS (Netherlands)

    de Jong, C.F.; Derks, R.J.E.; Bruyneel, B.; Niessen, W.M.A.; Irth, H.

    2006-01-01

    The present paper describes a High-performance liquid chromatography-mass spectrometry (LC-MS) methodology for the screening of acetylcholinesterase (AChE) inhibitors in natural extracts. AChE activity of sample components is monitored by a post-column biochemical assay that is based on the

  8. Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum.

    Science.gov (United States)

    Enders, Martin; Hunjet, Andrea; Gleich, Michael; Imdahl, Roland; Mühlbacher, Annelies; Schennach, Harald; Chaiwong, Kriangsak; Sakuldamrongpanich, Tasanee; Turhan, Ajda; Sertöz, Rüchan; Wolf, Eva; Mayer, Wolfgang; Tao, Chuanmin; Wang, Lan Lan; Semprini, Simona; Sambri, Vittorio

    2015-01-01

    Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  9. Performance evaluation of FlowCytomix assays to quantify cytokines in patients with rheumatoid arthritis

    Science.gov (United States)

    Wang, Xuefeng; Dong, Liyang; Liang, Yong; Ni, Hongchang; Tang, Jun; Xu, Chengcheng; Zhou, Yuepeng; Su, Yuting; Wang, Jun; Chen, Deyu; Mao, Chaoming

    2015-01-01

    Objectives: To compare the cytokine profile in RA patients and healthy control by using two methods-FlowCytomix assay and traditional ELISA. Methods: Cytokine levels were evaluated by FlowCytomix assay and ELISA in serum and supernatants of peripheral blood mononuclear cells (PBMC) cultures with and without stimulation by phytohaemagglutinin (PHA). Results: The levels of IL-6, IL-1β, and TNF-α were significantly higher in sera of RA patients than those of healthy controls. The levels of IL-22, IL-6, IL-1β, TNF-α, and IL-10 were higher in unstimulated PBMC culture supernatant of RA patients than those of healthy controls. PHA stimulation significantly increased the production of proinflammatory cytokines from PBMC with RA patients. Compared with detectable cytokine levels in sera, cytokine concentration in the supernatant of PBMCs was remarkably higher. FlowCytomix and ELISA showed significant correlation in detecting cytokines. However, the FlowCytomix assay detected more cytokines than ELISA. Conclusion: The supernatant of PBMCs provide a fine condition for the study of cytokine production because of the lack of interference factors in sera. The FlowCytomix assay is more sensitive than ELISA in detecting cytokines from RA patients. Multiple cytokine signatures using FlowCytomix assay may represent a more realistic approach in the future of personalized medicine in RA. PMID:26629129

  10. Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum

    Science.gov (United States)

    Enders, Martin; Hunjet, Andrea; Gleich, Michael; Imdahl, Roland; Mühlbacher, Annelies; Schennach, Harald; Chaiwong, Kriangsak; Sakuldamrongpanich, Tasanee; Turhan, Ajda; Sertöz, Rüchan; Wolf, Eva; Mayer, Wolfgang; Tao, Chuanmin; Wang, Lan Lan; Semprini, Simona

    2014-01-01

    Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified. PMID:25355799

  11. New high-performance liquid chromatography assay for glycosyltransferases based on derivatization with anthranilic acid and fluorescence detection.

    Science.gov (United States)

    Anumula, Kalyan Rao

    2012-07-01

    Assays were developed using the unique labeling chemistry of 2-aminobenzoic acid (2AA; anthranilic acid, AA) for measuring activities of both β1-4 galactosyltransferase (GalT-1) and α2-6 sialyltransferase (ST-6) by high-performance liquid chromatography (HPLC) with fluorescence detection (Anumula KR. 2006. Advances in fluorescence derivatization methods for high-performance liquid chromatographic analysis of glycoprotein carbohydrates. Anal Biochem. 350:1-23). N-Acetylglucosamine (GlcNAc) and N-acetyllactosamine were used as acceptors and uridine diphosphate (UDP)-galactose and cytidine monophosphate (CMP)-N-acetylneuraminic acid (NANA) as donors for GalT-1 and ST-6, respectively. Enzymatic products were labeled in situ with AA and were separated from the substrates on TSKgel Amide 80 column using normal-phase conditions. Enzyme units were determined from the peak areas by comparison with the concomitantly derivatized standards Gal-β1-4GlcNAc and NANA-α2-6 Gal-β1-4GlcNAc. Linearity (time and enzyme concentration), precision (intra- and interassay) and reproducibility for the assays were established. The assays were found to be useful in monitoring the enzyme activities during isolation and purification. The assays were highly sensitive and performed equal to or better than the traditional radioactive sugar-based measurements. The assay format can also be used for measuring the activity of other transferases, provided that the carbohydrate acceptors contain a reducing end for labeling. An assay for glycoprotein acceptors was developed using IgG. A short HPLC profiling method was developed for the separation of IgG glycans (biantennary G0, G1, G2, mono- and disialylated), which facilitated the determination of GalT-1 and ST-6 activities in a rapid manner. Furthermore, this profiling method should prove useful for monitoring the changes in IgG glycans in clinical settings.

  12. 40 CFR 63.7940 - By what date must I conduct performance tests or other initial compliance demonstrations?

    Science.gov (United States)

    2010-07-01

    ... compliance is not demonstrated using a performance test or design evaluation, you must demonstrate initial... performance tests or other initial compliance demonstrations? 63.7940 Section 63.7940 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS...

  13. Normalized performance and load data for the deepwind demonstrator in controlled conditions

    Directory of Open Access Journals (Sweden)

    L. Battisti

    2016-09-01

    Full Text Available Performance and load normalized coefficients, deriving from an experimental campaign of measurements conducted at the large scale wind tunnel of the Politecnico di Milano (Italy, are presented with the aim of providing useful benchmark data for the validation of numerical codes. Rough data, derived from real scale measurements on a three-bladed Troposkien vertical-axis wind turbine, are manipulated in a convenient form to be easily compared with the typical outputs provided by simulation codes. The here proposed data complement and support the measurements already presented in “Wind Tunnel Testing of the DeepWind Demonstrator in Design and Tilted Operating Conditions” (Battisti et al., 2016 [1]. Keywords: VAWT, DeepWind Project, Troposkien rotor, Skewed flow, Wind tunnel measurements, Wind turbine benchmark data

  14. Financial performance among adult day centers: results of a national demonstration program.

    Science.gov (United States)

    Reifler, B V; Henry, R S; Rushing, J; Yates, M K; Cox, N J; Bradham, D D; McFarlane, M

    1997-02-01

    This paper describes the financial performance (defined as percent of total expenses covered by net operating revenue) of 16 adult day centers participating in a national demonstration program on day services for people with dementia, including examination of possible predictors of financial performance. Participating sites submitted quarterly financial and utilization reports to the National Program Office. Descriptive statistics summarize the factors believed to influence financial performance. Sites averaged meeting 35% of expenses from self-pay and 29% from government (mainly Medicaid) revenue, totaling 64% of all (cash plus in-kind) expenses met by operating revenue. Examination of center characteristics suggests that factors related to meeting consumer needs, such as being open a full day (i.e., 7:30 am to 6:00 pm) rather than shorter hours, and providing transportation, may be related to improved utilization and, thus, improved financial performance. Higher fees were not related to lower enrollment, census, or revenue. Adult day centers are able to achieve financial viability through a combination of operating (i.e., fee-for-service) and non-operating revenue. Operating revenue is enhanced by placing emphasis on consumer responsiveness, such as being open a full day. Because higher fees were not related to lower utilization, centers should set fees to reflect actual costs. The figure of 64% of expenses met by operating revenue is conservative inasmuch as sites included in-kind revenue as expenses in their budgeting calculations, and percent of cash expenses met by operating revenue would be higher (approximately 75% for this group of centers).

  15. NDE performance demonstration in the US nuclear power industry - applications, costs, lessons learned, and connection to NDE reliability

    International Nuclear Information System (INIS)

    Ammirato, F.

    1997-01-01

    Periodic inservice inspection (ISI) of nuclear power plant components is performed in the United States to satisfy legal commitments and to provide plant owners with reliable information for managing degradation. Performance demonstration provides credible evidence that ISI will fulfill its objectives. This paper examines the technical requirements for inspection and discusses how these technical needs are used to develop effective performance demonstration applications. NDE reliability is discussed with particular reference to its role in structural integrity assessments and its connection with performance demonstration. It is shown that the role of NDE reliability can range from very small to critical depending on the particular application and must be considered carefully in design of inspection techniques and performance demonstration programs used to qualify the inspection. Finally, the costs, benefits, and problems associated with performance demonstration are reviewed along with lessons learned from more than 15 years of performance demonstration experience in the US. (orig.)

  16. Design and Performance of the NASA SCEPTOR Distributed Electric Propulsion Flight Demonstrator

    Science.gov (United States)

    Borer, Nicholas K.; Patterson, Michael D.; Viken, Jeffrey K.; Moore, Mark D.; Clarke, Sean; Redifer, Matthew E.; Christie, Robert J.; Stoll, Alex M.; Dubois, Arthur; Bevirt, JoeBen; hide

    2016-01-01

    Distributed Electric Propulsion (DEP) technology uses multiple propulsors driven by electric motors distributed about the airframe to yield beneficial aerodynamic-propulsion interaction. The NASA SCEPTOR flight demonstration project will retrofit an existing internal combustion engine-powered light aircraft with two types of DEP: small "high-lift" propellers distributed along the leading edge of the wing which accelerate the flow over the wing at low speeds, and larger cruise propellers co-located with each wingtip for primary propulsive power. The updated high-lift system enables a 2.5x reduction in wing area as compared to the original aircraft, reducing drag at cruise and shifting the velocity for maximum lift-to-drag ratio to a higher speed, while maintaining low-speed performance. The wingtip-mounted cruise propellers interact with the wingtip vortex, enabling a further efficiency increase that can reduce propulsive power by 10%. A tradespace exploration approach is developed that enables rapid identification of salient trades, and subsequent creation of SCEPTOR demonstrator geometries. These candidates were scrutinized by subject matter experts to identify design preferences that were not modeled during configuration exploration. This exploration and design approach is used to create an aircraft that consumes an estimated 4.8x less energy at the selected cruise point when compared to the original aircraft.

  17. Performance assessment of self-interrogation neutron resonance densitometry for spent nuclear fuel assay

    Energy Technology Data Exchange (ETDEWEB)

    Hu, Jianwei, E-mail: huj1@ornl.gov [Reactor and Nuclear Systems Division, Oak Ridge National Laboratory, 1 Bethel Valley Road, PO Box 2008, MS-6172, Oak Ridge, TN 37831-6172 (United States); Tobin, Stephen J.; LaFleur, Adrienne M.; Menlove, Howard O.; Swinhoe, Martyn T. [Nuclear Engineering and Nonproliferation Division, Los Alamos National Laboratory (United States)

    2013-11-21

    Self-Interrogation Neutron Resonance Densitometry (SINRD) is one of several nondestructive assay (NDA) techniques being integrated into systems to measure spent fuel as part of the Next Generation Safeguards Initiative (NGSI) Spent Fuel Project. The NGSI Spent Fuel Project is sponsored by the US Department of Energy's National Nuclear Security Administration to measure plutonium in, and detect diversion of fuel pins from, spent nuclear fuel assemblies. SINRD shows promising capability in determining the {sup 239}Pu and {sup 235}U content in spent fuel. SINRD is a relatively low-cost and lightweight instrument, and it is easy to implement in the field. The technique makes use of the passive neutron source existing in a spent fuel assembly, and it uses ratios between the count rates collected in fission chambers that are covered with different absorbing materials. These ratios are correlated to key attributes of the spent fuel assembly, such as the total mass of {sup 239}Pu and {sup 235}U. Using count rate ratios instead of absolute count rates makes SINRD less vulnerable to systematic uncertainties. Building upon the previous research, this work focuses on the underlying physics of the SINRD technique: quantifying the individual impacts on the count rate ratios of a few important nuclides using the perturbation method; examining new correlations between count rate ratio and mass quantities based on the results of the perturbation study; quantifying the impacts on the energy windows of the filtering materials that cover the fission chambers by tallying the neutron spectra before and after the neutrons go through the filters; and identifying the most important nuclides that cause cooling-time variations in the count rate ratios. The results of these studies show that {sup 235}U content has a major impact on the SINRD signal in addition to the {sup 239}Pu content. Plutonium-241 and {sup 241}Am are the two main nuclides responsible for the variation in the count

  18. Radiochemical assay for determination of dihydropyrimidinase activity using reversed-phase high-performance liquid chromatography

    NARCIS (Netherlands)

    van Kuilenburg, A. B.; van Lenthe, H.; van Gennip, A. H.

    1999-01-01

    A radiochemical assay was developed to measure the activity of dihydropyrimidinase (DHP) in human liver homogenates. The method is based on the separation of radiolabeled dihydrouracil from N-carbamyl-beta-alanine by HPLC with on-line detection of radioactivity combined with detection of 14CO2 by

  19. Analytical performances of a new enzymatic assay for hemoglobin A1c.

    Science.gov (United States)

    Jaisson, Stéphane; Desmons, Aurore; Renard, Benoît; Chevelle, Benjamin; Leroy, Nathalie; Gillery, Philippe

    2014-07-01

    HbA1c is considered the gold standard for the follow-up of diabetic patients and a new diagnostic tool for diabetes mellitus, which implies the availability of reliable assay methods. We have evaluated a new assay developed by Abbott Laboratories, based on the enzymatic quantification of HbA1c by a fructosyl dipeptide oxidase using Architect analyzers. Precision, linearity, correlation with a HPLC method, accuracy and potential impact interferences on HbA1c measurement have been evaluated. Intra-day and between-day CVs were lower than 1.2% and linearity was excellent from 19 mmol/mol (3.9%) to 163 mmol/mol (17.1%). The results were well correlated with those obtained by the HPLC (Variant II device, kit NU - BioRad): HbA1c [Architect, mmol/mol]=0.986×HbA1c [Variant II, mmol/mol]+0.713 (r=0.998, n=109). This method provided consistent results with IFCC titrated quality control samples. Classical interferences in HbA1c assays (i.e. labile HbA1c, carbamylated hemoglobin, triglycerides or bilirubin) did not have an impact on HbA1c quantification by this method. This new enzymatic assay proved to be a robust and reliable method for HbA1c measurement suitable for routine practice in clinical chemistry laboratories. Copyright © 2014 Elsevier B.V. All rights reserved.

  20. [Comparison of the clinical performance of the ECLusys HBsAg II assay with the Lumipulse f and HISCL 2000-i HBsAg screening assays].

    Science.gov (United States)

    Sugiura, Aya; Iwahara, Kunihiro; Suga, Yasuyuki; Uchiyama, Sachinori; Maekawa, Masato

    2012-02-01

    We compared the ECLusys HBsAgII (ECL HBsAg) assay to the Lumipulse Forte (LPf HBsAg) and HISCL (HIS HBsAg) assays. Measurement of dilution panels for which the WHO HBsAg international reference panel was the parent specimen revealed that the ECL and HIS assays enabled detection to a theoretical level of 0.04 IU/mL, whereas the LPf assay enabled detection to a level of 0.08 IU/mL. In a specificity test using high RF positive specimens (n = 33), pregnancy specimens (n = 35), cytomegalovirus antibody positive specimens (n = 36), and high M protein positive specimens (n = 21) that were confirmed negative for HBsAg by the LPf assay, negative results were obtained for all specimens on the HIS assay, but the ECL assay yielded a positive result for one of the high RF positive specimens. This individual was suggested on further testing to be an HBV carrier who was strongly positive for HBc antibody. In HBsAg mutants detection test, the detection rate was 92.3% with the ECL assay and 69.2% with the HIS assay. In a correlation test using routinely collected clinical specimens (n = 155), including positive stock specimens, aside from the one case where the LPf assay gave a negative result but both the ECL and HIS assays gave positive results, all of the results were consistent for all specimens. The above results confirmed that the ECL assay is both highly sensitive and specific, and also enables a high rate of HBsAg mutant detection.

  1. Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study.

    Science.gov (United States)

    Mahler, Michael; Radice, Antonella; Sinico, Renato A; Damoiseaux, Jan; Seaman, Andrea; Buckmelter, Kristen; Vizjak, Alenka; Buchner, Carol; Binder, Walter L; Fritzler, Marvin J; Cui, Zhao

    2012-01-01

    Autoantibodies to the non-collagen region (NC1) of the alpha-3 subunit of collagen IV represent a serological hallmark in the diagnosis of Goodpasture's syndrome (GPS). The objective of our study was to carefully analyze the performance characteristics of a novel anti-glomerular basement membrane (GBM) chemiluminescence immunoassay (CIA). Sera from patients with GPS (n = 90) were collected from four clinical centers. Samples from different disease groups (n = 397) and healthy individuals (n = 400) were used as controls. All samples were tested for anti-GBM antibodies by a rapid, random access CIA (QUANTA Flash™ GBM). Most of the samples were also tested using other methods including different commercial anti-GBM IgG assays and research assays for anti-GBM IgA and IgM. The sensitivity and specificity of the novel CIA was 95.6% [95% confidence interval (CI) 89.0-98.8%] and 99.6% (95% CI 98.9-99.9%), respectively. Receiver operating characteristic analysis showed good discrimination between GPS patients and controls. The area under the curve was 0.98 (CI 0.96-1.0). The three anti-GBM antibody-positive samples from the control group were from two healthy individuals and one human immunodeficiency virus (HIV)-infected patient. All three individuals had low levels of anti-GBM antibodies [20, 24 and 25 chemiluminescent unit (CU), cutoff 20 CU]. When the results of the new CIA were compared to other methods, good agreement was observed: 95.8% (kappa = 0.92) versus EliA™ GBM, 97.4% (kappa = 0.95) versus both BINDAZYME™ Anti-GBM and QUANTA Lite® GBM. Anti-GBM IgA was detectable in low concentrations in patients with GPS and was associated with anti-GBM IgG but was less useful in discriminating GPS patients and controls. No discrimination was found for anti-GBM IgM. The novel QUANTA Flash™ GBM CIA demonstrated good sensitivity and specificity and had good agreement with other methods. Our data confirm that ∼5% of patients with GPS do not have detectable levels of

  2. Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus

    Science.gov (United States)

    Pinsky, Benjamin A.; Sahoo, Malaya K.; Sandlund, Johanna; Kleman, Marika; Kulkarni, Medha; Grufman, Per; Nygren, Malin; Kwiatkowski, Robert; Baron, Ellen Jo; Tenover, Fred; Denison, Blake; Higuchi, Russell; Van Atta, Reuel; Beer, Neil Reginald; Carrillo, Alda Celena; Naraghi-Arani, Pejman; Mire, Chad E.; Ranadheera, Charlene; Grolla, Allen; Lagerqvist, Nina; Persing, David H.

    2015-01-01

    Background The recently developed Xpert® Ebola Assay is a novel nucleic acid amplification test for simplified detection of Ebola virus (EBOV) in whole blood and buccal swab samples. The assay targets sequences in two EBOV genes, lowering the risk for new variants to escape detection in the test. The objective of this report is to present analytical characteristics of the Xpert® Ebola Assay on whole blood samples. Methods and Findings This study evaluated the assay’s analytical sensitivity, analytical specificity, inclusivity and exclusivity performance in whole blood specimens. EBOV RNA, inactivated EBOV, and infectious EBOV were used as targets. The dynamic range of the assay, the inactivation of virus, and specimen stability were also evaluated. The lower limit of detection (LoD) for the assay using inactivated virus was estimated to be 73 copies/mL (95% CI: 51–97 copies/mL). The LoD for infectious virus was estimated to be 1 plaque-forming unit/mL, and for RNA to be 232 copies/mL (95% CI 163–302 copies/mL). The assay correctly identified five different Ebola viruses, Yambuku-Mayinga, Makona-C07, Yambuku-Ecran, Gabon-Ilembe, and Kikwit-956210, and correctly excluded all non-EBOV isolates tested. The conditions used by Xpert® Ebola for inactivation of infectious virus reduced EBOV titer by ≥6 logs. Conclusion In summary, we found the Xpert® Ebola Assay to have high analytical sensitivity and specificity for the detection of EBOV in whole blood. It offers ease of use, fast turnaround time, and remote monitoring. The test has an efficient viral inactivation protocol, fulfills inclusivity and exclusivity criteria, and has specimen stability characteristics consistent with the need for decentralized testing. The simplicity of the assay should enable testing in a wide variety of laboratory settings, including remote laboratories that are not capable of performing highly complex nucleic acid amplification tests, and during outbreaks where time to detection

  3. Analytical and clinical performance characteristics of the Abbott RealTime MTB RIF/INH Resistance, an assay for the detection of rifampicin and isoniazid resistant Mycobacterium tuberculosis in pulmonary specimens.

    Science.gov (United States)

    Kostera, Joshua; Leckie, Gregor; Tang, Ning; Lampinen, John; Szostak, Magdalena; Abravaya, Klara; Wang, Hong

    2016-12-01

    Clinical management of drug-resistant tuberculosis patients continues to present significant challenges to global health. To tackle these challenges, the Abbott RealTime MTB RIF/INH Resistance assay was developed to accelerate the diagnosis of rifampicin and/or isoniazid resistant tuberculosis to within a day. This article summarizes the performance of the Abbott RealTime MTB RIF/INH Resistance assay; including reliability, analytical sensitivity, and clinical sensitivity/specificity as compared to Cepheid GeneXpert MTB/RIF version 1.0 and Hain MTBDRplus version 2.0. The limit of detection (LOD) of the Abbott RealTime MTB RIF/INH Resistance assay was determined to be 32 colony forming units/milliliter (cfu/mL) using the Mycobacterium tuberculosis (MTB) strain H37Rv cell line. For rifampicin resistance detection, the Abbott RealTime MTB RIF/INH Resistance assay demonstrated statistically equivalent clinical sensitivity and specificity as compared to Cepheid GeneXpert MTB/RIF. For isoniazid resistance detection, the assay demonstrated statistically equivalent clinical sensitivity and specificity as compared to Hain MTBDRplus. The performance data presented herein demonstrate that the Abbott RealTime MTB RIF/INH Resistance assay is a sensitive, robust, and reliable test for realtime simultaneous detection of first line anti-tuberculosis antibiotics rifampicin and isoniazid in patient specimens. Copyright © 2016 The Author. Published by Elsevier Ltd.. All rights reserved.

  4. Performance evaluation of the QIAGEN EZ1 DSP Virus Kit with Abbott RealTime HIV-1, HBV and HCV assays.

    Science.gov (United States)

    Schneider, George J; Kuper, Kevin G; Abravaya, Klara; Mullen, Carolyn R; Schmidt, Marion; Bunse-Grassmann, Astrid; Sprenger-Haussels, Markus

    2009-04-01

    Automated sample preparation systems must meet the demands of routine diagnostics laboratories with regard to performance characteristics and compatibility with downstream assays. In this study, the performance of QIAGEN EZ1 DSP Virus Kit on the BioRobot EZ1 DSP was evaluated in combination with the Abbott RealTime HIV-1, HCV, and HBV assays, followed by thermalcycling and detection on the Abbott m2000rt platform. The following performance characteristics were evaluated: linear range and precision, sensitivity, cross-contamination, effects of interfering substances and correlation. Linearity was observed within the tested ranges (for HIV-1: 2.0-6.0 log copies/ml, HCV: 1.3-6.9 log IU/ml, HBV: 1.6-7.6 log copies/ml). Excellent precision was obtained (inter-assay standard deviation for HIV-1: 0.06-0.17 log copies/ml (>2.17 log copies/ml), HCV: 0.05-0.11 log IU/ml (>2.09 log IU/ml), HBV: 0.03-0.07 log copies/ml (>2.55 log copies/ml)), with good sensitivity (95% hit rates for HIV-1: 50 copies/ml, HCV: 12.5 IU/ml, HBV: 10 IU/ml). No cross-contamination was observed, as well as no negative impact of elevated levels of various interfering substances. In addition, HCV and HBV viral load measurements after BioRobot EZ1 DSP extraction correlated well with those obtained after Abbott m2000sp extraction. This evaluation demonstrates that the QIAGEN EZ1 DSP Virus Kit provides an attractive solution for fully automated, low throughput sample preparation for use with the Abbott RealTime HIV-1, HCV, and HBV assays.

  5. Performance of scintillation proximity assay (SPA) to measure the level of VEGFR 1 protein

    International Nuclear Information System (INIS)

    LEE, So-Young; LIM, Jae-Cheong; KIM, Jin-Joo

    2014-01-01

    Scintillation proximity assay is a one of radioimmunoassay and can be assayed without the washing or filtration procedures normally used to separate bound from free fractions. Due to its simplicity and high-throughput protocol, it is broadly applicable to immunology, receptor binding, monitoring receptor-ligand interactions and enzyme reactions. Briefly, an antibody or receptor is coated on SPA beads. When a radiolabeled antigen or ligand binds to the beads, the SPA beads stimulate to emit short range electrons. The 3 H and 125 I are commonly used for radiolabeling and the produced photons are detectable with a liquid scintillation counter (LSC). A binding affinity of unlabeled ligands can be determined by competitive reaction of the radiolabeled ligands. Bevacizumab is a recombinant humanized monoclonal antibody, and can stop or delay growth of tumors by inhibiting vascular endothelial growth factor (VEGF). Bevacizumab was approved by FDA for metastatic cancer such as colorectal cancers, ovarian cancers, breast cancers and glioblastoma multiform of the brain. Recently, Dan G. duda et al. was reported that the concentration of vascular endothelial growth factor receptor-1 (VEGFR-1) in plasma may potentially be used as a negative selection biomarker. In this study, we describe a method using scintillation proximity assay to detect the amounts of VEGFR-1 protein. This method is successfully used to measure the concentration of VEGFR-1 protein in human cell extracts. In summary, a simple and sensitive assay is developed for measuring the amount of VEGFR 1 protein in cancer cell lysate using SPA beads. The antibody coating on the beads and antigen binding are achieved in one mixing step

  6. Performance of scintillation proximity assay (SPA) to measure the level of VEGFR 1 protein

    Energy Technology Data Exchange (ETDEWEB)

    LEE, So-Young; LIM, Jae-Cheong; KIM, Jin-Joo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2014-10-15

    Scintillation proximity assay is a one of radioimmunoassay and can be assayed without the washing or filtration procedures normally used to separate bound from free fractions. Due to its simplicity and high-throughput protocol, it is broadly applicable to immunology, receptor binding, monitoring receptor-ligand interactions and enzyme reactions. Briefly, an antibody or receptor is coated on SPA beads. When a radiolabeled antigen or ligand binds to the beads, the SPA beads stimulate to emit short range electrons. The {sup 3}H and {sup 125}I are commonly used for radiolabeling and the produced photons are detectable with a liquid scintillation counter (LSC). A binding affinity of unlabeled ligands can be determined by competitive reaction of the radiolabeled ligands. Bevacizumab is a recombinant humanized monoclonal antibody, and can stop or delay growth of tumors by inhibiting vascular endothelial growth factor (VEGF). Bevacizumab was approved by FDA for metastatic cancer such as colorectal cancers, ovarian cancers, breast cancers and glioblastoma multiform of the brain. Recently, Dan G. duda et al. was reported that the concentration of vascular endothelial growth factor receptor-1 (VEGFR-1) in plasma may potentially be used as a negative selection biomarker. In this study, we describe a method using scintillation proximity assay to detect the amounts of VEGFR-1 protein. This method is successfully used to measure the concentration of VEGFR-1 protein in human cell extracts. In summary, a simple and sensitive assay is developed for measuring the amount of VEGFR 1 protein in cancer cell lysate using SPA beads. The antibody coating on the beads and antigen binding are achieved in one mixing step.

  7. On performance experience and measurements with Ningyo Waste Assay System (NWAS). 3

    International Nuclear Information System (INIS)

    Zaima, Naoki; Nakashima, Shin'ichi; Nakatsuka, Yoshiaki; Kado, Kazumi; Fujiki, Naoki

    2014-03-01

    A uranium mass assay system, NWAS (Ningyo Waste Assay System), for 200-litter wastes drums applied by NDA method was developed and accumulated the data of the actual uranium bearing wastes drums. The system consists of the 16 pieces of Helium-3 proportional counters for neutron detection generated from U-234(α,n) reaction or U-238 spontaneous fissions with polyethylene moderation and a Germanium solid state detector (Ge-SSD) for gamma ray detection as to determine uranium enrichment. In previous report, some measurement experiences had been introduced briefly. After that the measurements campaigns against the actual wastes drums stored in URCP had been carried out successfully, the uranium determination data of 850 drums had been accumulated approximately. Those characteristics were rich in variety including various kinds of matrices, uranium chemical compositions and range of uranium mass and so on. These works have contributed the decrease of the MUF in URCP, for which was the first purpose of introduction of NWAS. On the other hand several considerable problems on the system or methodology had been revealed technically or analytically through the measurements experiences. Such experiences are to be described precisely, in addition newly gained knowledge will be marshaled. Furthermore as the next improvement plans, the active neutrons assay for uranium bearing wastes drums are now progressing. The results of complications will lead us to the progressive next steps. (author)

  8. Standard compliance - NDE performance demonstration/inspection in the CANDU industry

    International Nuclear Information System (INIS)

    Choi, E.

    2011-01-01

    CANDU nuclear power plants are operated in 3 provinces in Canada for electric power generation. A table in the paper will show the built and operating plants in Ontario, Quebec, New Brunswick and overseas. The regulator for nuclear power in Canada is the Canadian Nuclear Safety Commission (CNSC). The CNSC holds the plant licensees accountable for compliance to CSA N285.4 for periodic inspections. The Standard basically specifies the 'what, when, where, how, how much and how frequently' NDE is to be done on pressure retaining systems and components in CANDU nuclear power plants. In inspection methods, the Standard specifies they must be non-destructive. The NDE methods were grouped into visual, dimensional, surface, volumetric and integrative. The Standard also specifies that the licensees are responsible for the performance demonstration (PD) of the adequacy of the procedures and the proficiency of the personnel. This paper describes the Standard's requirement in NDE qualification and presents a joint project participated by Canadian and overseas CANDU owners. The sub-project for NDE included providing evidence and technical justification on the adequacy of the procedures and the proficiency of the personnel. The paper describes the qualification methodology followed by the participants. This will be followed by how the participants produced Inspection Specification, tools and procedures, personnel training and qualification programs, test and qualification samples, independent peer reviews and Technical Justification. (author)

  9. Thermal performance test of hot gas ducts of helium engineering demonstration loop (HENDEL)

    International Nuclear Information System (INIS)

    Hishida, Makoto; Kunitomi, Kazuhiko; Ioka, Ikuo; Umenishi, Koji; Kondo, Yasuo; Tanaka, Toshiyuki; Shimomura, Hiroaki

    1984-01-01

    A hot gas duct provided with internal thermal insulation is supposed to be used for an experimental very high-temperature gas-cooled reactor (VHTR) which has been developed by the Japan Atomic Energy Research Institute (JAERI). This type of hot gas duct has not been used so far in industrial facilities, and only a couple of tests on such a large-scale model of hot gas duct have been conducted. The present test was to investigate the thermal performance of the hot gas ducts which are installed as parts of a helium engineering demonstration loop (HENDEL) of JAERI. Uniform temperature and heat flux distributions at the surface of the duct were observed, the experimental correlation being obtained for the effective thermal conductivity of the internal thermal insulation layer. The measured temperature distribution of the pressure tube was in good agreement with the calculation by a TRUMP heat transfer computer code. The temperature distribution of the inner tube of VHTR hot gas duct was evaluated, and no hot spot was detected. These results would be very valuable for the design and development of VHTR. (author)

  10. Performance demonstration of a high-power space-reactor heat-pipe design

    International Nuclear Information System (INIS)

    Merrigan, M.A.; Martinez, E.H.; Keddy, E.S.; Runyan, J.; Kemme, J.E.

    1983-01-01

    Performance of a 15.9-mm diam, 2-m long, artery heat pipe has been demonstrated at power levels to 22.6 kW and temperatures to 1500 0 K. The heat pipe employed lithium as a working fluid with distribution wicks and arteries fabricated from 400 mesh Mo-41 wt % Re screen. Molybdenum alloy (TZM) was used for the container. Peak axial power density attained in the testing was 19 kW/cm 2 at 1465 0 K. The corresponding radial flux density in the evaporator region of the heat pipe was 150 W/cm 2 . The extrapolated limit for the heat pipe at its 1500 0 K design point is 30 kW, corresponding to an axial flux density of 25 kW/cm 2 . Sonic and capillary limits for the design were investigated in the 1100 to 1500 0 K temperature range. Excellent agreement of measured and predicted temperature and power levels was observed

  11. Screening of antifungal azole drugs and agrochemicals with an adapted alamarBlue-based assay demonstrates antibacterial activity of croconazole against Mycobacterium ulcerans.

    Science.gov (United States)

    Scherr, Nicole; Röltgen, Katharina; Witschel, Matthias; Pluschke, Gerd

    2012-12-01

    An alamarBlue-based growth inhibition assay has been adapted for the thermosensitive and slow-growing pathogen Mycobacterium ulcerans. The standardized test procedure enables medium-throughput screening of preselected compound libraries. Testing of a set of 48 azoles with known antifungal activity led to the identification of an imidazole antifungal displaying an inhibitory dose (ID) of 9 μM for M. ulcerans.

  12. The influence of uncertainties of measurements in laboratory performance evaluation using an intercomparison program of radionuclide assays in environmental samples

    International Nuclear Information System (INIS)

    Tauhata, Luiz; Elizabeth Couto Machado Vianna, Maria; Eduardo de Oliveira, Antonio; Cristina de Melo Ferreira, Ana; Julia Camara da Silva Braganca, Maura; Faria Clain, Almir

    2006-01-01

    To show the influence of measurement uncertainties in performance evaluation of laboratories, data from 42 comparison runs were evaluated using two statistical criteria. The normalized standard deviation, D, used by US EPA, that mainly takes into account the accuracy, and the normalized deviation, E, that includes the individual laboratory uncertainty used for performance evaluation in the key-comparisons by BIPM. The results show that data evaluated by the different criteria give a significant deviation of laboratory performance in each radionuclide assay when we analyse a large quantity of data

  13. A Low-Cost, High-Performance System for Fluorescence Lateral Flow Assays

    Directory of Open Access Journals (Sweden)

    Linda G. Lee

    2013-10-01

    Full Text Available We demonstrate a fluorescence lateral flow system that has excellent sensitivity and wide dynamic range. The illumination system utilizes an LED, plastic lenses and plastic and colored glass filters for the excitation and emission light. Images are collected on an iPhone 4. Several fluorescent dyes with long Stokes shifts were evaluated for their signal and nonspecific binding in lateral flow. A wide range of values for the ratio of signal to nonspecific binding was found, from 50 for R-phycoerythrin (R-PE to 0.15 for Brilliant Violet 605. The long Stokes shift of R-PE allowed the use of inexpensive plastic filters rather than costly interference filters to block the LED light. Fluorescence detection with R-PE and absorbance detection with colloidal gold were directly compared in lateral flow using biotinylated bovine serum albumen (BSA as the analyte. Fluorescence provided linear data over a range of 0.4–4,000 ng/mL with a 1,000-fold signal change while colloidal gold provided non-linear data over a range of 16–4,000 ng/mL with a 10-fold signal change. A comparison using human chorionic gonadotropin (hCG as the analyte showed a similar advantage in the fluorescent system. We believe our inexpensive yet high-performance platform will be useful for providing quantitative and sensitive detection in a point-of-care setting.

  14. Performance evaluation of four type-specific commercial assays for detection of herpes simplex virus type 1 antibodies in a Middle East and North Africa population.

    Science.gov (United States)

    Aldisi, Rana S; Elsidiq, Malaz S; Dargham, Soha R; Sahara, Afifah S; Al-Absi, Enas S; Nofal, Mariam Y; Mohammed, Layla I; Abu-Raddad, Laith J; Nasrallah, Gheyath K

    2018-03-22

    The number of diagnostic assays for the detection of herpes simplex virus type 1 (HSV-1) antibodies has increased over the years. However, their performance characteristics could vary among global populations. To investigate performance of two commercial ELISA kits, HerpeSelect ® 1 ELISA and Euroimmun Anti-HSV-1 (gC1) ELISA (IgG); and two commercial immunoblot (IB)/Western blot (WB) assays, HerpeSelect ® 1 and 2 Immunoblot IgG, and Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB (IgG/IgM); in detecting HSV-1 antibodies in a Middle East and North Africa (MENA) population. Blood specimens were collected from blood donors in Doha, Qatar, June 2013-2016. Twenty specimens were randomly selected from 10 MENA nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200), and tested for HSV-1 antibodies. Across all six comparisons between assays, positive percent agreement ranged between 95.7% (95% CI: 91.4-98.3%) and 100.0% (95% CI: 97.8-100.0%). Negative percent agreement ranged between 86.2% (95% CI: 68.3-96.1%) and 96.2% (95% CI: 80.4-99.9%). Overall percent agreement ranged between 95.7% (95% CI: 91.7-97.8%) and 99.4% (95% CI: 96.7-99.9%). Cohen's kappa statistic ranged between 0.84 (95% CI: 0.73-0.95) and 0.98 (95% CI: 0.93-1.00). Compared against IB/WB, HerpeSelect ® and Euroimmun had sensitivities and specificities >96% and >86%, respectively. Positive and negative predictive values were >97% and >83%, respectively. The assays showed excellent concordance with one another, and with a high kappa statistic. The ELISA kits demonstrated robust diagnostic performance compared to the IB/WB assays. These findings support the assays' utility in clinical diagnosis and research in MENA populations. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  15. 40 CFR 63.5991 - By what date must I conduct an initial compliance demonstration or performance test?

    Science.gov (United States)

    2010-07-01

    ... compliance demonstration or performance test? 63.5991 Section 63.5991 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES National Emissions Standards for Hazardous Air Pollutants: Rubber Tire... initial compliance demonstration or performance test? (a) If you have a new or reconstructed affected...

  16. Evaluation of hemoglobin A1c measurement from filter paper using high-performance liquid chromatography and immunoturbidimetric assay.

    Science.gov (United States)

    Wu, Yonghua; Yang, Xu; Wang, Haining; Li, Zhenrong; Wang, Tiancheng

    2017-04-01

    Glycated hemoglobin (HbA 1c ) measurement from whole blood (WB) samples is inconvenient for epidemic surveillance and self-monitoring of glycemic level. We evaluated HbA 1c measurement from WB blotted on filter paper (FP), which can be easily transported to central laboratories, with high-performance liquid chromatography (HPLC) and immunoturbidimetric assay (ITA). WB was applied to Whatman filter paper. By using HPLC and WB samples as reference methods, these FP samples were evaluated on HPLC and ITA. Inter- and intra-assay variation, WB vs. FP agreement and sample stability at 20-25 °C and -70 °C were assessed by statistical analysis. Results showed that the coefficient of variation (CV, %) of FP samples for HPLC and ITA were 0.44-1.02% and 1.47-2.72%, respectively (intra-assay); 2.13-3.56% and 3.21-4.82%, respectively (inter-assay). The correlation of WB HPLC with FP analyzed using HPLC and ITA are both significant (p < 0.001). Sample stability showed that FP method up to 5 days at 20-25 °C and 5 weeks at -70 °C is accurate and reproducible. In conclusion, FP samples analyzed by HPLC and ITA can both provide an alternative to WB for HbA 1c measurement, supporting the use of FP method in epidemic surveillance and healthcare units.

  17. An easy-to-perform photometric assay for methyltransferase activity measurements.

    Science.gov (United States)

    Schäberle, Till F; Siba, Christian; Höver, Thomas; König, Gabriele M

    2013-01-01

    Methyltransferases (MTs) catalyze the transfer of a methyl group from S-adenosylmethionine (SAM) to a suitable substrate. Such methylations are important modifications in secondary metabolisms, especially on natural products produced by polyketide synthases and nonribosomal peptide synthetases, many of which are of special interest due to their prominent pharmacological activities (e.g., lovastatin, cyclosporin). To gain basic biochemical knowledge on the methylation process, it is of immense relevance to simplify methods concerning experimental problems caused by a large variety in substrates. Here, we present a photometric method to analyze MT activity by measuring SAM consumption in a coupled enzyme assay. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Performance of PCR-reverse blot hybridization assay for detection of rifampicin-resistant Mycobacterium leprae.

    Science.gov (United States)

    Wang, Hye-young; Kim, Hyunjung; Kim, Yeun; Bang, Hyeeun; Kim, Jong-Pill; Hwang, Joo Hwan; Cho, Sang-Nae; Kim, Tae Ue; Lee, Hyeyoung

    2015-10-01

    Drug resistance in Mycobacterium leprae is a significant problem in countries where leprosy is endemic. A sensitive, specific, and high-throughput reverse blot hybridization assay (REBA) for the detection of genotypic resistance to rifampicin (RIF) was designed and evaluated. It has been shown that resistance to RIF in M. leprae involves mutations in the rpoB gene encoding the -subunit of the RNA polymerase. The PCR-REBA simultaneously detects both 6 wild-type regions and 5 different mutations (507 AGC, 513 GTG, 516 TAT, 531 ATG, and 531 TTC) including the most prevalent mutations at positions 507 and 531. Thirty-one clinical isolates provided by Korea Institute of Hansen-s Disease were analyzed by PCR-REBA with RIF resistance of rpoB gene. As a result, missense mutations at codons 507 AGC and 531 ATG with 2-nucleotide substitutions were found in one sample, and a missense mutation at codon 516 TAT and ΔWT6 (deletion of 530-534) was found in another sample. These cases were confirmed by DNA sequence analysis. This rapid, simple, and highly sensitive assay provides a practical alternative to sequencing for genotypic evaluation of RIF resistance in M. leprae.

  19. Real Time Demonstration Project XRF Performance Evaluation Report for Paducah Gaseous Diffusion Plant AOC 492

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Robert L [Argonne National Laboratory

    2008-04-03

    This activity was undertaken to demonstrate the applicability of market-available XRF instruments to quantify metal concentrations relative to background and risk-based action and no action levels in Paducah Gaseous Diffusion Plant (PGDP) soils. As such, the analysis below demonstrates the capabilities of the instruments relative to soil characterization applications at the PGDP.

  20. Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus.

    Directory of Open Access Journals (Sweden)

    Gilberto A Santiago

    Full Text Available Dengue is an acute illness caused by the positive-strand RNA dengue virus (DENV. There are four genetically distinct DENVs (DENV-1-4 that cause disease in tropical and subtropical countries. Most patients are viremic when they present with symptoms; therefore, RT-PCR has been increasingly used in dengue diagnosis. The CDC DENV-1-4 RT-PCR Assay has been developed as an in-vitro diagnostic platform and was recently approved by the US Food and Drug Administration (FDA for detection of dengue in patients with signs or symptoms of mild or severe dengue. The primers and probes of this test have been designed to detect currently circulating strains of DENV-1-4 from around the world at comparable sensitivity. In a retrospective study with 102 dengue cases confirmed by IgM anti-DENV seroconversion in the convalescent sample, the RT-PCR Assay detected DENV RNA in 98.04% of the paired acute samples. Using sequencing as a positive indicator, the RT-PCR Assay had a 97.92% positive agreement in 86 suspected dengue patients with a single acute serum sample. After extensive validations, the RT-PCR Assay performance was highly reproducible when evaluated across three independent testing sites, did not produce false positive results for etiologic agents of other febrile illnesses, and was not affected by pathological levels of potentially interfering biomolecules. These results indicate that the CDC DENV-1-4 RT-PCR Assay provides a reliable diagnostic platform capable for confirming dengue in suspected cases.

  1. Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus.

    Science.gov (United States)

    Santiago, Gilberto A; Vergne, Edgardo; Quiles, Yashira; Cosme, Joan; Vazquez, Jesus; Medina, Juan F; Medina, Freddy; Colón, Candimar; Margolis, Harold; Muñoz-Jordán, Jorge L

    2013-01-01

    Dengue is an acute illness caused by the positive-strand RNA dengue virus (DENV). There are four genetically distinct DENVs (DENV-1-4) that cause disease in tropical and subtropical countries. Most patients are viremic when they present with symptoms; therefore, RT-PCR has been increasingly used in dengue diagnosis. The CDC DENV-1-4 RT-PCR Assay has been developed as an in-vitro diagnostic platform and was recently approved by the US Food and Drug Administration (FDA) for detection of dengue in patients with signs or symptoms of mild or severe dengue. The primers and probes of this test have been designed to detect currently circulating strains of DENV-1-4 from around the world at comparable sensitivity. In a retrospective study with 102 dengue cases confirmed by IgM anti-DENV seroconversion in the convalescent sample, the RT-PCR Assay detected DENV RNA in 98.04% of the paired acute samples. Using sequencing as a positive indicator, the RT-PCR Assay had a 97.92% positive agreement in 86 suspected dengue patients with a single acute serum sample. After extensive validations, the RT-PCR Assay performance was highly reproducible when evaluated across three independent testing sites, did not produce false positive results for etiologic agents of other febrile illnesses, and was not affected by pathological levels of potentially interfering biomolecules. These results indicate that the CDC DENV-1-4 RT-PCR Assay provides a reliable diagnostic platform capable for confirming dengue in suspected cases.

  2. Binding of 3H-iloprost to rat gastric mucosa: a pitfall in performing radioligand binding assays

    International Nuclear Information System (INIS)

    Beinborn, M.; Kromer, W.; Staar, U.; Sewing, K.F.

    1985-01-01

    Binding of 3 H-iloprost was studied in a 20,000 x g sediment of the rat gastric mucosa. When pH in both test tubes for total and non-specific binding was kept identical, no displaceable binding of iloprost could be detected. When no care was taken to keep the pH identical in corresponding test tubes of the binding assay, changes in pH simulated specific and displaceable binding of iloprost. Therefore it is concluded that - in contrast to earlier reports - it is not possible to demonstrate specific iloprost binding using the given method

  3. PERFORMANCE EVALUATION OF A PROTOTYPE ARCHITECT ANTIBODY ASSAY FOR BABESIA MICROTI.

    Science.gov (United States)

    Cheng, Kevin; Coller, Kelly E; Marohnic, Christopher C; Pfeiffer, Zachary A; Fino, James R; Elsing, Randee R; Bergsma, Janet; Marcinkus, Marilee A; Kar, Alak K; Gumbs, Orlando H; Otis, Kathy S; Fishpaugh, Jeffrey; Schultz, Phillip W; Pope, Mark R; Narvaez, Alfredo R; Wong, Susan J; Madison-Antenucci, Susan; Leary, Thomas P; Dawson, George J

    2018-05-09

    The tick-borne protozoan Babesia microti is responsible for more than 200 cases of transfusion-transmitted babesiosis (TTB) infection in the United States over the last 30 years. Measures to mitigate the risk of TTB include nucleic acid testing (NAT) and B. microti antibody testing. A fully automated prototype B. microti antibody test was developed on the ARCHITECT instrument. The specificity was determined to be 99.98% in volunteer blood donors (n=28,740) from areas considered as low endemic for B. microti The sensitivity of the prototype test was studied in experimentally-infected macaques; a total of 128 samples were detected compared to 125 with the indirect fluorescent antibody test (IFA), additionally, 83 (89.2%) of the PCR positive samples were detected compared to 81 (87.1%) using the IFA test. All PCR positive samples that tested negative in the prototype antibody test were pre-seroconversion period samples. Following seroconversion, periods of intermittent parasitemia occurred; 17 PCR negative samples drawn in-between PCR positive bleed dates, tested positive both by the prototype test (robust reactivity) and IFA (marginal reactivity) prior to the administration of therapeutic drugs, indicating that the PCR test failed to detect samples from persistently infected macaques. The prototype assay detected 56 of 58 (96.6%) human subjects diagnosed with clinical babesiosis by both PCR and IFA testing. Overall, the prototype anti-babesia assay provides a highly sensitive and specific test for the diagnosis of B. microti infection. While PCR is preferred for detection of window period parasitemia, antibody tests detect infected subjects during periods of low level parasitemia. Copyright © 2018 Cheng et al.

  4. Performance of a real-time PCR assay in routine bovine mastitis diagnostics compared with in-depth conventional culture.

    Science.gov (United States)

    Hiitiö, Heidi; Riva, Rauna; Autio, Tiina; Pohjanvirta, Tarja; Holopainen, Jani; Pyörälä, Satu; Pelkonen, Sinikka

    2015-05-01

    Reliable identification of the aetiological agent is crucial in mastitis diagnostics. Real-time PCR is a fast, automated tool for detecting the most common udder pathogens directly from milk. In this study aseptically taken quarter milk samples were analysed with a real-time PCR assay (Thermo Scientific PathoProof Mastitis Complete-12 Kit, Thermo Fisher Scientific Ltd.) and by semi-quantitative, in-depth bacteriological culture (BC). The aim of the study was to evaluate the diagnostic performance of the real-time PCR assay in routine use. A total of 294 quarter milk samples from routine mastitis cases were cultured in the national reference laboratory of Finland and examined with real-time PCR. With BC, 251 out of 294 (85.7%) of the milk samples had at least one colony on the plate and 38 samples were considered contaminated. In the PCR mastitis assay, DNA of target species was amplified in 244 samples out of 294 (83.0%). The most common bacterial species detected in the samples, irrespective of the diagnostic method, was the coagulase negative staphylococci (CNS) group (later referred as Staphylococcus spp.) followed by Staphylococcus aureus. Sensitivity (Se) and specificity (Sp) for the PCR assay to provide a positive Staph. aureus result was 97.0 and 95.8% compared with BC. For Staphylococcus spp., the corresponding figures were 86.7 and 75.4%. Our results imply that PCR performed well as a diagnostic tool to detect Staph. aureus but may be too nonspecific for Staphylococcus spp. in routine use with the current cut-off Ct value (37.0). Using PCR as the only microbiological method for mastitis diagnostics, clinical relevance of the results should be carefully considered before further decisions, for instance antimicrobial treatment, especially when minor pathogens with low amount of DNA have been detected. Introducing the concept of contaminated samples should also be considered.

  5. Strong interferon-gamma mediated cellular immunity to scrub typhus demonstrated using a novel whole cell antigen ELISpot assay in rhesus macaques and humans.

    Directory of Open Access Journals (Sweden)

    Manutsanun Sumonwiriya

    2017-09-01

    Full Text Available Scrub typhus is a febrile infection caused by the obligate intracellular bacterium Orientia tsutsugamushi, which causes significant morbidity and mortality across the Asia-Pacific region. The control of this vector-borne disease is challenging due to humans being dead-end hosts, vertical maintenance of the pathogen in the vector itself, and a potentially large rodent reservoir of unclear significance, coupled with a lack of accurate diagnostic tests. Development of an effective vaccine is highly desirable. This however requires better characterization of the natural immune response of this neglected but important disease. Here we implement a novel IFN-γ ELISpot assay as a tool for studying O. tsutsugamushi induced cellular immune responses in an experimental scrub typhus rhesus macaque model and human populations. Whole cell antigen for O. tsutsugamushi (OT-WCA was prepared by heat inactivation of Karp-strain bacteria. Rhesus macaques were infected intradermally with O. tsutsugamushi. Freshly isolated peripheral blood mononuclear cells (PBMC from infected (n = 10 and uninfected animals (n = 5 were stimulated with OT-WCA, and IFN-γ secreting cells quantitated by ELISpot assay at five time points over 28 days. PBMC were then assayed from people in a scrub typhus-endemic region of Thailand (n = 105 and responses compared to those from a partially exposed population in a non-endemic region (n = 14, and to a naïve population in UK (n = 12. Mean results at Day 0 prior to O. tsutsugamushi infection were 12 (95% CI 0-25 and 15 (2-27 spot-forming cells (SFC/106 PBMC for infected and control macaques respectively. Strong O. tsutsugamushi-specific IFN-γ responses were seen post infection, with ELISpot responses 20-fold higher than baseline at Day 7 (mean 235, 95% CI 200-270 SFC/106 PBMC, 105-fold higher at Day 14 (mean 1261, 95% CI 1,097-1,425 SFC/106 PBMC, 125-fold higher at Day 21 (mean 1,498, 95% CI 1,496-1,500 SFC/106 PBMC and 118-fold higher at

  6. Strong interferon-gamma mediated cellular immunity to scrub typhus demonstrated using a novel whole cell antigen ELISpot assay in rhesus macaques and humans.

    Science.gov (United States)

    Sumonwiriya, Manutsanun; Paris, Daniel H; Sunyakumthorn, Piyanate; Anantatat, Tippawan; Jenjaroen, Kemajittra; Chumseng, Suchintana; Im-Erbsin, Rawiwan; Tanganuchitcharnchai, Ampai; Jintaworn, Suthatip; Blacksell, Stuart D; Chowdhury, Fazle R; Kronsteiner, Barbara; Teparrukkul, Prapit; Burke, Robin L; Lombardini, Eric D; Richards, Allen L; Mason, Carl J; Jones, James W; Day, Nicholas P J; Dunachie, Susanna J

    2017-09-01

    Scrub typhus is a febrile infection caused by the obligate intracellular bacterium Orientia tsutsugamushi, which causes significant morbidity and mortality across the Asia-Pacific region. The control of this vector-borne disease is challenging due to humans being dead-end hosts, vertical maintenance of the pathogen in the vector itself, and a potentially large rodent reservoir of unclear significance, coupled with a lack of accurate diagnostic tests. Development of an effective vaccine is highly desirable. This however requires better characterization of the natural immune response of this neglected but important disease. Here we implement a novel IFN-γ ELISpot assay as a tool for studying O. tsutsugamushi induced cellular immune responses in an experimental scrub typhus rhesus macaque model and human populations. Whole cell antigen for O. tsutsugamushi (OT-WCA) was prepared by heat inactivation of Karp-strain bacteria. Rhesus macaques were infected intradermally with O. tsutsugamushi. Freshly isolated peripheral blood mononuclear cells (PBMC) from infected (n = 10) and uninfected animals (n = 5) were stimulated with OT-WCA, and IFN-γ secreting cells quantitated by ELISpot assay at five time points over 28 days. PBMC were then assayed from people in a scrub typhus-endemic region of Thailand (n = 105) and responses compared to those from a partially exposed population in a non-endemic region (n = 14), and to a naïve population in UK (n = 12). Mean results at Day 0 prior to O. tsutsugamushi infection were 12 (95% CI 0-25) and 15 (2-27) spot-forming cells (SFC)/106 PBMC for infected and control macaques respectively. Strong O. tsutsugamushi-specific IFN-γ responses were seen post infection, with ELISpot responses 20-fold higher than baseline at Day 7 (mean 235, 95% CI 200-270 SFC/106 PBMC), 105-fold higher at Day 14 (mean 1261, 95% CI 1,097-1,425 SFC/106 PBMC), 125-fold higher at Day 21 (mean 1,498, 95% CI 1,496-1,500 SFC/106 PBMC) and 118-fold higher at Day 28

  7. Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays

    OpenAIRE

    Saleh, Lanja; Mueller, Daniel; von Eckardstein, Arnold

    2015-01-01

    BACKGROUND: We evaluated the analytical and clinical performance of the new Lumipulse® G 25-OH vitamin D assay from Fujirebio, and compared it to a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and three other commercial automated assays. METHODS: Total 25 hydroxy vitamin D (25(OH)D) levels were measured in 100 selected serum samples from our routine analysis with Fujirebio 25(OH)D assay. The results were compared with those obtained with LC-MS/MS and three other automat...

  8. 76 FR 24831 - Site-Specific Analyses for Demonstrating Compliance With Subpart C Performance Objectives

    Science.gov (United States)

    2011-05-03

    ...-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance... public health and safety, these amendments would enhance the safe disposal of low-level radioactive waste... would be to enhance the safe disposal of low-level radioactive waste. The NRC is also proposing...

  9. Demonstration of short-range wind lidar in a high-performance wind tunnel

    DEFF Research Database (Denmark)

    Pedersen, Anders Tegtmeier; Montes, Belen Fernández; Pedersen, Jens Engholm

    2012-01-01

    -speed regimes very good correlation with reference measurements was found. Furthermore different staring directions were tested and taking a simple geometrical correction into account very good correlation was again found. These measurements all demonstrate the high accuracy of the lidar and indicate a possible...

  10. Diagnostic performance of automated liquid culture and molecular line probe assay in smear-negative pulmonary tuberculosis.

    Science.gov (United States)

    Kotwal, Aarti; Biswas, Debasis; Raghuvanshi, Shailendra; Sindhwani, Girish; Kakati, Barnali; Sharma, Shweta

    2017-04-01

    The diagnosis of smear-negative pulmonary tuberculosis (PTB) is particularly challenging, and automated liquid culture and molecular line probe assays (LPA) may prove particularly useful. The objective of our study was to evaluate the diagnostic potential of automated liquid culture (ALC) technology and commercial LPA in sputum smear-negative PTB suspects. Spot sputum samples were collected from 145 chest-symptomatic smear-negative patients and subjected to ALC, direct drug susceptibility test (DST) testing and LPA, as per manufacturers' instructions. A diagnostic yield of 26.2% was observed among sputum smear-negative TB suspects with 47.4% of the culture isolates being either INH- and/or rifampicin-resistant. Complete agreement was observed between the results of ALC assay and LPA except for two isolates which demonstrated sensitivity to INH and rifampicin at direct DST but were rifampicin-resistant in LPA. Two novel mutations were also detected among the multidrug isolates by LPA. In view of the diagnostic challenges associated with the diagnosis of TB in sputum smear-negative patients, our study demonstrates the applicability of ALC and LPA in establishing diagnostic evidence of TB.

  11. New and highly sensitive assay for L-5-hydroxytryptophan decarboxylase activity by high-performance liquid chromatography-voltammetry.

    Science.gov (United States)

    Rahman, M K; Nagatsu, T; Kato, T

    1980-12-12

    This paper describes a new, inexpensive and highly sensitive assay for aromatic L-amino acid decarboxylase (AADC) activity, using L-5-hydroxytryptophan (L-5-HTP) as substrate, in rat and human brains and serum by high-performance liquid chromatography (HPLC) with voltammetric detection. L-5-HTP was used as substrate and D-5-HTP for the blank. After isolating serotonin (5-HT) formed enzymatically from L-5-HTP on a small Amberlite CG-50 column, the 5-HT was eluted with hydrochloric acid and assayed by HPLC with a voltammetric detector. N-Methyldopamine was added to each incubation mixture as an internal standard. This method is sensitive enough to measure 5-HT, formed by the enzyme, 100 fmol to 140 pmol or more. An advantage of this method is that one can incubate the enzyme for longer time (up to 150 min), as compared with AADC assay using L-DOPA as substrate, resulting in a very high sensitivity. By using this new method, AADC activity was discovered in rat serum.

  12. Performance Characteristics of Different Anti-Double-Stranded DNA Antibody Assays in the Monitoring of Systemic Lupus Erythematosus

    Directory of Open Access Journals (Sweden)

    Michael Mahler

    2017-01-01

    Full Text Available Objective. We sought to evaluate different anti-double-stranded DNA assays for their performance characteristics in monitoring disease activity fluctuations in systemic lupus erythematosus (SLE. Methods. 36 active SLE patients were followed monthly. At each study visit (total n=371, blood was collected and disease activity was scored using the SELENA-SLEDAI (excluding anti-dsDNA or complement components and by a physician’s global assessment (PGA. Four anti-dsDNA tests were compared. Linear mixed-effects models with random intercept and fixed slopes were used to evaluate the relationship between the longitudinal fluctuations of disease activity and anti-dsDNA titers. Results. At enrollment, positivity for QUANTA Lite and high-avidity anti-dsDNA assay was both 64% and significantly lower than anti-dsDNA positivity by QUANTA Flash (83% and CLIFT (96%. Linear mixed-effects modeling indicated that the change in clinical SELENA-SLEDAI scores was associated with the titers of all anti-dsDNA with QUANTA Flash yielding the highest marginal R2 (0.15; p<0.01. QUANTA Flash was the only anti-dsDNA assay significantly associated with the change in PGA (marginal R2=0.05; p<0.01. Conclusion. These data indicate that anti-dsDNA antibodies determined by QUANTA Flash have a value in monitoring SLE disease activity.

  13. Performance of the flow cytometric E-screen assay in screening estrogenicity of pure compounds and environmental samples

    Energy Technology Data Exchange (ETDEWEB)

    Vanparys, Caroline, E-mail: caroline.vanparys@ua.ac.be [Laboratory of Ecophysiology, Biochemistry and Toxicology, University of Antwerp, Antwerp (Belgium); Depiereux, Sophie; Nadzialek, Stephanie [Research Unit in Organismal Biology (URBO), University of Namur (FUNDP), Namur (Belgium); Robbens, Johan; Blust, Ronny [Laboratory of Ecophysiology, Biochemistry and Toxicology, University of Antwerp, Antwerp (Belgium); Kestemont, Patrick [Research Unit in Organismal Biology (URBO), University of Namur (FUNDP), Namur (Belgium); De Coen, Wim [Laboratory of Ecophysiology, Biochemistry and Toxicology, University of Antwerp, Antwerp (Belgium); European Chemicals Agency (ECHA), Helsinki (Finland)

    2010-09-15

    In vitro estrogenicity screens are believed to provide a first prioritization step in hazard characterization of endocrine disrupting chemicals. When applied to complex environmental matrices or mixture samples, they have been indicated valuable in estimating the overall estrogen-mimicking load. In this study, the performance of an adapted format of the classical E-screen or MCF-7 cell proliferation assay was profoundly evaluated to rank pure compounds as well as influents and effluents of sewage treatment plants (STPs) according to estrogenic activity. In this adapted format, flow cytometric cell cycle analysis was used to allow evaluation of the MCF-7 cell proliferative effects after only 24 h of exposure. With an average EC{sub 50} value of 2 pM and CV of 22%, this assay appears as a sensitive and reproducible system for evaluation of estrogenic activity. Moreover, estrogenic responses of 17 pure compounds corresponded well, qualitatively and quantitatively, with other in vitro and in vivo estrogenicity screens, such as the classical E-screen (R{sup 2} = 0.98), the estrogen receptor (ER) binding (R{sup 2} = 0.84) and the ER transcription activation assay (R{sup 2} = 0.87). To evaluate the applicability of this assay for complex samples, influents and effluents of 10 STPs covering different treatment processes, were compared and ranked according to estrogenic removal efficiencies. Activated sludge treatment with phosphorus and nitrogen removal appeared most effective in eliminating estrogenic activity, followed by activated sludge, lagoon and filter bed. This is well in agreement with previous findings based on chemical analysis or biological activity screens. Moreover, ER blocking experiments indicated that cell proliferative responses were mainly ER mediated, illustrating that the complexity of the end point, cell proliferation, compared to other ER screens, does not hamper the interpretation of the results. Therefore, this study, among other E-screen studies

  14. Analytical and diagnostic performance of a qPCR assay for Ichthyophonus spp. compared to the tissue culture 'gold standard'.

    Science.gov (United States)

    Lowe, Vanessa C; Hershberger, Paul K; Friedman, Carolyn S

    2018-06-04

    Parasites of the genus Ichthyophonus infect many fish species and have a non-uniform distribution within host tissues. Due in part to this uneven distribution, the comparative sensitivity and accuracy of using molecular-based detection methods versus culture to estimate parasite prevalence is under debate. We evaluated the analytical and diagnostic performance of an existing qPCR assay in comparison to the 'gold standard' culture method using Pacific herring Clupea pallasii with known exposure history. We determined that the assay is suitable for use in this host, and diagnostic specificity was consistently high (>98%) in both heart and liver tissues. Diagnostic sensitivity could not be fully assessed due to low infection rates, but our results suggest that qPCR is not as sensitive as culture under all circumstances. Diagnostic sensitivity of qPCR relative to culture is likely affected by the amount of sample processed. The prevalence values estimated by the 2 methods were not significantly different when sample amounts were equal (heart tissue), but when the assayed sample amounts were unequal (liver tissue), the culture method detected a significantly higher prevalence of the parasite than qPCR. Further, culture of liver also detected significantly more Ichthyophonus infections than culture of heart, suggesting that the density and distribution of parasites in tissues also plays a role in assay sensitivity. This sensitivity issue would be most problematic for fish with light infections. Although qPCR does not detect the presence of a live organism, DNA-based pathogen detection methods provide the opportunity for alternate testing strategies when culture is not possible.

  15. Performance of the flow cytometric E-screen assay in screening estrogenicity of pure compounds and environmental samples

    International Nuclear Information System (INIS)

    Vanparys, Caroline; Depiereux, Sophie; Nadzialek, Stephanie; Robbens, Johan; Blust, Ronny; Kestemont, Patrick; De Coen, Wim

    2010-01-01

    In vitro estrogenicity screens are believed to provide a first prioritization step in hazard characterization of endocrine disrupting chemicals. When applied to complex environmental matrices or mixture samples, they have been indicated valuable in estimating the overall estrogen-mimicking load. In this study, the performance of an adapted format of the classical E-screen or MCF-7 cell proliferation assay was profoundly evaluated to rank pure compounds as well as influents and effluents of sewage treatment plants (STPs) according to estrogenic activity. In this adapted format, flow cytometric cell cycle analysis was used to allow evaluation of the MCF-7 cell proliferative effects after only 24 h of exposure. With an average EC 50 value of 2 pM and CV of 22%, this assay appears as a sensitive and reproducible system for evaluation of estrogenic activity. Moreover, estrogenic responses of 17 pure compounds corresponded well, qualitatively and quantitatively, with other in vitro and in vivo estrogenicity screens, such as the classical E-screen (R 2 = 0.98), the estrogen receptor (ER) binding (R 2 = 0.84) and the ER transcription activation assay (R 2 = 0.87). To evaluate the applicability of this assay for complex samples, influents and effluents of 10 STPs covering different treatment processes, were compared and ranked according to estrogenic removal efficiencies. Activated sludge treatment with phosphorus and nitrogen removal appeared most effective in eliminating estrogenic activity, followed by activated sludge, lagoon and filter bed. This is well in agreement with previous findings based on chemical analysis or biological activity screens. Moreover, ER blocking experiments indicated that cell proliferative responses were mainly ER mediated, illustrating that the complexity of the end point, cell proliferation, compared to other ER screens, does not hamper the interpretation of the results. Therefore, this study, among other E-screen studies, supports the use of

  16. Evaluation of safe performance secondary school driver education curriculum demonstration project

    Science.gov (United States)

    1983-06-01

    The primary objective of this Project was to determine the crash reduction potential of a quality, competency-based driver training program known as the Safe Performance Curriculum (SPC). The experimental design called for the random assignment of 18...

  17. GATEWAY Report Brief: SSL Demonstration: Long-Term Evaluation of Indoor Field Performance

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2017-02-28

    Report brief summarizing a GATEWAY program evaluation of the long-term performance characteristics (chromaticity change, maintained illuminance, and operations and maintenance) of LED lighting systems in four field installations previously documented in separate DOE GATEWAY reports.

  18. GATEWAY Demonstrations: Long-Term Evaluation of SSL Field Performance in Select Interior Projects

    Energy Technology Data Exchange (ETDEWEB)

    Davis, Tess E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Davis, Robert G. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Wilkerson, Andrea M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2017-02-28

    The GATEWAY program evaluated the long-term performance characteristics (chromaticity change, maintained illuminance, and operations and maintenance) of LED lighting systems in four field installations previously documented in separate DOE GATEWAY reports.

  19. Area-under-the-curve monitoring of cyclosporine therapy: Performance of different assay methods and their target concentrations

    International Nuclear Information System (INIS)

    Grevel, J.; Napoli, K.L.; Gibbons, S.; Kahan, B.D.

    1990-01-01

    The measurement of areas under the concentration-time curve (AUC) was recently introduced as an alternative to trough level monitoring of cyclosporine therapy. The AUC is divided by the oral dosing interval to calculate an average concentration. All measurements are performed at clinical steady state. The initial evaluation of AUC monitoring showed advantages over trough level monitoring with concentrations of cyclosporine measured in serum by the polyclonal radioimmunoassay of Sandoz. This assay technique is no longer available and the following assays were performed in parallel during up to 173 AUC determinations in 51 consecutive renal transplant patients: polyclonal fluorescence polarization immunoassay of Abbott in serum, specific and nonspecific monoclonal radioimmunoassays using 3 H and 125 I tracers in serum and whole blood, and high performance liquid chromatography in whole blood. Both trough levels and average concentrations at steady state measured by those different techniques were significantly correlated with the oral dose. The best correlation (r2 = 0.54) was shown by average concentrations measured in whole blood by the specific monoclonal radioimmunoassay of Sandoz ( 3 H tracer). This monitoring technique was also associated with the smallest absolute error between repeated observations in the same patient while the oral dose rate remained the same or was changed. Both allegedly specific monoclonal radioimmunoassays (with 3 H and 125 I tracer) measured significantly higher concentrations than the liquid chromatography

  20. Measurement of dabigatran: previously demonstrated Hemoclot® Thrombin Inhibitor assay reagent instability on Sysmex CS-2100i is no longer an issue

    DEFF Research Database (Denmark)

    Comuth, Willemijn; Faaborg, Louise; Henriksen, Linda Østervig

    2017-01-01

    hours. Since the reagent composition was unchanged, the increased stability could be due to changed logistics by the supplier, with stock and transfer closer by. Previously demonstrated HTI reagent instability is no longer an issue at our laboratory. The reliability of results of clinical studies...

  1. Demonstration of uncertainty quantification and sensitivity analysis for PWR fuel performance with BISON

    International Nuclear Information System (INIS)

    Zhang, Hongbin; Zhao, Haihua; Zou, Ling; Burns, Douglas; Ladd, Jacob

    2017-01-01

    BISON is an advanced fuels performance code being developed at Idaho National Laboratory and is the code of choice for fuels performance by the U.S. Department of Energy (DOE)’s Consortium for Advanced Simulation of Light Water Reactors (CASL) Program. An approach to uncertainty quantification and sensitivity analysis with BISON was developed and a new toolkit was created. A PWR fuel rod model was developed and simulated by BISON, and uncertainty quantification and sensitivity analysis were performed with eighteen uncertain input parameters. The maximum fuel temperature and gap conductance were selected as the figures of merit (FOM). Pearson, Spearman, and partial correlation coefficients were considered for all of the figures of merit in sensitivity analysis. (author)

  2. Demonstration of Uncertainty Quantification and Sensitivity Analysis for PWR Fuel Performance with BISON

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Hongbin; Ladd, Jacob; Zhao, Haihua; Zou, Ling; Burns, Douglas

    2015-11-01

    BISON is an advanced fuels performance code being developed at Idaho National Laboratory and is the code of choice for fuels performance by the U.S. Department of Energy (DOE)’s Consortium for Advanced Simulation of Light Water Reactors (CASL) Program. An approach to uncertainty quantification and sensitivity analysis with BISON was developed and a new toolkit was created. A PWR fuel rod model was developed and simulated by BISON, and uncertainty quantification and sensitivity analysis were performed with eighteen uncertain input parameters. The maximum fuel temperature and gap conductance were selected as the figures of merit (FOM). Pearson, Spearman, and partial correlation coefficients were considered for all of the figures of merit in sensitivity analysis.

  3. Chest radiography with a shaped filter has no diagnostic advantage: Demonstration by observer performance tests

    International Nuclear Information System (INIS)

    Guilbeau, J.C.; Mazoyer, B.; Pruvost, P.; Verrey, B.; Grenier, P.

    1987-01-01

    The effectiveness of a shaped filter in improving the detection of mediastinal and retrocardiac abnormalities on 140-kV posteroanterior chest radiographs was measured by observer performance testing. The filtered and unfiltered radiographs of 50 patients were randomly selected from 1,000 radiographs obtained from 500 ambulatory or hospitalized patients and were independently read by five observers. Observer performance in detecting abnormalities in the central area was analyzed by receiver operating characteristic (ROC) techniques. The results indicate that the use of a filter has no significant diagnostic advantage, regardless of type or location of lesions over the mediastinum and the retrocardiac areas

  4. Performance Demonstration Initiative U.S. implementation of ASME B and PV code section 11 Appendix 8

    International Nuclear Information System (INIS)

    Becker, F.L.; Ammirato, F.; Huffman, K.

    1994-01-01

    New requirements have now been added to Section 11 as mandatory Appendix 8, ''Performance Demonstration Requirements for Ultrasonic Examination systems''. The appendix was recently published and incorporates performance demonstration requirements for ultrasonic examination equipment, procedures, and personnel. These new requirements will have far reaching and significant impact on the conduct of ISI at all nuclear power plants. For the first time since Section 11 was issued in 1970, the effectiveness of ultrasonic examination procedures and the proficiency of examiners must be demonstrated on reactor pressure vessel (RPV), piping, and bolting markups containing real flaws, Recognizing the importance and complexity of Appendix 8 implementation, representatives from all US nuclear utilities have formed the Performance Demonstration Initiative (PDI) to implement Appendix 8 to provide for uniform implementation

  5. Assessing the performance of a Loop Mediated Isothermal Amplification (LAMP) assay for the detection and subtyping of high-risk suptypes of Human Papilloma Virus (HPV) for Oropharyngeal Squamous Cell Carcinoma (OPSCC) without DNA purification.

    Science.gov (United States)

    Rohatensky, Mitchell G; Livingstone, Devon M; Mintchev, Paul; Barnes, Heather K; Nakoneshny, Steven C; Demetrick, Douglas J; Dort, Joseph C; van Marle, Guido

    2018-02-08

    Oropharyngeal Squamous Cell Carcinoma (OPSCC) is increasing in incidence despite a decline in traditional risk factors. Human Papilloma Virus (HPV), specifically subtypes 16, 18, 31 and 35, has been implicated as the high-risk etiologic agent. HPV positive cancers have a significantly better prognosis than HPV negative cancers of comparable stage, and may benefit from different treatment regimens. Currently, HPV related carcinogenesis is established indirectly through Immunohistochemistry (IHC) staining for p16, a tumour suppressor gene, or polymerase chain reaction (PCR) that directly tests for HPV DNA in biopsied tissue. Loop mediated isothermal amplification (LAMP) is more accurate than IHC, more rapid than PCR and is significantly less costly. In previous work we showed that a subtype specific HPV LAMP assay performed similar to PCR on purified DNA. In this study we examined the performance of this LAMP assay without DNA purification. We used LAMP assays using established primers for HPV 16 and 18, and new primers for HPV 31 and 35. LAMP reaction conditions were tested on serial dilutions of plasmid HPV DNA to confirm minimum viral copy number detection thresholds. LAMP was then performed directly on different human cell line samples without DNA purification. Our LAMP assays could detect 10 5 , 10 3 , 10 4 , and 10 5 copies of plasmid DNA for HPV 16, 18, 31, and 35, respectively. All primer sets were subtype specific, with no cross-amplification. Our LAMP assays also reliably amplified subtype specific HPV DNA from samples without requiring DNA isolation and purification. The high risk OPSCC HPV subtype specific LAMP primer sets demonstrated, excellent clinically relevant, minimum copy number detection thresholds with an easy readout system. Amplification directly from samples without purification illustrated the robust nature of the assay, and the primers used. This lends further support HPV type specific LAMP assays, and these specific primer sets and assays

  6. The Development of Accepted Performance Items to Demonstrate Competence in Literary Braille

    Science.gov (United States)

    Lewis, Sandra; D'Andrea, Frances Mary; Rosenblum, L. Penny

    2012-01-01

    Introduction: This research attempted to establish the content validity of several performance statements that are associated with basic knowledge, production, and reading of braille by beginning teachers. Methods: University instructors (n = 21) and new teachers of students with visual impairments (n = 20) who had taught at least 2 braille…

  7. Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

    DEFF Research Database (Denmark)

    Ejegod, Ditte Møller; Junge, Jette; Franzmann, Maria

    2016-01-01

    BACKGROUND: The novel BD Onclarity(TM) HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY...

  8. Performance demonstration testing at the EPRI NDE center for intergranular stress corrosion cracking in BWR piping

    International Nuclear Information System (INIS)

    Pherigo, G.

    1986-01-01

    Intergranular stress corrosion cracking (IGSCC) has become a significant concern for the commercial electric utility industry during the past four years. As the IGSCC problem manifested itself, the Nuclear Regulatory Commission (NRC) responded by issuing Inspection and Enforcement (I and E) Bulletin 82-03 which required that ultrasonic inspection procedures be demonstrated on service- removed samples. The ability to reliably detect and discriminate IGSCC was recognized by the industry as a very difficult task, at best. Concurrent with the NRC bulletin, state-of-the-art yet practical techniques for the detection and discrimination of IGSCC had to be developed, demonstrated, and transferred to the field in a relatively short time. With the release of I and E Bulletin 83-02, procedures as well as personnel had to be qualified on service-removed samples. This paper reports how the EPRI Nondestructive Evaluation (NDE) Center developed the necessary technology and a formal training and qualification program to meet these needs on behalf of the industry

  9. Performance of the Epstein-Barr Virus and Herpes Simplex Virus Immunoglobulin M Assays on the Liaison Platform with Sera from Patients Displaying Acute Parvovirus B19 Infection▿

    Science.gov (United States)

    Costa, Elisa; Tormo, Nuria; Clari, María Ángeles; Bravo, Dayana; Muñoz-Cobo, Beatriz; Navarro, David

    2009-01-01

    Acute parvovirus B19 infection has been reported to cause false-positive results frequently in the Epstein-Barr (EBV) and herpes simplex virus (HSV) immunoglobulin M (IgM) assays from DiaSorin performed on the Liaison platform. We tested 65 sera from patients with a presumptive or conclusive diagnosis of acute parvovirus B19 infection in both assays and obtained no false-positive results in the EBV IgM test and 10.4% nonspecific reactivities in the HSV IgM assay. Our data support the specificity of both assays in this clinical setting. PMID:19571110

  10. High performance liquid chromatographic-mass spectrometric assay for the quantitation of BMS-204352 in dog K(3)EDTA plasma.

    Science.gov (United States)

    Yao, Ming; Mantha, Subbarao; Shah, Vinod R; Vachharajani, Nimish N; Arnold, Mark E; Pursley, Janice M; Srinivas, Nuggehally R

    2002-05-01

    A high performance liquid chromatographic-mass spectrometric (LC/MS) assay was developed and validated for the determination of BMS-204352 in dog K(3)EDTA plasma. A 0.5 mL aliquot of control plasma was spiked with BMS-204352 and internal standard (IS) and buffered with 1 mL of 5 mM ammonium acetate. The mixture was then extracted with 3 mL of toluene. After separation and evaporation of the organic phase to dryness using nitrogen at 40 degrees C, the residue was reconstituted in the mobile phase and 25 microL of the sample were injected onto a Hypersil C(18) column (2 x 50 mm; 3 microm) at a flow rate of 0.5 mL/min. The mobile phase was consisted of two solvent mixtures (A and B). Solvent A was composed of 5 mM ammonium acetate and 0.1% triethylamine in 75:25 v/v water:methanol, pH adjusted to 5.5 with glacial acetic acid, and solvent B was 5 mM ammonium acetate in methanol. A linear gradient system was used to elute the analytes. The mass spectrometer was programmed to admit the de-protonated molecules at m/z 352.7 (IS) and m/z 357.9 (BMS-204352). Standard curves of BMS-204352 were linear (r(2) > or = 0.998) over the concentration range of 0.5-1000 ng/mL. The mean predicted quality control (QC) concentrations deviated less than 5.1% from the corresponding nominal values (ie 4, 80, 400 and 2000 ng/mL); the within- and between-assay precision of the assay were within 5.5% relative standard deviation. Stability of BMS-204352 was confirmed after at least three freeze/thaw cycles and BMS-204532 was stable in dog plasma when stored frozen at or below -20 degrees C for at least 16 weeks in spiked QC samples and for at least 4 1/2 weeks for in vivo study samples. BMS-204352 and IS were stable in the injection solvent at room temperature for at least 24 h. The assay was applied to delineate the pharmacokinetic disposition of BMS-204352 in dogs following a single intravenous dose administration. In conclusion, the assay is accurate, precise, specific, sensitive and

  11. Demonstration of advanced combustion NO(sub X) control techniques for a wall-fired boiler. Project performance summary, Clean Coal Technology Demonstration Program

    International Nuclear Information System (INIS)

    None

    2001-01-01

    The project represents a landmark assessment of the potential of low-NO(sub x) burners, advanced overtire air, and neural-network control systems to reduce NO(sub x) emissions within the bounds of acceptable dry-bottom, wall-fired boiler performance. Such boilers were targeted under the Clean Air Act Amendments of 1990 (CAAA). Testing provided valuable input to the Environmental Protection Agency ruling issued in March 1994, which set NO(sub x) emission limits for ''Group 1'' wall-fired boilers at 0.5 lb/10(sup 6) Btu to be met by January 1996. The resultant comprehensive database served to assist utilities in effectively implementing CAAA compliance. The project is part of the U.S. Department of Energy's Clean Coal Technology Demonstration Program established to address energy and environmental concerns related to coal use. Five nationally competed solicitations sought cost-shared partnerships with industry to accelerate commercialization of the most advanced coal-based power generation and pollution control technologies. The Program, valued at over$5 billion, has leveraged federal funding twofold through the resultant partnerships encompassing utilities, technology developers, state governments, and research organizations. This project was one of 16 selected in May 1988 from 55 proposals submitted in response to the Program's second solicitation. Southern Company Services, Inc. (SCS) conducted a comprehensive evaluation of the effects of Foster Wheeler Energy Corporation's (FWEC) advanced overfire air (AOFA), low-NO(sub x) burners (LNB), and LNB/AOFA on wall-fired boiler NO(sub x) emissions and other combustion parameters. SCS also evaluated the effectiveness of an advanced on-line optimization system, the Generic NO(sub x) Control Intelligent System (GNOCIS). Over a six-year period, SCS carried out testing at Georgia Power Company's 500-MWe Plant Hammond Unit 4 in Coosa, Georgia. Tests proceeded in a logical sequence using rigorous statistical analyses to

  12. An on-line high performance liquid chromatography-crocin bleaching assay for detection of antioxidants

    NARCIS (Netherlands)

    Bountagkidou, O.; Klift, van der E.J.C.; Tsimidou, M.Z.; Ordoudi, S.A.; Beek, van T.A.

    2012-01-01

    An on-line HPLC (high performance liquid chromatography) method for the rapid screening of individual antioxidants in mixtures was developed using crocin as a substrate (i.e. oxidation probe) and 2,2'-azobis(2-amidinopropane dihydrochloride (AAPH)) in phosphate buffer (pH 7.5) as a radical

  13. Demonstrating the Performance and Emission Characteristics of a Variable Compression Ratio, Alvar-Cycle Engine

    OpenAIRE

    Erlandsson, Olof; Lundholm, Gunnar; Söderberg, Fredrik; Johansson, Bengt; Wong, Victor W.

    1998-01-01

    This paper is a direct continuation of a previous study that addressed the performance and design of a variable compression engine, the Alvar-Cycle Engine [1]. The earlier study was presented at the SAE International Conference and Exposition in Detroit during February 23- 26, 1998 as SAE paper 981027. In the present paper test results from a single cylinder prototype are reviewed and compared with a similar conventional engine. Efficiency and emissions are shown as fu...

  14. Build and Demonstrate a Training Program that Integrates Human Dimension to Optimize Human Performance

    Science.gov (United States)

    2016-12-01

    health, and sports medicine to the overall fitness level of Soldiers.  Social: The social component focuses on the ways in which Army...has, then you can approach that person from a different perspective and knock down some barriers. You have to understand where the student is...and sports medicine contributions for optimal physical performance. (TRADOC Pam 525-3-7 (05/2014). The U.S. Army Human Dimension Concept) Human

  15. Performance of in situ chemical oxidation field demonstrations at DOE sites

    International Nuclear Information System (INIS)

    Cline, S.R.; West, O.R.; Siegrist, R.L.; Holden, W.L.

    1997-01-01

    Researchers at the Oak Ridge National Laboratory (ORNL) have been investigating the use of in situ chemical oxidation to remediate organic contaminants (VOCs, SVOCs, and PCBs) in soils and groundwater at the laboratory and field scales. Field scale design parameters (e.g., oxidant loading rates and oxidant delivery techniques) are often dictated by site conditions (e.g., soil properties and initial contaminant concentrations). Chemical destruction of organic compounds can be accomplished using a variety of oxidants. Recent research has involved field scale in situ chemical oxidation demonstrations using H 2 O 2 and KMnO 4 in conjunction with soil mixing as the oxidant delivery mechanism. A description of some of these fields activities and future field-scale work is presented here

  16. Product Stewardship in Uranium: A Way for the Industry to Demonstrate its High Performance

    International Nuclear Information System (INIS)

    Harris, Frank

    2014-01-01

    Conclusions: • Product stewardship is an means for communicating the high performance on health, safety and environment of the nuclear fuel cycle including uranium mining. • It has been effective with other products and is appropriate for uranium. • Can be a vehicle for addressing public concerns across the industry. • Due to uranium’s unique characteristics it has the potential to be a best practice example of product stewardship. • Work is underway in the international arena to progress uranium product stewardship and it represent a unique opportunity to provide whole of industry benefits

  17. Demonstrating Starshade Performance as Part of NASA's Technology Development for Exoplanet Missions

    Science.gov (United States)

    Kasdin, N. Jeremy; Spergel, D. N.; Vanderbei, R. J.; Lisman, D.; Shaklan, S.; Thomson, M. W.; Walkemeyer, P. E.; Bach, V. M.; Oakes, E.; Cady, E. J.; Martin, S. R.; Marchen, L. F.; Macintosh, B.; Rudd, R.; Mikula, J. A.; Lynch, D. H.

    2012-01-01

    In this poster we describe the results of our project to design, manufacture, and measure a prototype starshade petal as part of the Technology Development for Exoplanet Missions program. An external occult is a satellite employing a large screen, or starshade,that flies in formation with a spaceborne telescope to provide the starlight suppression needed for detecting and characterizing exoplanets. Among the advantages of using an occulter are the broadband allowed for characterization and the removal of light for the observatory, greatly relaxing the requirements on the telescope and instrument. In this first two-year phase we focused on the key requirement of manufacturing a precision petal with the precise tolerances needed to meet the overall error budget. These tolerances are established by modeling the effect that various mechanical and thermal errors have on scatter in the telescope image plane and by suballocating the allowable contrast degradation between these error sources. We show the results of this analysis and a representative error budget. We also present the final manufactured occulter petal and the metrology on its shape that demonstrates it meets requirements. We show that a space occulter built of petals with the same measured shape would achieve better than 1e-9 contrast. We also show our progress in building and testing sample edges with the sharp radius of curvature needed for limiting solar glint. Finally, we describe our plans for the second TDEM phase.

  18. The performance of the SEPT9 gene methylation assay and a comparison with other CRC screening tests: A meta-analysis.

    Science.gov (United States)

    Song, Lele; Jia, Jia; Peng, Xiumei; Xiao, Wenhua; Li, Yuemin

    2017-06-08

    The SEPT9 gene methylation assay is the first FDA-approved blood assay for colorectal cancer (CRC) screening. Fecal immunochemical test (FIT), FIT-DNA test and CEA assay are also in vitro diagnostic (IVD) tests used in CRC screening. This meta-analysis aims to review the SEPT9 assay performance and compare it with other IVD CRC screening tests. By searching the Ovid MEDLINE, EMBASE, CBMdisc and CJFD database, 25 out of 180 studies were identified to report the SEPT9 assay performance. 2613 CRC cases and 6030 controls were included, and sensitivity and specificity were used to evaluate its performance at various algorithms. 1/3 algorithm exhibited the best sensitivity while 2/3 and 1/1 algorithm exhibited the best balance between sensitivity and specificity. The performance of the blood SEPT9 assay is superior to that of the serum protein markers and the FIT test in symptomatic population, while appeared to be less potent than FIT and FIT-DNA tests in asymptomatic population. In conclusion, 1/3 algorithm is recommended for CRC screening, and 2/3 or 1/1 algorithms are suitable for early detection for diagnostic purpose. The SEPT9 assay exhibited better performance in symptomatic population than in asymptomatic population.

  19. Calibration of UFBC counters and their performance in the assay of large mass plutonium samples

    International Nuclear Information System (INIS)

    Verrecchia, G.P.D.; Smith, B.G.R.; Cranston, R.

    1991-01-01

    This paper reports on the cross-calibration of four Universal Fast Breeder reactor assembly coincidence (UFBC) counters using multi-can containers of Plutonium oxide powders with masses between 2 and 12 Kg of plutonium and a parametric study on the sensitivity of the detector response to the positioning or removal and substitution of the material with empty cans. The paper also reports on the performance of the UFBC for routine measurements on large mass, multi-can containers of plutonium oxide powders and compares the results to experience previously obtained in the measurement of fast reactor type fuel assemblies in the mass range 2 to 16 Kg of plutonium

  20. Non-Tuberculous Mycobacteria and the Performance of Interferon Gamma Release Assays in Denmark

    DEFF Research Database (Denmark)

    Hermansen, Thomas Stig; Thomsen, Vibeke Østergaard; Lillebaek, Troels

    2014-01-01

    , nationwide patient data on positive NTM cultures (n = 925) were combined with nationwide data on QFT results (n = 16,133), both retrieved from the International Reference Laboratory of Mycobacteriology, Denmark. A total of 112 patients with NTM infections had a QFT performed, 53 patients had definite NTM...... disease, 10 had possible disease and 49 had NTM colonization. RESULTS: QFT was positive in 8% (4/53) of patients with definite disease, 40% (4/10) with possible disease and 31% (15/49) with colonization. Positivity rate was lowest among patients with definite disease infected with NTM without the RD1...

  1. Fuel R and D international programmes, a way to demonstrate future fuel performances

    International Nuclear Information System (INIS)

    Vanderborck, Y.; Mertens, L.; Dekeyser, J.; Sannen, L.

    1997-01-01

    As a MOX fuel manufacturer, BELGONUCLEAIRE have spent more than 15 years promoting and managing International R and D Programmes, many of them in close cooperation with SCK''centrdot'' CEN. Such programmes dedicated to MOX versus UO 2 fuel behaviour are most of the time based on irradiation in research reactors in which the investigated fuel is submitted to power variations and to ramp testing or are performed in commercial reactors. This paper is focused on recent programmes concerned by high and medium burn-up in BWR and PWR conditions for MOX fuel. It will present also the new opportunities for new programmes. The goals, the programmes descriptions and the expected data being part of these R and D programmes is presented. (author)

  2. Self-motivated and stress-response performance assays in mice are age-dependent.

    Science.gov (United States)

    Ge, Xuan; Ciol, Marcia A; Pettan-Brewer, Christina; Goh, Jorming; Rabinovitch, Peter; Ladiges, Warren

    2017-05-01

    Chronic health conditions of the elderly lead to limitations in physical activity with disability, anxiety, and increased need for medical care and assisted living conditions. Physical performance tests are used to screen for pending loss of mobility and can serve as endpoints to monitor the effectiveness of intervention measures. Since limited mobility is associated with the physical and mental health of a person, evaluation of this in preclinical aging studies in mice will provide a translational approach for testing new intervention strategies. We assessed physiological parameters in 4, 12, 20 and 28month old C57BL/6 and CB6F1 male mice using a rotating rod, a free running wheel, and a photo beam activity field, designed to determine changes in coordinated walking ability, self-motivated running distance, and anxiety response to a novel environment, respectively. Older mice showed decreased coordinated walking times and decreased running distances, predictive of physical performance ability and motivation in the elderly. Changes in both lateral and vertical movements were observed in a novel cage environment suggesting different levels of anxiety. Because the genetic background of the two mouse strains influenced test results in an age-dependent manner, it is imperative to recognize that diverse genetic backgrounds in mice may yield different data in preclinical studies and would need to be interpreted individually for translational applications. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Used Nuclear Fuel Loading and Structural Performance Under Normal Conditions of Transport- Demonstration of Approach and Results on Used Fuel Performance Characterization

    Energy Technology Data Exchange (ETDEWEB)

    Adkins, Harold [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Geelhood, Ken [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Koeppel, Brian [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Coleman, Justin [Idaho National Lab. (INL), Idaho Falls, ID (United States); Bignell, John [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Flores, Gregg [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Wang, Jy-An [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Sanborn, Scott [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Spears, Robert [Idaho National Lab. (INL), Idaho Falls, ID (United States); Klymyshyn, Nick [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2013-09-30

    This document addresses Oak Ridge National Laboratory milestone M2FT-13OR0822015 Demonstration of Approach and Results on Used Nuclear Fuel Performance Characterization. This report provides results of the initial demonstration of the modeling capability developed to perform preliminary deterministic evaluations of moderate-to-high burnup used nuclear fuel (UNF) mechanical performance under normal conditions of storage (NCS) and normal conditions of transport (NCT) conditions. This report also provides results from the sensitivity studies that have been performed. Finally, discussion on the long-term goals and objectives of this initiative are provided.

  4. GATEWAY Demonstrations: LED System Performance in a Trial Installation--Two Years Later, Yuma Border Patrol, Yuma, Arizona

    Energy Technology Data Exchange (ETDEWEB)

    Wilkerson, Andrea M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Sullivan, Gregory P. [Efficiency Solutions, Inc., Richland, WA (United States); Davis, Robert G. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2016-04-01

    Along the Yuma Sector Border Patrol Area in Yuma, Arizona, the GATEWAY program conducted a trial demonstration in which the incumbent quartz metal halide area lighting was replaced with LED at three pole locations at the Yuma Sector Border Patrol Area in Yuma, Arizona. The retrofit was documented to better understand LED technology performance in high-temperature environments. This report follows the GATEWAY Yuma Phase 1.1 Report and reflects LED system results documented two years after the demonstration began.

  5. Use of proficiency samples to assess diagnostic laboratories in France performing a Trichinella digestion assay.

    Science.gov (United States)

    Vallée, Isabelle; Macé, Pauline; Forbes, Lorry; Scandrett, Brad; Durand, Benoit; Gajadhar, Alvin; Boireau, Pascal

    2007-07-01

    Routine diagnosis of animal trichinellosis for food safety and trade relies on a method of artificial digestion to free Trichinella muscle larvae from meat for subsequent identification by microscopy. As part of a quality control system, the French National Reference Laboratory (NRL) initiated ring trials to determine the sensitivity of the test performed in the 72 routine diagnostic laboratories in France. A method was devised to obtain calibrated meat samples containing known numbers of capsules with Trichinella spiralis muscle larvae. This method was based on an incomplete artificial digestion of Trichinella-infected mice carcasses to allow the collection of intact Trichinella capsules. Capsules were placed into a meatball of 100 +/- 2 g of pork and horsemeat to produce proficiency samples. Three categories of samples were prepared: small (3 to 5 capsules), medium (7 to 10), and large (12 to 15). The sensitivity was expressed as the percentage of muscle larvae recovered from each proficiency sample. Reproducibility was tested with ring trials organized between two NRLs (France and Canada), and a reference sensitivity of 84.9% was established. National ring trials were then organized in France, with the 72 routine diagnostic laboratories each receiving four proficiency samples per session. After five sessions, an improvement in the digest test sensitivity was observed. Results at the fifth session indicated sensitivities of 78.60% +/- 23.70%, 81.19% +/- 19.59%, and 80.52% +/- 14.71% muscle larvae for small, medium, and large samples, respectively. This study supports the use of proficiency samples to accurately evaluate the performance of routine diagnostic laboratories that conduct digestion tests for animal trichinellosis diagnosis.

  6. Design, demonstration and performance of a versatile electrospray aerosol generator for nanomaterial research and applications

    International Nuclear Information System (INIS)

    Jennerjohn, Nancy; Fung, David C; Hirakawa, Karen S; Hinds, William; Kennedy, Nola J; Eiguren-Fernandez, Arantzazu; Prikhodko, Sergey; Zavala-Mendez, Jose D

    2010-01-01

    Carbon nanotubes are difficult to aerosolize in a controlled manner. We present a method for generating aerosols not only of carbon nanotubes, but also of many reference and proprietary materials including quantum dots, diesel particulate matter, urban dust, and their mixtures, using electrospraying. This method can be used as a teaching tool, or as the starting point for advanced research, or to deliver nanomaterials in animal exposure studies. This electrospray system generates 180 μg of nanotubes per m 3 of carrier gas, and thus aerosolizes an occupationally relevant mass concentration of nanotubes. The efficiency achievable for single-walled carbon nanotubes is 9.4%. This system is simple and quick to construct using ordinary lab techniques and affordable materials. Since it is easy to replace soiled parts with clean ones, experiments on different types of nanomaterial can be performed back to back without contamination from previous experiments. In this paper, the design, fabrication, operation and characterization of our versatile electrospray method are presented. Also, the morphological changes that carbon nanotubes undergo as they make the transition from dry powders to aerosol particles are presented.

  7. Demonstration of high performance negative central magnetic shear discharges on the DIII-D tokamak

    International Nuclear Information System (INIS)

    Rice, B.W.; Burrell, K.H.; Lao, L.L.

    1996-01-01

    Reliable operation of discharges with negative central magnetic shear has led to significant increases in plasma performance and reactivity in both low confinement, L-mode, and high confinement, H-mode, regimes in the DIII-D tokamak. Using neutral beam injection early in the initial current ramp, a large range of negative shear discharges have been produced with durations lasting up to 3.2 s. The total non- inductive current (beam plus bootstrap) ranges from 50% to 80% in these discharges. In the region of shear reversal, significant peaking of the toroidal rotation [f φ ∼ 30-60 kHz] and ion temperature [T i (0) ∼ 15-22 keV] profiles are observed. In high power discharges with an L-mode edge, peaked density profiles are also observed. Confinement enhancement factors up to H ≡ τ E /τ ITER-89P ∼ 2.5 with an L-mode edge, and H ∼ 3.3 in an Edge Localized Mode (ELM)-free H-mode, are obtained. Transport analysis shows both ion thermal diffusivity and particle diffusivity to be near or below standard neoclassical values in the core. Large pressure peaking in L- mode leads to high disruptivity with Β N ≡ Β T /(I/aB) ≤ 2.3, while broader pressure profiles in H- mode gives low disruptivity with Β N ≤ 4.2

  8. Optimization and development of a high-performance liquid chromatography-based one-site immunometric assay with chemiluminescence detection

    International Nuclear Information System (INIS)

    Oates, Matthew R.; Clarke, William; Zimlich, Alden; Hage, David S.

    2002-01-01

    Various practical and theoretical considerations were examined in the creation and optimization of a high-performance liquid chromatography (HPLC)-based one-site immunometric assay. This method used an HPLC analyte analog column and post-column chemiluminescence detection. The specific analyte chosen as the model for this study was L-thyroxine (also known as T 4 ). In this technique, a sample containing thyroxine was first combined with an excess of anti-T 4 antibody Fab fragments that had earlier been conjugated with chemiluminescent acridinium ester labels. After incubation, the mixture was injected onto a column that contained immobilized T 4 . The amount of thyroxine in the original sample was then determined by measuring the labeled Fab fragments that appeared in the non-retained fraction, or the decrease in excess Fab fragments that were bound to and later eluted from the column. Items considered in creating this assay included the preparation of acridinium ester-labeled Fab fragments, the detection of these fragments with a post-column reactor, and the creation of a suitable immobilized analog column for capturing excess labeled Fab fragments. The final method could measure T 4 in standards at clinically-relevant concentrations and provided a response within 1.5 min of sample injection, following a 20-45 min incubation with the labeled Fab fragments. Possible applications of this method include its use in clinical chemistry and the screening of proteomic or combinatorial libraries

  9. A high-performance liquid chromatography-based radiometric assay for acyl-CoA:alcohol transacylase from jojoba.

    Science.gov (United States)

    Garver, W S; Kemp, J D; Kuehn, G D

    1992-12-01

    Acyl-CoA:alcohol transacylase catalyzes the final step in the biosynthesis of storage liquid wax esters from acyl-CoA fatty acids and fatty alcohols in a limited number of microbes, algae, and Simmondsia chinensis Link (jojoba). An improved and automated method of enzyme assay for this catalyst from cotyledons of jojoba is described. The assay method uses reversed-phase C18 high performance liquid chromatography (HPLC) to separate the labeled C30:1 liquid wax product, [14C]-dodecanyl-octadecenoate, from the unreacted substrate, [14C]octadecenoyl-CoA (oleyl-CoA), and other components produced from enzymes present in the crude homogenate of jojoba cotyledons, including [14C]-octadecenoic acid (oleic acid) and [14C]octadecenol (oleyol). Methods are also described for microscale chemical synthesis in one vessel of 14C-radiolabeled substrates and products for the transacylase. These labeled reagents are required to confirm the HPLC separations of reaction products. The radioactive components are quantitated using an on-line flow-through scintillation detector enabling sensitive and precise analysis of the reaction products.

  10. High-performance liquid chromatographic assay for two rifamycin-derived hypocholesterolemic agents in liver and biological fluids.

    Science.gov (United States)

    Moore, D J; Perrino, P J; Klerer, C P; Robertson, P

    1993-02-26

    CGP 43371 (compound I), a mono-pivaloyl oxazole derivative of a 3-piperazino-rifamycin, has been in clinical trials as a potential hypocholesterolemic agent. A reversed-phase high-performance liquid chromatographic (HPLC) assay was developed using a C18 column and a gradient solvent system of methanol-0.1 M sodium acetate, pH 4.5, at a flow-rate of 1 ml/min. The compound and internal standard (rifampicin) were detected by their ultraviolet absorption at 254 nm. Isolation of the compounds from plasma and liver homogenates was accomplished by precipitation of proteins with acetonitrile, followed by evaporation under nitrogen and reconstitution in methanol. Bile, lymph and urine were injected onto the HPLC column without pretreatment. Calibration curves were linear (r > 0.999) over the concentration range 0.25-20.0 micrograms/ml. The assay procedure was also applicable to other rifamycin derivatives and was able to distinguish between molecular species containing small differences in functionality.

  11. A high performance liquid chromatographic assay of Mefloquine in saliva after a single oral dose in healthy adult Africans

    Directory of Open Access Journals (Sweden)

    Gbotosho Grace O

    2012-02-01

    Full Text Available Abstract Background Mefloquine-artesunate is a formulation of artemisinin based combination therapy (ACT recommended by the World Health Organization and historically the first ACT used clinically. The use of ACT demands constant monitoring of therapeutic efficacies and drug levels, in order to ensure that optimum drug exposure is achieved and detect reduced susceptibility to these drugs. Quantification of anti-malarial drugs in biological fluids other than blood would provide a more readily applicable method of therapeutic drug monitoring in developing endemic countries. Efforts in this study were devoted to the development of a simple, field applicable, non-invasive method for assay of mefloquine in saliva. Methods A high performance liquid chromatographic method with UV detection at 220 nm for assaying mefloquine in saliva was developed and validated by comparing mefloquine concentrations in saliva and plasma samples from four healthy volunteers who received single oral dose of mefloquine. Verapamil was used as internal standard. Chromatographic separation was achieved using a Hypersil ODS column. Results Extraction recoveries of mefloquine in plasma or saliva were 76-86% or 83-93% respectively. Limit of quantification of mefloquine was 20 ng/ml. Agreement between salivary and plasma mefloquine concentrations was satisfactory (r = 0.88, p Conclusion Disposition of mefloquine in saliva paralleled that in plasma, making salivary quantification of mefloquine potentially useful in therapeutic drug monitoring.

  12. Validation of Non-Invasive Waste Assay System (Gamma Box Counter) Performance at AECL Whiteshell Laboratories - 13136

    International Nuclear Information System (INIS)

    Attas, E.M.; Bialas, E.; Rhodes, M.J.

    2013-01-01

    Low-level radioactive waste (LLW) in solid form, resulting from decommissioning and operations activities at AECL's Whiteshell Laboratories (WL), is packaged in B-25 and B-1000 standard waste containers and characterized before it is shipped to an on-site interim storage facility, pending AECL decisions on long term management of its LLW. Assay of the waste packages before shipment contributes to an inventory of the interim storage facility and provides data to support acceptance at a future repository. A key characterization step is a gamma spectrometric measurement carried out under standard conditions using an automated, multi-detector Waste Assay System (WAS), purchased from Antech Corporation. A combination of ORTEC gamma acquisition software and custom software is used in this system to incorporate multiple measurements from two collimated high-resolution detectors. The software corrects the intensities of the gamma spectral lines for geometry and attenuation, and generates a table of calculated activities or limits of detection for a user-defined list of radioisotopes that may potentially be present. Validation of WAS performance was a prerequisite to routine operation. Documentation of the validation process provides assurance of the quality of the results produced, which may be needed one or two decades after they were generated. Aspects of the validation included setting up a quality control routine, measurements of standard point sources in reproducible positions, study of the gamma background, optimization of user-selectable software parameters, investigation of the effect of non-uniform distribution of materials and radionuclides, and comparison of results with measurements made using other gamma detector systems designed to assay bulk materials. The following key components of the validation process have been established. A daily quality control routine has been instituted, to verify stability of the gamma detector operation and the background levels

  13. Performance of highly sensitive cardiac troponin T assay to detect ischaemia at PET-CT in low-risk patients with acute coronary syndrome: a prospective observational study.

    Science.gov (United States)

    Morawiec, Beata; Fournier, Stephane; Tapponnier, Maxime; Prior, John O; Monney, Pierre; Dunet, Vincent; Lauriers, Nathalie; Recordon, Frederique; Trana, Catalina; Iglesias, Juan-Fernando; Kawecki, Damian; Boulat, Olivier; Bardy, Daniel; Lamsidri, Sabine; Eeckhout, Eric; Hugli, Olivier; Muller, Olivier

    2017-07-10

    Highly sensitive troponin T (hs-TnT) assay has improved clinical decision-making for patients admitted with chest pain. However, this assay's performance in detecting myocardial ischaemia in a lowrisk population has been poorly documented. To assess hs-TnT assay's performance to detect myocardial ischaemia at positron emission tomography/CT (PET-CT) in low-risk patients admitted with chest pain. Patients admitted for chest pain with a nonconclusive ECG and negative standard cardiac troponin T results at admission and after 6 hours were prospectively enrolled. Their hs-TnT samples were at T0, T2 and T6. Physicians were blinded to hs-TnT results. All patients underwent a PET-CT at rest and during adenosine-induced stress. All patients with a positive PET-CT result underwent a coronary angiography. Forty-eight patients were included. Six had ischaemia at PET-CT. All of them had ≥1 significant stenosis at coronary angiography. Areas under the curve (95% CI) for predicting significant ischaemia at PET-CT using hs-TnT were 0.764 (0.515 to 1.000) at T0, 0.812(0.616 to 1.000) at T2 and 0.813(0.638 to 0.989) at T6. The receiver operating characteristicbased optimal cut-off value for hs-TnT at T0, T2 and T6 needed to exclude significant ischaemia at PET-CT was <4 ng/L. Using this value, sensitivity, specificity, positive and negative predictive values of hs-TnT to predict significant ischaemia were 83%/38%/16%/94% at T0, 100%/40%/19%/100% at T2 and 100%/43%/20%/100% at T6, respectively. Our findings suggest that in low-risk patients, using the hs-TnT assay with a cut-off value of 4 ng/L demonstrates excellent negative predictive value to exclude myocardial ischaemia detection at PET-CT, at the expense of weak specificity and positive predictive value. ClinicalTrials.gov Identifier: NCT01374607. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly

  14. Medipix3 Demonstration and understanding of near ideal detector performance for 60 & 80 keV electrons

    CERN Document Server

    Mir, J.A.; MacInnes, R.; Gough, C.; Plackett, R.; Shipsey, I.; Sawada, H.; MacLaren, I.; Ballabriga, R.; Maneuski, D.; O'Shea, V.; McGrouther, D.; Kirkland, A.I.

    2016-01-01

    In our article we report first quantitative measurements of imaging performance for the current generation of hybrid pixel detector, Medipix3, as direct electron detector. Utilising beam energies of 60 & 80 keV, measurements of modulation transfer function (MTF) and detective quantum efficiency (DQE) have revealed that, in single pixel mode (SPM), energy threshold values can be chosen to maximize either the MTF or DQE, obtaining values near to, or even exceeding, those for an ideal detector. We have demonstrated that the Medipix3 charge summing mode (CSM) can deliver simultaneous, near ideal values of both MTF and DQE. To understand direct detection performance further we have characterized the detector response to single electron events, building an empirical model which can predict detector MTF and DQE performance based on energy threshold. Exemplifying our findings we demonstrate the Medipix3 imaging performance, recording a fully exposed electron diffraction pattern at 24-bit depth and images in SPM a...

  15. Immunodiagnosis of Human Fascioliasis: An Update of Concepts and Performances of the Serological Assays

    Science.gov (United States)

    Khabisi, Samaneh Abdolahi

    2017-01-01

    Human Fascioliasis (HF) is a foodborne neglected parasitic disease caused by Fasciola hepatica and Fasciola gigantica. New epidemiological data suggest that the endemic areas of the disease are expanding and HF is being reported from areas where it was previously not observed. Diagnosis of HF is challenging. Performances of parasitological approaches, based on the detection of parasite’s egg in the stool, are not satisfactory. Currently serological methods for the diagnosis of HF are mainly based on detection of anti-Fasciola antibodies in serum. Although, there have been some improvement in the development of immunological diagnostic tests for the diagnosis of HF, yet these tests suffer from insufficiency in sensitivity or/and specificity. Detection of antigens, rather than antibodies, seems to be a suitable approach in the diagnosis of HF. Antigen can be detected in sera or stool of the fascioliasis patients. Circulating antigen in serum disappears within a short time and most of the circulating antigens are in immune complex forms which are not freely available to be detected. Therefore, antigenemia might not be an appropriate method for the diagnosis of HF. Detection of antigen in stool (coproantigens) seems to be a suitable alternative method for the diagnosis of HF. Recent data provided convincing evidence that detection of coproantigen improved and simplified the diagnosis of HF. The present review highlights the new achievements in designing and improvement of diagnostic approaches for the immunodiagnosis of HF. Moreover, current status of the available immunodiagnostic techniques for the diagnosis of HF, their strengths and weaknesses has been discussed. PMID:28764235

  16. [Evaluation of the Performance of Two Kinds of Anti-TP Enzyme-Linked Immunosorbent Assay].

    Science.gov (United States)

    Gao, Nan; Huang, Li-Qin; Wang, Rui; Jia, Jun-Jie; Wu, Shuo; Zhang, Jing; Ge, Hong-Wei

    2018-06-01

    To evaluate the accuracy and precision of 2 kinds of anti-treponema pallidum (anti-TP) ELISA reagents in our laboratory for detecting the anti-TP in voluntary blood donors, so as to provide the data support for use of ELISA reagents after introduction of chemiluminescene immunoassay (CLIA). The route detection of anti-TP was performed by using 2 kinds of ELISA reagents, then 546 responsive positive samples detected by anti-TP ELISA were collected, and the infections status of samples confirmed by treponema pallidum particle agglutination (TPPA) test was identified. The confirmed results of responsive samples detected by 2 kinds of anti-TP ELISA reagents were compared, the accuracy of 2 kinds of anti-TP ELISA reagents was analyzed by drawing ROC and comparing area under curve (AUC), and precision of 2 kinds of anti-TP ELISA reagents was compared by statistical analysis of quality control data from 7.1 2016 to 6.30 2017. There were no statistical difference in confirmed positive rate of responsive samples and weak positive samples between 2 kinds of anti-TP ELISA reagents. The responsive samples detected by 2 kinds of anti-TP ELISA reagents accounted for 85.53%(467/546) of all responsive samples, the positive rate confirmed by TPPA test was 82.87%. 44 responsive samples detected by anti-TP ELISA reagent A and 35 responsive samples detected by anti-TP ELISA reagent B were confirmed to be negative by TPPA test. Comparison of AUC showed that the accuracy of 2 kinds of anti-TP ELISA reagents was more high, the difference between 2 reagents was not statistically significant. The coefficient of variation (CV) of anti-TP ELISA reagent A and B was 14.98% and 18.04% respectively, which met the precision requirement of ELISA test. The accuracy and precision of 2 kinds of anti-TP ELISA reagents used in our laboratory are similar, and using any one of anti-TP ELISA reagents all can satisfy the requirements of blood screening.

  17. Development and validation of a chiral high-performance liquid chromatography assay for rogletimide and rogletimide-N-oxide isomers in plasma.

    Science.gov (United States)

    Etienne, M C; Oster, W; Milano, G

    1996-01-01

    The purpose of the present study was to develop and validate a stereo-specific high-performance liquid chromatography (HPLC) assay for rogletimide (Rog) and rogletimide-N-oxide (Nox) isomers in plasma. The assay was performed with a chiral cellulose-[4-methylbenzoate]ester column (Chiracel OJ). Optimal separation was achieved isocratically with a mobile phase consisting of n-hexane/anhydrous ethanol (65/35, v/v) at a flow rate of 0.9 ml/min, with the column being thermostated at +35 degrees C (UV detection at 257 nm). Under these conditions, retention times were approximately 17, 28, 31 and 76 min for R-Rog, S-Rog, R-Nox and S-Nox, respectively. S-aminoglutethimide (S-Ag) served as the internal standard (retention time 70 min). An extraction procedure from plasma samples was developed on Bond Elut RP8 500-mg cartridges; conditioning was performed with 5 ml methanol and 5 ml water, after which 1 ml plasma that had previously been spiked with 5 microM S-Ag was applied. Washing was done with 6 ml water and elution, with 4 ml methanol. After evaporation to dryness, residues were dissolved in 400 microliters anhydrous ethanol and 12-48 microliters was injected onto the HPLC system. Blank plasma from healthy donors showed the random presence of a small interference eluting at the retention time of R-Rog, precluding the accurate quantification of R-Rog concentrations below 2.5 microM. Reproducibility assays demonstrated the need to use an internal standard. Taking into account the internal standard, at 2.5 microM the intra- and inter-assay coefficients of variation were 10.5% and 21.0% for R-Rog 5.5% and 8.7% for S-Rog, 7.6% and 20.8% for R-Nox and 11.7% and 6.4% for S-Nox, respectively. The detection limit was 2.5 microM for R-Rog, 0.5 microM for S-Rog, 0.25 microM for R-Nox and 0.5 microM for S-Nox. Linearity was satisfactory at concentrations ranging from 2.5 to 10 microM for R-Rog, from 0.5 to 10 microM for S-Rog, from 0.25 to 2.5 microM for R-Nox and from 0.50 to 2

  18. A high-performance liquid chromatography method for the serotonin release assay is equivalent to the radioactive method.

    Science.gov (United States)

    Sono-Koree, N K; Crist, R A; Frank, E L; Rodgers, G M; Smock, K J

    2016-02-01

    The serotonin release assay (SRA) is considered the gold standard laboratory test for heparin-induced thrombocytopenia (HIT). The historic SRA method uses platelets loaded with radiolabeled serotonin to evaluate platelet activation by HIT immune complexes. However, a nonradioactive method is desirable. We report the performance characteristics of a high-performance liquid chromatography (HPLC) SRA method. We validated the performance characteristics of an HPLC-SRA method, including correlation with a reference laboratory using the radioactive method. Serotonin released from reagent platelets was quantified by HPLC using fluorescent detection. Results were expressed as % release and classified as positive, negative, or indeterminate based on previously published cutoffs. Serum samples from 250 subjects with suspected HIT were tested in the HPLC-SRA and with the radioactive method. Concordant classifications were observed in 230 samples (92%). Sera from 41 healthy individuals tested negative. Between-run imprecision studies showed standard deviation of performance characteristics, equivalent to the historic radioactive method, but avoids the complexities of working with radioactivity. © 2015 John Wiley & Sons Ltd.

  19. The Impact of Computer Simulations as Interactive Demonstration Tools on the Performance of Grade 11 Learners in Electromagnetism

    Science.gov (United States)

    Kotoka, Jonas; Kriek, Jeanne

    2014-01-01

    The impact of computer simulations on the performance of 65 grade 11 learners in electromagnetism in a South African high school in the Mpumalanga province is investigated. Learners did not use the simulations individually, but teachers used them as an interactive demonstration tool. Basic concepts in electromagnetism are difficult to understand…

  20. Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers.

    Science.gov (United States)

    Lim, Jinsook; Song, Kyung Eun; Song, Sang Hoon; Choi, Hyun-Jung; Koo, Sun Hoe; Kwon, Gye Choel

    2016-05-01

    -The traceability of clinical results to internationally recognized and accepted reference materials and reference measurement procedures has become increasingly important. Therefore, the establishment of traceability has become a mandatory requirement for all in vitro diagnostics devices. -To evaluate the traceability of the Abbott Architect c8000 system (Abbott Laboratories, Abbott Park, Illinois), consisting of calibrators and reagents, across 4 different chemistry analyzers, and to evaluate its general performance on the Toshiba 2000FR NEO (Toshiba Medical Systems Corporation, Otawara-shi, Tochigi-ken, Japan). -For assessment of traceability, secondary reference materials were evaluated 5 times, and then bias was calculated. Precision, linearity, and carryover were determined according to the guidelines of the Clinical and Laboratory Standards Institute (Wayne, Pennsylvania). -The biases from 4 different analyzers ranged from -2.33% to 2.70% on the Toshiba 2000FR NEO, -2.33% to 5.12% on the Roche Hitachi 7600 (Roche Diagnostics International, Basel, Switzerland), -0.93% to 2.87% on the Roche Modular, and -2.16% to 2.86% on the Abbott Architect c16000. The total coefficients of variance of all analytes were less than 5%. The coefficients of determination (R(2)) were more than 0.9900. The carryover rate ranged from -0.54% to 0.17%. -Abbott clinical chemistry assays met the performance criteria based on desirable biological variation for precision, bias, and total error. They also showed excellent linearity and carryover. Therefore, these clinical chemistry assays were found to be accurate and reliable and are readily applicable on the various platforms used in this study.

  1. Multi-laboratory evaluations of the performance of Catellicoccus marimammalium PCR assays developed to target gull fecal sources

    Science.gov (United States)

    Sinigalliano, Christopher D.; Ervin, Jared S.; Van De Werfhorst, Laurie C.; Badgley, Brian D.; Ballestée, Elisenda; Bartkowiaka, Jakob; Boehm, Alexandria B.; Byappanahalli, Muruleedhara N.; Goodwin, Kelly D.; Gourmelon, Michèle; Griffith, John; Holden, Patricia A.; Jay, Jenny; Layton, Blythe; Lee, Cheonghoon; Lee, Jiyoung; Meijer, Wim G.; Noble, Rachel; Raith, Meredith; Ryu, Hodon; Sadowsky, Michael J.; Schriewer, Alexander; Wang, Dan; Wanless, David; Whitman, Richard; Wuertz, Stefan; Santo Domingo, Jorge W.

    2013-01-01

    Here we report results from a multi-laboratory (n = 11) evaluation of four different PCR methods targeting the 16S rRNA gene of Catellicoccus marimammalium originally developed to detect gull fecal contamination in coastal environments. The methods included a conventional end-point PCR method, a SYBR® Green qPCR method, and two TaqMan® qPCR methods. Different techniques for data normalization and analysis were tested. Data analysis methods had a pronounced impact on assay sensitivity and specificity calculations. Across-laboratory standardization of metrics including the lower limit of quantification (LLOQ), target detected but not quantifiable (DNQ), and target not detected (ND) significantly improved results compared to results submitted by individual laboratories prior to definition standardization. The unit of measure used for data normalization also had a pronounced effect on measured assay performance. Data normalization to DNA mass improved quantitative method performance as compared to enterococcus normalization. The MST methods tested here were originally designed for gulls but were found in this study to also detect feces from other birds, particularly feces composited from pigeons. Sequencing efforts showed that some pigeon feces from California contained sequences similar to C. marimammalium found in gull feces. These data suggest that the prevalence, geographic scope, and ecology of C. marimammalium in host birds other than gulls require further investigation. This study represents an important first step in the multi-laboratory assessment of these methods and highlights the need to broaden and standardize additional evaluations, including environmentally relevant target concentrations in ambient waters from diverse geographic regions.

  2. Use of activity-based probes to develop high throughput screening assays that can be performed in complex cell extracts.

    Directory of Open Access Journals (Sweden)

    Edgar Deu

    2010-08-01

    Full Text Available High throughput screening (HTS is one of the primary tools used to identify novel enzyme inhibitors. However, its applicability is generally restricted to targets that can either be expressed recombinantly or purified in large quantities.Here, we described a method to use activity-based probes (ABPs to identify substrates that are sufficiently selective to allow HTS in complex biological samples. Because ABPs label their target enzymes through the formation of a permanent covalent bond, we can correlate labeling of target enzymes in a complex mixture with inhibition of turnover of a substrate in that same mixture. Thus, substrate specificity can be determined and substrates with sufficiently high selectivity for HTS can be identified. In this study, we demonstrate this method by using an ABP for dipeptidyl aminopeptidases to identify (Pro-Arg2-Rhodamine as a specific substrate for DPAP1 in Plasmodium falciparum lysates and Cathepsin C in rat liver extracts. We then used this substrate to develop highly sensitive HTS assays (Z'>0.8 that are suitable for use in screening large collections of small molecules (i.e >300,000 for inhibitors of these proteases. Finally, we demonstrate that it is possible to use broad-spectrum ABPs to identify target-specific substrates.We believe that this approach will have value for many enzymatic systems where access to large amounts of active enzyme is problematic.

  3. Clonogenic assay: adherent cells.

    Science.gov (United States)

    Rafehi, Haloom; Orlowski, Christian; Georgiadis, George T; Ververis, Katherine; El-Osta, Assam; Karagiannis, Tom C

    2011-03-13

    The clonogenic (or colony forming) assay has been established for more than 50 years; the original paper describing the technique was published in 1956. Apart from documenting the method, the initial landmark study generated the first radiation-dose response curve for X-ray irradiated mammalian (HeLa) cells in culture. Basically, the clonogenic assay enables an assessment of the differences in reproductive viability (capacity of cells to produce progeny; i.e. a single cell to form a colony of 50 or more cells) between control untreated cells and cells that have undergone various treatments such as exposure to ionising radiation, various chemical compounds (e.g. cytotoxic agents) or in other cases genetic manipulation. The assay has become the most widely accepted technique in radiation biology and has been widely used for evaluating the radiation sensitivity of different cell lines. Further, the clonogenic assay is commonly used for monitoring the efficacy of radiation modifying compounds and for determining the effects of cytotoxic agents and other anti-cancer therapeutics on colony forming ability, in different cell lines. A typical clonogenic survival experiment using adherent cells lines involves three distinct components, 1) treatment of the cell monolayer in tissue culture flasks, 2) preparation of single cell suspensions and plating an appropriate number of cells in petri dishes and 3) fixing and staining colonies following a relevant incubation period, which could range from 1-3 weeks, depending on the cell line. Here we demonstrate the general procedure for performing the clonogenic assay with adherent cell lines with the use of an immortalized human keratinocyte cell line (FEP-1811). Also, our aims are to describe common features of clonogenic assays including calculation of the plating efficiency and survival fractions after exposure of cells to radiation, and to exemplify modification of radiation-response with the use of a natural antioxidant

  4. Comparison among performances of a ligase chain reaction-based assay and two enzyme immunoassays in detecting Chlamydia trachomatis in urine specimens from men with nongonococcal urethritis.

    Science.gov (United States)

    Deguchi, T; Yasuda, M; Uno, M; Tada, K; Iwata, H; Komeda, H; Maeda, S; Latila, V; Saito, I; Kawada, Y

    1996-01-01

    We evaluated the performances of a ligase chain reaction (LCR)-based assay and two enzyme immunoassays (Chlamydiazyme and IDEIA) in the detection of Chlamydia trachomatis in urine specimens. We compared the results of testing urine specimens by these assays with those of urethral swab culture by examining samples from 131 men with nongonococcal urethritis. Discrepant results were analyzed by testing urethral swab specimens for C. trachomatis by a PCR-based assay. After the resolution of discrepant results, the sensitivity of urethral swab culture was 85.3%, whereas those of the LCR assay, Chlamydiazyme, and IDEIA with urine specimens were 94.1, 82.4, and 94.1%, respectively. The LCR assay and IDEIA were more sensitive than was urethral swab culture. In addition, the LCR assay, with a sensitivity equal to that of IDEIA, was more specific. Overall, the LCR assay proved to be superior to the enzyme immunoassays in detecting C. trachomatis in urine specimens. Testing urine specimens by LCR assay should be a helpful alternative method for diagnosing C. trachomatis urethral infection in men with nongonococcal urethritis. PMID:8784574

  5. Performance of two Aspergillus IgG EIA assays compared with the precipitin test in chronic and allergic aspergillosis.

    Science.gov (United States)

    Baxter, C G; Denning, D W; Jones, A M; Todd, A; Moore, C B; Richardson, M D

    2013-04-01

    Detection of Aspergillus IgG antibodies is important in the diagnosis of chronic pulmonary aspergillosis and allergic bronchopulmonary aspergillosis. Immunoprecipitation techniques to detect these antibodies appear to lack sensitivity and accurate quantitation compared with enzyme immunoassays (EIA). This study assessed the performance of two commercial EIAs compared with counterimmunoelectrophoresis (CIE). This was a prospective cohort study of 175 adult patients with chronic or allergic pulmonary aspergillosis. Aspergillus IgG antibodies were detected using CIE, Phadia ImmunoCap Aspergillus IgG and Bio-Rad Platelia Aspergillus IgG. Inter-assay reproducibility was determined for each method and 25 patients had two serum samples analysed within a 6-month interval. When compared with CIE, both ImmunoCap and Platelia Aspergillus IgG had good sensitivity (97 and 93%, respectively) for detection of Aspergillus IgG antibodies. The level of agreement between the two EIAs for positive results was good, but the concentration of antibodies was not correlated between the tests or with CIE titre. ImmunoCap IgG inter-assay coefficient of variation was 5%, whereas Platelia IgG was 33%. Median ImmunoCap IgG values for CPA and allergic aspergillosis were 95 and 32 mg/L, respectively, whereas Platelia IgG values were >80 and 6 AU/mL. The direction of CIE titre change over 6 months was mirrored by ImmunoCap IgG levels in 92% of patients, and by Platelia IgG in 72% of patients. Both ImmunoCap and Platelia Aspergillus IgG EIAs are sensitive measures of Aspergillus IgG antibodies compared with CIE. However, ImmunoCap appears to have better reproducibility and may be more suitable for monitoring patient disease. © 2012 The Authors Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

  6. Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX? Colon Cancer Assay

    OpenAIRE

    Clark-Langone, Kim M; Sangli, Chithra; Krishnakumar, Jayadevi; Watson, Drew

    2010-01-01

    Abstract Background The Oncotype DX® Colon Cancer Assay is a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection using fixed paraffin embedded (FPE) primary colon tumor tissue. Like the Oncotype DX Breast Cancer Assay, this is a high complexity, multi-analyte, reverse transcription (RT) polymerase chain reaction (PCR) assay that measures the expression levels of specific cancer-related genes. By capturing the biology unde...

  7. High-performance liquid chromatographic assay of parabens in wash-off cosmetic products and foods using chemiluminescence detection

    International Nuclear Information System (INIS)

    Zhang Qunlin; Lian Mei; Liu Lijuan; Cui Hua

    2005-01-01

    A new method for the simultaneous determination of parabens including methylparaben, ethylparaben, propylparaben, and butylparaben by high-performance liquid chromatography (HPLC) coupled with chemiluminescence detection was developed. The procedure was based on the chemiluminescent enhancement by parabens of the cerium(IV)-rhodamine 6G system in the strong sulfuric acid medium. The good separation of parabens was carried out with an isocratic elution using a mixture of methanol and water (60:40, v/v) within 8.5 min. Under the optimized conditions, a linear working range extends three orders of magnitude with the relative standard deviations of intra- and inter-day precision below 4.5%, and the detection limits were 1.9 x 10 -9 , 2.7 x 10 -9 , 3.9 x 10 -9 , and 5.3 x 10 -9 g ml -1 for methylparaben, ethylparaben, propylparaben, and butylparaben, respectively. The chemiluminescence reaction was well compatible with the mobile phase of high-performance liquid chromatography. The proposed method has been successfully applied to the assay of parabens in wash-off cosmetic products and foods with the minimal sample preparation

  8. Clean Coal Technology III: 10 MW Demonstration of Gas Suspension Absorption final project performance and economics report

    Energy Technology Data Exchange (ETDEWEB)

    Hsu, F.E.

    1995-08-01

    The 10 MW Demonstration of the Gas Suspension Absorption (GSA) program is a government and industry co-funded technology development. The objective of the project is to demonstrate the performance of the GSA system in treating a 10 MW slipstream of flue gas resulting from the combustion of a high sulfur coal. This project involves design, fabrication, construction and testing of the GSA system. The Project Performance and Economics Report provides the nonproprietary information for the ``10 MW Demonstration of the Gas Suspension Absorption (GSA) Project`` installed at Tennessee Valley Authority`s (TVA) Shawnee Power Station, Center for Emissions Research (CER) at Paducah, Kentucky. The program demonstrated that the GSA flue-gas-desulfurization (FGD) technology is capable of achieving high SO{sub 2} removal efficiencies (greater than 90%), while maintaining particulate emissions below the New Source Performance Standards (NSPS), without any negative environmental impact (section 6). A 28-day test demonstrated the reliability and operability of the GSA system during continuous operation. The test results and detailed discussions of the test data can be obtained from TVA`s Final Report (Appendix A). The Air Toxics Report (Appendix B), prepared by Energy and Environmental Research Corporation (EERC) characterizes air toxic emissions of selected hazardous air pollutants (HAP) from the GSA process. The results of this testing show that the GSA system can substantially reduce the emission of these HAP. With its lower capital costs and maintenance costs (section 7), as compared to conventional semi-dry scrubbers, the GSA technology commands a high potential for further commercialization in the United States. For detailed information refer to The Economic Evaluation Report (Appendix C) prepared by Raytheon Engineers and Constructors.

  9. Performance analysis of an optical self-interference cancellation system with a directly modulated laser-based demonstration.

    Science.gov (United States)

    Yu, Yinghong; Zhang, Yunhao; Huang, Lin; Xiao, Shilin

    2018-02-20

    In this paper, two main performance indices of the optical self-interference cancellation (OSIC) system are theoretically analyzed: cancellation bandwidth and depth. Delay deviation is investigated to be the determining factor of cancellation bandwidth, based on which the bandwidth advantage of the OSIC system over electrical schemes is also proven theoretically. Cancellation depth in the narrowband is mostly influenced by attenuation and delay-adjusting deviation, while in the broadband case, the performance is mostly limited by frequency-dependent amplitude and phase mismatch. The cancellation performance analysis is suitable for most linear modulation-demodulation OSIC systems, including the directly modulated laser (DML)-based OSIC system verified experimentally in this paper. The cancellation model is well demonstrated by the agreement between experimental cancellation results and predicted performance. For over-the-air demonstration with the employment of antennas, broadband cancellation within 450 MHz bandwidth of 22 dB and 25 dB is achieved at 900 MHz and 2.4 GHz, respectively. In addition, orthogonal frequency division multiplexing signals are employed to show in-band full-duplex transmission with good performance by the DML-based OSIC system, with successful suppression of self-interference and recovery of the signal of interest.

  10. First demonstration and performance of an injection locked continuous wave magnetron to phase control a superconducting cavity

    Directory of Open Access Journals (Sweden)

    A. C. Dexter

    2011-03-01

    Full Text Available The applications of magnetrons to high power proton and cw electron linacs are discussed. An experiment is described where a 2.45 GHz magnetron has been used to drive a single cell superconducting cavity. With the magnetron injection locked, a modest phase control accuracy of 0.95° rms has been demonstrated. Factors limiting performance have been identified.

  11. A model for the training effects in swimming demonstrates a strong relationship between parasympathetic activity, performance and index of fatigue.

    Directory of Open Access Journals (Sweden)

    Sébastien Chalencon

    Full Text Available Competitive swimming as a physical activity results in changes to the activity level of the autonomic nervous system (ANS. However, the precise relationship between ANS activity, fatigue and sports performance remains contentious. To address this problem and build a model to support a consistent relationship, data were gathered from national and regional swimmers during two 30 consecutive-week training periods. Nocturnal ANS activity was measured weekly and quantified through wavelet transform analysis of the recorded heart rate variability. Performance was then measured through a subsequent morning 400 meters freestyle time-trial. A model was proposed where indices of fatigue were computed using Banister's two antagonistic component model of fatigue and adaptation applied to both the ANS activity and the performance. This demonstrated that a logarithmic relationship existed between performance and ANS activity for each subject. There was a high degree of model fit between the measured and calculated performance (R(2=0.84±0.14,p<0.01 and the measured and calculated High Frequency (HF power of the ANS activity (R(2=0.79±0.07, p<0.01. During the taper periods, improvements in measured performance and measured HF were strongly related. In the model, variations in performance were related to significant reductions in the level of 'Negative Influences' rather than increases in 'Positive Influences'. Furthermore, the delay needed to return to the initial performance level was highly correlated to the delay required to return to the initial HF power level (p<0.01. The delay required to reach peak performance was highly correlated to the delay required to reach the maximal level of HF power (p=0.02. Building the ANS/performance identity of a subject, including the time to peak HF, may help predict the maximal performance that could be obtained at a given time.

  12. Performance evaluation of the Aptima HSV-1 and 2 assay for the detection of HSV in cutaneous and mucocutaneous lesion specimens.

    Science.gov (United States)

    Sam, Soya S; Caliendo, Angela M; Ingersoll, Jessica; Abdul-Ali, Deborah; Kraft, Colleen S

    Timely and precise laboratory diagnosis of Herpes simplex viruses (HSV) is required to guide clinical management. The study evaluated limit of detection (LOD) and performance characteristics of the Aptima HSV 1 & 2 assay in comparison to four assays. The multi-center study compared qualitative detection of HSV-1 and 2 by the Aptima HSV-1 and 2 assay (Hologic) to ELVIS culture, Lyra Direct (Quidel), AmpliVue (Quidel) and a laboratory developed test (LDT). LOD was performed using VTM and STM diluted viral concentrations and clinical performance was evaluated using 505 swab specimens. The Aptima LOD studies performed showed a lower detection limit for STM specimens as 1450 copies/mL and 430 copies/mL for HSV1 and HSV-2 respectively; the LOD for VTM specimens was 9370 copies/mL and 8045 copies/mL for HSV-1 and HSV-2 respectively. When the assays were analyzed based on the positive consensus result established the Aptima had 95% of percent positive agreement (PPA) and 100% negative percent agreement (NPA) for the HSV-1. For the HSV-2, the PPA and NPA for Aptima were 96% and 100% respectively. AmpliVue had 1.8% invalid rate, while Lyra had no invalid results but an inhibition rate of 0.8%. Aptima and LDT did not have any invalid or inhibited results. The results indicate that the Aptima HSV-1 & 2 assay is sensitive and the performance characteristics of the Aptima assay is comparable to the assays analyzed for the detection and differentiation of HSV-1 and 2 from cutaneous and mucocutaneous lesions. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Highly sensitive reversed-phase high-performance liquid chromatography assay for the detection of Tamm-Horsfall protein in human urine.

    Science.gov (United States)

    Akimoto, Masaru; Hokazono, Eisaku; Ota, Eri; Tateishi, Takiko; Kayamori, Yuzo

    2016-01-01

    Tamm-Horsfall protein (also known as uromodulin) is the most abundant urinary protein in healthy individuals. Since initially characterized by Tamm and Horsfall, the amount of urinary excretion and structural mutations of Tamm-Horsfall protein is associated with kidney diseases. However, currently available assays for Tamm-Horsfall protein, which are mainly enzyme-linked immunosorbent assay-based, suffer from poor reproducibility and might give false negative results. We developed a novel, quantitative assay for Tamm-Horsfall protein using reversed-phase high-performance liquid chromatography. A precipitation pretreatment avoided urine matrix interference and excessive sample dilution. High-performance liquid chromatography optimization based on polarity allowed excellent separation of Tamm-Horsfall protein from other major urine components. Our method exhibited high precision (based on the relative standard deviations of intraday [≤2.77%] and interday [≤5.35%] repetitions). The Tamm-Horsfall protein recovery rate was 100.0-104.2%. The mean Tamm-Horsfall protein concentration in 25 healthy individuals was 31.6 ± 18.8 mg/g creatinine. There was a strong correlation between data obtained by high-performance liquid chromatography and enzyme-linked immunosorbent assay (r = 0.906), but enzyme-linked immunosorbent assay values tended to be lower than high-performance liquid chromatography values at low Tamm-Horsfall protein concentrations. The high sensitivity and reproducibility of our Tamm-Horsfall protein assay will reduce the number of false negative results of the sample compared with enzyme-linked immunosorbent assay. Moreover, our method is superior to other high-performance liquid chromatography methods, and a simple protocol will facilitate further research on the physiological role of Tamm-Horsfall protein. © The Author(s) 2015.

  14. Performance of 2 commercial real-time polymerase chain reaction assays for the detection of Aspergillus and Pneumocystis DNA in bronchoalveolar lavage fluid samples from critical care patients.

    Science.gov (United States)

    Orsi, Carlotta Francesca; Gennari, William; Venturelli, Claudia; La Regina, Annunziata; Pecorari, Monica; Righi, Elena; Machetti, Marco; Blasi, Elisabetta

    2012-06-01

    This article investigates the performance of 2 commercial real-time polymerase chain reaction (PCR) assays, MycAssay™ Aspergillus (Myc(Asp)Assay) and MycAssay™ Pneumocystis (Myc(PCP)Assay), on the ABI 7300 platform for the detection of Aspergillus (Asp) or Pneumocystis jirovecii (Pj) DNA in bronchoalveolar lavage (BAL) samples from 20 patients. Operationally, patients enrolled were clustered into 3 groups: invasive aspergillosis group (IA, 7 patients), Pj pneumonia group (PCP, 8 patients), and negative control group (5 patients). All the IA patients were Myc(Asp)Assay positive, whereas 12 non-IA patients returned negative PCR results. Furthermore, 7 of 8 PCP patients were Myc(PCP)Assay positive, while 9 non-PCP patients were PCR negative. In conclusion, these data provide an early indication of the effectiveness of both the Myc(Asp)Assay and Myc(PCP)Assay on the ABI 7300 platform for the detection of either Asp or Pj DNA in BAL from patients with deep fungal infections. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Performance demonstration and evaluation of the synergetic application of vanadium dioxide glazing and phase change material in passive buildings

    International Nuclear Information System (INIS)

    Long, Linshuang; Ye, Hong; Gao, Yanfeng; Zou, Ruqiang

    2014-01-01

    Highlights: • VO 2 and PCM were combined in passive building application for the first time. • Synergetic performance of them is demonstrated in a full size room. • Synergetic application has a better performance than the solo ones. • The materials interact with each other in synergetic application. • ESI can be used to evaluate the performance of the synergetic application. - Abstract: One of the key methods to improve the energy saving performance of a building is to apply advanced materials or components to the building envelope. However, the two parts of a building’s envelope, the transparent one and the non-transparent one, are usually investigated individually by existing literature. In this study, vanadium dioxide (VO 2 ) glazing, an advanced energy-efficient element applied to the transparent parts of the building envelope, and phase change material (PCM), a typical thermal storage material used to improve the non-transparent parts of the building envelope, were adopted simultaneously for the first time. The synergetic performance of VO 2 glazing and PCM, demonstrated in a full-scale, lightweight, passive room, resulted in a significant improvement in the thermal comfort degree. The Energy Saving Index (ESI) is a simple and effective indicator that can be used to evaluate the passive application performance of a single energy-efficient material or component on a common standpoint. In this work, the index was broadened to evaluate the performance of more than one material, showing that ESI is feasible and favorable to analyze the coefficient application of several building materials and/or components. Using the ESI, the performance of the synergetic application was also compared with those of the sole materials, indicating that the synergetic application has a better performance during the cooling period. Furthermore the synergetic application involves an interplay rather than a simple combination of the energy-efficient materials. The

  16. Comparison of the performance in detection of HPV infections between the high-risk HPV genotyping real time PCR and the PCR-reverse dot blot assays.

    Science.gov (United States)

    Zhang, Lahong; Dai, Yibei; Chen, Jiahuan; Hong, Liquan; Liu, Yuhua; Ke, Qiang; Chen, Yiwen; Cai, Chengsong; Liu, Xia; Chen, Zhaojun

    2018-01-01

    A new multiplex real-time PCR assay, the high-risk HPV genotyping real time PCR assay (HR HPV RT-PCR), has been developed to detect 15 high-risk HPV types with respective viral loads. In this report, a total of 684 cervical specimens from women diagnosed with vaginitis were assessed by the HR HPV RT-PCR and the PCR reaction and reverse dot blot (PCR-RDB) assays, using a PCR-sequencing method as a reference standard. A total coincidence of 97.7% between the HR HPV RT PCR and the PCR-RDB assays was determined with a Kappa value of 0.953. The HR HPV RT PCR assay had sensitivity, specificity, and concordance rates (accuracy) of 99.7%, 99.7%, and 99.7%, respectively, as confirmed by PCR-sequencing, while the PCR-RDB assay had respective rates of 98.8%, 97.1%, and 98.0%. The overall rate of HPV infection, determined by PCR-sequencing, in women diagnosed with vaginitis was 49.85%, including 36.26% of single infection and 13.6% of multiple infections. The most common infections among the 15 high-risk HPV types in women diagnosed with vaginitis were HPV-52, HPV-16, and HPV-58, with a total detection rate of 10.23%, 7.75%, and 5.85%, respectively. We conclude that the HR HPV RT PCR assay exhibits better clinical performance than the PCR-RDB assay, and is an ideal alternative method for HPV genotyping. In addition, the HR HPV RT PCR assay provides HPV DNA viral loads, and could serve as a quantitative marker in the diagnosis and treatment of single and multiple HPV infections. © 2017 Wiley Periodicals, Inc.

  17. Factor VII assay performance: an analysis of the North American Specialized Coagulation Laboratory Association proficiency testing results.

    Science.gov (United States)

    Zantek, N D; Hsu, P; Refaai, M A; Ledford-Kraemer, M; Meijer, P; Van Cott, E M

    2013-06-01

    The performance of factor VII (FVII) assays currently used by clinical laboratories was examined in North American Specialized Coagulation Laboratory Association (NASCOLA) proficiency tests. Data from 12 surveys conducted between 2008 and 2010, involving 20 unique specimens plus four repeat-tested specimens, were analyzed. The number of laboratories per survey was 49-54 with a total of 1224 responses. Numerous reagent/instrument combinations were used. For FVII > 80 or 50 U/dL, among commonly used methods, one thromboplastin and one calibrator produced results 5-6 U/dL higher and another thromboplastin and calibrator produced results 5-6 U/dL lower than all other methods, and human thromboplastin differed from rabbit by +7.6 U/dL. Preliminary evidence suggests these differences could be due to the calibrator. For FVII <50 U/dL, differences among the commonly used reagents and calibrators were generally not significant. © 2013 Blackwell Publishing Ltd.

  18. [Comparison of the performance of the ECLusys anti-HCV reagent with the Lumipulse f and HISCL 2000-i HCVAb assays].

    Science.gov (United States)

    Sugiura, Aya; Iwahara, Kunihiro; Suga, Yasuyuki; Uchiyama, Sachinori; Maekawa, Masato

    2012-09-01

    We compared the ECLusys Anti-HCV (ECL) reagent to the Lumipulse f (LPf) and HISCL (HIS) HCV assays. In a correlation test using 210 routine clinical specimens measured using the Lumipulse method (96 positive and 114 negative), most of the results were consistent for all specimens. In a dilution sensitivity test using three different routine positive specimens, the ECL assay enabled detection at higher levels of sensitivity than either the LPf or the HIS assay. Moreover, when the distribution of the cut-off index (C.O.I.) values of the routine LPf negative specimens were compared to those on the ECL and HIS assays, it was found that on the ECL assay, most of the specimens had cut-off index values < 0.1, indicating a more clear-cut distribution. In a specificity test using high RF positive specimens(n = 33), pregnancy specimens (n = 35), cytomegalovirus (CMV) antibody positive specimens (n = 36), and high M protein positive specimens (n = 21), the ECL assay yielded positive results for a CMV antibody positive specimen and three high M protein positive specimens. Further testing using samples from the same patients collected on different days than these four samples resulted in a second positive result for the CMV positive specimen, and single antigen measurement yielded a Core/NS3 positive result, as well, suggesting past infection. However, since negative results were obtained for the three M protein positive specimens, the possibility of this being a ECLusys non-specific reaction could not be ruled out. The above results confirmed that the ECL assay provides superior fundamental performance, and possesses test performance nearly identical to that of the existing measurement methods that are widely used at a large number of facilities, and would therefore be a suitable assay for use in routine HCV antibody screening.

  19. Factors associated with the performance of a blood-based interferon-γ release assay in diagnosing tuberculosis.

    Directory of Open Access Journals (Sweden)

    Sally Banfield

    Full Text Available BACKGROUND: Indeterminate results are a recognised limitation of interferon-γ release assays (IGRA in the diagnosis of latent tuberculosis (TB infection (LTBI and TB disease, especially in children. We investigated whether age and common co-morbidities were associated with IGRA performance in an unselected cohort of resettled refugees. METHODS: A retrospective cross-sectional study of refugees presenting for their post-resettlement health assessment during 2006 and 2007. Refugees were investigated for prevalent infectious diseases, including TB, and for common nutritional deficiencies and haematological abnormalities as part of standard clinical screening protocols. Tuberculosis screening was performed by IGRA; QuantiFERON-TB Gold in 2006 and QuantiFERON-TBGold In-Tube in 2007. RESULTS: Complete data were available on 1130 refugees, of whom 573 (51% were children less than 17 years and 1041 (92% were from sub-Saharan Africa. All individuals were HIV negative. A definitive IGRA result was obtained in 1004 (89% refugees, 264 (26% of which were positive; 256 (97% had LTBI and 8 (3% had TB disease. An indeterminate IGRA result was obtained in 126 (11% refugees (all failed positive mitogen control. In multivariate analysis, younger age (linear OR= 0.93 [95% CI 0.91-0.95], P<0.001, iron deficiency anaemia (2.69 [1.51-4.80], P = 0.001, malaria infection (3.04 [1.51-6.09], P = 0.002, and helminth infection (2.26 [1.48-3.46], P<0.001, but not vitamin D deficiency or insufficiency, were associated with an indeterminate IGRA result. CONCLUSIONS: Younger age and a number of common co-morbidities are significantly and independently associated with indeterminate IGRA results in resettled predominantly African refugees.

  20. Initial demonstration of the NRC`s capability to conduct a performance assessment for a High-Level Waste Repository

    Energy Technology Data Exchange (ETDEWEB)

    Codell, R.; Eisenberg, N.; Fehringer, D.; Ford, W.; Margulies, T.; McCartin, T.; Park, J.; Randall, J.

    1992-05-01

    In order to better review licensing submittals for a High-Level Waste Repository, the US Nuclear Regulatory Commission staff has expanded and improved its capability to conduct performance assessments. This report documents an initial demonstration of this capability. The demonstration made use of the limited data from Yucca Mountain, Nevada to investigate a small set of scenario classes. Models of release and transport of radionuclides from a repository via the groundwater and direct release pathways provided preliminary estimates of releases to the accessible environment for a 10,000 year simulation time. Latin hypercube sampling of input parameters was used to express results as distributions and to investigate model sensitivities. This methodology demonstration should not be interpreted as an estimate of performance of the proposed repository at Yucca Mountain, Nevada. By expanding and developing the NRC staff capability to conduct such analyses, NRC would be better able to conduct an independent technical review of the US Department of Energy (DOE) licensing submittals for a high-level waste (HLW) repository. These activities were divided initially into Phase 1 and Phase 2 activities. Additional phases may follow as part of a program of iterative performance assessment at the NRC. The NRC staff conducted Phase 1 activities primarily in CY 1989 with minimal participation from NRC contractors. The Phase 2 activities were to involve NRC contractors actively and to provide for the transfer of technology. The Phase 2 activities are scheduled to start in CY 1990, to allow Sandia National Laboratories to complete development and transfer of computer codes and the Center for Nuclear Waste Regulatory Analyses (CNWRA) to be in a position to assist in the acquisition of the codes.

  1. Analyses to demonstrate the structural performance of the CASTOR KN12 in hypothetical accident drop accident scenarios

    International Nuclear Information System (INIS)

    Diersch, R.; Weiss, M.; Tso, C.F.; Chung, S.H.; Lee, H.Y.

    2004-01-01

    CASTORc ircledR KN-12 is a new cask design by GNB for KHNP-NETEC for dry and wet transportation of up to twelve spent PWR fuel assemblies in Korea. It received its transport license from the Korean Competent Authority KINS in July 2002 and is now in use in South Korea. It has been designed to satisfy the regulatory requirements of the 10 CFR 71 and the IAEA ST-1 for Type B(U)F packages. Its structural performance was demonstrated against the load cases and boundary conditions as defined in 10 CFR 71 and NRC's Regulatory Guide 7.8, and further explained in NUREG 1617. This included normal conditions of transport load cases - including Hot Environment, Cold Environment, Increased External Pressure (140MPa), Minimum External Pressure (24.5kPa), Vibration and shock, and 0.3m free drop - and the hypothetical accident conditions load cases - including the 9m Free Drop, Puncture, Thermal Fire Accident, 200m Water Immersion and 1.5 x MNOP Internal Pressure. Structural performance were demonstrated by analysis, including state-of-the-art finite element (FE) simulation, and confirmed by tests using a 1/3-scale model. Test results were also used to verify the numerical tool and the methods used in the analyses. All the structural analyses including validation against drop tests were carried out by Arup, and testing were carried out by KAERI. This paper concentrates on the analysis carried out to demonstrate performance in the hypothetical accident 9m free drop scenarios, and results from a small selection of them

  2. Analyses to demonstrate the structural performance of the CASTOR KN12 in hypothetical accident drop accident scenarios

    Energy Technology Data Exchange (ETDEWEB)

    Diersch, R.; Weiss, M. [Gesellschaft fuer Nuklear-Behaelter mbH (Germany); Tso, C.F. [Arup (United Kingdom); Chung, S.H.; Lee, H.Y. [KHNP-NETEC (Korea)

    2004-07-01

    CASTORc{sup ircledR} KN-12 is a new cask design by GNB for KHNP-NETEC for dry and wet transportation of up to twelve spent PWR fuel assemblies in Korea. It received its transport license from the Korean Competent Authority KINS in July 2002 and is now in use in South Korea. It has been designed to satisfy the regulatory requirements of the 10 CFR 71 and the IAEA ST-1 for Type B(U)F packages. Its structural performance was demonstrated against the load cases and boundary conditions as defined in 10 CFR 71 and NRC's Regulatory Guide 7.8, and further explained in NUREG 1617. This included normal conditions of transport load cases - including Hot Environment, Cold Environment, Increased External Pressure (140MPa), Minimum External Pressure (24.5kPa), Vibration and shock, and 0.3m free drop - and the hypothetical accident conditions load cases - including the 9m Free Drop, Puncture, Thermal Fire Accident, 200m Water Immersion and 1.5 x MNOP Internal Pressure. Structural performance were demonstrated by analysis, including state-of-the-art finite element (FE) simulation, and confirmed by tests using a 1/3-scale model. Test results were also used to verify the numerical tool and the methods used in the analyses. All the structural analyses including validation against drop tests were carried out by Arup, and testing were carried out by KAERI. This paper concentrates on the analysis carried out to demonstrate performance in the hypothetical accident 9m free drop scenarios, and results from a small selection of them.

  3. Radiation protection - Performance criteria for laboratories performing cytogenetic triage for assessment of mass casualties in radiological or nuclear emergencies - General principles and application to dicentric assay

    International Nuclear Information System (INIS)

    2008-01-01

    The potential for nuclear and radiological emergencies involving mass casualties from accidental or malicious acts or terrorism requires generic procedures for emergency dose assessment to help the development of medical response capabilities. A mass-casualties incident is defined here as an event that exceeds the local medical resources. Biological dosimetry, based on cytogenetic analysis using the dicentric assay, typically applied for accidental dose assessment, has been defined in ISO 19238. Cytogenetic triage is the use of chromosome damage to evaluate and assess approximately and rapidly radiation doses received by individuals in order to supplement the clinical categorization of casualties. This International Standard focuses on the use of the dicentric assay for rapid cytogenetic triage involving mass-casualty incidents. The primary purpose of this International Standard is to provide a guideline to all laboratories in order to perform the dicentric-bioassay - cytogenetic triage for dose assessment using documented and validated procedures. Secondly, it can facilitate the application of cytogenetic biodosimetry networks to permit comparison of results obtained in different laboratories. Finally, it is expected that laboratories newly commissioned to carry out the cytogenetic triage conform to this International Standard in order to perform the triage reproducibly and accurately. This International Standard is written in the form of procedures to adopt for dicentric-bioassay - cytogenetic triage biological dosimetry for overexposures involving mass radiological casualties. The criteria required for such measurements usually depend on the application of the results: medical management when appropriate, radiation-protection management, record keeping and medical/legal requirements. For example, selected cases can be analysed to produce a more accurate evaluation of high partial-body exposure; secondly, doses can be estimated for persons exposed below the

  4. Evaluation of finite element codes for demonstrating the performance of radioactive material packages in hypothetical accident drop scenarios

    Energy Technology Data Exchange (ETDEWEB)

    Tso, C.F. [Arup (United Kingdom); Hueggenberg, R. [Gesellschaft fuer Nuklear-Behaelter mbH (Germany)

    2004-07-01

    Drop testing and analysis are the two methods for demonstrating the performance of packages in hypothetical drop accident scenarios. The exact purpose of the tests and the analyses, and the relative prominence of the two in the license application, may depend on the Competent Authority and will vary between countries. The Finite Element Method (FEM) is a powerful analysis tool. A reliable finite element (FE) code when used correctly and appropriately, will allow a package's behaviour to be simulated reliably. With improvements in computing power, and in sophistication and reliability of FE codes, it is likely that FEM calculations will increasingly be used as evidence of drop test performance when seeking Competent Authority approval. What is lacking at the moment, however, is a standardised method of assessing a FE code in order to determine whether it is sufficiently reliable or pessimistic. To this end, the project Evaluation of Codes for Analysing the Drop Test Performance of Radioactive Material Transport Containers, funded by the European Commission Directorate-General XVII (now Directorate-General for Energy and Transport) and jointly performed by Arup and Gesellschaft fuer Nuklear-Behaelter mbH, was carried out in 1998. The work consisted of three components: Survey of existing finite element software, with a view to finding codes that may be capable of analysing drop test performance of radioactive material packages, and to produce an inventory of them. Develop a set of benchmark problems to evaluate software used for analysing the drop test performance of packages. Evaluate the finite element codes by testing them against the benchmarks This paper presents a summary of this work.

  5. Evaluation of finite element codes for demonstrating the performance of radioactive material packages in hypothetical accident drop scenarios

    International Nuclear Information System (INIS)

    Tso, C.F.; Hueggenberg, R.

    2004-01-01

    Drop testing and analysis are the two methods for demonstrating the performance of packages in hypothetical drop accident scenarios. The exact purpose of the tests and the analyses, and the relative prominence of the two in the license application, may depend on the Competent Authority and will vary between countries. The Finite Element Method (FEM) is a powerful analysis tool. A reliable finite element (FE) code when used correctly and appropriately, will allow a package's behaviour to be simulated reliably. With improvements in computing power, and in sophistication and reliability of FE codes, it is likely that FEM calculations will increasingly be used as evidence of drop test performance when seeking Competent Authority approval. What is lacking at the moment, however, is a standardised method of assessing a FE code in order to determine whether it is sufficiently reliable or pessimistic. To this end, the project Evaluation of Codes for Analysing the Drop Test Performance of Radioactive Material Transport Containers, funded by the European Commission Directorate-General XVII (now Directorate-General for Energy and Transport) and jointly performed by Arup and Gesellschaft fuer Nuklear-Behaelter mbH, was carried out in 1998. The work consisted of three components: Survey of existing finite element software, with a view to finding codes that may be capable of analysing drop test performance of radioactive material packages, and to produce an inventory of them. Develop a set of benchmark problems to evaluate software used for analysing the drop test performance of packages. Evaluate the finite element codes by testing them against the benchmarks This paper presents a summary of this work

  6. FY16 Status of Immersion Phased Array Ultrasonic Probe Development and Performance Demonstration Results for Under Sodium Viewing

    International Nuclear Information System (INIS)

    Diaz, Aaron A.; Chamberlin, Clyde E.; Edwards, Matthew K.; Hagge, Tobias J.; Hughes, Michael S.; Larche, Michael R.; Mathews, Royce A.; Neill, Kevin J.; Prowant, Matthew S.

    2016-01-01

    This section of the Joint summary technical letter report (TLR) describes work conducted at the Pacific Northwest National Laboratory (PNNL) during FY 2016 (FY16) on the under-sodium viewing (USV) PNNL project 58745, work package AT-16PN230102. This section of the TLR satisfies PNNL's M3AT-16PN2301025 milestone and is focused on summarizing the design, development, and evaluation of two different phased-array ultrasonic testing (PA-UT) probe designs - a two-dimensional (2D) matrix phased-array probe, and two one-dimensional (1D) linear array probes, referred to as serial number 4 (SN4) engineering test units (ETUs). The 2D probe is a pulse-echo (PE), 32x2, 64-element matrix phased-array ETU. The 1D probes are 32x1 element linear array ETUs. This TLR also provides the results from a performance demonstration (PD) of in-sodium target detection trials at 260°C using both probe designs. This effort continues the iterative evolution supporting the longer term goal of producing and demonstrating a pre-manufacturing prototype ultrasonic probe that possesses the fundamental performance characteristics necessary to enable the development of a high-temperature sodium-cooled fast reactor (SFR) inspection system for in-sodium detection and imaging.

  7. FY16 Status of Immersion Phased Array Ultrasonic Probe Development and Performance Demonstration Results for Under Sodium Viewing

    Energy Technology Data Exchange (ETDEWEB)

    Diaz, Aaron A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Chamberlin, Clyde E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Edwards, Matthew K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hagge, Tobias J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hughes, Michael S. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Larche, Michael R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Mathews, Royce A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Neill, Kevin J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Prowant, Matthew S. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2016-08-31

    This section of the Joint summary technical letter report (TLR) describes work conducted at the Pacific Northwest National Laboratory (PNNL) during FY 2016 (FY16) on the under-sodium viewing (USV) PNNL project 58745, work package AT-16PN230102. This section of the TLR satisfies PNNL’s M3AT-16PN2301025 milestone and is focused on summarizing the design, development, and evaluation of two different phased-array ultrasonic testing (PA-UT) probe designs—a two-dimensional (2D) matrix phased-array probe, and two one-dimensional (1D) linear array probes, referred to as serial number 4 (SN4) engineering test units (ETUs). The 2D probe is a pulse-echo (PE), 32×2, 64-element matrix phased-array ETU. The 1D probes are 32×1 element linear array ETUs. This TLR also provides the results from a performance demonstration (PD) of in-sodium target detection trials at 260°C using both probe designs. This effort continues the iterative evolution supporting the longer term goal of producing and demonstrating a pre-manufacturing prototype ultrasonic probe that possesses the fundamental performance characteristics necessary to enable the development of a high-temperature sodium-cooled fast reactor (SFR) inspection system for in-sodium detection and imaging.

  8. Validation and application of a high-performance liquid chromatography--tandem mass spectrometry assay for mosapride in human plasma.

    Science.gov (United States)

    Ramakrishna, N V S; Vishwottam, K N; Manoj, S; Koteshwara, M; Chidambara, J; Varma, D P

    2005-09-01

    A simple, rapid, sensitive and specific liquid chromatography-tandem mass spectrometry method was developed and validated for quantification of mosapride (I), a novel and potent gastroprokinetic agent that enhances the upper gastrointestinal motility by stimulating 5-HT(4) receptor. The analyte and internal standard, tamsulosin (II), were extracted by liquid-liquid extraction with diethyl ether-dichloromethane (70:30, v/v) using a Glas-Col Multi-Pulse Vortexer. The chromatographic separation was performed on a reversed-phase Waters symmetry C(18) column with a mobile phase of 0.03% formic acid-acetonitrile (10:90, v/v). The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The mass transitions m/z 422.3 -->198.3 and m/z 409.1 -->228.1 were used to measure I and II, respectively. The assay exhibited a linear dynamic range of 0.5-100.0 ng/mL for mosapride in human plasma. The lower limit of quantitation was 500 pg/mL with a relative standard deviation of less than 15%. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. A run time of 2.0 min for each sample made it possible to analyze a throughput of more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies. Copyright (c) 2005 John Wiley & Sons, Ltd.

  9. Saccharification Performances of Miscanthus at the Pilot and Miniaturized Assay Scales: Genotype and Year Variabilities According to the Biomass Composition

    Directory of Open Access Journals (Sweden)

    Nassim Belmokhtar

    2017-05-01

    Full Text Available HIGHLIGHTSBiomass production and cell wall composition are differentially impacted by harvesting year and genotypes, influencing then cellulose conversion in miniaturized assay.Using a high-throughput miniaturized and semi-automated method for performing the pretreatment and saccharification steps at laboratory scale allows for the assessment of these factors on the biomass potential for producing bioethanol before moving to the industrial scale.The large genetic diversity of the perennial grass miscanthus makes it suitable for producing cellulosic ethanol in biorefineries. The saccharification potential and year variability of five genotypes belonging to Miscanthus × giganteus and Miscanthus sinensis were explored using a miniaturized and semi-automated method, allowing the application of a hot water treatment followed by an enzymatic hydrolysis. The studied genotypes highlighted distinct cellulose conversion yields due to their distinct cell wall compositions. An inter-year comparison revealed significant variations in the biomass productivity and cell wall compositions. Compared to the recalcitrant genotypes, more digestible genotypes contained higher amounts of hemicellulosic carbohydrates and lower amounts of cellulose and lignin. In contrast to hemicellulosic carbohydrates, the relationships analysis between the biomass traits and cellulose conversion clearly showed the same negative effect of cellulose and lignin on cellulose digestion. The miniaturized and semi-automated method we developed was usable at the laboratory scale and was reliable for mimicking the saccharification at the pilot scale using a steam explosion pretreatment and enzymatic hydrolysis. Therefore, this miniaturized method will allow the reliable screening of many genotypes for saccharification potential. These findings provide valuable information and tools for breeders to create genotypes combining high yield, suitable biomass composition, and high saccharification

  10. Performance Evaluation of the VIDAS® Measles IgG Assay and Its Diagnostic Value for Measuring IgG Antibody Avidity in Measles Virus Infection

    Science.gov (United States)

    Dina, Julia; Creveuil, Christian; Gouarin, Stephanie; Viron, Florent; Hebert, Amelie; Freymuth, Francois; Vabret, Astrid

    2016-01-01

    The objective of this study is primarily to compare the performance of the VIDAS® Measles immunoglobulin (Ig)G assay to that of two other serological assays using an immunoassay technique, Enzygnost® Anti-measles Virus/IgG (Siemens) and Measles IgG CAPTURE EIA® (Microimmune). The sensitivity and the agreement of the VIDAS® Measles IgG assay compared to the Enzygnost® Anti-measles Virus/IgG assay and the Measles IgG CAPTURE EIA® assay are 100%, 97.2% and 99.0%, 98.4%, respectively. The very low number of negative sera for IgG antibodies does not allow calculation of specificity. As a secondary objective, we have evaluated the ability of the VIDAS® Measles IgG assay to measure anti-measles virus IgG antibody avidity with the help of the VIDAS® CMV IgG Avidity reagent, using 76 sera from subjects with measles and 238 other sera. Different groups of populations were analyzed. In the primary infection measles group, the mean IgG avidity index was 0.16 (range of 0.07 to 0.93) compared to 0.79 (range of 0.25 to 1) in the serum group positive for IgG antibodies and negative for IgM. These data allow to define a weak anti-measles virus IgG antibody avidity as an avidity index (AI) 0.6. The VIDAS® Measles IgG assay has a performance equivalent to that of other available products. Its use, individual and quick, is well adapted to testing for anti-measles immunity in exposed subjects. PMID:27556477

  11. Development and performance assessment of a luminex xMAP® direct hybridization assay for the detection and identification of indoor air fungal contamination.

    Science.gov (United States)

    Libert, Xavier; Packeu, Ann; Bureau, Fabrice; Roosens, Nancy H; De Keersmaecker, Sigrid C J

    2017-01-01

    Considered as a public health problem, indoor fungal contamination is generally monitored using classical protocols based on culturing. However, this culture dependency could influence the representativeness of the fungal population detected in an analyzed sample as this includes the dead and uncultivable fraction. Moreover, culture-based protocols are often time-consuming. In this context, molecular tools are a powerful alternative, especially those allowing multiplexing. In this study a Luminex xMAP® assay was developed for the simultaneous detection of 10 fungal species which are most frequently in indoor air and that may cause health problems. This xMAP® assay was found to be sensitive, i.e. its limit of detection is ranging between 0.05 and 0.01 ng of gDNA. The assay was subsequently tested with environmental air samples which were also analyzed with a classical protocol. All the species identified with the classical method were also detected with the xMAP® assay, however in a shorter time frame. These results demonstrate that the Luminex xMAP® fungal assay developed in this study could contribute to the improvement of public health and specifically to the indoor fungal contamination treatment.

  12. Development and performance assessment of a luminex xMAP® direct hybridization assay for the detection and identification of indoor air fungal contamination.

    Directory of Open Access Journals (Sweden)

    Xavier Libert

    Full Text Available Considered as a public health problem, indoor fungal contamination is generally monitored using classical protocols based on culturing. However, this culture dependency could influence the representativeness of the fungal population detected in an analyzed sample as this includes the dead and uncultivable fraction. Moreover, culture-based protocols are often time-consuming. In this context, molecular tools are a powerful alternative, especially those allowing multiplexing. In this study a Luminex xMAP® assay was developed for the simultaneous detection of 10 fungal species which are most frequently in indoor air and that may cause health problems. This xMAP® assay was found to be sensitive, i.e. its limit of detection is ranging between 0.05 and 0.01 ng of gDNA. The assay was subsequently tested with environmental air samples which were also analyzed with a classical protocol. All the species identified with the classical method were also detected with the xMAP® assay, however in a shorter time frame. These results demonstrate that the Luminex xMAP® fungal assay developed in this study could contribute to the improvement of public health and specifically to the indoor fungal contamination treatment.

  13. Dual Testing Algorithm of BED-CEIA and AxSYM Avidity Index Assays Performs Best in Identifying Recent HIV Infection in a Sample of Rwandan Sex Workers

    NARCIS (Netherlands)

    Braunstein, Sarah L.; Nash, Denis; Kim, Andrea A.; Ford, Ken; Mwambarangwe, Lambert; Ingabire, Chantal M.; Vyankandondera, Joseph; van de Wijgert, Janneke H. H. M.

    2011-01-01

    To assess the performance of BED-CEIA (BED) and AxSYM Avidity Index (Ax-AI) assays in estimating HIV incidence among female sex workers (FSW) in Kigali, Rwanda. Eight hundred FSW of unknown HIV status were HIV tested; HIV-positive women had BED and Ax-AI testing at baseline and ≥12 months later to

  14. Application of heat stress in situ demonstrates a protective role of irradiation on photosynthetic performance in alpine plants.

    Science.gov (United States)

    Buchner, Othmar; Stoll, Magdalena; Karadar, Matthias; Kranner, Ilse; Neuner, Gilbert

    2015-04-01

    The impact of sublethal heat on photosynthetic performance, photosynthetic pigments and free radical scavenging activity was examined in three high mountain species, Rhododendron ferrugineum, Senecio incanus and Ranunculus glacialis using controlled in situ applications of heat stress, both in darkness and under natural solar irradiation. Heat treatments applied in the dark reversibly reduced photosynthetic performance and the maximum quantum efficiency of photosystem II (Fv /Fm), which remained impeded for several days when plants were exposed to natural light conditions subsequently to the heat treatment. In contrast, plants exposed to heat stress under natural irradiation were able to tolerate and recover from heat stress more readily. The critical temperature threshold for chlorophyll fluorescence was higher under illumination (Tc (')) than in the dark (Tc). Heat stress caused a significant de-epoxidation of the xanthophyll cycle pigments both in the light and in the dark conditions. Total free radical scavenging activity was highest when heat stress was applied in the dark. This study demonstrates that, in the European Alps, heat waves can temporarily have a negative impact on photosynthesis and, importantly, that results obtained from experiments performed in darkness and/or on detached plant material may not reliably predict the impact of heat stress under field conditions. © 2014 The Authors. Plant, Cell & Environment published by John Wiley & Sons Ltd.

  15. Demonstration of high-performance p-type tin oxide thin-film transistors using argon-plasma surface treatments

    Science.gov (United States)

    Bae, Sang-Dae; Kwon, Soo-Hun; Jeong, Hwan-Seok; Kwon, Hyuck-In

    2017-07-01

    In this work, we investigated the effects of low-temperature argon (Ar)-plasma surface treatments on the physical and chemical structures of p-type tin oxide thin-films and the electrical performance of p-type tin oxide thin-film transistors (TFTs). From the x-ray photoelectron spectroscopy measurement, we found that SnO was the dominant phase in the deposited tin oxide thin-film, and the Ar-plasma treatment partially transformed the tin oxide phase from SnO to SnO2 by oxidation. The resistivity of the tin oxide thin-film increased with the plasma-treatment time because of the reduced hole concentration. In addition, the root-mean-square roughness of the tin oxide thin-film decreased as the plasma-treatment time increased. The p-type oxide TFT with an Ar-plasma-treated tin oxide thin-film exhibited excellent electrical performance with a high current on-off ratio (5.2 × 106) and a low off-current (1.2 × 10-12 A), which demonstrates that the low-temperature Ar-plasma treatment is a simple and effective method for improving the electrical performance of p-type tin oxide TFTs.

  16. Comparison of the analytical and clinical performances of Abbott RealTime High Risk HPV, Hybrid Capture 2, and DNA Chip assays in gynecology patients.

    Science.gov (United States)

    Park, Seungman; Kang, Youjin; Kim, Dong Geun; Kim, Eui-Chong; Park, Sung Sup; Seong, Moon-Woo

    2013-08-01

    The detection of high-risk (HR) HPV in cervical cancer screening is important for early diagnosis of cervical cancer or pre-cancerous lesions. We evaluated the analytical and clinical performances of 3 HR HPV assays in Gynecology patients. A total of 991 specimens were included in this study: 787 specimens for use with a Hybrid Capture 2 (HC2) and 204 specimens for a HPV DNA microarray (DNA Chip). All specimens were tested using an Abbott RealTime High Risk HPV assay (Real-time HR), PGMY PCR, and sequence analysis. Clinical sensitivities for severe abnormal cytology (severe than high-grade squamous intraepithelial lesion) were 81.8% for Real-time HR, 77.3% for HC2, and 66.7% for DNA Chip, and clinical sensitivities for severe abnormal histology (cervical intraepithelial neoplasia grade 2+) were 91.7% for HC2, 87.5% for Real-time HR, and 73.3% for DNA Chip. As compared to results of the sequence analysis, HC2, Real-time HR, and DNA Chip showed concordance rates of 94.3% (115/122), 90.0% (117/130), and 61.5% (16/26), respectively. The HC2 assay and Real-time HR assay showed comparable results to each other in both clinical and analytical performances, while the DNA Chip assay showed poor clinical and analytical performances. The Real-time HR assay can be a good alternative option for HR HPV testing with advantages of allowing full automation and simultaneous genotyping of HR types 16 and 18. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Experimental demonstration of the transmission performance for LDPC-coded multiband OFDM ultra-wideband over fiber system

    Science.gov (United States)

    He, Jing; Wen, Xuejie; Chen, Ming; Chen, Lin; Su, Jinshu

    2015-01-01

    To improve the transmission performance of multiband orthogonal frequency division multiplexing (MB-OFDM) ultra-wideband (UWB) over optical fiber, a pre-coding scheme based on low-density parity-check (LDPC) is adopted and experimentally demonstrated in the intensity-modulation and direct-detection MB-OFDM UWB over fiber system. Meanwhile, a symbol synchronization and pilot-aided channel estimation scheme is implemented on the receiver of the MB-OFDM UWB over fiber system. The experimental results show that the LDPC pre-coding scheme can work effectively in the MB-OFDM UWB over fiber system. After 70 km standard single-mode fiber (SSMF) transmission, at the bit error rate of 1 × 10-3, the receiver sensitivities are improved about 4 dB when the LDPC code rate is 75%.

  18. FY15 Status of Immersion Phased Array Ultrasonic Probe Development and Performance Demonstration Results for Under Sodium Viewing

    Energy Technology Data Exchange (ETDEWEB)

    Diaz, Aaron A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Larche, Michael R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Mathews, Royce [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Neill, Kevin J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Baldwin, David L. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Prowant, Matthew S. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Edwards, Matthew K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Chamberlin, Clyde E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-09-01

    This Technical Letter Report (TLR) describes work conducted at the Pacific Northwest National Laboratory (PNNL) during FY 2015 on the under-sodium viewing (USV) PNNL project 58745, Work Package AT-15PN230102. This TLR satisfies PNNL’s M3AT-15PN2301027 milestone, and is focused on summarizing the design, development, and evaluation of a two-dimensional matrix phased-array probe referred to as serial number 3 (SN3). In addition, this TLR also provides the results from a performance demonstration of in-sodium target detection trials at 260°C using a one-dimensional 22-element linear array developed in FY14 and referred to as serial number 2 (SN2).

  19. Experimental demonstration of radiation effects on the performance of a stirling-alternator convertor and candidate materials evaluation

    Science.gov (United States)

    Mireles, Omar R.

    Free-piston Stirling power convertors are under consideration by NASA for service in the Advanced Stirling Radioisotope Generator (ASRG) and Fission Surface Power (FSP) systems to enable aggressive exploration missions by providing a reliable and constant power supply. The ASRG must withstand environmental radiation conditions, while the FSP system must tolerate a mixed neutron and gamma-ray environment resulting from self-irradiation. Stirling-alternators utilize rare earth magnets and a variety of organic materials whose radiation limits dominate service life estimates and shielding requirements. The project objective was to demonstrate the performance of the alternator, identify materials that exhibit excessive radiation sensitivity, identify radiation tolerant substitutes, establish empirical dose limits, and demonstrate the feasibility of cost effective nuclear and radiation tests by selection of the appropriate personnel and test facilities as a function of hardware maturity. The Stirling Alternator Radiation Test Article (SARTA) was constructed from linear alternator components of a Stirling convertor and underwent significant pre-exposure characterization. The SARTA was operated at the Sandia National Laboratories Gamma Irradiation Facility to a dose of over 40 Mrad. Operating performance was within nominal variation, although modestly decreasing trends occurred in later runs as well as the detection of an electrical fault after the final exposure. Post-irradiation disassembly and internal inspection revealed minimal degradation of the majority of the organic components. Radiation testing of organic material coupons was conducted since the majority of the literature was inconsistent. These inconsistencies can be attributed to testing at environmental conditions vastly different than those Stirling-alternator organics will experience during operation. Samples were irradiated at the Texas A&M TRIGA reactor to above expected FSP neutron fluence. A thorough

  20. Modification of the BAX System PCR assay for detecting Salmonella in beef, produce, and soy protein isolate. Performance Tested Method 100201.

    Science.gov (United States)

    Peng, Linda X; Wallace, Morgan; Andaloro, Bridget; Fallon, Dawn; Fleck, Lois; Delduco, Dan; Tice, George

    2011-01-01

    The BAX System PCR assay for Salmonella detection in foods was previously validated as AOAC Research Institute (RI) Performance Tested Method (PTM) 100201. New studies were conducted on beef and produce using the same media and protocol currently approved for the BAX System PCR assay for E. coli O157:H7 multiplex (MP). Additionally, soy protein isolate was tested for matrix extension using the U.S. Food and Drug Administration-Bacteriological Analytical Manual (FDA-BAM) enrichment protocols. The studies compared the BAX System method to the U.S. Department of Agriculture culture method for detecting Salmonella in beef and the FDA-BAM culture method for detecting Salmonella in produce and soy protein isolate. Method comparison studies on low-level inoculates showed that the BAX System assay for Salmonella performed as well as or better than the reference method for detecting Salmonella in beef and produce in 8-24 h enrichment when the BAX System E. coli O157:H7 MP media was used, and soy protein isolate in 20 h enrichment with lactose broth followed by 3 h regrowth in brain heart infusion broth. An inclusivity panel of 104 Salmonella strains with diverse serotypes was tested by the BAX System using the proprietary BAX System media and returned all positive results. Ruggedness factors involved in the enrichment phase were also evaluated by testing outside the specified parameters, and none of the factors examined affected the performance of the assay.

  1. Techniques for laser processing, assay, and examination of spent fuel

    International Nuclear Information System (INIS)

    Gray, J.H.; Mitchell, R.C.; Rogell, M.L.

    1981-11-01

    Fuel examination studies were performed which have application to interim spent fuel storage. These studies were in three areas, i.e., laser drilling and rewelding demonstration, nondestructive assay techniques survey, and fuel examination techniques survey

  2. Ultra-performance liquid chromatography-tandem mass spectrometry-based multiplex enzyme assay for six enzymes associated with hereditary hemolytic anemia.

    Science.gov (United States)

    Park, Chul Min; Lee, Kyunghoon; Jun, Sun-Hee; Song, Sang Hoon; Song, Junghan

    2017-08-15

    Deficiencies in erythrocyte metabolic enzymes are associated with hereditary hemolytic anemia. Here, we report the development of a novel multiplex enzyme assay for six major enzymes, namely glucose-6-phosphate dehydrogenase, pyruvate kinase, pyrimidine 5'-nucleotidase, hexokinase, triosephosphate isomerase, and adenosine deaminase, deficiencies in which are implicated in erythrocyte enzymopathies. To overcome the drawbacks of traditional spectrophotometric enzyme assays, the present assay was based on ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). The products of the six enzymes were directly measured by using ion pairing UPLC-MS/MS, and the precision, linearity, ion suppression, optimal sample amounts, and incubation times were evaluated. Eighty-three normal individuals and 13 patients with suspected enzymopathy were analyzed. The UPLC running time was within 5min. No ion suppression was observed at the retention time for the products or internal standards. We selected an optimal dilution factor and incubation time for each enzyme system. The intra- and inter-assay imprecision values (CVs) were 2.5-12.1% and 2.9-14.3%, respectively. The linearity of each system was good, with R 2 values >0.97. Patient samples showed consistently lower enzyme activities than those from normal individuals. The present ion paring UPLC-MS/MS assay enables facile and reproducible multiplex evaluation of the activity of enzymes implicated in enzymopathy-associated hemolytic anemia. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Impact of inter-genotypic recombination and probe cross-reactivity on the performance of the Abbott RealTime HCV Genotype II assay for hepatitis C genotyping.

    Science.gov (United States)

    Sridhar, Siddharth; Yip, Cyril C Y; Chan, Jasper F W; To, Kelvin K W; Cheng, Vincent C C; Yuen, Kwok-Yung

    2018-05-01

    The Abbott RealTime HCV Genotype II assay (Abbott-RT-HCV assay) is a real-time PCR based genotyping method for hepatitis C virus (HCV). This study measured the impact of inter-genotypic recombination and probe cross-reactivity on the performance of the Abbott-RT-HCV assay. 517 samples were genotyped using the Abbott-RT-HCV assay over a one-year period, 34 (6.6%) were identified as HCV genotype 1 without further subtype designation raising the possibility of inaccurate genotyping. These samples were subjected to confirmatory sequencing. 27 of these 34 (79%) samples were genotype 1b while five (15%) were genotype 6. One HCV isolate was an inter-genotypic 1a/4o recombinant. This is a novel natural HCV recombinant that has never been reported. Inter-genotypic recombination and probe cross-reactivity can affect the accuracy of the Abbott-RT-HCV assay, both of which have significant implications on antiviral regimen choice. Confirmatory sequencing of ambiguous results is crucial for accurate genotyping. Copyright © 2018 Elsevier Inc. All rights reserved.

  4. Multicenter analytical performance evaluation of a fully automated anti-Müllerian hormone assay and reference interval determination

    NARCIS (Netherlands)

    Anckaert, E.; Öktem, M.; Thies, A.; Cohen-Bacrie, M.; Daan, N. M P; Schiettecatte, J.; Müller, C.; Topcu, D.; Gröning, A.; Ternaux, F.; Engel, C.; Engelmann, S.; Milczynski, C.

    2016-01-01

    Objectives: Anti-Müllerian hormone (AMH) is an established biomarker for assessing ovarian reserve and predicting response to controlled ovarian stimulation. Its routine clinical use is hampered by the variability and low-throughput of available enzyme-linked immunosorbent assays (ELISA). The

  5. Performance analysis for bounded persistent disturbances in PD/PID-controlled robotic systems with its experimental demonstrations

    Science.gov (United States)

    Kim, Jung Hoon; Hur, Sung-Moon; Oh, Yonghwan

    2018-03-01

    This paper is concerned with performance analysis of proportional-derivative/proportional-integral-derivative (PD/PID) controller for bounded persistent disturbances in a robotic manipulator. Even though the notion of input-to-state stability (ISS) has been widely used to deal with the effect of disturbances in control of a robotic manipulator, the corresponding studies cannot be directly applied to the treatment of persistent disturbances occurred in robotic manipulators. This is because the conventional studies relevant to ISS consider the H∞ performance for robotic systems, which is confined to the treatment of decaying disturbances, i.e. the disturbances those in the L2 space. To deal with the effect of persistent disturbances in robotic systems, we first provide a new treatment of ISS in the L∞ sense because bounded persistent disturbances should be intrinsically regarded as elements of the L∞ space. We next derive state-space representations of trajectory tracking control in the robotic systems which allow us to define the problem formulations more clearly. We then propose a novel control law that has a PD/PID control form, by which the trajectory tracking system satisfies the reformulated ISS. Furthermore, we can obtain a theoretical argument about the L∞ gain from the disturbance to the regulated output through the proposed control law. Finally, experimental studies for a typical 3-degrees of freedom robotic manipulator are given to demonstrate the effectiveness of the method introduced in this paper.

  6. Hybrid Capture 2 and cobas human papillomavirus assays perform similarly on SurePath samples from women with abnormalities

    DEFF Research Database (Denmark)

    Fornari, D; Rebolj, M; Bjerregaard, B

    2016-01-01

    OBJECTIVE: In two laboratories (Departments of Pathology, Copenhagen University Hospitals of Herlev and Hvidovre), we compared cobas and Hybrid Capture 2 (HC2) human papillomavirus (HPV) assays using SurePath® samples from women with atypical squamous cells of undetermined significance (ASCUS......) at ≥30 years and women after treatment of cervical intraepithelial neoplasia (CIN). METHODS: Samples from 566 women with ASCUS and 411 women after treatment were routinely tested with HC2 and, thereafter, with cobas. Histological outcomes were retrieved from the Danish Pathology Data Base. We calculated...... the overall agreement between the assays, and compared their sensitivity and specificity for ≥CIN2. RESULTS: In women with ASCUS, HC2 and cobas testing results were similar in the two laboratories. The overall agreement was 91% (95% CI, 88-93). After CIN treatment, the overall agreement was 87% (95% CI, 82...

  7. Performance demonstration of a single-frequency optically-pumped cesium beam frequency standard for space applications

    Science.gov (United States)

    Lecomte, S.; Haldimann, M.; Ruffieux, R.; Thomann, P.; Berthoud, P.

    2017-11-01

    Observatoire de Neuchâtel (ON) is developing a compact optically-pumped cesium beam frequency standard in the frame of an ESA-ARTES 5 project. The simplest optical scheme, which is based on a single optical frequency for both preparation and detection processes of atoms, has been chosen to fulfill reliability constraints of space applications. With our laboratory demonstrator operated at 852 nm (D2 line), we have measured a frequency stability of σy=2.74x10-12 τ -1/2, which is compliant with the Galileo requirement. The atomic resonator is fully compliant to be operated with a single diode laser at 894 nm (D1 line). Sensitivity measurements of the clock signal to the microwave power and to the optical pumping power are also presented. Present performance limitations are discussed and further improvements are proposed in order to reach our ultimate frequency stability goal of σy=1x10-12 τ -1/2. The clock driving software is also briefly described.

  8. Demonstration of High Performance in Layered Deuterium-Tritium Capsule Implosions in Uranium Hohlraums at the National Ignition Facility.

    Science.gov (United States)

    Döppner, T; Callahan, D A; Hurricane, O A; Hinkel, D E; Ma, T; Park, H-S; Berzak Hopkins, L F; Casey, D T; Celliers, P; Dewald, E L; Dittrich, T R; Haan, S W; Kritcher, A L; MacPhee, A; Le Pape, S; Pak, A; Patel, P K; Springer, P T; Salmonson, J D; Tommasini, R; Benedetti, L R; Bond, E; Bradley, D K; Caggiano, J; Church, J; Dixit, S; Edgell, D; Edwards, M J; Fittinghoff, D N; Frenje, J; Gatu Johnson, M; Grim, G; Hatarik, R; Havre, M; Herrmann, H; Izumi, N; Khan, S F; Kline, J L; Knauer, J; Kyrala, G A; Landen, O L; Merrill, F E; Moody, J; Moore, A S; Nikroo, A; Ralph, J E; Remington, B A; Robey, H F; Sayre, D; Schneider, M; Streckert, H; Town, R; Turnbull, D; Volegov, P L; Wan, A; Widmann, K; Wilde, C H; Yeamans, C

    2015-07-31

    We report on the first layered deuterium-tritium (DT) capsule implosions indirectly driven by a "high-foot" laser pulse that were fielded in depleted uranium hohlraums at the National Ignition Facility. Recently, high-foot implosions have demonstrated improved resistance to ablation-front Rayleigh-Taylor instability induced mixing of ablator material into the DT hot spot [Hurricane et al., Nature (London) 506, 343 (2014)]. Uranium hohlraums provide a higher albedo and thus an increased drive equivalent to an additional 25 TW laser power at the peak of the drive compared to standard gold hohlraums leading to higher implosion velocity. Additionally, we observe an improved hot-spot shape closer to round which indicates enhanced drive from the waist. In contrast to findings in the National Ignition Campaign, now all of our highest performing experiments have been done in uranium hohlraums and achieved total yields approaching 10^{16} neutrons where more than 50% of the yield was due to additional heating of alpha particles stopping in the DT fuel.

  9. Detection of enteropathogens associated with travelers’ diarrhea using a multiplex Luminex-based assay performed on stool samples smeared on Whatman FTA Elute cards

    Science.gov (United States)

    Lalani, Tahaniyat; Tisdale, Michele D; Maguire, Jason D; Wongsrichanalai, Chansuda; Riddle, Mark S; Tribble, David R

    2015-01-01

    We evaluated the limits of detection (LoD) for an 11-plex PCR-Luminex assay performed on Whatman FTA Elute cards smeared with stool containing pathogens associated with travelers’ diarrhea. LoDs ranged between 102-105 CFU, PFU or cysts/g for most pathogens except Cryptosporidium. Campylobacter and norovirus LoD increased with prolonged storage of cards. PMID:26072151

  10. Detection of enteropathogens associated with travelers' diarrhea using a multiplex Luminex-based assay performed on stool samples smeared on Whatman FTA Elute cards.

    Science.gov (United States)

    Lalani, Tahaniyat; Tisdale, Michele D; Maguire, Jason D; Wongsrichanalai, Chansuda; Riddle, Mark S; Tribble, David R

    2015-09-01

    We evaluated the limits of detection (LoD) for an 11-plex PCR-Luminex assay performed on Whatman(™) FTA Elute cards smeared with stool containing pathogens associated with travelers' diarrhea. LoDs ranged from 10(2) to 10(5)CFU, PFU, or cysts/g for most pathogens except Cryptosporidium. Campylobacter and norovirus LoDs increased with prolonged storage of cards. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Performance characteristics of CA 19-9 radioimmunoassay and clinical significance of serum CA 19-9 assay in patients with malignancy

    International Nuclear Information System (INIS)

    Kim, S.E.; Shong, Y.K.; Cho, B.Y.; Kim, N.K.; Koh, C.S.; Lee, M.H.; Hong, K.S.

    1985-01-01

    To evaluate the performance characteristics of CA 19-9 radioimmunoassay and the clinical significance of serum CA 19-9 assay in patients with malignancy, serum CA 19-9 levels were measured by radioimmunoassay using monoclonal antibody in 135 normal controls, 81 patients with various untreated malignancy, 9 patients of postoperative colon cancer without recurrence and 20 patients with benign gastrointestinal diseases, who visited Seoul National University Hospital from June, 1984 to March, 1985. (Author)

  12. Method and apparatus for purifying nucleic acids and performing polymerase chain reaction assays using an immiscible fluid

    Energy Technology Data Exchange (ETDEWEB)

    Koh, Chung-Yan; Light, Yooli Kim; Piccini, Matthew Ernest; Singh, Anup K.

    2017-10-31

    Embodiments of the present invention are directed toward devices, systems, and methods for purifying nucleic acids to conduct polymerase chain reaction (PCR) assays. In one example, a method includes generating complexes of silica beads and nucleic acids in a lysis buffer, transporting the complexes through an immiscible fluid to remove interfering compounds from the complexes, further transporting the complexes into a density medium containing components required for PCR where the nucleic acids disassociate from the silica beads, and thermocycling the contents of the density medium to achieve PCR. Signal may be detected from labeling agents in the components required for PCR.

  13. Through-the-Sensor Determination of AN/AQS-20 Sensor Performance Demonstration 1, December 13 through 17, 2004

    National Research Council Canada - National Science Library

    Harris, Michael; Avera, William; Steed, Chad; Sample, John; Bibee, Leonard D; Wood, Warren T; Morgerson, Dave; Robinson, Christopher S

    2005-01-01

    ...) Tactical Decision Aid (TDA). This demonstration was a representative simulation that showed the connectivity and functionality using previously collected raw AN/AQS-20 Engineering Development Model (EDM...

  14. Genetic mouse embryo assay: improving performance and quality testing for assisted reproductive technology (ART) with a functional bioassay.

    Science.gov (United States)

    Gilbert, Rebecca S; Nunez, Brandy; Sakurai, Kumi; Fielder, Thomas; Ni, Hsiao-Tzu

    2016-03-24

    Growing concerns about safety of ART on human gametes, embryos, clinical outcomes and long-term health of offspring require improved methods of risk assessment to provide functionally relevant assays for quality control testing and pre-clinical studies prior to clinical implementation. The one-cell mouse embryo assay (MEA) is the most widely used for development and quality testing of human ART products; however, concerns exist due to the insensitivity/variability of this bioassay which lacks standardization and involves subjective analysis by morphology alone rather than functional analysis of the developing embryos. We hypothesized that improvements to MEA by the use of functional molecular biomarkers could enhance sensitivity and improve detection of suboptimal materials/conditions. Fresh one-cell transgenic mouse embryos with green fluorescent protein (GFP) expression driven by Pou6f1 or Cdx2 control elements were harvested and cultured to blastocysts in varied test and control conditions to compare assessment by standard morphology alone versus the added dynamic expression of GFP for screening and selection of critical raw materials and detection of suboptimal culture conditions. Transgenic mouse embryos expressing functionally relevant biomarkers of normal early embryo development can be used to monitor the developmental impact of culture conditions. This novel approach provides a superior MEA that is more meaningful and sensitive for detection of embryotoxicity than morphological assessment alone.

  15. Single Doses up to 800 mg of E-52862 Do Not Prolong the QTc Interval--A Retrospective Validation by Pharmacokinetic-Pharmacodynamic Modelling of Electrocardiography Data Utilising the Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity.

    Science.gov (United States)

    Täubel, Jörg; Ferber, Georg; Lorch, Ulrike; Wang, Duolao; Sust, Mariano; Camm, A John

    2015-01-01

    E-52862 is a Sigma-1 receptor antagonist (S1RA) currently under investigation as a potential analgesic medicine. We successfully applied a concentration-effect model retrospectively to a four-way crossover Phase I single ascending dose study and utilized the QTc shortening effects of a meal to demonstrate assay sensitivity by establishing the time course effects from baseline in all four periods, independently from any potential drug effects. Thirty two healthy male and female subjects were included in four treatment periods to receive single ascending doses of 500 mg, 600 mg or 800 mg of E-52862 or placebo. PK was linear over the dose range investigated and doses up to 600 mg were well tolerated. The baseline electrocardiography (ECG) measurements on Day-1 were time-matched with ECG and pharmacokinetic (PK) samples on Day 1 (dosing day). In this conventional mean change to time-matched placebo analysis, the largest time-matched difference to placebo QTcI was 1.44 ms (90% CI: -4.04, 6.93 ms) for 500 mg; -0.39 ms (90% CI: -3.91, 3.13 ms) for 600 mg and 1.32 ms (90% CI: -1.89, 4.53 ms) for 800 mg of E-52862, thereby showing the absence of any QTc prolonging effect at the doses tested. In addition concentration-effect models, one based on the placebo corrected change from baseline and one for the change of QTcI from average baseline with time as fixed effect were fitted to the data confirming the results of the time course analysis. The sensitivity of this study to detect small changes in the QTc interval was confirmed by demonstrating a shortening of QTcF of -8.1 (90% CI: -10.4, -5.9) one hour and -7.2 (90% CI: -9.4, -5.0) three hours after a standardised meal. EU Clinical Trials Register EudraCT 2010 020343 13.

  16. The impact of HIV infection and CD4 cell count on the performance of an interferon gamma release assay in patients with pulmonary tuberculosis

    DEFF Research Database (Denmark)

    Aabye, Martine G.; Ravn, Pernille; PrayGod, George

    2009-01-01

    pulmonary tuberculosis (PTB) in a TB- and HIV-endemic population and the effect of HIV-infection and CD4 cell count on test performance. METHODOLOGY/PRINCIPAL FINDINGS: 161 patients with sputum culture confirmed PTB were subjected to HIV- and QFT-IT testing and measurement of CD4 cell count. The QFT......BACKGROUND: The performance of the tuberculosis specific Interferon Gamma Release Assays (IGRAs) has not been sufficiently documented in tuberculosis- and HIV-endemic settings. This study evaluated the sensitivity of the QuantiFERON TB-Gold In-Tube (QFT-IT) in patients with culture confirmed...

  17. High performance of a new PCR-based urine assay for HPV-DNA detection and genotyping.

    Science.gov (United States)

    Tanzi, Elisabetta; Bianchi, Silvia; Fasolo, Maria Michela; Frati, Elena R; Mazza, Francesca; Martinelli, Marianna; Colzani, Daniela; Beretta, Rosangela; Zappa, Alessandra; Orlando, Giovanna

    2013-01-01

    Human papillomavirus (HPV) testing has been proposed as a means of replacing or supporting conventional cervical screening (Pap test). However, both methods require the collection of cervical samples. Urine sample is easier and more acceptable to collect and could be helpful in facilitating cervical cancer screening. The aim of this study was to evaluate the sensitivity and specificity of urine testing compared to conventional cervical smear testing using a PCR-based method with a new, designed specifically primer set. Paired cervical and first voided urine samples collected from 107 women infected with HIV were subjected to HPV-DNA detection and genotyping using a PCR-based assay and a restriction fragment length polymorphism method. Sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) were calculated using the McNemar's test for differences. Concordance between tests was assessed using the Cohen's unweighted Kappa (k). HPV DNA was detected in 64.5% (95% CI: 55.1-73.1%) of both cytobrush and urine samples. High concordance rates of HPV-DNA detection (k = 0.96; 95% CI: 0.90-1.0) and of high risk-clade and low-risk genotyping in paired samples (k = 0.80; 95% CI: 0.67-0.92 and k = 0.74; 95% CI: 0.60-0.88, respectively) were observed. HPV-DNA detection in urine versus cervix testing revealed a sensitivity of 98.6% (95% CI: 93.1-99.9%) and a specificity of 97.4% (95% CI: 87.7-99.9%), with a very high NPV (97.4%; 95% CI: 87.7-99.9%). The PCR-based assay utilized in this study proved highly sensitive and specific for HPV-DNA detection and genotyping in urine samples. These data suggest that a urine-based assay would be a suitable and effective tool for epidemiological surveillance and, most of all, screening programs. Copyright © 2012 Wiley Periodicals, Inc.

  18. Analysis of performance of a PCR-based assay to detect DNA of Aspergillus fumigatus in whole blood and serum: a comparative study with clinical samples.

    Science.gov (United States)

    Bernal-Martínez, Leticia; Gago, Sara; Buitrago, María J; Gomez-Lopez, Alicia; Rodríguez-Tudela, Juan L; Cuenca-Estrella, Manuel

    2011-10-01

    The performance of a real-time PCR-based assay was retrospectively analyzed (according to European Organization for Research and Treatment of Cancer/Mycosis Study Group criteria) in the samples of patients with invasive aspergillosis. A total of 711 serial samples (356 whole-blood and 355 serum samples) from 38 adult patients were analyzed. The Aspergillus fumigatus PCR assay results were positive for 89 of 356 (25%) whole-blood samples and 90 of 355 (25.35%) serum samples. Positive PCR results were seen in 29 of 31 (93.5%) patients for which serum was analyzed and in 31 of 33 (93.9%) cases with whole-blood specimens. Both blood and serum samples were available in 26 cases, and significant differences were not observed in this subgroup of cases. The average number of threshold cycles (C(T)) for positive blood samples was 37.6, and the average C(T) for serum was 37.4. The DNA concentration ranged between 2 and 50 fg per μl of sample, with average DNA concentrations of 10.2 and 11.7 fg in positive blood and serum samples, respectively (P > 0.01). The performance of this PCR-based quantitative assay was similar for both serum and blood samples. We recommend serum samples as the most convenient hematological sample to use for Aspergillus DNA quantification when serial determinations are done.

  19. 40 CFR 63.1571 - How and when do I conduct a performance test or other initial compliance demonstration?

    Science.gov (United States)

    2010-07-01

    ..., according to § 63.7(a)(2)(ix). (b) What are the general requirements for performance test and performance... according to the provisions in § 63.7(a)(2). If you are required to do a performance evaluation or test for a semi-regenerative catalytic reforming unit catalyst regenerator vent, you may do them at the first...

  20. A survey of 17α-ethinylestradiol and mestranol residues in Hawkesbury River, Australia, using a highly specific enzyme-linked immunosorbent assay (ELISA) demonstrates the levels of potential biological significance.

    Science.gov (United States)

    Uraipong, Chatchaporn; Allan, Robin D; Li, Chunhua; Kennedy, Ivan R; Wong, Victor; Lee, Nanju Alice

    2017-10-01

    This study reports on the potential status of 17α-ethinylestradiol (EE2) and mestranol (MeEE2) residues in aquatic environments in New South Wales (NSW), Australia, based on the analysis by a specific ELISA we developed. Polyclonal antibodies were raised against the EE2 hapten with a linker attached at the C3-position to direct the antibody binding towards the ring D of EE2/MeEE2. Using this approach, an ELISA highly specific to EE2 and MeEE2 was successfully developed, showing less than 3.1% cross-reactivity (% CR) with other major steroidal sex hormones and their derivatives. The assay performed with the limit of detection (LOD) of 0.04 ± 0.01µg/L for both EE2 and MeEE2, and the limit of quantitation (LOQ) of 0.05 ± 0.01ng/L when it was coupled with the SM2-Biobeads solid phase extraction. Prior to conducting the survey study, it was validated against the gas chromatography-mass spectrophotometry (GC-MS) method, which showed high correlation with R 2 of 0.934. Fresh surface water samples collected at different sites along Hawkesbury River in New South Wales (NSW) were analyzed for the EE2/ MeEE2 residues using the developed ELISA. The EE2/MeEE2 levels were found to range between 4.1 and 8.3ng/L in Emigrant Creek, NSW, where the primary activity was macadamia plantation, and higher levels between 15 and 29ng/L in South Creek, NSW, Greater Western Sydney at sites upstream and downstream of the municipal sewage treatment plants. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Evaluation of the performance of two tuberculosis interferon gamma release assays (IGRA-ELISA and T-SPOT.TB) for diagnosing Mycobacterium tuberculosis infection.

    Science.gov (United States)

    Wang, Linchuan; Tian, Xu-Dong; Yu, Yan; Chen, Wei

    2018-04-01

    The IGRA-ELISA and T-SPOT.TB are widely used in China. The aim of the study was to evaluate the performance of the two assays in diagnosis Mycobacterium tuberculosis infection. Of the 3727 patients in the study, 204 underwent testing using both the T-SPOT.TB and IGRA-ELISA, 1794 were tested using the T-SPOT.TB only, and 1729 were tested using the IGRA-ELISA only. The positive rate and consistency of the two assays were analyzed, and their sensitivity and specificity for diagnosing active tuberculosis were compared. There were no significant differences in the positive rate between the T-SPOT.TB test (25.8%) and IGRA-ELISA (28.6%), p = .065. The two assays were highly consistent, with a kappa value of 0.852 (p SPOT.TB test were 82.9% (107/129) and 78.6% (1309/1665), respectively, and those of IGRA-ELISA were 81.7% (94/115) and 75.2% (1214/1614), respectively. There were no significant differences in sensitivity (p > .05), but the specificity of the T-SPOT.TB test was slightly higher than that of IGRA-ELISA (p = .023). Both in terms of diagnosing M. tuberculosis infection and ruling out active tuberculosis, the performance of the IGRA-ELISA-a simple, almost labor-free assay that allows simultaneous processing of a very large number of samples-was well-matched with that of T-SPOT.TB test. However, IGRAs cannot be used as the only test to diagnose active tuberculosis. Copyright © 2018 Elsevier B.V. All rights reserved.

  2. Validation of Performance of the Gen-Probe Human Immunodeficiency Virus Type 1 Viral Load Assay with Genital Swabs and Breast Milk Samples

    Science.gov (United States)

    DeVange Panteleeff, Dana; Emery, Sandra; Richardson, Barbra A.; Rousseau, Christine; Benki, Sarah; Bodrug, Sharon; Kreiss, Joan K.; Overbaugh, Julie

    2002-01-01

    Human immunodeficiency type 1 (HIV-1) continues to spread at an alarming rate. The virus may be transmitted through blood, genital secretions, and breast milk, and higher levels of systemic virus in the index case, as measured by plasma RNA viral load, have been shown to correlate with increased risk of transmitting HIV-1 both vertically and sexually. Less is known about the correlation between transmission and HIV-1 levels in breast milk or genital secretions, in part because reliable quantitative assays to detect HIV-1 in these fluids are not available. Here we show that the Gen-Probe HIV-1 viral load assay can be used to accurately quantify viral load in expressed breast milk and in cervical and vaginal samples collected on swabs. Virus could be quantified from breast milk and swab samples spiked with known amounts of virus, including HIV-1 subtypes A, C, and D. As few as 10 copies of HIV-1 RNA could be detected above background threshold levels in ≥77% of assays performed with spiked breast milk supernatants and mock swabs. In genital swab samples from HIV-1-infected women, similar levels of HIV-1 RNA were consistently detected in duplicate swabs taken from the same woman on the same clinic visit, suggesting that the RNA values from a single swab sample can be used to measure genital viral load. PMID:12409354

  3. Arsenic Removal from Drinking Water by Absorptive Media-U.S. EPA Demonstration Project at Desert Sands MDWCA, NM Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the arsenic removal treatment technology demonstration project at the Desert Sands Mutual Domestic Water Consumers Association (MDWCA) facility in Anthony, NM. The objectives of the project were to evalu...

  4. Arsenic Removal from Drinking Water by Adsorptive Media U.S. EPA Demonstration Project at Richmond Elementary School in Susanville, CA Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the arsenic removal treatment technology demonstration project at Richmond Elementary School in Susanville, CA. The objectives of the project were to evaluate: (1) the effectiveness of an Aquatic Treatme...

  5. Arsenic Removal from Drinking Water by Adsorptive Media, U.S. EPA Demonstration Project at LEADS Head Start Building in Buckeye Lake, OH - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the arsenic removal treatment technology demonstration project at Licking Economic Action Development Study (LEADS) Head Start School in Buckeye Lake, Ohio. The objectives of the project were to evaluate...

  6. The Comet Assay: Tails of the (Unexpected. Use of the comet assay in pharmaceutical development.

    Directory of Open Access Journals (Sweden)

    Bas-jan Van Der Leede

    2015-08-01

    Full Text Available In genotoxicity testing of pharmaceuticals the rodent alkaline comet assay is being increasingly used as a second in vivo assay in addition to the in vivo micronucleus assay to mitigate in vitro positive results as recommended by regulatory guidance. In this presentation we want to give insight into the circumstances in vivo comet assay is deployed in a Genetic Toxicology Department of a pharmaceutical company. As the in vivo comet assay is a salvage assay, it means that some events have occurred in an in vitro assay and that the compound (or metabolite responsible for this signal is potentially deselected for further development. More than often the decision to perform an in vivo comet assay is at a very early stage in development and the first time that the compound will be tested in vivo at high/toxic dose levels. As almost no toxicokinetic data and tissue distribution data are available a careful design with maximizes the chances for successful mitigation is necessary. Decisions on acute or repeated dosing need to be made and arrangements for combining the in vivo comet assay with the in vivo micronucleus assay are to be considered. Often synthesis methods need to be scaled up fast to provide the required amount of compound and information on suitable formulations needs to be in place. As exposure data is crucial for interpretation of results, analytical methods need to be brought in place rapidly. An experienced multi skilled and communicative team needs to be available to deploy successfully this kind of assays at an early stage of development. We will present a few scenarios on study conduct and demonstrate how this assay can make a difference for the further development of a new drug.

  7. Standardization and performance evaluation of "modified" and "ultrasensitive" versions of the Abbott RealTime HIV-1 assay, adapted to quantify minimal residual viremia.

    Science.gov (United States)

    Amendola, Alessandra; Bloisi, Maria; Marsella, Patrizia; Sabatini, Rosella; Bibbò, Angela; Angeletti, Claudio; Capobianchi, Maria Rosaria

    2011-09-01

    Numerous studies investigating clinical significance of HIV-1 minimal residual viremia (MRV) suggest potential utility of assays more sensitive than those routinely used to monitor viral suppression. However currently available methods, based on different technologies, show great variation in detection limit and input plasma volume, and generally suffer from lack of standardization. In order to establish new tools suitable for routine quantification of minimal residual viremia in patients under virological suppression, some modifications were introduced into standard procedure of the Abbott RealTime HIV-1 assay leading to a "modified" and an "ultrasensitive" protocols. The following modifications were introduced: calibration curve extended towards low HIV-1 RNA concentration; 4 fold increased sample volume by concentrating starting material; reduced volume of internal control; adoption of "open-mode" software for quantification. Analytical performances were evaluated using the HIV-1 RNA Working Reagent 1 for NAT assays (NIBSC). Both tests were applied to clinical samples from virologically suppressed patients. The "modified" and the "ultrasensitive" configurations of the assay reached a limit of detection of 18.8 (95% CI: 11.1-51.0 cp/mL) and 4.8 cp/mL (95% CI: 2.6-9.1 cp/mL), respectively, with high precision and accuracy. In clinical samples from virologically suppressed patients, "modified" and "ultrasensitive" protocols allowed to detect and quantify HIV RNA in 12.7% and 46.6%, respectively, of samples resulted "not-detectable", and in 70.0% and 69.5%, respectively, of samples "detected laboratories for measuring MRV. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. The diagnostic performance of a single GeneXpert MTB/RIF assay in an intensified tuberculosis case finding survey among HIV-infected prisoners in Malaysia.

    Directory of Open Access Journals (Sweden)

    Haider Abdulrazzaq Abed Al-Darraji

    Full Text Available Delays in tuberculosis (TB diagnosis, particularly in prisons, is associated with detrimental outcomes. The new GeneXpert MTB/RIF assay (Xpert offers accurate and rapid diagnosis of active TB, but its performance in improving case detection in high-transmission congregate settings has yet to be evaluated. We assessed the diagnostic accuracy of a single Xpert assay in an intensified case finding survey among HIV-infected prisoners in Malaysia.HIV-infected prisoners at a single site provided two early-morning sputum specimens to be examined using fluorescence smear microscopy, BACTEC MGIT 960 liquid culture and a single Xpert. The sensitivity, specificity, negative and positive predictive values of Xpert were calculated relative to gold-standard results using MGIT 960 liquid culture. Relevant clinical and demographic data were used to examine correlates of active TB disease.The majority of enrolled subjects with complete data (N=125 were men (90.4%, age <40 years (61.6% and had injected drugs (75.2%. Median CD4 lymphocyte count was 337 cells/µL (IQR 149-492; only 19 (15.2% were receiving antiretroviral therapy. Of 15 culture-positive TB cases, single Xpert assay accurately detected only eight previously undiagnosed TB cases, resulting in a sensitivity, specificity, positive predictive value and negative predictive value of 53.3% (95% CI 30.12-75.2%, 100% (95% CI 96.6-100%, 100% (95% CI 67.56-100% and 94.0% (95% CI 88.2-97.1%, respectively. Only 1 of 15 (6.7% active TB cases was smear-positive. The prevalence (12% of undiagnosed active pulmonary TB (15 of 125 prisoners was high and associated with longer duration of drug use (AOR 1.14, 95% CI 1.03-1.26, for each year of drug use.Single Xpert assay improved TB case detection and outperformed AFB smear microscopy, but yielded low screening sensitivity. Further examination of the impact of HIV infection on the diagnostic performance of the new assay alongside other screening methods in correctional

  9. Application of heat stress in situ demonstrates a protective role of irradiation on photosynthetic performance in alpine plants

    OpenAIRE

    Buchner, Othmar; STOLL, Magdalena; Karadar, Matthias; Kranner, Ilse; Neuner, Gilbert

    2014-01-01

    The impact of sublethal heat on photosynthetic performance, photosynthetic pigments and free radical scavenging activity was examined in three high mountain species, R hododendron ferrugineum, S enecio incanus and R anunculus glacialis using controlled in situ applications of heat stress, both in darkness and under natural solar irradiation. Heat treatments applied in the dark reversibly reduced photosynthetic performance and the maximum quantum efficiency of photosystem II (Fv/Fm), which rem...

  10. Performance characteristics of a reverse transcriptase-polymerase chain reaction assay for the detection of tumor-specific fusion transcripts from archival tissue.

    Science.gov (United States)

    Fritsch, Michael K; Bridge, Julia A; Schuster, Amy E; Perlman, Elizabeth J; Argani, Pedram

    2003-01-01

    Pediatric small round cell tumors still pose tremendous diagnostic problems. In difficult cases, the ability to detect tumor-specific gene fusion transcripts for several of these neoplasms, including Ewing sarcoma/peripheral primitive neuroectodermal tumor (ES/PNET), synovial sarcoma (SS), alveolar rhabdomyosarcoma (ARMS), and desmoplastic small round cell tumor (DSRCT) using reverse transcriptase-polymerase chain reaction (RT-PCR), can be extremely helpful. Few studies to date, however, have systematically examined several different tumor types for the presence of multiple different fusion transcripts in order to determine the specificity and sensitivity of the RT-PCR method, and no study has addressed this issue for formalin-fixed material. The objectives of this study were to address the specificity, sensitivity, and practicality of such an assay applied strictly to formalin-fixed tissue blocks. Our results demonstrate that, for these tumors, the overall sensitivity for detecting each fusion transcript is similar to that reported in the literature for RT-PCR on fresh or formalin-fixed tissues. The specificity of the assay is very high, being essentially 100% for each primer pair when interpreting the results from visual inspection of agarose gels. However, when these same agarose gels were examined using Southern blotting, a small number of tumors also yielded reproducibly detectable weak signals for unexpected fusion products, in addition to a strong signal for the expected fusion product. Fluorescence in situ hybridization (FISH) studies in one such case indicated that a rearrangement that would account for the unexpected fusion was not present, while another case was equivocal. The overall specificity for each primer pair used in this assay ranged from 94 to 100%. Therefore, RT-PCR using formalin-fixed paraffin-embedded tissue sections can be used to detect chimeric transcripts as a reliable, highly sensitive, and highly specific diagnostic assay. However, we

  11. Solid phase assays

    International Nuclear Information System (INIS)

    Reese, M.G.; Johnson, L.R.; Ransom, D.K.

    1980-01-01

    In a solid phase assay for quantitative determination of biological and other analytes, a sample such as serum is contacted with a receptor for the analyte being assayed, the receptor being supported on a solid support. No tracer for the analyte is added to the sample before contacting with the receptor; instead the tracer is contacted with the receptor after unbound analyte has been removed from the receptor. The assay can be otherwise performed in a conventional manner but can give greater sensitivity. (author)

  12. Hormone assay

    International Nuclear Information System (INIS)

    Eisentraut, A.M.

    1977-01-01

    An improved radioimmunoassay is described for measuring total triiodothyronine or total thyroxine levels in a sample of serum containing free endogenous thyroid hormone and endogenous thyroid hormone bound to thyroid hormone binding protein. The thyroid hormone is released from the protein by adding hydrochloric acid to the serum. The pH of the separated thyroid hormone and thyroid hormone binding protein is raised in the absence of a blocking agent without interference from the endogenous protein. 125 I-labelled thyroid hormone and thyroid hormone antibodies are added to the mixture, allowing the labelled and unlabelled thyroid hormone and the thyroid hormone antibody to bind competitively. This results in free thyroid hormone being separated from antibody bound thyroid hormone and thus the unknown quantity of thyroid hormone may be determined. A thyroid hormone test assay kit is described for this radioimmunoassay. It provides a 'single tube' assay which does not require blocking agents for endogenous protein interference nor an external solid phase sorption step for the separation of bound and free hormone after the competitive binding step; it also requires a minimum number of manipulative steps. Examples of the assay are given to illustrate the reproducibility, linearity and specificity of the assay. (UK)

  13. Assay system

    International Nuclear Information System (INIS)

    Patzke, J.B.; Rosenberg, B.J.

    1984-01-01

    The accuracy of assays for monitoring concentrations of basic drugs in biological fluids containing a 1 -acid glycoproteins, such as blood (serum or plasma), is improved by the addition of certain organic phosphate compounds to minimize the ''protein effect.'' Kits containing the elements of the invention are also disclosed

  14. A European multicientre study on the comparison of HIV-1 viral loads between VERIS HIV-1 Assay and Roche COBAS® TAQMAN® HIV-1 test, Abbott RealTime HIV-1 Assay, and Siemens VERSANT HIV-1 Assay.

    Science.gov (United States)

    Braun, Patrick; Delgado, Rafael; Drago, Monica; Fanti, Diana; Fleury, Hervé; Hofmann, Jörg; Izopet, Jacques; Kühn, Sebastian; Lombardi, Alessandra; Mancon, Alessandro; Marcos, Mª Angeles; Mileto, Davide; Sauné, Karine; O'Shea, Siobhan; Pérez-Rivilla, Alfredo; Ramble, John; Trimoulet, Pascale; Vila, Jordi; Whittaker, Duncan; Artus, Alain; Rhodes, Daniel

    2017-07-01

    Viral load monitoring is essential for patients under treatment for HIV. Beckman Coulter has developed the VERIS HIV-1 Assay for use on the novel, automated DxN VERIS Molecular Diagnostics System. ¥ OBJECTIVES: Evaluation of the clinical performance of the new quantitative VERIS HIV-1 Assay at multiple EU laboratories. Method comparison with the VERIS HIV-1 Assay was performed with 415 specimens at 5 sites tested with COBAS ® AmpliPrep/COBAS ® TaqMan ® HIV-1 Test, v2.0, 169 specimens at 3 sites tested with RealTime HIV-1 Assay, and 202 specimens from 2 sites tested with VERSANT HIV-1 Assay. Patient monitoring sample results from 4 sites were also compared. Bland-Altman analysis showed the average bias between VERIS HIV-1 Assay and COBAS HIV-1 Test, RealTime HIV-1 Assay, and VERSANT HIV-1 Assay to be 0.28, 0.39, and 0.61 log 10 cp/mL, respectively. Bias at low end levels below 1000cp/mL showed predicted bias to be <0.3 log 10 cp/mL for VERIS HIV-1 Assay versus COBAS HIV-1 Test and RealTime HIV-1 Assay, and <0.5 log 10 cp/mL versus VERSANT HIV-1 Assay. Analysis on 174 specimens tested with the 0.175mL volume VERIS HIV-1 Assay and COBAS HIV-1 Test showed average bias of 0.39 log 10 cp/mL. Patient monitoring results using VERIS HIV-1 Assay demonstrated similar viral load trends over time to all comparators. The VERIS HIV-1 Assay for use on the DxN VERIS System demonstrated comparable clinical performance to COBAS ® HIV-1 Test, RealTime HIV-1 Assay, and VERSANT HIV-1 Assay. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. LIFAC Demonstration at Richmond Power and Light Whitewater Valley Unit No. 2 Volume II: Project Performance and Economics

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1998-04-01

    The C1ean Coal Technology (CCT) Program has been recognized in the National Energy Strategy as a major initiative whereby coal will be able to reach its full potential as a source of energy for the nation and the international marketplace. Attainment of this goal depends upon the development of highly efficient, environmentally sound, competitive coal utilization technologies responsive to diverse energy markets and varied consumer needs. The CCT Program is an effort jointly funded by government and industry whereby the most promising of the advanced coal-based technologies are being moved into the marketplace through demonstration. The CCT Program is being implemented through a total of five competitive solicitations. LIFAC North America, a joint venture partnership of ICF Kaiser Engineers, Inc., and Tampella Power Corporation, is currently demonstrating the LIFAC flue gas desulfurization technology developed by Tampella Power. This technology provides sulfur dioxide emission control for power plants, especially existing facilities with tight space limitations. Sulfur dioxide emissions are expected to be reduced by up to 85% by using limestone as a sorbent. The LIFAC technology is being demonstrated at Whitewater Valley Unit No. 2, a 60-MW coal-fired power plant owned and operated by Richmond Power and Light (RP&L) and located in Richmond, Indiana. The Whitewater plant consumes high-sulfur coals, with sulfur contents ranging from 2.0-2.9 $ZO. The project, co-funded by LIFAC North America and DOE, is being conducted with the participation of Richmond Power and Light, the State of Indiana, the Electric Power Research Institute (EPRI), and the Black Beauty Coal Company. The project has a total cost of $21.4 million and a duration of 48 months from the preliminary design phase through the testing program.

  16. High-performance thin-layer chromatography linked with (bio)assays and mass spectrometry - a suited method for discovery and quantification of bioactive components? Exemplarily shown for turmeric and milk thistle extracts.

    Science.gov (United States)

    Taha, Mahmoud N; Krawinkel, Michael B; Morlock, Gertrud E

    2015-05-15

    Extraction parameters, chemical fingerprint, and the single compounds' activity levels were considered for the selection of active botanicals. For an initial survey, the total bioactivity (i.e., total reducing capacity, total flavonoids contents and free radical scavenging capacity) of 21 aqueous and 21 ethanolic plant extracts was investigated. Ethanolic extracts showed a higher yield and were further analyzed by HPTLC in detail to obtain fingerprints of single flavonoids and further bioactive components. Exemplarily shown for turmeric (Curcuma longa) and milk thistle (Silybum marianum), effect-directed analysis (EDA) was performed using three selected (bio)assays, the Aliivibrio fischeri bioassay, the Bacillus subtilis bioassay and the 2,2-diphenyl-1-picrylhydrazyl (DPPH*) assay. As a proof of principle, the bioactive components found in the extracts were confirmed by HPTLC-MS. Bioassays in combination with planar chromatography directly linked to the known, single effective compounds like curcumin and silibinin. However, also some unknown bioactive components were discovered and exemplarily characterized, which demonstrated the strength of this kind of EDA. HPTLC-UV/Vis/FLD-EDA-MS could become a useful tool for selection of active botanicals and for the activity profiling of the active ingredients therein. The flexibility in effect-directed detections allows a comprehensive survey of effective ingredients in samples. This streamlined methodology comprised a non-targeted, effect-directed screening first, followed by a highly targeted characterization of the discovered bioactive compounds. HPTLC-EDA-MS can also be recommended for bioactivity profiling of food on the food intake side, as not only effective phytochemicals, but also unknown bioactive degradation products during food processing or contamination products or residues or metabolites can be detected. Thus, an efficient survey on potential food intake effects on wellness could be obtained. Having performed

  17. Arsenic and Uranium Removal from Drinking Water by Adsorptive Media U.S. EPA Demonstration Project at Upper Bodfish in Lake Isabella, CA -Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed during and the results obtained from the performance evaluation of an arsenic (As) and uranium (U) removal technology demonstrated at Upper Bodfish in Lake Isabella, CA. The objectives of the project are to evaluate: (1) the effecti...

  18. Network Performance and Coordination in the Health, Education, Telecommunications System. Satellite Technology Demonstration, Technical Report No. 0422.

    Science.gov (United States)

    Braunstein, Jean; Janky, James M.

    This paper describes the network coordination for the Health, Education, Telecommunications (HET) system. Specifically, it discusses HET network performance as a function of a specially-developed coordination system which was designed to link terrestrial equipment to satellite operations centers. Because all procedures and equipment developed for…

  19. Validated assay for the simultaneous quantification of total vincristine and actinomycin-D concentrations in human EDTA plasma and of vincristine concentrations in human plasma ultrafiltrate by high-performance liquid chromatography coupled with tandem mass spectrometry

    NARCIS (Netherlands)

    Damen, Carola W. N.; Israëls, Trijn; Caron, Huib N.; Schellens, Jan H. M.; Rosing, Hilde; Beijnen, Jos H.

    2009-01-01

    A sensitive, specific and efficient high-performance liquid chromatography/tandem mass spectrometry (HPLC/MS/MS) assay for the simultaneous determination of total vincristine and actinomycin-D concentrations in human plasma and an assay for the determination of unbound vincristine are presented.

  20. Performance Evaluation of a Demonstration System with PCM for Seasonal Heat Storage: Charge with Evacuated Tubular Collectors

    DEFF Research Database (Denmark)

    Englmair, Gerald; Furbo, Simon; Kong, Weiqiang

    with sunshine, the storage system performance was evaluated regarding charge with solar heat. It shows the system behavior during typical operation resulting from the control strategy. Heat transfer rates from the solar collector array (22.4 m2 aperture area) to the heat stores reached a peak of 19 kW, when PCM......A seasonal heat storage with phase change material (PCM) for a solar space heating and domestic hot water combisystem was tested in automated operation during charge with solar collectors. A water tank was operating as buffer heat storage. Based on measurements during a representative day...... temperatures were increasing with the state of charge. This is in contrast to maximization of solar yield. However, the energy conversion efficiency (65 %) of the collector array was satisfying. By considering pump electricity consumption, an overall performance ratio of 30.8 was obtained....

  1. Investigation of OMNIgene·SPUTUM performance in delayed tuberculosis testing by smear, culture, and Xpert MTB/RIF assays in Uganda

    Directory of Open Access Journals (Sweden)

    C.D. Kelly-Cirino

    2017-06-01

    Full Text Available OMNIgene·SPUTUM (OM-S is a sample transport reagent designed to work with all tuberculosis diagnostics while eliminating the need for cold chain. OM-S-treated sputum samples were assayed in several tests after multiday holds. Raw sputa from 100 patients underwent direct smear microscopy, were manually split and assigned to the OM-S group [OM-S added at collection (no other processing required and tested after 0- to 5-day holds at room temperature] or standard-of-care (SOC group (NaOH/N-acetyl l-cysteine decontamination, all tested on day of collection. Concentrated smear microscopy, Lowenstein Jensen (LJ culture, and mycobacteria growth indicator tube (MGIT culture were performed. For patients with negative direct smear, a second sample was split, with SOC (raw sputum and OM-S portions (sediment tested in the Xpert MTB/RIF (Xpert assay. OM-S group and SOC group results were strongly concordant on all four tests [range, 89% (MGIT–97% (Xpert]. OM-S MGIT, LJ, and Xpert tests were in statistical agreement with SOC MGIT as reference. OM-S specimens had lower culture contamination rates (3% vs. 10% LJ; 2% vs. 5% MGIT but required, on average, 5.6 additional days to become MGIT-positive. The findings suggest that samples held/transported in OM-S are compatible with smear microscopy, LJ or MGIT culture, and Xpert, and perform comparably to fresh sputum samples. Larger feasibility studies are warranted.

  2. Comparison of five assays for detection of Clostridium difficile toxin.

    Science.gov (United States)

    Chapin, Kimberle C; Dickenson, Roberta A; Wu, Fongman; Andrea, Sarah B

    2011-07-01

    Performance characteristics of five assays for detection of Clostridium difficile toxin were compared using fresh stool samples from patients with C. difficile infection (CDI). Assays were performed simultaneously and according to the manufacturers' instructions. Patients were included in the study if they exhibited clinical symptoms consistent with CDI. Nonmolecular assays included glutamate dehydrogenase antigen tests, with positive findings followed by the Premier Toxin A and B Enzyme Immunoassay (GDH/EIA), and the C. Diff Quik Chek Complete test. Molecular assays (PCR) included the BD GeneOhm Cdiff Assay, the Xpert C. difficile test, and the ProGastro Cd assay. Specimens were considered true positive if results were positive in two or more assays. For each method, the Youden index was calculated and cost-effectiveness was analyzed. Of 81 patients evaluated, 26 (32.1%) were positive for CDI. Sensitivity of the BD GeneOhm Cdiff assay, the Xpert C. difficile test, the ProGastro Cd assay, C. Diff Quik Chek Complete test, and two-step GDH/EIA was 96.2%, 96.2%, 88.5%, 61.5%, and 42.3%, respectively. Specificity of the Xpert C. difficile test was 96.4%, and for the other four assays was 100%. Compared with nonmolecular methods, molecular methods detected 34.7% more positive specimens. Assessment of performance characteristics and cost-effectiveness demonstrated that the BD GeneOhm Cdiff assay yielded the best results. While costly, the Xpert C. difficile test required limited processing and yielded rapid results. Because of discordant results, specimen processing, and extraction equipment requirements, the ProGastro Cd assay was the least favored molecular assay. The GDH/EIA method lacked sufficient sensitivity to be recommended. Copyright © 2011 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

  3. Comparison of Five Assays for Detection of Clostridium difficile Toxin

    Science.gov (United States)

    Chapin, Kimberle C.; Dickenson, Roberta A.; Wu, Fongman; Andrea, Sarah B.

    2011-01-01

    Performance characteristics of five assays for detection of Clostridium difficile toxin were compared using fresh stool samples from patients with C. difficile infection (CDI). Assays were performed simultaneously and according to the manufacturers' instructions. Patients were included in the study if they exhibited clinical symptoms consistent with CDI. Nonmolecular assays included glutamate dehydrogenase antigen tests, with positive findings followed by the Premier Toxin A and B Enzyme Immunoassay (GDH/EIA), and the C. Diff Quik Chek Complete test. Molecular assays (PCR) included the BD GeneOhm Cdiff Assay, the Xpert C. difficile test, and the ProGastro Cd assay. Specimens were considered true positive if results were positive in two or more assays. For each method, the Youden index was calculated and cost-effectiveness was analyzed. Of 81 patients evaluated, 26 (32.1%) were positive for CDI. Sensitivity of the BD GeneOhm Cdiff assay, the Xpert C. difficile test, the ProGastro Cd assay, C. Diff Quik Chek Complete test, and two-step GDH/EIA was 96.2%, 96.2%, 88.5%, 61.5%, and 42.3%, respectively. Specificity of the Xpert C. difficile test was 96.4%, and for the other four assays was 100%. Compared with nonmolecular methods, molecular methods detected 34.7% more positive specimens. Assessment of performance characteristics and cost-effectiveness demonstrated that the BD GeneOhm Cdiff assay yielded the best results. While costly, the Xpert C. difficile test required limited processing and yielded rapid results. Because of discordant results, specimen processing, and extraction equipment requirements, the ProGastro Cd assay was the least favored molecular assay. The GDH/EIA method lacked sufficient sensitivity to be recommended. PMID:21704273

  4. Performance of the fully automated progesterone assays on the Abbott AxSYM and the Technicon Immuno 1 Analyser compared with the radioimmunoassay progesterone MAIA

    International Nuclear Information System (INIS)

    Reinsberg, J.; Jost, E.; Van der Ven, H.

    1997-01-01

    Test performance of two automated progesterone assays available on the immunoassay analysers Abbott AxSYM and Technicon Immuno 1, respectively, was evaluated in comparison with the radioimmunoassay Progesterone MAIA. For assessment of test performance imprecision, functional sensitivity and linearity of dilution was examined. Correlation with the manual radioimmunoassay was assessed using 122 serum samples over the range 0-110 nmol/L. Imprecision studies revealed for the AxSYM Progesterone within-run CV's of 1.8-6.4% and day-to-day CV's of 3.5-9.7% (concentration range 2.3-75 nmol/L); Immuno 1 Progesterone: within-run CV's 1.0-7.3%, day-to-day CV's 2.3-7.7% (concentration range 1.2-60 nmol/L). The functional sensitivity was <1.7 nmol/L for the AxSYM Progesterone and <1.1 nmol/L for the Immuno 1 Progesterone. With the AxSYM Progesterone the mean recovery after dilution from five samples was 102% (89-107%), from one sample only 69-80% was recovered; with the Immuno 1 Progesterone the mean recovery was 95% (80-105%). Despite of a quite good overall correlation (coefficients 0.972 and 0.981) the relationship of both assays to the Progesterone MAIA significantly deviate from linearity with a considerably higher slope within the lower concentration range. The relationship between the automated assays was linear over the entire concentration range (Immuno = 1.207 * AxSYM + 1; r = 0.986). The time to first result was 20 min for the AxSYM Progesterone, 45 min for the Immuno 1 Progesterone and 90 min for the Progesterone MAIA. The evaluated progesterone assays both exhibit an excellent precision and a high degree of sensitivity. They offer a rapid and flexible method for progesterone determination which may be especially useful for the monitoring of ovarian stimulation during in-vitro fertilization. (author)

  5. Evaluation of the HOOF-Print assay for typing Brucella abortus strains isolated from cattle in the United States: results with four performance criteria

    Directory of Open Access Journals (Sweden)

    Ewalt Darla R

    2005-06-01

    Full Text Available Abstract Background A fundamental question that arises during epidemiological investigations of bacterial disease outbreaks is whether the outbreak strain is genetically related to a proposed index strain. Highly discriminating genetic markers for characterizing bacterial strains can help in clarifying the genetic relationships among strains. Under the auspices of the European Society of Clinical Microbiology and Infectious Diseases, the European Study Group for Epidemiological Markers (ESGEM established guidelines for evaluating the performance of typing systems based of a number of criteria. Recently, HOOF-Print genotype analysis, a new method for typing Brucella abortus strains based on hypervariability at eight tandem repeat loci, was described. This paper evaluates the HOOF-Print assay by four of the criteria set out by the ESGEM: typeability, reproducibility, power of discrimination, and concordance with other typing methods. Results The HOOF-Print Assay was evaluated with a test population composed of 97 unrelated field isolates and 6 common laboratory strains of B. abortus. Both typeability and reproducibility of the assay were excellent. Allele diversity and frequency varied widely among the eight loci, ranging from 1 to 13 alleles. The power of discrimination, measured by the Hunter-Gaston discrimination index (HGDI, varied by locus ranging from 0 to 0.89, where a maximal value of 1.0 indicates discrimination of all strains. The HGDI values calculated for subgroups sorted by biovar were similar to the values determined for the whole population. None of the individual loci achieved the recommended HGDI threshold of 0.95, but the HGDI of the composite profiles was 0.99 (93 unique genotypes from 97 field strains evaluated, well above the recommended threshold. By comparison, the HGDI value for biovar typing was 0.61 in a test population biased with disproportionate numbers of the less common biovars. Cluster analysis based on HOOF

  6. Analytical performance evaluation of the Elecsys® Cyclosporine and Elecsys® Tacrolimus assays on the cobas e411 analyzer

    Directory of Open Access Journals (Sweden)

    Maki Sasano

    2017-08-01

    Full Text Available Background: Cyclosporine (CsA and tacrolimus (TAC are immunosuppressant drugs that are often used to treat autoimmune diseases and as transplantation therapy; therefore, their concentrations need to be monitored carefully. We herein evaluated the analytical performance of the Elecsys® Cyclosporine and Elecsys® Tacrolimus assay kits, which have been newly developed to measure CsA and TAC concentrations in the whole blood. Methods: We used residual whole blood samples from autoimmune disease and transplantation patients who were being treated with CsA or TAC. CsA concentrations were measured using an affinity chrome-mediated immunoassay (ACMIA and an electrochemiluminescence immunoassay (ECLIA. TAC concentrations were measured using a chemiluminescence immunoassay (CLIA and ECLIA. We investigated assay precision, linearity, lower limit of quantitation (LOQ, stability of calibration, influence of interference substances and the hematocrit, correlation of ACMIA with ECLIA, and correlation of CLIA with ECLIA. Results: Within-assay coefficients of variation were 1.8−3.6% (CsA: 94−1238 ng/mL and 2.9−3.9% (TAC: 2.1−17.8 ng/mL, whereas day-to-day coefficients of variation ranged between 3.0−4.1% (CsA and 2.8−3.9% (TAC. The limits of quantitation were defined as the concentration at which the CV was approximately 10%. Each lower LOQ obtained was 16 ng/mL (CsA, and 0.95 ng/mL (TAC. CsA and TAC calibrations were stable for at least 21 days. Neither the presence of conjugated bilirubin, unconjugated bilirubin, chyle, and rheumatoid factor nor the hematocrit affected these assays. A method comparison using a standardized major axis regression analysis of ACMIA and ECLIA was r=0.995, y=0.924x −1.175, n=200 (CsA, while that of CLIA and ECLIA was r=0.994, y=1.080x −0.197, n=200 (TAC. Conclusions: The analytical performances of the Elecsys® Cyclosporine and Elecsys®Tacrolimus assays were acceptable

  7. Dataset demonstrating the modeling of a high performance Cu(In,GaSe2 absorber based thin film photovoltaic cell

    Directory of Open Access Journals (Sweden)

    Md. Asaduzzaman

    2017-04-01

    Full Text Available The physical data of the semiconductor materials used in the design of a CIGS absorber based thin film photovoltaic cell have been presented in this data article. Besides, the values of the contact parameter and operating conditions of the cell have been reported. Furthermore, by conducting the simulation with data corresponding to the device structure: soda-lime glass (SLG substrate/Mo back-contact/CIGS absorber/CdS buffer/intrinsic ZnO/Al-doped ZnO window/Al-grid front-contact, the solar cell performance parameters such as open circuit voltage (Voc, short circuit current density Jsc, fill factor (FF, efficiency (η, and collection efficiency ηc have been analyzed.

  8. Performance and diagnostic usefulness of commercially available enzyme linked immunosorbent assay and rapid kits for detection of HIV, HBV and HCV in India

    Directory of Open Access Journals (Sweden)

    Maity Susmita

    2012-11-01

    Full Text Available Abstract Background HIV, HBV and HCV pose a major public health problem throughout the world. Detection of infection markers for these agents is a major challenge for testing laboratories in a resource poor setting. As blood transfusion is an important activity saving millions of live every year, it also carries a risk of transfusion transmissible infections caused by these fatal blood borne pathogens if the quality of testing is compromised. Conventional ELISA is regarded as the mostly used screening technique but due to limitations like high cost, unavailability in many blood banks and testing sites, involvement of costly instruments, time taking nature and requirement of highly skilled personnel for interpretation, rapid tests are gaining more importance and warrants comparison of performance. Results A comparative study between these two techniques has been performed using commercially available diagnostic kits to assess their efficacy for detection of HIV, HBV and HCV infections. Rapid kits were more efficient in specificity with synthetic antigens along with high PPV than ELISA in most cases. Comparison between different ELISA kits revealed that Microlisa HIV and Hepalisa (J. Mitra & Co. Pvt. Ltd.; ERBA LISA HIV1 + 2, ERBA LISA Hepatitis B and ERBA LISA HCV (Transasia Bio-medicals Ltd. gives uniform result with good performance in terms of sensitivity, specificity, PPV, NPV and efficiency, whereas, Microlisa HCV (J. Mitra & Co. Pvt. Ltd., Microscreen HBsAg ELISA and INNOVA HCV (Span Diagnostics Ltd. did not perform well. Rapid kits were also having high degree of sensitivity and specificity (100% except in HIV Comb and HCV Comb (J. Mitra & Co. Pvt. Ltd.. The kit efficiency didn’t vary significantly among different companies and lots in all the cases except for HCV ELISA showing statistically significant variation (p  Conclusions ELISA is a good screening assay for markers of HIV, HBV and HCV infections. Rapid tests are useful for

  9. High-performance liquid chromatographic assay for acetaminophen and phenacetin in the presence of their metabolites in biological fluids

    International Nuclear Information System (INIS)

    Pang, K.S.; Taburet, A.M.; Hinson, J.A.; Gillette, J.R.

    1979-01-01

    The authors propose a method in which tracer amounts of a radiolabeled compound are used as the internal standard for the same unlabeled compound in high-performance liquid chromatography. The approach is valuable when a response from the internal standard becomes undesirable due to the presence of interference by the metabolites. The authors tested their approach with phenacetin and its metabolites, 2-hydroxyphenacetin, N-hydroxyphenacetin, phenetidine, acetaminophen sulfate conjugate and acetaminophen glucuronide conjugate in biological fluids with the use of [ 14 C] phenacetin and [ 3 H] acetaminophen as the internal standards, and were able to quantitate both phenacetin and acetaminophen simultaneously. They also tested the alternative approach in which the unlabeled drug was used as internal standard for tracer amounts of the same radiolabeled compound, with phenacetin and acetaminophen as the internal standards for tracer amounts of [ 14 C] phenacetin and [ 3 H] acetaminophen. Again, they were able to quantiate the two tracer radiolabeled compounds simultaneously. (Auth.)

  10. Proof-of-Concept Demonstrations for Computation-Based Human Reliability Analysis. Modeling Operator Performance During Flooding Scenarios

    International Nuclear Information System (INIS)

    Joe, Jeffrey Clark; Boring, Ronald Laurids; Herberger, Sarah Elizabeth Marie; Mandelli, Diego; Smith, Curtis Lee

    2015-01-01

    The United States (U.S.) Department of Energy (DOE) Light Water Reactor Sustainability (LWRS) program has the overall objective to help sustain the existing commercial nuclear power plants (NPPs). To accomplish this program objective, there are multiple LWRS 'pathways,' or research and development (R&D) focus areas. One LWRS focus area is called the Risk-Informed Safety Margin and Characterization (RISMC) pathway. Initial efforts under this pathway to combine probabilistic and plant multi-physics models to quantify safety margins and support business decisions also included HRA, but in a somewhat simplified manner. HRA experts at Idaho National Laboratory (INL) have been collaborating with other experts to develop a computational HRA approach, called the Human Unimodel for Nuclear Technology to Enhance Reliability (HUNTER), for inclusion into the RISMC framework. The basic premise of this research is to leverage applicable computational techniques, namely simulation and modeling, to develop and then, using RAVEN as a controller, seamlessly integrate virtual operator models (HUNTER) with 1) the dynamic computational MOOSE runtime environment that includes a full-scope plant model, and 2) the RISMC framework PRA models already in use. The HUNTER computational HRA approach is a hybrid approach that leverages past work from cognitive psychology, human performance modeling, and HRA, but it is also a significant departure from existing static and even dynamic HRA methods. This report is divided into five chapters that cover the development of an external flooding event test case and associated statistical modeling considerations.

  11. Proof-of-Concept Demonstrations for Computation-Based Human Reliability Analysis. Modeling Operator Performance During Flooding Scenarios

    Energy Technology Data Exchange (ETDEWEB)

    Joe, Jeffrey Clark [Idaho National Lab. (INL), Idaho Falls, ID (United States); Boring, Ronald Laurids [Idaho National Lab. (INL), Idaho Falls, ID (United States); Herberger, Sarah Elizabeth Marie [Idaho National Lab. (INL), Idaho Falls, ID (United States); Mandelli, Diego [Idaho National Lab. (INL), Idaho Falls, ID (United States); Smith, Curtis Lee [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-09-01

    The United States (U.S.) Department of Energy (DOE) Light Water Reactor Sustainability (LWRS) program has the overall objective to help sustain the existing commercial nuclear power plants (NPPs). To accomplish this program objective, there are multiple LWRS “pathways,” or research and development (R&D) focus areas. One LWRS focus area is called the Risk-Informed Safety Margin and Characterization (RISMC) pathway. Initial efforts under this pathway to combine probabilistic and plant multi-physics models to quantify safety margins and support business decisions also included HRA, but in a somewhat simplified manner. HRA experts at Idaho National Laboratory (INL) have been collaborating with other experts to develop a computational HRA approach, called the Human Unimodel for Nuclear Technology to Enhance Reliability (HUNTER), for inclusion into the RISMC framework. The basic premise of this research is to leverage applicable computational techniques, namely simulation and modeling, to develop and then, using RAVEN as a controller, seamlessly integrate virtual operator models (HUNTER) with 1) the dynamic computational MOOSE runtime environment that includes a full-scope plant model, and 2) the RISMC framework PRA models already in use. The HUNTER computational HRA approach is a hybrid approach that leverages past work from cognitive psychology, human performance modeling, and HRA, but it is also a significant departure from existing static and even dynamic HRA methods. This report is divided into five chapters that cover the development of an external flooding event test case and associated statistical modeling considerations.

  12. Application of 3D Printing Technology in Increasing the Diagnostic Performance of Enzyme-Linked Immunosorbent Assay (ELISA for Infectious Diseases

    Directory of Open Access Journals (Sweden)

    Harpal Singh

    2015-07-01

    Full Text Available Enzyme-linked Immunosorbent Assay (ELISA-based diagnosis is the mainstay for measuring antibody response in infectious diseases and to support pathogen identification of potential use in infectious disease outbreaks and clinical care of individual patients. The development of laboratory diagnostics using readily available 3D printing technologies provides a timely opportunity for further expansion of this technology into immunodetection systems. Utilizing available 3D printing platforms, a ‘3D well’ was designed and developed to have an increased surface area compared to those of 96-well plates. The ease and rapidity of the development of the 3D well prototype provided an opportunity for its rapid validation through the diagnostic performance of ELISA in infectious disease without modifying current laboratory practices for ELISA. The improved sensitivity of the 3D well of up to 2.25-fold higher compared to the 96-well ELISA provides a potential for the expansion of this technology towards miniaturization and Lab-On-a-Chip platforms to reduce time, volume of reagents and samples needed for such assays in the laboratory diagnosis of infectious and other diseases including applications in other disciplines.

  13. Application of 3D Printing Technology in Increasing the Diagnostic Performance of Enzyme-Linked Immunosorbent Assay (ELISA) for Infectious Diseases

    Science.gov (United States)

    Singh, Harpal; Shimojima, Masayuki; Shiratori, Tomomi; An, Le Van; Sugamata, Masami; Yang, Ming

    2015-01-01

    Enzyme-linked Immunosorbent Assay (ELISA)-based diagnosis is the mainstay for measuring antibody response in infectious diseases and to support pathogen identification of potential use in infectious disease outbreaks and clinical care of individual patients. The development of laboratory diagnostics using readily available 3D printing technologies provides a timely opportunity for further expansion of this technology into immunodetection systems. Utilizing available 3D printing platforms, a ‘3D well’ was designed and developed to have an increased surface area compared to those of 96-well plates. The ease and rapidity of the development of the 3D well prototype provided an opportunity for its rapid validation through the diagnostic performance of ELISA in infectious disease without modifying current laboratory practices for ELISA. The improved sensitivity of the 3D well of up to 2.25-fold higher compared to the 96-well ELISA provides a potential for the expansion of this technology towards miniaturization and Lab-On-a-Chip platforms to reduce time, volume of reagents and samples needed for such assays in the laboratory diagnosis of infectious and other diseases including applications in other disciplines. PMID:26184194

  14. Application of 3D Printing Technology in Increasing the Diagnostic Performance of Enzyme-Linked Immunosorbent Assay (ELISA) for Infectious Diseases.

    Science.gov (United States)

    Singh, Harpal; Shimojima, Masayuki; Shiratori, Tomomi; An, Le Van; Sugamata, Masami; Yang, Ming

    2015-07-08

    Enzyme-linked Immunosorbent Assay (ELISA)-based diagnosis is the mainstay for measuring antibody response in infectious diseases and to support pathogen identification of potential use in infectious disease outbreaks and clinical care of individual patients. The development of laboratory diagnostics using readily available 3D printing technologies provides a timely opportunity for further expansion of this technology into immunodetection systems. Utilizing available 3D printing platforms, a '3D well' was designed and developed to have an increased surface area compared to those of 96-well plates. The ease and rapidity of the development of the 3D well prototype provided an opportunity for its rapid validation through the diagnostic performance of ELISA in infectious disease without modifying current laboratory practices for ELISA. The improved sensitivity of the 3D well of up to 2.25-fold higher compared to the 96-well ELISA provides a potential for the expansion of this technology towards miniaturization and Lab-On-a-Chip platforms to reduce time, volume of reagents and samples needed for such assays in the laboratory diagnosis of infectious and other diseases including applications in other disciplines.

  15. Changing Feeding Regimes To Demonstrate Flexible Biogas Production: Effects on Process Performance, Microbial Community Structure, and Methanogenesis Pathways

    Science.gov (United States)

    Mulat, Daniel Girma; Jacobi, H. Fabian; Feilberg, Anders; Adamsen, Anders Peter S.; Richnow, Hans-Hermann

    2015-01-01

    Flexible biogas production that adapts biogas output to energy demand can be regulated by changing feeding regimes. In this study, the effect of changes in feeding intervals on process performance, microbial community structure, and the methanogenesis pathway was investigated. Three different feeding regimes (once daily, every second day, and every 2 h) at the same organic loading rate were studied in continuously stirred tank reactors treating distiller's dried grains with solubles. A larger amount of biogas was produced after feeding in the reactors fed less frequently (once per day and every second day), whereas the amount remained constant in the reactor fed more frequently (every 2 h), indicating the suitability of the former for the flexible production of biogas. Compared to the conventional more frequent feeding regimes, a methane yield that was up to 14% higher and an improved stability of the process against organic overloading were achieved by employing less frequent feeding regimes. The community structures of bacteria and methanogenic archaea were monitored by terminal restriction fragment length polymorphism (T-RFLP) analysis of 16S rRNA and mcrA genes, respectively. The results showed that the composition of the bacterial community varied under the different feeding regimes, and the observed T-RFLP patterns were best explained by the differences in the total ammonia nitrogen concentrations, H2 levels, and pH values. However, the methanogenic community remained stable under all feeding regimes, with the dominance of the Methanosarcina genus followed by that of the Methanobacterium genus. Stable isotope analysis showed that the average amount of methane produced during each feeding event by acetoclastic and hydrogenotrophic methanogenesis was not influenced by the three different feeding regimes. PMID:26497462

  16. Changing Feeding Regimes To Demonstrate Flexible Biogas Production: Effects on Process Performance, Microbial Community Structure, and Methanogenesis Pathways.

    Science.gov (United States)

    Mulat, Daniel Girma; Jacobi, H Fabian; Feilberg, Anders; Adamsen, Anders Peter S; Richnow, Hans-Hermann; Nikolausz, Marcell

    2016-01-15

    Flexible biogas production that adapts biogas output to energy demand can be regulated by changing feeding regimes. In this study, the effect of changes in feeding intervals on process performance, microbial community structure, and the methanogenesis pathway was investigated. Three different feeding regimes (once daily, every second day, and every 2 h) at the same organic loading rate were studied in continuously stirred tank reactors treating distiller's dried grains with solubles. A larger amount of biogas was produced after feeding in the reactors fed less frequently (once per day and every second day), whereas the amount remained constant in the reactor fed more frequently (every 2 h), indicating the suitability of the former for the flexible production of biogas. Compared to the conventional more frequent feeding regimes, a methane yield that was up to 14% higher and an improved stability of the process against organic overloading were achieved by employing less frequent feeding regimes. The community structures of bacteria and methanogenic archaea were monitored by terminal restriction fragment length polymorphism (T-RFLP) analysis of 16S rRNA and mcrA genes, respectively. The results showed that the composition of the bacterial community varied under the different feeding regimes, and the observed T-RFLP patterns were best explained by the differences in the total ammonia nitrogen concentrations, H2 levels, and pH values. However, the methanogenic community remained stable under all feeding regimes, with the dominance of the Methanosarcina genus followed by that of the Methanobacterium genus. Stable isotope analysis showed that the average amount of methane produced during each feeding event by acetoclastic and hydrogenotrophic methanogenesis was not influenced by the three different feeding regimes. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  17. Performance Characteristics of CA 19-9 Radioimmunoassay and Clinical Significance of Serum CA 19-9 Assay in Patients with Malignancy

    International Nuclear Information System (INIS)

    Kim, Sang Eun; Shong, Young Kee; Cho, Bo Youn; Kim, Noe Kyeong; Koh, Chang Soon; Lee, Mun Ho; Hong, Seong Woon; Hong, Kee Suk

    1985-01-01

    To evaluate the performance characteristics of CA 19-9 radioimmunoassay and the clinical significance of serum CA 19-9 assay in patients with malignancy, serum. CA 19-9 levels were measured by radioimmunoassay using monoclonal antibody in 135 normal controls, 81 patients with various untreated malignancy, 9 patients of postoperative colon cancer without recurrence and 20 patients with benign gastrointestinal diseases, who visited Seoul National University Hospital from June, 1984 to March, 1985. The results were as follows; 1) The CA 19-9 radioimmunoassay was simple to perform and can be completed in one work day. And the between-assay reproducibility and the assay recovery were both excellent. 2) The mean serum CA 19-9 level in 135 normal controls was 8.4±4.2 U/mL. Normal upper limit of serum CA 19-9 was defined as 21.0 U/mL. 4 out of 135 (3.0%) normal controls showed elevated CA 19-9 levels above the normal upper limit. 3) One out of 20 (5.0%) patients with benign gastrointestinal diseases showed elevated serum CA 19-9 level above the normal upper limit. 4) In 81 patients with various untreated malignancy, 41 patients (50.6%) showed elevated serum CA 19-9 levels. 66.7% of 18 patients with colorectal cancer, 100% of 2 patients with pancreatic cancer, 100% of 3 patients with common bile duct cancer, 47.1% of 17 patients with stomach cancer, 28.6% of 28 patients with hepatoma and 60.0% of 5 gastrointestinal tract cancers showed elevated serum CA 19-9 levels. 5) The sensitivities of serum CA 19-9 related to respectability in colorectal and stomach cancer were 33.3% in resectable colorectal cancer, 83.3% in unresectable colorectal cancer, 41.7% in resectable stomach cancer, 60.0% in unresectable stomach cancer respectively. 6) The sensitivity of serum CA 19-9 in 9 patients of postoperative colorectal cancer without recurrence were 33.3% and significantly decreased compared with that of untreated colorectal cancer, 66.7% (p<0.05). 7) In Patients with colorectal cancer

  18. Technical and clinical performance of a new assay to detect squamous cell carcinoma antigen levels for the differential diagnosis of cervical, lung, and head and neck cancer.

    Science.gov (United States)

    Holdenrieder, Stefan; Molina, Rafael; Qiu, Ling; Zhi, Xiuyi; Rutz, Sandra; Engel, Christine; Kasper-Sauer, Pia; Dayyani, Farshid; Korse, Catharina M

    2018-04-01

    In squamous cell carcinoma, squamous cell carcinoma antigen levels are often elevated. This multi-center study evaluated the technical performance of a new Elecsys ® squamous cell carcinoma assay, which measures serum squamous cell carcinoma antigen 1 and 2 levels in an equimolar manner, and investigated the potential of squamous cell carcinoma antigen for differential diagnosis of cervical, lung, and head and neck squamous cell carcinoma.Assay precision and method comparison experiments were performed across three European sites. Reference ranges for reportedly healthy individuals were determined using samples from banked European and Chinese populations. Differential diagnosis experiments determined whether cervical, lung, or head and neck cancer could be differentiated from apparently healthy, benign, or other malignant cohorts using squamous cell carcinoma antigen levels alone. Squamous cell carcinoma antigen cut-off levels were calculated based on squamous cell carcinoma antigen levels at 95% specificity. Repeatability coefficients of variation across nine analyte concentrations were ≤5.3%, and intermediate precision coefficients of variation were ≤10.3%. Method comparisons showed good correlations with Architect and Kryptor systems (slopes of 1.1 and 1.5, respectively). Reference ranges for 95th percentiles for apparently healthy individuals were 2.3 ng/mL (95% confidence interval: 1.9-3.8; European cohort, n = 153) and 2.7 ng/mL (95% confidence interval: 2.2-3.3; Chinese cohort, n = 146). Strongest differential diagnosis results were observed for cervical squamous cell carcinoma: receiver operating characteristic analysis showed that squamous cell carcinoma antigen levels (2.9 ng/mL cut-off) differentiate cervical squamous cell carcinoma (n = 127) from apparently healthy females (n = 286; area under the curve: 86.2%; 95% confidence interval: 81.8-90.6; sensitivity: 61.4%; specificity: 95.6%), benign diseases (n = 187; area

  19. The relative test performance characteristics of two commercial assays for the detection of Mycobacterium tuberculosis complex in paraffin-fixed human biopsy specimens

    Directory of Open Access Journals (Sweden)

    Broukhanski George

    2008-09-01

    Full Text Available Abstract The Seeplex™ TB Detection-2 assay (Rockville, MD is a nested endpoint PCR for the Mycobacterium tuberculosis complex (MTBC targets IS6110 and MPB64 that utilizes dual priming oligonucleotide technology. When used to detect the presence of MTBC DNA in formalin-fixed paraffin-embedded tissue specimens, the sensitivity and specificity of this assay is equivalent to a labor-intensive traditional endpoint PCR assay and is more sensitive than a commercial real-time PCR assay.

  20. A demonstration of the 'isotope wind tunnel principle' in JET and its use in predicting reactor performance

    International Nuclear Information System (INIS)

    Cordey, J.; Alper, B.; Budny, R.

    2000-01-01

    ELMy H-mode pulses have been obtained with different hydrogenic isotopes (H and D) but having the same profiles of the dimensionless parameters ρ*, β*, ν* and q, to test whether the confinement scale invariance principle is valid in a tokamak. The fact that the confinement times, the ELM and sawtooth frequencies in the two pulses all scale as expected suggests that the invariance principle is satisfied through the plasma radial extent, in spite of the differing physical processes taking place in the plasma centre, core and edge regions. An application of this 'isotope windtunnel technique' to predicting D-T performance of next step devices is discussed. In tokamak discharges, such as the steady state ELMy H-mode, the physical processes change dramatically as one moves out in minor radius. In the central region the temperature gradient is controlled by MHD modes (sawteeth), whilst outside in what is known as the core confinement region the transport is thought to be due to small scale Larmor radius (r i ) size turbulence, such as that caused by the ion temperature gradient instability. Finally in the edge region the transport is almost neoclassical with intermittent MHD events (ELMs) controlling the steepness of the gradients in this region. From theoretical analysis, in particular the confinement scale invariance principle, it should be possible to describe the transport properties in all three regions in terms of the profiles of the basic dimensionless plasma physics parameters ρ*(∝(MT) 1/2 /aB), β(∝ nT/B 2 ), ν* (∝ na/T 2 ) and q (∝Bκ/Rj). The thermal diffusivity should have the form χ ∝ Ba 2 /M F(ρ*, β, ν*, q, ...) where the form of the function F will be different in each of the three regions. One method of checking whether the invariance principle is correct is to complete wind tunnel or identity experiments on different tokamaks. This involves setting up discharges on different tokamaks with the same profiles of ρ*, β, ν* and q and

  1. Paying It Forward: A Technical Assistance Guide for Developing and Implementing Performance-Based Scholarships. The Performance-Based Scholarship Demonstration

    Science.gov (United States)

    Welbeck, Rashida; Ware, Michelle; Cerna, Oscar; Valenzuela, Ireri

    2014-01-01

    Difficulties in paying for college and in maintaining good academic performance are two major hurdles to college graduation for low-income students. In recent years, state and federal budgets for postsecondary education have been cut significantly, limiting the options policymakers, education leaders, and communities have to improve rates of…

  2. Determination of vitamin B6 vitamers and pyridoxic acid in plasma: development and evaluation of a high-performance liquid chromatographic assay

    DEFF Research Database (Denmark)

    Bisp, Marianne R; Bor, Mustafa Vakur; Heinsvig, Else-Marie

    2002-01-01

    buffer containing 1 g/L sodium bisulfite. The performance of the assay was evaluated by analyzing six plasma samples with interrelated concentration and two control samples (unspiked and vitamer spiked) over a 3-months period. The HPLC method was able to identify PLP, 4-PA, PM, PL, PN, and PMP from all...... other compounds in plasma in an analytical run of 46 min. The imprecisions and mean values (presented in parenthesis in nmol/L) were (unspiked and spiked sample) 9-8% (41-65) for PLP, 12-7% (18-40) for 4-PA, 67-28% (4-19) for PL, 15% (21) for PN, 10% (27) for PM, and 27% (17) for PMP. All three B6...... will be suitable for routine quantitation of PLP and 4-PA in human plasma. Udgivelsesdato: 2002-Jun-1...

  3. High-performance liquid chromatography coupled with post-column dual-bioactivity assay for simultaneous screening of xanthine oxidase inhibitors and free radical scavengers from complex mixture.

    Science.gov (United States)

    Li, D Q; Zhao, J; Li, S P

    2014-06-06

    Xanthine oxidase (XO) can catalyze hypoxanthine and xanthine to generate uric acid and reactive oxygen species (ROS), including superoxide anion radical (O₂(•-)) and hydrogen peroxide. XO inhibitors and free radical scavengers are beneficial to the treatment of gout and many related diseases. In the present study, an on-line high-performance liquid chromatography (HPLC) coupled with post-column dual-bioactivity assay was established and successfully applied to simultaneously screening of XO inhibitors and free radical scavengers from a complex mixture, Oroxylum indicum extract. The integrated system of HPLC separation, bioactivity screening and mass spectrometry identification was proved to be simple and effective for rapid and sensitive screening of individual bioactive compounds in complex mixtures. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. A high-performance liquid chromatography-based radiometric assay for sucrose-phosphate synthase and other UDP-glucose requiring enzymes

    International Nuclear Information System (INIS)

    Salvucci, M.E.; Crafts-Brandner, S.J.

    1991-01-01

    A method for product analysis that eliminates a problematic step in the radiometric sucrose-phosphate synthase assay is described. The method uses chromatography on a boronate-derivatized high-performance liquid chromatography column to separate the labeled product, [14C]sucrose phosphate, from unreacted uridine 5'-diphosphate-[14C]glucose (UDP-Glc). Direct separation of these compounds eliminates the need for treatment of the reaction mixtures with alkaline phosphatase, thereby avoiding the problem of high background caused by contaminating phosphodiesterase activity in alkaline phosphatase preparations. The method presented in this paper can be applied to many UDP-Glc requiring enzymes; here the authors show its use for determining the activities of sucrose-phosphate synthase, sucrose synthase, and uridine diphosphate-glucose pyrophosphorylase in plant extracts

  5. Arsenic Removal from Drinking Water by Iron Removal U.S. EPA Demonstration Project at Sabin, MN Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from January 30, 2006 to April 29, 2007 at the U.S. Environmental Protection Agency (EPA) Arsenic Removal Technology Demonstration site in Sabin, MN. The main objective of the project was to evaluate the eff...

  6. Arsenic Removal from Drinking Water by Adsorptive Media U.S. EPA Demonstration Project at Webb Consolidated Independent School District in Bruni, TX - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the arsenic removal treatment technology demonstration project at the Webb Consolidated Independent School District (Webb CISD) in Bruni, TX. The main objective of the project was to evaluate the effect...

  7. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Rollinsford, NH, Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the arsenic removal treatment technology demonstration project at Rollinsford, New Hampshire. The objectives of the project were to evaluate: 1) the effectiveness of AdEdge Technologies’ AD -33TM media ...

  8. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Hot Springs Mobile Home Park in Willard, Utah - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents activities performed for and results obtained from the arsenic removal treatment technology demonstration project at the Hot Springs Mobile Home Park (HSMHP) in Willard, UT. The objectives of the project were to evaluate the effectiveness of Adsorbsia™ GTO™...

  9. Arsenic Removal from Drinking Water by Iron Removal U.S. EPA Demonstration Project at Vintage on the Ponds in Delavan, WI Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the arsenic removal treatment technology demonstration project at Vintage on the Ponds in Delavan, WI. The objectives of the project were to evaluate: (1) the effectiveness of a Kinetico Macrolite® press...

  10. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Covered Wells in Tohono O’odham Nation, AZ - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the arsenic removal treatment technology demonstration project at Covered Wells in Tohono O’odham Nation, AZ. The main objective of the project was to evaluate the effectiveness of AdEdge Technologies’ ...

  11. Arsenic Removal from Drinking Water by Coagulation/Filtration - U.S. EPA Demonstration Project at Village of Waynesville, IL - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the arsenic removal drinking water treatment technology demonstration project at the Village of Waynesville, IL. The main objective of the project was to evaluate the effectiveness of the Peerless coagu...

  12. Arsenic Removal from Drinking Water by Iron Removal - U.S. EPA Demonstration Project at Northeastern Elementary School in Fountain City, IN - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the arsenic removal treatment technology demonstration project at Northeastern Elementary School in Fountain City, IN. The main objective of the project was to evaluate the effectiveness of US Water Sys...

  13. ARSENIC REMOVAL FROM DRINKING WATER BY IRON REMOVAL. U.S. EPA DEMONSTRATION PROJECT AT CLIMAX, MN. FINAL PERFORMANCE EVALUATION REPORT.

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the arsenic removal treatment technology demonstration project following one year of operation at the Climax, Minnesota, site. The objectives of the project were to evaluate: (1) the effectiveness of Kin...

  14. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Taos, NM, Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the EPA arsenic removal technology demonstration project at the Town of Taos in New Mexico. The main objective of the project was to evaluate the effectiveness of Severn Trent Services’ (STS) SORB 33™ ad...

  15. Arsenic Removal from Drinking Water by Coagulation/Filtration - U.S. EPA Demonstration Project at Town of Arnaudville, LA - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed during and the results obtained from the arsenic removal treatment technology demonstration project at the United Water Systems’ facility in Arnaudville, LA. The objectives of the project were to evaluate: (1) the effectiveness of K...

  16. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Woodstock Middle School in Woodstock, CT - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed for and the results obtained from the arsenic removal treatment technology demonstration project at the Woodstock Middle School in Woodstock, CT. The objectives of the project were to evaluate the effectiveness of Adsorbsia™ GTO™ me...

  17. Arsenic Removal from Drinking Water by Coagulation/Filtration, U.S. EPA Demonstration Project at the City of Okanogan, WA - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed during and the results obtained from the arsenic removal treatment technology demonstration project at the City of Okanogan, WA facility. The objectives of the project were to evaluate: (1) the effectiveness of Filtronics’ FH-13 Ele...

  18. ARSENIC REMOVAL FROM DRINKING WATER BY PROCESS MODIFICATION TO COAGULATION/FILTRATION. USEPA DEMONSTRATION PROJECT AT LIDGERWOOD, ND. FINAL PERFORMANCE EVALUATION REPORT

    Science.gov (United States)

    This report documents the activities performed and the results obtained for the arsenic removal treatment technology demonstration project at the Lidgerwood, North Dakota site. The objectives of the project were to evaluate: (1) the effectiveness of process modifications to an e...

  19. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Seely-Brown Village in Pomfret, CT - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed for and the results obtained from the arsenic removal treatment technology demonstration project at Seely-Brown Village in Pomfret, CT. The objectives of the project were to evaluate the effectiveness of ArsenXnp adsorption media in...

  20. Arsenic Removal from Drinking Water by Adsorptive Media - U.S. EPA Demonstration Project at Geneseo Hills Subdivision, in Geneseo, IL Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the arsenic removal treatment technology demonstration project at the Geneseo Hills Subdivision in Geneseo, IL. The main objective of the project was to evaluate the effectiveness of AdEdge Technologies...

  1. Arsenic Removal from Drinking Water by Iron Removal and Adsorptive Media U.S. EPA Demonstration Project at Stewart, MN, Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed and the results obtained from the one-year U.S. Environmental Protection Agency (EPA) arsenic removal technology demonstration project at the Stewart, MN facility. The main objective of the project was to evaluate the effectiveness ...

  2. Development and evaluation of the performance of a computer program for the quality control of radioligant assays, application to the radioassay of insulin

    International Nuclear Information System (INIS)

    Mesquita, C.H. de.

    1983-01-01

    A computer program was developed to evaluate several parameters of in radioligant assays. The program was written in FORTRAN-IV having a modular structure. The present version is designed to compute a number of parameters pertinent to the activities of the radioassays. The standard curve is fitted to the empirical model which has four parameters following Marquardt i-iterative scheme. The curve is weighted according to Rodbard criterion. The mini mum detectable dose (MDD) is estimated by a criterion which considers the standard deviation of the experimental data measured with respect to the zero concentration, theoretically computed by the power function. This function considers the standard deviations of all samples and standards being assayed. The Scatchard plot is drawn for one binding component, but it is suitable for up to five components including that nonspecific and non saturated one. The specific activity is computed by the self-displacement method including the corrections suggested by Morris. The computer program processes data pertinent to the thermodynamic analysis through the incubation temperature and its respective reaction affinity constant 'K'. Starting from the estimated enthalpy and entropy of the reaction, the program produces theoretical standard curves for any level of incubation temperature. This allows the analyst to select the interval which best attends the dosage needs. Other general data pertinent to the radioisotope methodology can also be processed by the present program, such as radiochromatogram analysis chi-square test and the estimate the error during the procedures of pipetting. In order to demonstrate the use and the quality of the informations given by the program, a radioimmunoassay of insulin was carried out. The results obtained are in good agreement with those found in the literature. (Author) [pt

  3. Enzyme-linked immunosorbent assay and polymerase chain reaction performance using Mexican and Guatemalan discrete typing unit I strains of Trypanosoma cruzi.

    Science.gov (United States)

    Ballinas-Verdugo, Martha; Reyes, Pedro Antonio; Mejia-Dominguez, Ana; López, Ruth; Matta, Vivian; Monteón, Victor M

    2011-12-01

    Thirteen Trypanosoma cruzi isolates from different geographic regions of Mexico and Guatemala belonging to discrete typing unit (DTU) I and a reference CL-Brener (DTU VI) strain were used to perform enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR). A panel of 57 Mexican serum samples of patients with chronic chagasic cardiopathy and asymptomatic infected subjects (blood bank donors) were used in this study. DNA from the above 14 T. cruzi strains were extracted and analyzed by PCR using different sets of primers designed from minicircle and satellite T. cruzi DNA. The chronic chagasic cardiopathy serum samples were easily recognized with ELISA regardless of the source of antigenic extract used, even with the CL-Brener TcVI, but positive serum samples from blood bank donors in some cases were not recognized by some Mexican antigenic extracts. On the other hand, PCR showed an excellent performance despite the set of primers used, since all Mexican and Guatemalan T. cruzi strains were correctly amplified. In general terms, Mexican, Guatemalan, and CL-Brener T. cruzi strains are equally good sources of antigen when using the ELISA test to detect Mexican serum samples. However, there are some strains with poor performance. The DTU I strains are easily detected using either kinetoplast or satellite DNA target designed from DTU VI strains.

  4. FLUIDICS DEVICE FOR ASSAY

    DEFF Research Database (Denmark)

    2007-01-01

    The present invention relates to a device for use in performing assays on standard laboratory solid supports whereon chemical entities are attached. The invention furthermore relates to the use of such a device and a kit comprising such a device. The device according to the present invention is a...

  5. Principles of validation of diagnostic assays for infectious diseases

    International Nuclear Information System (INIS)

    Jacobson, R.H.

    1998-01-01

    Assay validation requires a series of inter-related processes. Assay validation is an experimental process: reagents and protocols are optimized by experimentation to detect the analyte with accuracy and precision. Assay validation is a relative process: its diagnostic sensitivity and diagnostic specificity are calculated relative to test results obtained from reference animal populations of known infection/exposure status. Assay validation is a conditional process: classification of animals in the target population as infected or uninfected is conditional upon how well the reference animal population used to validate the assay represents the target population; accurate predictions of the infection status of animals from test results (PV+ and PV-) are conditional upon the estimated prevalence of disease/infection in the target population. Assay validation is an incremental process: confidence in the validity of an assay increases over time when use confirms that it is robust as demonstrated by accurate and precise results; the assay may also achieve increasing levels of validity as it is upgraded and extended by adding reference populations of known infection status. Assay validation is a continuous process: the assay remains valid only insofar as it continues to provide accurate and precise results as proven through statistical verification. Therefore, the work required for validation of diagnostic assays for infectious diseases does not end with a time-limited series of experiments based on a few reference samples rather, to assure valid test results from an assay requires constant vigilance and maintenance of the assay, along with reassessment of its performance characteristics for each unique population of animals to which it is applied. (author)

  6. Analytical Performance of Four Polymerase Chain Reaction (PCR and Real Time PCR (qPCR Assays for the Detection of Six Leishmania Species DNA in Colombia

    Directory of Open Access Journals (Sweden)

    Cielo M. León

    2017-10-01

    Full Text Available Leishmaniasis comprises a spectrum of parasitic diseases caused by protozoans of the genus Leishmania. Molecular tools have been widely employed for the detection of Leishmania due to its high sensitivity and specificity. However, the analytical performance of molecular platforms as PCR and real time PCR (qPCR including a wide variety of molecular markers has never been evaluated. Herein, the aim was to evaluate the analytical performance of 4 PCR-based assays (designed on four different targets and applied on conventional and real-time PCR platforms. We evaluated the analytical performance of conventional PCR and real time PCR, determining exclusivity and inclusivity, Anticipated Reportable Range (ARR, limit of detection (LoD and accuracy using primers directed to kDNA, HSP70, 18S and ITS-1 targets. We observed that the kDNA was the most sensitive but does not meet the criterion of exclusivity. The HSP70 presented a higher LoD in conventional PCR and qPCR in comparison with the other markers (1 × 101 and 1 × 10-1 equivalent parasites/mL respectively and had a higher coefficient of variation in qPCR. No statistically significant differences were found between the days of the test with the four molecular markers. The present study revealed that the 18S marker presented the best performance in terms of analytical sensitivity and specificity for the qPCR in the species tested (species circulating in Colombia. Therefore, we recommend to explore the analytical and diagnostic performance in future studies using a broader number of species across America.

  7. Analytical Performance of Four Polymerase Chain Reaction (PCR) and Real Time PCR (qPCR) Assays for the Detection of Six Leishmania Species DNA in Colombia

    Science.gov (United States)

    León, Cielo M.; Muñoz, Marina; Hernández, Carolina; Ayala, Martha S.; Flórez, Carolina; Teherán, Aníbal; Cubides, Juan R.; Ramírez, Juan D.

    2017-01-01

    Leishmaniasis comprises a spectrum of parasitic diseases caused by protozoans of the genus Leishmania. Molecular tools have been widely employed for the detection of Leishmania due to its high sensitivity and specificity. However, the analytical performance of molecular platforms as PCR and real time PCR (qPCR) including a wide variety of molecular markers has never been evaluated. Herein, the aim was to evaluate the analytical performance of 4 PCR-based assays (designed on four different targets) and applied on conventional and real-time PCR platforms. We evaluated the analytical performance of conventional PCR and real time PCR, determining exclusivity and inclusivity, Anticipated Reportable Range (ARR), limit of detection (LoD) and accuracy using primers directed to kDNA, HSP70, 18S and ITS-1 targets. We observed that the kDNA was the most sensitive but does not meet the criterion of exclusivity. The HSP70 presented a higher LoD in conventional PCR and qPCR in comparison with the other markers (1 × 101 and 1 × 10-1 equivalent parasites/mL respectively) and had a higher coefficient of variation in qPCR. No statistically significant differences were found between the days of the test with the four molecular markers. The present study revealed that the 18S marker presented the best performance in terms of analytical sensitivity and specificity for the qPCR in the species tested (species circulating in Colombia). Therefore, we recommend to explore the analytical and diagnostic performance in future studies using a broader number of species across America. PMID:29046670

  8. Comparison of In-Vitro and Ex-Vivo Wound Healing Assays for the Investigation of Diabetic Wound Healing and Demonstration of a Beneficial Effect of a Triterpene Extract.

    Directory of Open Access Journals (Sweden)

    Christopher Ueck

    Full Text Available Diabetes mellitus is a frequent cause for chronic, difficult-to-treat wounds. New therapies for diabetic wounds are urgently needed and in-vitro or ex-vivo test systems are essential for the initial identification of new active molecules. The aim of this study is to compare in-vitro and ex-vivo test systems for their usability for early drug screening and to investigate the efficacy of a birch bark triterpene extract (TE that has been proven ex-vivo and clinically to accelerate non-diabetic wound healing (WH, in a diabetic context. We investigated in-vitro models for diabetic WH, i.e. scratch assays with human keratinocytes from diabetic donors or cultured under hyperglycaemic conditions and a newly developed porcine ex-vivo hyperglycaemic WH model for their potential to mimic delayed diabetic WH and for the influence of TE in these test systems. We show that keratinocytes from diabetic donors often fail to exhibit significantly delayed WH. For cells under hyperglycaemic conditions significant decrease is observed but is influenced by choice of medium and presence of supplements. Also, donor age plays a role. Interestingly, hyperglycaemic effects are mainly hyperosmolaric effects in scratch assays. Ex-vivo models under hyperglycaemic conditions show a clear and substantial decrease of WH, and here both glucose and hyperosmolarity effects are involved. Finally, we provide evidence that TE is also beneficial for ex-vivo hyperglycaemic WH, resulting in significantly increased length of regenerated epidermis to 188±16% and 183±11% (SEM; p<0.05 compared to controls when using two different TE formulations. In conclusion, our results suggest that microenvironmental influences are important in WH test systems and that therefore the more complex hyperglycaemic ex-vivo model is more suitable for early drug screening. Limitations of the in-vitro and ex-vivo models are discussed. Furthermore our data recommend TE as a promising candidate for in

  9. Minimal_Set_of_In_Vitro_ER_Agonist_Assays_Selection_RegToxPharm_Data

    Data.gov (United States)

    U.S. Environmental Protection Agency — A dataset for the manuscript which demonstrates that it is possible to achieve levels of performance equivalent to the full 16 assay ER agonist model against both in...

  10. Effect-directed fingerprints of 77 botanical extracts via a generic high-performance thin-layer chromatography method combined with assays and mass spectrometry.

    Science.gov (United States)

    Krüger, S; Hüsken, L; Fornasari, R; Scainelli, I; Morlock, G E

    2017-12-22

    Quantitative effect-directed profiles of 77 industrially and freshly extracted botanicals like herbs, spices, vegetables and fruits, widely used as food ingredients, dietary supplements or traditional medicine, gave relevant information on their quality. It allows the assessment of food, dietary supplements and phytomedicines with regard to potential health-promoting activities. In contrary to sum parameter assays and targeted analysis, chromatography combined with effect-directed analysis allows fast assignment of single active compounds and evaluation of their contribution to the overall activity, originating from a food or botanical sample. High-performance thin-layer chromatography was hyphenated with UV/Vis/FLD detection and effect-directed analysis, using the 2,2-diphenyl-1-picrylhydrazyl radical, Gram-negative Aliivibrio fischeri, Gram-positive Bacillus subtilis, acetylcholinesterase and tyrosinase assays. Bioactive compounds of interest were eluted using an elution head-based interface and further characterized by electrospray ionization (high-resolution) mass spectrometry. This highly streamlined workflow resulted in a hyphenated HPTLC-UV/Vis/FLD-EDA-ESI + /ESI - -(HR)MS method. The excellent quantification power of the method was shown on three compounds. For rosmarinic acid, contents ranged from 4.5mg/g (rooibos) to 32.6mg/g (rosemary), for kaempferol-3-glucoside from 0.6mg/g (caraway) to 4.4mg/g (wine leaves), and for quercetin-3-glucoside from 1.1mg/g (hawthorn leaves) to 17.7mg/g (thyme). Three mean repeatabilities (%RSD) over 18 quantifications for the three compounds were ≤2.2% and the mean intermediate precision over three different days (%RSD, n=3) was 5.2%. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Tested Demonstrations.

    Science.gov (United States)

    Gilbert, George L.

    1983-01-01

    An apparatus is described in which effects of pressure, volume, and temperature changes on a gas can be observed simultaneously. Includes use of the apparatus in demonstrating Boyle's, Gay-Lussac's, and Charles' Laws, attractive forces, Dalton's Law of Partial pressures, and in illustrating measurable vapor pressures of liquids and some solids.…

  12. Tested Demonstrations.

    Science.gov (United States)

    Gilbert, George L., Ed.

    1987-01-01

    Describes two demonstrations to illustrate characteristics of substances. Outlines a method to detect the changes in pH levels during the electrolysis of water. Uses water pistols, one filled with methane gas and the other filled with water, to illustrate the differences in these two substances. (TW)

  13. Rover waste assay system

    Energy Technology Data Exchange (ETDEWEB)

    Akers, D.W.; Stoots, C.M.; Kraft, N.C.; Marts, D.J. [Idaho National Engineering Lab., Idaho Falls, ID (United States)

    1997-11-01

    The Rover Waste Assay System (RWAS) is a nondestructive assay system designed for the rapid assay of highly-enriched {sup 235}U contaminated piping, tank sections, and debris from the Rover nuclear rocket fuel processing facility at the Idaho Chemical Processing Plant. A scanning system translates a NaI(Tl) detector/collimator system over the structural components where both relative and calibrated measurements for {sup 137}Cs are made. Uranium-235 concentrations are in operation and is sufficiently automated that most functions are performed by the computer system. These functions include system calibration, problem identification, collimator control, data analysis, and reporting. Calibration of the system was done through a combination of measurements on calibration standards and benchmarked modeling. A description of the system is presented along with the methods and uncertainties associated with the calibration and analysis of the system for components from the Rover facility. 4 refs., 2 figs., 4 tabs.

  14. Rover waste assay system

    International Nuclear Information System (INIS)

    Akers, D.W.; Stoots, C.M.; Kraft, N.C.; Marts, D.J.

    1997-01-01

    The Rover Waste Assay System (RWAS) is a nondestructive assay system designed for the rapid assay of highly-enriched 235 U contaminated piping, tank sections, and debris from the Rover nuclear rocket fuel processing facility at the Idaho Chemical Processing Plant. A scanning system translates a NaI(Tl) detector/collimator system over the structural components where both relative and calibrated measurements for 137 Cs are made. Uranium-235 concentrations are in operation and is sufficiently automated that most functions are performed by the computer system. These functions include system calibration, problem identification, collimator control, data analysis, and reporting. Calibration of the system was done through a combination of measurements on calibration standards and benchmarked modeling. A description of the system is presented along with the methods and uncertainties associated with the calibration and analysis of the system for components from the Rover facility. 4 refs., 2 figs., 4 tabs

  15. Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test.

    Science.gov (United States)

    Kim, Hanah; Hur, Mina; Bae, Eunsin; Lee, Kyung-A; Lee, Woo-In

    2018-02-19

    Hepatitis B virus (HBV) nucleic acid amplification testing (NAAT) is important for the diagnosis and management of HBV infection. We evaluated the analytical performance of the cobas HBV NAAT (Roche Diagnostics GmbH, Mannheim, Germany) on the cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test (CAP/CTM HBV). Precision was evaluated using three levels of cobas HBV/HCV/HIV-1 Control Kit, and linearity was evaluated across the anticipated measuring range (10.0-1.0×109 IU/mL) at seven levels using clinical samples. Detection capability, including limit of blank (LOB), limit of detection (LOD) and limit of quantitation (LOQ), was verified using the 4th WHO International Standard for HBV DNA for NAT (NIBSC code: 10/266). Correlation between the two systems was compared using 205 clinical samples (102 sera and 103 EDTA plasma). Repeatability and total imprecision (coefficient of variation) ranged from 0.5% to 3.8% and from 0.5% to 3.5%, respectively. Linearity (coefficient of determination, R2) was 0.999. LOB, LOD and LOQ were all acceptable within the observed proportion rate (85%). Correlation was very high between the two systems in both serum and plasma samples (correlation coefficient [r]=0.995). The new cobas HBV real-time PCR assay on the cobas 4800 System showed reliable analytical performances.

  16. Assay method and compositions

    International Nuclear Information System (INIS)

    1977-01-01

    Methods are described for measuring catecholamine levels in human and animal body fluids and tissues using the catechol-O-methyl-transferase (COMT) radioassay. The assay involves incubating the biological sample with COMT and the tritiated methyl donor, S-adenosyl-L-methionine( 3 H)-methyl. The O-methylated ( 3 H) epinephrine and/or norepinephrine are extracted and oxidised to vanillin- 3 H which in turn is extracted and its radioactivity counted. When analysing dopamine levels the assay is extended by vanillin- 3 H and raising the pH of the aqueous periodate phase from which O-methylated ( 3 H) dopamine is extracted and counted. The assay may be modified depending on whether measurements of undifferentiated total endogenous catecholamine levels or differential analyses of the catecholamine levels are being performed. The sensitivity of the assay can be as low as 5 picograms for norepinephrine and epinephrine and 12 picograms for dopamine. The assemblance of the essential components of the assay into a kit for use in laboratories is also described. (U.K.)

  17. Performance and diagnostic usefulness of commercially available enzyme linked immunosorbent assay and rapid kits for detection of HIV, HBV and HCV in India.

    Science.gov (United States)

    Maity, Susmita; Nandi, Srijita; Biswas, Subrata; Sadhukhan, Salil Kumar; Saha, Malay Kumar

    2012-11-26

    HIV, HBV and HCV pose a major public health problem throughout the world. Detection of infection markers for these agents is a major challenge for testing laboratories in a resource poor setting. As blood transfusion is an important activity saving millions of live every year, it also carries a risk of transfusion transmissible infections caused by these fatal blood borne pathogens if the quality of testing is compromised. Conventional ELISA is regarded as the mostly used screening technique but due to limitations like high cost, unavailability in many blood banks and testing sites, involvement of costly instruments, time taking nature and requirement of highly skilled personnel for interpretation, rapid tests are gaining more importance and warrants comparison of performance. A comparative study between these two techniques has been performed using commercially available diagnostic kits to assess their efficacy for detection of HIV, HBV and HCV infections. Rapid kits were more efficient in specificity with synthetic antigens along with high PPV than ELISA in most cases. Comparison between different ELISA kits revealed that Microlisa HIV and Hepalisa (J. Mitra & Co. Pvt. Ltd.); ERBA LISA HIV1 + 2, ERBA LISA Hepatitis B and ERBA LISA HCV (Transasia Bio-medicals Ltd.) gives uniform result with good performance in terms of sensitivity, specificity, PPV, NPV and efficiency, whereas, Microlisa HCV (J. Mitra & Co. Pvt. Ltd.), Microscreen HBsAg ELISA and INNOVA HCV (Span Diagnostics Ltd.) did not perform well. Rapid kits were also having high degree of sensitivity and specificity (100%) except in HIV Comb and HCV Comb (J. Mitra & Co. Pvt. Ltd.). The kit efficiency didn't vary significantly among different companies and lots in all the cases except for HCV ELISA showing statistically significant variation (p bank. For availability of quality commercial diagnostic assays, evaluation of kit may be helpful.

  18. Diagnostic performance of a novel loop-mediated isothermal amplification (LAMP) assay targeting the apicoplast genome for malaria diagnosis in a field setting in sub-Saharan Africa.

    Science.gov (United States)

    Oriero, Eniyou C; Okebe, Joseph; Jacobs, Jan; Van Geertruyden, Jean-Pierre; Nwakanma, Davis; D'Alessandro, Umberto

    2015-10-09

    New diagnostic tools to detect reliably and rapidly asymptomatic and low-density malaria infections are needed as their treatment could interrupt transmission. Isothermal amplification techniques are being explored for field diagnosis of malaria. In this study, a novel molecular tool (loop-mediated isothermal amplification-LAMP) targeting the apicoplast genome of Plasmodium falciparum was evaluated for the detection of asymptomatic malaria-infected individuals in a rural setting in The Gambia. A blood was collected from 341 subjects (median age 9 years, range 1-68 years) screened for malaria. On site, a rapid diagnostic test (RDT, SD Bioline Malaria Antigen P.f) was performed, thick blood films (TBF) slides for microscopy were prepared and dry blood spots (DBS) were collected on Whatman(®) 903 Specimen collection paper. The TBF and DBS were transported to the field laboratory where microscopy and LAMP testing were performed. The latter was done on DNA extracted from the DBS using a crude (methanol/heating) extraction method. A laboratory-based PCR amplification was done on all the samples using DNA extracted with the Qiagen kit and its results were taken as reference for all the other tests. Plasmodium falciparum malaria prevalence was 37 % (127/341) as detected by LAMP, 30 % (104/341) by microscopy and 37 % (126/341) by RDT. Compared to the reference PCR method, sensitivity was 92 % for LAMP, 78 % for microscopy, and 76 % for RDT; specificity was 97 % for LAMP, 99 % for microscopy, and 88 % for RDT. Area under the receiver operating characteristic (ROC) curve in comparison with the reference standard was 0.94 for LAMP, 0.88 for microscopy and 0.81 for RDT. Turn-around time for the entire LAMP assay was approximately 3 h and 30 min for an average of 27 ± 9.5 samples collected per day, compared to a minimum of 10 samples an hour per operator by RDT and over 8 h by microscopy. The LAMP assay could produce reliable results the same day of the screening. It could

  19. Analytical and clinical performance of the Hologic Aptima HCV Quant Dx Assay for the quantification of HCV RNA in plasma samples

    DEFF Research Database (Denmark)

    Schønning, Kristian; Pedersen, Martin Schou; Johansen, Kim

    2017-01-01

    obtained from 13 patients undergoing treatment with DAAs. RESULTS: Deming regression of results from 187 plasma samples with HCV RNA >2 Log IU/mL indicated that the Aptima assay quantified higher than the CAPCTMv2 test for HCV RNA >4.9 Log IU/mL. The linearity of the Aptima assay was excellent across...

  20. On the safety and performance demonstration tests of Prototype Gen-IV Sodium-Cooled Fast Reactor and validation and verification of computational codes

    International Nuclear Information System (INIS)

    Kim, Jong Bum; Jeong, Ji Young; Lee, Tae Ho; Kim, Sung Kyun; Euh, Dong Jin; Joo, Hyung Kook

    2016-01-01

    The design of Prototype Gen-IV Sodium-Cooled Fast Reactor (PGSFR) has been developed and the validation and verification (V and V) activities to demonstrate the system performance and safety are in progress. In this paper, the current status of test activities is described briefly and significant results are discussed. The large-scale sodium thermal-hydraulic test program, Sodium Test Loop for Safety Simulation and Assessment-1 (STELLA-1), produced satisfactory results, which were used for the computer codes V and V, and the performance test results of the model pump in sodium showed good agreement with those in water. The second phase of the STELLA program with the integral effect tests facility, STELLA-2, is in the detailed design stage of the design process. The sodium thermal-hydraulic experiment loop for finned-tube sodium-to-air heat exchanger performance test, the intermediate heat exchanger test facility, and the test facility for the reactor flow distribution are underway. Flow characteristics test in subchannels of a wire-wrapped rod bundle has been carried out for safety analysis in the core and the dynamic characteristic test of upper internal structure has been performed for the seismic analysis model for the PGSFR. The performance tests for control rod assemblies (CRAs) have been conducted for control rod drive mechanism driving parts and drop tests of the CRA under scram condition were performed. Finally, three types of inspection sensors under development for the safe operation of the PGSFR were explained with significant results

  1. On the safety and performance demonstration tests of Prototype Gen-IV Sodium-Cooled Fast Reactor and validation and verification of computational codes

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Jong Bum; Jeong, Ji Young; Lee, Tae Ho; Kim, Sung Kyun; Euh, Dong Jin; Joo, Hyung Kook [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    The design of Prototype Gen-IV Sodium-Cooled Fast Reactor (PGSFR) has been developed and the validation and verification (V and V) activities to demonstrate the system performance and safety are in progress. In this paper, the current status of test activities is described briefly and significant results are discussed. The large-scale sodium thermal-hydraulic test program, Sodium Test Loop for Safety Simulation and Assessment-1 (STELLA-1), produced satisfactory results, which were used for the computer codes V and V, and the performance test results of the model pump in sodium showed good agreement with those in water. The second phase of the STELLA program with the integral effect tests facility, STELLA-2, is in the detailed design stage of the design process. The sodium thermal-hydraulic experiment loop for finned-tube sodium-to-air heat exchanger performance test, the intermediate heat exchanger test facility, and the test facility for the reactor flow distribution are underway. Flow characteristics test in subchannels of a wire-wrapped rod bundle has been carried out for safety analysis in the core and the dynamic characteristic test of upper internal structure has been performed for the seismic analysis model for the PGSFR. The performance tests for control rod assemblies (CRAs) have been conducted for control rod drive mechanism driving parts and drop tests of the CRA under scram condition were performed. Finally, three types of inspection sensors under development for the safe operation of the PGSFR were explained with significant results.

  2. Quantification of imatinib in human serum: validation of a high-performance liquid chromatography-mass spectrometry method for therapeutic drug monitoring and pharmacokinetic assays.

    Science.gov (United States)

    Rezende, Vinicius Marcondes; Rivellis, Ariane; Novaes, Mafalda Megumi Yoshinaga; de Alencar Fisher Chamone, Dalton; Bendit, Israel

    2013-01-01

    Imatinib mesylate has been a breakthrough treatment for chronic myeloid leukemia. It has become the ideal tyrosine kinase inhibitor and the standard treatment for chronic-phase leukemia. Striking results have recently been reported, but intolerance to imatinib and noncompliance with treatment remain to be solved. Molecular monitoring by quantitative real-time polymerase chain reaction is the gold standard for monitoring patients, and imatinib blood levels have also become an important tool for monitoring. A fast and cheap method was developed and validated using high-performance liquid chromatography-mass spectrometry for quantification of imatinib in human serum and tamsulosin as the internal standard. Remarkable advantages of the method includes use of serum instead of plasma, less time spent on processing and analysis, simpler procedures, and requiring reduced amounts of biological material, solvents, and reagents. Stability of the analyte was also studied. This research also intended to drive the validation scheme in clinical centers. The method was validated according to the requirements of the US Food and Drug Administration and Brazilian National Health Surveillance Agency within the range of 0.500-10.0 μg/mL with a limit of detection of 0.155 μg/mL. Stability data for the analyte are also presented. Given that the validated method has proved to be linear, accurate, precise, and robust, it is suitable for pharmacokinetic assays, such as bioavailability and bioequivalence, and is being successfully applied in routine therapeutic drug monitoring in the hospital service.

  3. High-performance liquid chromatography assay using ultraviolet detection for urinary quantification of milrinone concentrations in cardiac surgery patients undergoing cardiopulmonary bypass.

    Science.gov (United States)

    Gavra, Paul; Nguyen, Anne Q N; Beauregard, Natasha; Denault, André Y; Varin, France

    2014-08-01

    An analytical assay using liquid-liquid extraction and high-performance liquid chromatography with ultraviolet detection was developed for the quantification of total (conjugated and unconjugated) urinary concentrations of milrinone after the inhalation of a 5 mg dose in 15 cardiac patients undergoing cardiopulmonary bypass. Urine samples (700 μL) were extracted with ethyl-acetate and subsequently underwent acid back-extraction before and after deconjugation by mild acid hydrolysis. Milrinone was separated on a strong cation exchange analytical column. The mobile phase consisted of a constant mixture of acetonitrile:tetrahydrofurane-NaH2 PO4 buffer (40:60 v/v, pH 3.0). Thirteen calibration curves were linear in the concentration range of 31.25-4000 ng/mL, using olprinone as the internal standard (r(2) range 0.9911-0.9999, n = 13). Mean milrinone recovery and accuracy were respectively 85.2 ± 3.1% and ≥93%. Intra- and inter-day precisions (coefficients of variation) were ≤5% and ≤8%, respectively. Over a 24 h collection period, the cumulative urinary milrinone recovered from 15 patients was 26.1 ± 7.7% of the nominal 5 mg dose administered. The relative amount of milrinone glucuronic acid conjugate was negligible in the urine of patients undergoing cardiopulmonary bypass This method proved to be reliable, specific and accurate to determine the cumulative amount of total milrinone recovered in urine after inhalation. Copyright © 2014 John Wiley & Sons, Ltd.

  4. Assay of common sunscreen agents in suncare products by high-performance liquid chromatography on a cyanopropyl-bonded silica column.

    Science.gov (United States)

    Simeoni, Silvia; Tursilli, Rosanna; Bianchi, Anna; Scalia, Santo

    2005-06-15

    A rapid high-performance liquid chromatographic method was developed for the simultaneous assay of eight of the most common sunscreen agents (octyl-methoxycinnamate, oxybenzone, butyl-methoxydibenzoylmethane, octyl-salicilate, methylbenzylidene camphor, octyl-dimethylamminobenzoate, phenylbenzimidazole sulphonic acid and octocrylene) in sun protection products. Evaluation of the influence of different stationary phases and eluents on the separation selectivity showed that optimal resolution was obtained on a cyanopropyl-silica column eluted with methanol-acetonitrile-tetrahydrofuran-aqueous acetic acid. A small adjustment of the proposed chromatographic system (reduction in the aqueous content of the mobile phase) permitted also the determination of the extremely hydrophobic UV filter, methylene bis-benzotriazolyl tetramethylbutylphenol along with three other sunscreen agents, octyl-methoxycinnamate, oxybenzone, butyl-methoxydibenzoylmethane. Recoveries of the UV filters from the spiked formulation were between 95.7 and 103.7% and the precision of the method was better than 6.1% relative standard deviation. The developed HPLC procedure is suitable for quality control and photostability analyses of commercial suncare products.

  5. Comparative performance of PCR-based assay versus microscopy and culture for the direct detection of Mycobacterium tuberculosis in clinical respiratory specimens in Lebanon.

    Science.gov (United States)

    Araj, G F; Talhouk, R S; Itani, L Y; Jaber, W; Jamaleddine, G W

    2000-09-01

    American University of Beirut Medical Center, Lebanon. To assess the performance of a polymerase chain reaction (PCR) using primers that flank 542 bp within IS6110 in Mycobacterium tuberculosis (TB) vs. microscopy and BACTEC culture, in the diagnosis of tuberculosis. A total of 82 clinical respiratory pulmonary specimens and 73 samples from BACTEC vials were tested by the three methods. Of 24 smear-positive culture-positive (SP-CP) and 11 smear-negative culture-positive (SN-CP) TB specimens, PCR detected 83% and 64%, respectively. Among 17 specimens yielding mycobacteria other than tuberculosis (MOTT), the PCR was positive in 33% SP-CP and 14% SN-CP specimens. Among the 73 BACTEC vials, PCR was positive in 36 of 38 (95%) yielding culture-positive TB, and in one of 20 (5%) yielding culture positive MOTT. None of the 30 smear-negative culture-negative (SN-CN) clinical specimens and 15 of the CN vials were positive by PCR. The overall sensitivity of PCR was 77% and 95% for TB detection in respiratory specimens and BACTEC vials, respectively, and the specificity was 94% in both. Because a substantial number of TB cases are missed, especially in SN-CP specimens, a PCR-based assay utilizing these primers cannot be used reliably, alone, in clinical laboratory diagnosis of mycobacterial respiratory infections.

  6. Performance of a RT-PCR Assay in Comparison to FISH and Immunohistochemistry for the Detection of ALK in Non-Small Cell Lung Cancer.

    Science.gov (United States)

    Hout, David R; Schweitzer, Brock L; Lawrence, Kasey; Morris, Stephan W; Tucker, Tracy; Mazzola, Rosetta; Skelton, Rachel; McMahon, Frank; Handshoe, John; Lesperance, Mary; Karsan, Aly; Saltman, David L

    2017-08-01

    Patients with lung cancers harboring an activating anaplastic lymphoma kinase ( ALK ) rearrangement respond favorably to ALK inhibitor therapy. Fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) are validated and widely used screening tests for ALK rearrangements but both methods have limitations. The ALK RGQ RT-PCR Kit (RT-PCR) is a single tube quantitative real-time PCR assay for high throughput and automated interpretation of ALK expression. In this study, we performed a direct comparison of formalin-fixed paraffin-embedded (FFPE) lung cancer specimens using all three ALK detection methods. The RT-PCR test (diagnostic cut-off Δ C t of ≤8) was shown to be highly sensitive (100%) when compared to FISH and IHC. Sequencing of RNA detected full-length ALK transcripts or EML4-ALK and KIF5B-ALK fusion variants in discordant cases in which ALK expression was detected by the ALK RT-PCR test but negative by FISH and IHC. The overall specificity of the RT-PCR test for the detection of ALK in cases without full-length ALK expression was 94% in comparison to FISH and sequencing. These data support the ALK RT-PCR test as a highly efficient and reliable diagnostic screening approach to identify patients with non-small cell lung cancer whose tumors are driven by oncogenic ALK.

  7. Intramolecular cyclization in irradiated nucleic acids: correlation between high-performance liquid chromatography and an immunochemical assay for 8,5'-cycloadenosine in irradiated poly(A)

    International Nuclear Information System (INIS)

    Fuciarelli, A.F.; Shum, F.Y.; Raleigh, J.A.

    1987-01-01

    A correlation between high-performance liquid chromatography (HPLC) analysis and an in situ enzyme-linked immunosorbent assay (ELISA) for 8,5'-cycloadenosine formation in irradiated poly(A) has been established. The correlation shows that the ELISA precisely reflects changes in the combined yield of R- and S-8,5'-cycloadenosine but that a correction factor must be applied to the ELISA values for accuracy. The HPLC analysis reveals that the intramolecular cyclization proceeds stereoselectively in irradiated poly(A) to preferentially produce the R isomer at pH 7.0 which is similar to the result for irradiated adenosine but in contrast to the result for 5'-AMP where the S isomer predominates at neutral pH. The HPLC analysis shows that two events originating in hydroxyl radical attack at the sugar phosphate backbone in poly(A); that is, adenine release and 8,5'-cycloadenosine formation have somewhat different dose-yield responses. The formation of 8-hydroxyadenosine was detected in the HPLC chromatograms of poly(A) irradiated under N2O at neutral pH, and the yield of this compound was similar to the yield observed in 5'-AMP or adenosine irradiated under similar conditions

  8. Clinical performance of LOCI™-based tumor marker assays for tumor markers CA 15-3, CA 125, CEA, CA 19-9 and AFP in gynecological cancers.

    Science.gov (United States)

    Dolscheid-Pommerich, Ramona C; Keyver-Paik, Mignon; Hecking, Thomas; Kuhn, Walther; Hartmann, Gunther; Stoffel-Wagner, Birgit; Holdenrieder, Stefan

    2017-10-01

    Evidence is sparse regarding the clinical performance of luminescent oxygen channeling immunoassays-based tumor marker assays in gynecological cancer. Analyzing serum samples of 336 patients with Dimension™Vista1500, we investigated the diagnostic power of carbohydrate antigen 15-3, carbohydrate antigen 125, carcinoembryonic antigen, carbohydrate antigen 19-9, and alpha-fetoprotein in patients suffering from different types of gynecological cancer and precancerous gynecological diseases and compared findings to appropriate control groups. The cohort comprised 177 female patients with gynecological cancers (73 breast, 22 cervical, 16 endometrial, 17 vulva, and 49 ovarian cancers), 26 patients with precancerous gynecological diseases (11 vulva, 4 cervical, and 10 breast), 109 patients with benign gynecological diseases, and 24 healthy controls. Discriminative power was assessed by areas under the curve in receiver operating characteristic curves, and sensitivities were determined at a fixed specificity of 95%. Levels of biomarkers in healthy controls were in the expected ranges and a discriminative power between gynecological cancers and healthy controls was observed for several tumor markers. Established tumor type-associated markers were elevated in specific gynecological cancers and benign controls as well as within precancerous gynecological diseases and healthy control group. In ovarian cancer, carbohydrate antigen 125 and carbohydrate antigen 15-3 were significantly elevated compared to the respective benign diseases. Carbohydrate antigen 125 was the most conclusive marker (area under the curve = 0.86% and 77.6% sensitivity at 95% specificity). In breast cancer, carcinoembryonic antigen and carbohydrate antigen 15-3 were significantly higher than in the respective benign diseases. Carcinoembryonic antigen achieved the most conclusive area under the curve (0.65) with 31.5% sensitivity at 95% specificity. None of the investigated markers was found to be of

  9. Performance of the Abbott RealTime MTB RIF/INH resistance assay when used to test Mycobacterium tuberculosis specimens from Bangladesh

    Directory of Open Access Journals (Sweden)

    Kostera J

    2018-05-01

    Full Text Available Joshua Kostera, Gregor Leckie, Klara Abravaya, Hong Wang Abbott Molecular, Abbott Laboratories, Des Plaines, IL, USA Introduction: The Abbott RealTime MTB RIF/INH Resistance Assay (RT MTB RIF/INH is an assay for the detection of rifampicin (RIF- and/or isoniazid (INH-resistant Mycobacterium tuberculosis (MTB. The assay can be used to test sputum, bronchial alveolar lavage, and N-Acetyl-L-Cysteine (NALC/NaOH pellets prepared from these samples. The assay can be used in direct testing mode, or in reflex mode following a MTB positive result produced by its companion assay, Abbott RT MTB. Methods: In this study, the direct testing mode was used to test paired sputum and NALC/NaOH pellets prepared from sputum collected from Bangladesh TB patients. One hundred and thirty two paired samples were tested. Results: The RT MTB RIF/INH inhibition rate was 0%. One hundred and twenty-two paired samples had results above the assay limit of detection and were analyzed by comparing with results from phenotypic drug sensitivity testing, GeneXpert MTB/RIF (Xpert, and MTBDR plus (Hain. RT MTB RIF/INH results were in good agreement with those of GeneXpert and Hain. Conclusion: The ability of this assay to detect RIF and INH resistance may contribute to the global control of multidrug resistant tuberculosis. Keywords: tuberculosis, rifampicin, isoniazid, resistance

  10. Quantification of imatinib in human serum: validation of a high-performance liquid chromatography-mass spectrometry method for therapeutic drug monitoring and pharmacokinetic assays

    Directory of Open Access Journals (Sweden)

    Rezende VM

    2013-08-01

    Full Text Available Vinicius Marcondes Rezende,1 Ariane Rivellis,1 Mafalda Megumi Yoshinaga Novaes,1 Dalton de Alencar Fisher Chamone,2 Israel Bendit1,21Laboratory of Tumor Biology, 2Department of Hematology, School of Medicine, University of São Paulo, São Paulo, BrazilBackground: Imatinib mesylate has been a breakthrough treatment for chronic myeloid leukemia. It has become the ideal tyrosine kinase inhibitor and the standard treatment for chronic-phase leukemia. Striking results have recently been reported, but intolerance to imatinib and noncompliance with treatment remain to be solved. Molecular monitoring by quantitative real-time polymerase chain reaction is the gold standard for monitoring patients, and imatinib blood levels have also become an important tool for monitoring.Methods: A fast and cheap method was developed and validated using high-performance liquid chromatography-mass spectrometry for quantification of imatinib in human serum and tamsulosin as the internal standard. Remarkable advantages of the method includes use of serum instead of plasma, less time spent on processing and analysis, simpler procedures, and requiring reduced amounts of biological material, solvents, and reagents. Stability of the analyte was also studied. This research also intended to drive the validation scheme in clinical centers. The method was validated according to the requirements of the US Food and Drug Administration and Brazilian National Health Surveillance Agency within the range of 0.500–10.0 µg/mL with a limit of detection of 0.155 µg/mL. Stability data for the analyte are also presented.Conclusion: Given that the validated method has proved to be linear, accurate, precise, and robust, it is suitable for pharmacokinetic assays, such as bioavailability and bioequivalence, and is being successfully applied in routine therapeutic drug monitoring in the hospital service.Keywords: imatinib, high-performance liquid chromatography-mass spectrometry, therapeutic

  11. Expert system technology for nondestructive waste assay

    International Nuclear Information System (INIS)

    Becker, G.K.; Determan, J.C.

    1998-01-01

    Nondestructive assay waste characterization data generated for use in the National TRU Program must be of known and demonstrable quality. Each measurement is required to receive an independent technical review by a qualified expert. An expert system prototype has been developed to automate waste NDA data review of a passive/active neutron drum counter system. The expert system is designed to yield a confidence rating regarding measurement validity. Expert system rules are derived from data in a process involving data clustering, fuzzy logic, and genetic algorithms. Expert system performance is assessed against confidence assignments elicited from waste NDA domain experts. Performance levels varied for the active, passive shielded, and passive system assay modes of the drum counter system, ranging from 78% to 94% correct classifications

  12. Dual isotope assays

    International Nuclear Information System (INIS)

    Smith, G.F.W.; Stevens, R.A.J.; Jacoby, B.

    1980-01-01

    Dual isotope assays for thyroid function are performed by carrying out a radio-immunoassay for two of thyroxine (T4), tri-iodothyronine (T3), thyroid stimulating hormone (TSH), and thyroxine binding globulin (TBG), by a method wherein a version of one of the thyroid components, preferably T4 or T3 is labelled with Selenium-75 and the version of the other thyroid component is labelled with a different radionuclide, preferably Iodine-125. (author)

  13. On the Safety and Performance Demonstration Tests of Prototype Gen-IV Sodium-Cooled Fast Reactor and Validation and Verification of Computational Codes

    Directory of Open Access Journals (Sweden)

    Jong-Bum Kim

    2016-10-01

    Full Text Available The design of Prototype Gen-IV Sodium-Cooled Fast Reactor (PGSFR has been developed and the validation and verification (V&V activities to demonstrate the system performance and safety are in progress. In this paper, the current status of test activities is described briefly and significant results are discussed. The large-scale sodium thermal-hydraulic test program, Sodium Test Loop for Safety Simulation and Assessment-1 (STELLA-1, produced satisfactory results, which were used for the computer codes V&V, and the performance test results of the model pump in sodium showed good agreement with those in water. The second phase of the STELLA program with the integral effect tests facility, STELLA-2, is in the detailed design stage of the design process. The sodium thermal-hydraulic experiment loop for finned-tube sodium-to-air heat exchanger performance test, the intermediate heat exchanger test facility, and the test facility for the reactor flow distribution are underway. Flow characteristics test in subchannels of a wire-wrapped rod bundle has been carried out for safety analysis in the core and the dynamic characteristic test of upper internal structure has been performed for the seismic analysis model for the PGSFR. The performance tests for control rod assemblies (CRAs have been conducted for control rod drive mechanism driving parts and drop tests of the CRA under scram condition were performed. Finally, three types of inspection sensors under development for the safe operation of the PGSFR were explained with significant results.

  14. Dual-energy CT in vertebral compression fractures: performance of visual and quantitative analysis for bone marrow edema demonstration with comparison to MRI

    International Nuclear Information System (INIS)

    Bierry, Guillaume; Venkatasamy, Aina; Kremer, Stephane; Dosch, Jean-Claude; Dietemann, Jean-Louis

    2014-01-01

    To prospectively evaluate the performance of virtual non-calcium (VNC) dual-energy CT (DECT) images for the demonstration of trauma-related abnormal marrow attenuation in collapsed and non-collapsed vertebral compression fractures (VCF) with MRI as a reference standard. Twenty patients presenting with non-tumoral VCF were consecutively and prospectively included in this IRB-approved study, and underwent MRI and DECT of the spine. MR examination served as a reference standard. Two independent readers visually evaluated all vertebrae for abnormal marrow attenuation (''CT edema'') on VNC DECT images; specificity, sensitivity, predictive values, intra and inter-observer agreements were calculated. A last reader performed a quantitative evaluation of CT numbers; cut-off values were calculated using ROC analysis. In the visual analysis, VNC DECT images had an overall sensitivity of 84 %, specificity of 97 %, and accuracy of 95 %, intra- and inter-observer agreements ranged from k = 0.74 to k = 0.90. CT numbers were significantly different between vertebrae with edema on MR and those without (p < 0.0001). Cut-off values provided sensitivity of 85 % (77 %) and specificity of 82 % (74 %) for ''CT edema'' on thoracic (lumbar) vertebrae. VNC DECT images allowed an accurate demonstration of trauma-related abnormal attenuation in VCF, revealing the acute nature of the fracture, on both visual and quantitative evaluation. (orig.)

  15. Dual-energy CT in vertebral compression fractures: performance of visual and quantitative analysis for bone marrow edema demonstration with comparison to MRI

    Energy Technology Data Exchange (ETDEWEB)

    Bierry, Guillaume; Venkatasamy, Aina; Kremer, Stephane; Dosch, Jean-Claude; Dietemann, Jean-Louis [University Hospital of Strasbourg, Department of Radiology, Strasbourg (France)

    2014-04-15

    To prospectively evaluate the performance of virtual non-calcium (VNC) dual-energy CT (DECT) images for the demonstration of trauma-related abnormal marrow attenuation in collapsed and non-collapsed vertebral compression fractures (VCF) with MRI as a reference standard. Twenty patients presenting with non-tumoral VCF were consecutively and prospectively included in this IRB-approved study, and underwent MRI and DECT of the spine. MR examination served as a reference standard. Two independent readers visually evaluated all vertebrae for abnormal marrow attenuation (''CT edema'') on VNC DECT images; specificity, sensitivity, predictive values, intra and inter-observer agreements were calculated. A last reader performed a quantitative evaluation of CT numbers; cut-off values were calculated using ROC analysis. In the visual analysis, VNC DECT images had an overall sensitivity of 84 %, specificity of 97 %, and accuracy of 95 %, intra- and inter-observer agreements ranged from k = 0.74 to k = 0.90. CT numbers were significantly different between vertebrae with edema on MR and those without (p < 0.0001). Cut-off values provided sensitivity of 85 % (77 %) and specificity of 82 % (74 %) for ''CT edema'' on thoracic (lumbar) vertebrae. VNC DECT images allowed an accurate demonstration of trauma-related abnormal attenuation in VCF, revealing the acute nature of the fracture, on both visual and quantitative evaluation. (orig.)

  16. Dual-energy CT in vertebral compression fractures: performance of visual and quantitative analysis for bone marrow edema demonstration with comparison to MRI.

    Science.gov (United States)

    Bierry, Guillaume; Venkatasamy, Aïna; Kremer, Stéphane; Dosch, Jean-Claude; Dietemann, Jean-Louis

    2014-04-01

    To prospectively evaluate the performance of virtual non-calcium (VNC) dual-energy CT (DECT) images for the demonstration of trauma-related abnormal marrow attenuation in collapsed and non-collapsed vertebral compression fractures (VCF) with MRI as a reference standard. Twenty patients presenting with non-tumoral VCF were consecutively and prospectively included in this IRB-approved study, and underwent MRI and DECT of the spine. MR examination served as a reference standard. Two independent readers visually evaluated all vertebrae for abnormal marrow attenuation ("CT edema") on VNC DECT images; specificity, sensitivity, predictive values, intra and inter-observer agreements were calculated. A last reader performed a quantitative evaluation of CT numbers; cut-off values were calculated using ROC analysis. In the visual analysis, VNC DECT images had an overall sensitivity of 84%, specificity of 97%, and accuracy of 95%, intra- and inter-observer agreements ranged from k = 0.74 to k = 0.90. CT numbers were significantly different between vertebrae with edema on MR and those without (p VNC DECT images allowed an accurate demonstration of trauma-related abnormal attenuation in VCF, revealing the acute nature of the fracture, on both visual and quantitative evaluation.

  17. ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

    Science.gov (United States)

    de Dianous, Valérie; Fiévez, Cécile

    2006-03-31

    Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

  18. New low-viscosity overlay medium for viral plaque assays

    Directory of Open Access Journals (Sweden)

    Garten Wolfgang

    2006-08-01

    Full Text Available Abstract Background Plaque assays in cell culture monolayers under solid or semisolid overlay media are commonly used for quantification of viruses and antiviral substances. To overcome the pitfalls of known overlays, we tested suspensions of microcrystalline cellulose Avicel RC/CL™ as overlay media in the plaque and plaque-inhibition assay of influenza viruses. Results Significantly larger plaques were formed under Avicel-containing media, as compared to agar and methylcellulose (MC overlay media. The plaque size increased with decreasing Avicel concentration, but even very diluted Avicel overlays (0.3% ensured formation of localized plaques. Due to their low viscosity, Avicel overlays were easier to use than methylcellulose overlays, especially in the 96-well culture plates. Furthermore, Avicel overlay could be applied without prior removal of the virus inoculum thus facilitating the assay and reducing chances of cross-contamination. Using neuraminidase inhibitor oseltamivir carboxylate, we demonstrated applicability of the Avicel-based plaque reduction assay for testing of antiviral substances. Conclusion Plaque assay under Avicel-containing overlay media is easier, faster and more sensitive than assays under agar- and methylcellulose overlays. The assay can be readily performed in a 96-well plate format and seems particularly suitable for high-throughput virus titrations, serological studies and experiments on viral drug sensitivity. It may also facilitate work with highly pathogenic agents performed under hampered conditions of bio-safety labs.

  19. Towards a high throughput droplet-based agglutination assay

    KAUST Repository

    Kodzius, Rimantas; Castro, David; Foulds, Ian G.

    2013-01-01

    This work demonstrates the detection method for a high throughput droplet based agglutination assay system. Using simple hydrodynamic forces to mix and aggregate functionalized microbeads we avoid the need to use magnetic assistance or mixing structures. The concentration of our target molecules was estimated by agglutination strength, obtained through optical image analysis. Agglutination in droplets was performed with flow rates of 150 µl/min and occurred in under a minute, with potential to perform high-throughput measurements. The lowest target concentration detected in droplet microfluidics was 0.17 nM, which is three orders of magnitude more sensitive than a conventional card based agglutination assay.

  20. Towards a high throughput droplet-based agglutination assay

    KAUST Repository

    Kodzius, Rimantas

    2013-10-22

    This work demonstrates the detection method for a high throughput droplet based agglutination assay system. Using simple hydrodynamic forces to mix and aggregate functionalized microbeads we avoid the need to use magnetic assistance or mixing structures. The concentration of our target molecules was estimated by agglutination strength, obtained through optical image analysis. Agglutination in droplets was performed with flow rates of 150 µl/min and occurred in under a minute, with potential to perform high-throughput measurements. The lowest target concentration detected in droplet microfluidics was 0.17 nM, which is three orders of magnitude more sensitive than a conventional card based agglutination assay.

  1. Specific high-performance liquid chromatographic assay with ultraviolet detection for the determination of 1-(2-chloroethyl)-3-sarcosinamide-1-nitrosourea in plasma.

    Science.gov (United States)

    Supko, J G; Phillips, L R; Malspeis, L

    1996-03-03

    A facile, sensitive and highly specific HPLC method for assaying 1-(2-chloroethyl)-3-sarcosinamide-1-nitrosourea (SarCNU) in plasma has been developed. The drug was efficiently isolated from plasma by extraction with tert.-butyl methyl ether. A structurally related compound with similar physicochemical properties served as the internal standard (I.S.). Following evaporation of the organic solvent, the extract was reconstituted with 0.05 M ammonium acetate buffer, pH 5.0, and loaded onto a 4 micron Nova-Pak C18 column (15 cm x 3.9 mm), which was preceded by a 7 micron Brownlee RP-18 precolumn (1.5 cm x 3.2 mm). Chromatography was performed at ambient temperature using a mobile phase of methanol-0.1 M ammonium formate buffer, pH 3.7 (25:75, v/v). UV absorbance of the effluent was monitored at 240 nm. A flow-rate of 1.0 ml/ min was used for analyzing mouse and dog plasma extracts. Under these conditions, the drug eluted at 4.0 min and was followed by the I.S. at 6.1 min. An automatic switching valve was employed to allow the precolumn to be flushed 1.5 min into the run, without interrupting the flow of the mobile phase to the analytical column, thereby preventing the apparent build-up of extractable, strongly retained, UV-absorbing components present in mouse and dog plasma. Operating in this manner, more than 100 samples could be analyzed during a day using a refrigerated autosampler for overnight injection. The method was readily adapted to the determination of SarCNU in human plasma by simply decreasing the eluent flow-rate to 0.6 ml/min, whereby SarCNU and the I.S. eluted at approximately 5.8 and 9.1 min, respectively. Furthermore, the switching valve was not necessary for the analysis of human plasma samples. With a 50-microliter sample volume, the lowest concentration of SarCNU included in the plasma standard curves, 0.10 micrograms/ml, was quantified with a 7.8% R.S.D. (n = 27) over a 2 month period. Plasma standards, with concentrations of 0.26 to 5

  2. Industry Application ECCS / LOCA Integrated Cladding/Emergency Core Cooling System Performance: Demonstration of LOTUS-Baseline Coupled Analysis of the South Texas Plant Model

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Hongbin [Idaho National Lab. (INL), Idaho Falls, ID (United States); Szilard, Ronaldo [Idaho National Lab. (INL), Idaho Falls, ID (United States); Epiney, Aaron [Idaho National Lab. (INL), Idaho Falls, ID (United States); Parisi, Carlo [Idaho National Lab. (INL), Idaho Falls, ID (United States); Vaghetto, Rodolfo [Texas A & M Univ., College Station, TX (United States); Vanni, Alessandro [Texas A & M Univ., College Station, TX (United States); Neptune, Kaleb [Texas A & M Univ., College Station, TX (United States)

    2017-06-01

    Under the auspices of the DOE LWRS Program RISMC Industry Application ECCS/LOCA, INL has engaged staff from both South Texas Project (STP) and the Texas A&M University (TAMU) to produce a generic pressurized water reactor (PWR) model including reactor core, clad/fuel design and systems thermal hydraulics based on the South Texas Project (STP) nuclear power plant, a 4-Loop Westinghouse PWR. A RISMC toolkit, named LOCA Toolkit for the U.S. (LOTUS), has been developed for use in this generic PWR plant model to assess safety margins for the proposed NRC 10 CFR 50.46c rule, Emergency Core Cooling System (ECCS) performance during LOCA. This demonstration includes coupled analysis of core design, fuel design, thermalhydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results. Within this context, a multi-physics best estimate plus uncertainty (MPBEPU) methodology framework is proposed.

  3. Wireless Transmission of Monitoring Data out of an Underground Repository: Results of Field Demonstrations Performed at the HADES Underground Laboratory - 13589

    International Nuclear Information System (INIS)

    Schroeder, T.J.; Rosca-Bocancea, E.; Hart, J.

    2013-01-01

    As part of the European 7. framework project MoDeRn, Nuclear Research and Consultancy Group (NRG) performed experiments in order to demonstrate the feasibility of wireless data transmission through the subsurface over large distances by low frequency magnetic fields in the framework of the geological disposal of radioactive waste. The main objective of NRG's contribution is to characterize and optimize the energy use of this technique within the specific context of post-closure monitoring of a repository. For that, measurements have been performed in the HADES Underground Research Laboratory (URL) located at Mol, Belgium, at 225 m depth. The experimental set-up utilizes a loop antenna for the transmitter that has been matched to the existing infrastructure of the HADES. Between 2010 and 2012 NRG carried out several experiments at the HADES URL in order to test the technical set-up and to characterize the propagation behavior of the geological medium and the local background noise pattern. Transmission channels have been identified and data transmission has been demonstrated at several frequencies, with data rates up to 10 bit/s and bit error rates <1%. A mathematical model description that includes the most relevant characteristics of the transmitter, transmission path, and receiver has been developed and applied to analyze possible options to optimize the set-up. With respect to the energy-efficiency, results so far have shown that data transmission over larger distances through the subsurface is a feasible option. To support the conclusions on the energy need per bit of transmitted data, additional experiments are foreseen. (authors)

  4. Diagnostic performance of HPV E6/E7 mRNA assay for detection of cervical high-grade intraepithelial neoplasia and cancer among women with ASCUS Papanicolaou smears.

    Science.gov (United States)

    Ren, Chenchen; Zhu, Yuanhang; Yang, Li; Zhang, Xiaoan; Liu, Ling; Ren, Chunying

    2018-02-01

    The aim of this study was to investigate the clinical performance of high risk (HR) HPV E6/E7 mRNA assay in detecting cervical high-grade intraepithelial neoplasia and cancer among women with atypical squamous cells of undetermined significance (ASCUS) Papanicolaou (Pap) smears. A total of 160 patients with ASCUS who underwent HR-HPV DNA assay, HR-HPV E6/E7 mRNA assay and colposcopy biopsy at Third Affiliated Hospital of Zhengzhou University, China, from December 2015 to March 2017, were enrolled. Logistic regression analysis was used to evaluate the relationship between pathological results with clinical biologic factors. Univariate analysis showed that the qualitative results of HR-HPV DNA, qualitative results of HR-HPV E6/E7 mRNA and expression levels of HR-HPV E6/E7 mRNA were risk factors of high-grade cervical intraepithelial neoplasia (CIN) and cervical cancer (all P HPV E6/E7 mRNA was associated with high-grade CIN and cervical cancer (OR = 8.971, 95% CI = 2.572-31.289, P = 0.001). An optimal cut-off value of ≥ 558.26 copies/ml was determined using receiver operating characteristic curve, and specificity of cut-off value were higher than E6/E7 mRNA qualitative assay and DNA qualitative assay. HPV E6/E7 mRNA quantitative assay may be a valuable tool in triage of ASCUS pap smears. A high specificity of E6/E7 mRNA quantitative assay as a triage test in women with ASCUS can be translated into a low referral for colposcopy.

  5. MS transport assays for γ-aminobutyric acid transporters--an efficient alternative for radiometric assays.

    Science.gov (United States)

    Schmitt, Sebastian; Höfner, Georg; Wanner, Klaus T

    2014-08-05

    Transport assays for neurotransmitters based on radiolabeled substrates are widely spread and often indispensable in basic research and the drug development process, although the use of radioisotopes is inherently coupled to issues concerning radioactive waste and safety precautions. To overcome these disadvantages, we developed mass spectrometry (MS)-based transport assays for γ-aminobutyric acid (GABA), which is the major inhibitory neurotransmitter in the central nervous system (CNS). These "MS Transport Assays" provide all capabilities of [(3)H]GABA transport assays and therefore represent the first substitute for the latter. The performance of our approach is demonstrated for GAT1, the most important GABA transporter (GAT) subtype. As GABA is endogenously present in COS-7 cells employed as hGAT1 expression system, ((2)H6)GABA was used as a substrate to differentiate transported from endogenous GABA. To record transported ((2)H6)GABA, a highly sensitive, short, robust, and reliable HILIC-ESI-MS/MS quantification method using ((2)H2)GABA as an internal standard was developed and validated according to the Center for Drug Evaluation and Research (CDER) guidelines. Based on this LC-MS quantification, a setup to characterize hGAT1 mediated ((2)H6)GABA transport in a 96-well format was established, that enables automated processing and avoids any sample preparation. The K(m) value for ((2)H6)GABA determined for hGAT1 is in excellent agreement with results obtained from [(3)H]GABA uptake assays. In addition, the established assay format enables efficient determination of the inhibitory potency of GAT1 inhibitors, is capable of identifying those inhibitors transported as substrates, and furthermore allows characterization of efflux. The approach described here combines the strengths of LC-MS/MS with the high efficiency of transport assays based on radiolabeled substrates and is applicable to all GABA transporter subtypes.

  6. Mistaken identity of an open reading frame proposed for PCR-based identification of Mycoplasma bovis and the effect of polymorphisms and insertions on assay performance

    Science.gov (United States)

    Mycoplasma bovis is an important cause of disease in cattle and bison. Because the bacterium requires specialized growth conditions many diagnostic laboratories routinely use PCR to replace or complement conventional isolation and identification methods. A frequently used target of such assays is th...

  7. Design, construction and operating experience of demonstration LMFBRs. The application of core and fuel performance experience in British reactors to commercial fast reactor design

    International Nuclear Information System (INIS)

    Bagley, K.Q.

    1978-01-01

    The Prototype Fast Reactor (PFR) sub-assembly design is described with particular emphasis on the choice of factors that are important in determining satisfactory performance. Reasons for the adoption of specific clad and fuel design details are given in their historical context, and irradiation experience - mostly from the Dounreay Fast Reactor (DFR) - in support of the choices is described. The implications of factors that are now better understood than when the PFR fuel was designed, notably neutron-induced void swelling and irradiation creep, are then considered. It is shown that the 'free-standing' core design used in PFR, in which the sub-assembly is unsupported above the level of the lower axial breeder, relies on the availability of low-swelling, preferably irradiation-creep-resistant alloys as sub-assembly structural materials in order to achieve the prescribed burn-up target. The advantages of a 'restrained core', which makes use of irradiation creep to redress the effects of material swelling, are noted briefly, and the application of this concept to the Commercial Demonstration Fast Reactor (CDFR) core design is described. Probable future trends in pin and sub-assembly design are reviewed and the scope of associated irradiation testing programmes defined. Arrangements for monitoring and evaluating fuel performance, both in reactor and post-irradiation, are outlined and the provisions for endorsement of CDFR pin, sub-assembly and core design details in PFR are indicated. (author)

  8. Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay.

    Science.gov (United States)

    Cronin, Maureen; Pho, Mylan; Dutta, Debjani; Stephans, James C; Shak, Steven; Kiefer, Michael C; Esteban, Jose M; Baker, Joffre B

    2004-01-01

    Throughout the last decade many laboratories have shown that mRNA levels in formalin-fixed and paraffin-embedded (FPE) tissue specimens can be quantified by reverse transcriptase-polymerase chain reaction (RT-PCR) techniques despite the extensive RNA fragmentation that occurs in tissues so preserved. We have developed RT-PCR methods that are sensitive, precise, and that have multianalyte capability for potential wide use in clinical research and diagnostic assays. Here it is shown that the extent of fragmentation of extracted FPE tissue RNA significantly increases with archive storage time. Probe and primer sets for RT-PCR assays based on amplicons that are both short and homogeneous in length enable effective reference gene-based data normalization for cross comparison of specimens that differ substantially in age. A 48-gene assay used to compare gene expression profiles from the same breast cancer tissue that had been either frozen or FPE showed very similar profiles after reference gene-based normalization. A 92-gene assay, using RNA extracted from three 10- micro m FPE sections of archival breast cancer specimens (dating from 1985 to 2001) yielded analyzable data for these genes in all 62 tested specimens. The results were substantially concordant when estrogen receptor, progesterone receptor, and HER2 receptor status determined by RT-PCR was compared with immunohistochemistry assays for these receptors. Furthermore, the results highlight the advantages of RT-PCR over immunohistochemistry with respect to quantitation and dynamic range. These findings support the development of RT-PCR analysis of FPE tissue RNA as a platform for multianalyte clinical diagnostic tests.

  9. Comparison of Simplexa universal direct PCR with cytotoxicity assay for diagnosis of Clostridium difficile infection: performance, cost, and correlation with disease.

    Science.gov (United States)

    Landry, Marie L; Ferguson, David; Topal, Jeffrey

    2014-01-01

    Simplexa Clostridium difficile universal direct PCR, a real-time PCR assay for the detection of the C. difficile toxin B (tcdB) gene using the 3M integrated cycler, was compared with a two-step algorithm which includes the C. Diff Chek-60 glutamate dehydrogenase (GDH) antigen assay followed by cytotoxin neutralization. Three hundred forty-two liquid or semisolid stools submitted for diagnostic C. difficile testing, 171 GDH antigen positive and 171 GDH antigen negative, were selected for the study. All samples were tested by the C. Diff Chek-60 GDH antigen assay, cytotoxin neutralization, and Simplexa direct PCR. Of 171 GDH-positive samples, 4 were excluded (from patients on therapy or from whom duplicate samples were obtained) and 88 were determined to be true positives for toxigenic C. difficile. Of the 88, 67 (76.1%) were positive by the two-step method and 86 (97.7%) were positive by PCR. Seventy-nine were positive by the GDH antigen assay only. Of 171 GDH antigen-negative samples, none were positive by PCR. One antigen-negative sample positive by the cytotoxin assay only was deemed a false positive based on chart review. Simplexa C. difficile universal direct PCR was significantly more sensitive for detecting toxigenic C. difficile bacteria than cytotoxin neutralization (P = 0.0002). However, most PCR-positive/cytotoxin-negative patients did not have clear C. difficile disease. The estimated cost avoidance provided by a more rapid molecular diagnosis was outweighed by the cost of isolating and treating PCR-positive/cytotoxin-negative patients. The costs, clinical consequences, and impact on nosocomial transmission of treating and/or isolating patients positive for toxigenic C. difficile by PCR but negative for in vivo toxin production merit further study.

  10. Review on the acute Daphnia magna toxicity test – Evaluation of the sensitivity and the precision of assays performed with organisms from laboratory cultures or hatched from dormant eggs

    Directory of Open Access Journals (Sweden)

    Persoone G.

    2009-08-01

    “Culture/maintenance free” aquatic microbiotests with species of different phylogenetic groups were developed in the early 1990s at the Laboratory for Environmental Toxicology and Aquatic Ecology at the Ghent University in Belgium. These assays which were given the generic name “Toxkits”, are unique in that they employ dormant stages (“cryptobiotic eggs” of the test species, which can be stored for long periods of time and “hatched” at the time of performance of the assays. One of these microbiotests is the Daphtoxkit F magna, which is currently used in many laboratories worldwide for research as well as for toxicity monitoring purposes. The microbiotest technology has several advantages in comparison to the “traditional” tests based on laboratory cultures, especially its independence of the stock culturing burden. However, the acceptance (or possible non-acceptance of performing assays with test organisms obtained from “dormant eggs” should be clearly dictated by the “sensitivity” and “precision” criteria of the former assays in comparison to the latter. The first part of this review therefore thoroughly reviews the scientific literature and of data obtained from various laboratories for assays performed with either D. magna test organisms obtained from lab cultures or hatched from dormant eggs. Attention has focused on data of quality control tests performed on reference chemicals, and in particular on potassium dichromate (K2Cr2O7 for which an acceptability range of 0.6–2.1 mg·L–1 has been set in ISO standard 6341 for the 24 h EC50 of the acute D. magna assay. Mean EC50s, standard deviations and variation coefficients were calculated from the collected data, all of which are presented in tables and figures and discussed in detail. The major conclusions drawn from the analysis of the large number of quality control (QC data on the acute D. magna toxicity test are that : (1 Virtually all results from assays performed with

  11. Data transformation methods for multiplexed assays

    Science.gov (United States)

    Tammero, Lance F. Bentley; Dzenitis, John M; Hindson, Benjamin J

    2013-07-23

    Methods to improve the performance of an array assay are described. A correlation between fluorescence intensity-related parameters and negative control values of the assay is determined. The parameters are then adjusted as a function of the correlation. As a result, sensitivity of the assay is improved without changes in its specificity.

  12. Duplex recombinase polymerase amplification assays incorporating competitive internal controls for bacterial meningitis detection.

    Science.gov (United States)

    Higgins, Owen; Clancy, Eoin; Forrest, Matthew S; Piepenburg, Olaf; Cormican, Martin; Boo, Teck Wee; O'Sullivan, Nicola; McGuinness, Claire; Cafferty, Deirdre; Cunney, Robert; Smith, Terry J

    2018-04-01

    Recombinase polymerase amplification (RPA) is an isothermal nucleic acid amplification technology that provides rapid and robust infectious disease pathogen detection, ideal for point-of-care (POC) diagnostics in disease-prevalent low-resource countries. We have developed and evaluated three duplex RPA assays incorporating competitive internal controls for the detection of leading bacterial meningitis pathogens. Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae singleplex RPA assays were initially developed and evaluated, demonstrating 100% specificity with limits of detection of 4.1, 8.5 and 3.9 genome copies per reaction, respectively. Each assay was further developed into internally controlled duplex RPA assays via the incorporation of internal amplification control templates. Clinical performance of each internally controlled duplex RPA assay was evaluated by testing 64 archived PCR-positive clinical samples. Compared to real-time PCR, all duplex RPA assays demonstrated 100% diagnostic specificity, with diagnostic sensitivities of 100%, 86.3% and 100% for the S. pneumoniae, N. meningitidis and H. influenzae assays, respectively. This study details the first report of internally controlled duplex RPA assays for the detection of bacterial meningitis pathogens: S. pneumoniae, N. meningitidis and H. influenzae. We have successfully demonstrated the clinical diagnostic utility of each duplex RPA assay, introducing effective diagnostic technology for POC bacterial meningitis identification in disease-prevalent developing countries. Copyright © 2018 Elsevier Inc. All rights reserved.

  13. Integrated bioassays in microfluidic devices: botulinum toxin assays.

    Science.gov (United States)

    Mangru, Shakuntala; Bentz, Bryan L; Davis, Timothy J; Desai, Nitin; Stabile, Paul J; Schmidt, James J; Millard, Charles B; Bavari, Sina; Kodukula, Krishna

    2005-12-01

    A microfluidic assay was developed for screening botulinum neurotoxin serotype A (BoNT-A) by using a fluorescent resonance energy transfer (FRET) assay. Molded silicone microdevices with integral valves, pumps, and reagent reservoirs were designed and fabricated. Electrical and pneumatic control hardware were constructed, and software was written to automate the assay protocol and data acquisition. Detection was accomplished by fluorescence microscopy. The system was validated with a peptide inhibitor, running 2 parallel assays, as a feasibility demonstration. The small footprint of each bioreactor cell (0.5 cm2) and scalable fluidic architecture enabled many parallel assays on a single chip. The chip is programmable to run a dilution series in each lane, generating concentration-response data for multiple inhibitors. The assay results showed good agreement with the corresponding experiments done at a macroscale level. Although the system has been developed for BoNT-A screening, a wide variety of assays can be performed on the microfluidic chip with little or no modification.

  14. Test procedure for boxed waste assay system

    International Nuclear Information System (INIS)

    Wachter, J.

    1994-01-01

    This document, prepared by Los Alamos National Laboratory's NMT-4 group, details the test methodology and requirements for Acceptance/Qualification testing of a Boxed Waste Assay System (BWAS) designed and constructed by Pajarito Scientific Corporation. Testing of the BWAS at the Plutonium Facility (TA55) at Los Alamos National Laboratory will be performed to ascertain system adherence to procurement specification requirements. The test program shall include demonstration of conveyor handling capabilities, gamma ray energy analysis, and imaging passive/active neutron accuracy and sensitivity. Integral to these functions is the system's embedded operating and data reduction software

  15. Making transuranic assay measurements using modern controllers

    International Nuclear Information System (INIS)

    Kuckertz, T.H.; Caldwell, J.T.; Medvick, P.A.; Kunz, W.E.; Hastings, R.D.

    1987-01-01

    This paper describes methodology and computer-controlled instrumentation developed at the Los Alamos National Laboratory that accurately performs nondestructive assays of large containers bearing transuranic wastes and nonradioactive matrix materials. These assay systems can measure fissile isotopes with 1-mg sensitivity and spontaneous neutron-emitting isotopes at a 10-mg sensitivity. The assays are performed by neutron interrogation, detection, and counting in a custom assay chamber. An International Business Machines Personal Computer (IBM-PC) is used to control the CAMAC-based instrumentation system that acquires the assay data. 6 refs., 7 figs

  16. Review on the acute Daphnia magna toxicity test – Evaluation of the sensitivity and the precision of assays performed with organisms from laboratory cultures or hatched from dormant eggs

    Directory of Open Access Journals (Sweden)

    G. Persoone

    2009-08-01

    Full Text Available One of the most internationally used bioassays for toxicity screening of chemicals and for toxicity monitoring of effluents and contaminated waters is the acute toxicity test with daphnid crustaceans, and in particular that performed with Daphnia magna.Standard methods have been developed for this assay that were gradually endorsed by national and international organisations dealing with toxicity testing procedures, in view of its application within a regulatory framework. As for all toxicity tests, the organisms used for the acute D. magna assay have to be obtained from live stocks which are cultured in the laboratory on live food (micro-algae.Unsurprisingly the various standard protocols of this particular assay differ – at least to a certain extent – with regard to the test organism culturing conditions. In addition, some technical aspects of the toxicity test such as the effect criterion (mortality of immobility, the exposure time, the type of dilution water, etc., also vary from one standard to another.Although this particular assay is currently used in many countries, the technical and biological problems inherent in year-round culturing and availability of the biological material and the culturing/maintenance costs of live stocks restrict its application to a limited number of highly specialised laboratories.This fundamental bottleneck in toxicity testing triggered investigations which brought forward the concept of “microbiotests” or “small-scale” toxicity tests. “Culture/maintenance free” aquatic microbiotests with species of different phylogenetic groups were developed in the early 1990s at the Laboratory for Environmental Toxicology and Aquatic Ecology at the Ghent University in Belgium.These assays which were given the generic name “Toxkits”, are unique in that they employ dormant stages (“cryptobiotic eggs” of the test species, which can be stored for long periods of time and “hatched” at the time of

  17. Comparison of Antioxidant Evaluation Assays for Investigating Antioxidative Activity of Gallic Acid and Its Alkyl Esters in Different Food Matrices.

    Science.gov (United States)

    Phonsatta, Natthaporn; Deetae, Pawinee; Luangpituksa, Pairoj; Grajeda-Iglesias, Claudia; Figueroa-Espinoza, Maria Cruz; Le Comte, Jérôme; Villeneuve, Pierre; Decker, Eric A; Visessanguan, Wonnop; Panya, Atikorn

    2017-08-30

    The addition of antioxidants is one of the strategies to inhibit lipid oxidation, a major cause of lipid deterioration in foods leading to rancidity development and nutritional losses. However, several studies have been reported that conventional antioxidant assays, e.g., TPC, ABTS, FRAP, and ORAC could not predict antioxidant performance in several foods. This study aimed to investigate the performance of two recently developed assays, e.g., the conjugated autoxidizable triene (CAT) and the apolar radical-initiated conjugated autoxidizable triene (ApoCAT) assays to predict the antioxidant effectiveness of gallic acid and its esters in selected food models in comparison with the conventional antioxidant assays. The results indicated that the polarities of the antioxidants have a strong impact on antioxidant activities. In addition, different oxidant locations demonstrated by the CAT and ApoCAT assays influenced the overall antioxidant performances of the antioxidants with different polarities. To validate the predictability of the assays, the antioxidative performance of gallic acid and its alkyl esters was investigated in oil-in-water (O/W) emulsions, bulk soybean oils, and roasted peanuts as the lipid food models. The results showed that only the ApoCAT assay could be able to predict the antioxidative performances in O/W emulsions regardless of the antioxidant polarities. This study demonstrated that the relevance of antioxidant assays to food models was strongly dependent on physical similarities between the tested assays and the food structure matrices.

  18. Analytic performance studies and clinical reproducibility of a real-time PCR assay for the detection of epidermal growth factor receptor gene mutations in formalin-fixed paraffin-embedded tissue specimens of non-small cell lung cancer

    International Nuclear Information System (INIS)

    O’Donnell, Patrick; Shieh, Felice; Wei, Wen; Lawrence, H Jeffrey; Wu, Lin; Schilling, Robert; Bloom, Kenneth; Maltzman, Warren; Anderson, Steven; Soviero, Stephen; Ferguson, Jane; Shyu, Johnny; Current, Robert; Rehage, Taraneh; Tsai, Julie; Christensen, Mari; Tran, Ha Bich; Chien, Sean Shih-Chang

    2013-01-01

    Epidermal growth factor receptor (EGFR) gene mutations identify patients with non-small cell lung cancer (NSCLC) who have a high likelihood of benefiting from treatment with anti-EGFR tyrosine kinase inhibitors. Sanger sequencing is widely used for mutation detection but can be technically challenging, resulting in longer turn-around-time, with limited sensitivity for low levels of mutations. This manuscript details the technical performance verification studies and external clinical reproducibility studies of the cobas EGFR Mutation Test, a rapid multiplex real-time PCR assay designed to detect 41 mutations in exons 18, 19, 20 and 21. The assay’s limit of detection was determined using 25 formalin-fixed paraffin-embedded tissue (FFPET)-derived and plasmid DNA blends. Assay performance for a panel of 201 specimens was compared against Sanger sequencing with resolution of discordant specimens by quantitative massively parallel pyrosequencing (MPP). Internal and external reproducibility was assessed using specimens tested in duplicate by different operators, using different reagent lots, instruments and at different sites. The effects on the performance of the cobas EGFR test of endogenous substances and nine therapeutic drugs were evaluated in ten FFPET specimens. Other tests included an evaluation of the effects of necrosis, micro-organisms and homologous DNA sequences on assay performance, and the inclusivity of the assay for less frequent mutations. A >95% hit rate was obtained in blends with >5% mutant alleles, as determined by MPP analysis, at a total DNA input of 150 ng. The overall percent agreement between Sanger sequencing and the cobas test was 96.7% (negative percent agreement 97.5%; positive percent agreement 95.8%). Assay repeatability was 98% when tested with two operators, instruments, and reagent lots. In the external reproducibility study, the agreement was > 99% across all sites, all operators and all reagent lots for 11/12 tumors tested. Test

  19. Nondestructive assay of subassemblies of various spent or fresh fuels by active neutron interrogation

    International Nuclear Information System (INIS)

    Ragan, G.L.; Ricker, C.W.; Chiles, M.M.; Ingersoll, D.T.; Slaughter, G.G.

    1979-01-01

    Recent studies show that subassemblies containing various spent fuels could be assayed rapidly and accurately by a nondestructive assay system using active neutron interrogation and prompt-neutron detection. Subassembly penetration is achieved by 24-keV (Sb--Be) interrogation neutrons; the spent-fuel neutron background is overridden by using strong interrogating sources and prompt-neutron signals, and background gammas are absorbed by lead. Experiments have demonstrated the potential for assaying with better than 5% accuracy, three spent plutonium-fueled subassemblies per hour. Calculations, validated by experiments, predict even better performance for fresh or uranium-fueled subassemblies; several performance estimates are given

  20. An acoustic prion assay

    Directory of Open Access Journals (Sweden)

    Gordon Hayward

    2016-12-01

    Full Text Available An acoustic prion assay has been demonstrated for sheep brain samples. Only five false positives and no false negatives were observed in a test of 45 positive and 45 negative samples. The acoustic prion sensor was constructed using a thickness shear mode quartz resonator coated with a covalently bound recombinant prion protein. The characteristic indicator of a scrapie infected sheep brain sample was an observed shoulder in the frequency decrease in response to a sample.The response of the sensor aligns with a conformational shift in the surface protein and with the propagation mechanism of the disease. This alignment is evident in the response timing and shape, dependence on concentration, cross species behaviour and impact of blood plasma. This alignment is far from sufficient to prove the mechanism of the sensor but it does offer the possibility of a rapid and inexpensive additional tool to explore prion disease. Keywords: Prions, Thickness shear mode quartz sensor

  1. ESTCP Cost and Performance Report: Field Demonstration of Rhizosphere-Enhanced Treatment of Organics-Contaminated Soils on Native American Lands with Application to Northern FUD Sites

    National Research Council Canada - National Science Library

    Reynolds, C. M

    2004-01-01

    ... can be used in other situations dealing with surface soil contamination. This project included field demonstrations of rhizosphere-enhanced bioremediation of petroleum, oils, and lubricants (POLs...

  2. Education Payload Operation - Demonstrations

    Science.gov (United States)

    Keil, Matthew

    2009-01-01

    Education Payload Operation - Demonstrations (EPO-Demos) are recorded video education demonstrations performed on the International Space Station (ISS) by crewmembers using hardware already onboard the ISS. EPO-Demos are videotaped, edited, and used to enhance existing NASA education resources and programs for educators and students in grades K-12. EPO-Demos are designed to support the NASA mission to inspire the next generation of explorers.

  3. Correlation between the genotoxicity endpoints measured by two different genotoxicity assays: comet assay and CBMN assay

    Directory of Open Access Journals (Sweden)

    Carina Ladeira

    2015-06-01

    The results concerning of positive findings by micronuclei and non significant ones by comet assay, are corroborated by Deng et al. (2005 study performed in workers occupationally exposed to methotrexate, also a cytostatic drug. According to Cavallo et al. (2009, the comet assay seems to be more suitable for the prompt evaluation of the genotoxic effects, for instance, of polycyclic aromatic hydrocarbons mixtures containing volatile substances, whereas the micronucleus test seems more appropriate to evaluate the effects of exposure to antineoplastic agents. However, there are studies that observed an increase in both the comet assay and the micronucleus test in nurses handling antineoplastic drugs, although statistical significance was only seen in the comet assay, quite the opposite of our results (Maluf & Erdtmann, 2000; Laffon et al. 2005.

  4. Performance of a Highly Sensitive Mycobacterium tuberculosis Complex Real-Time PCR Assay for Diagnosis of Pulmonary Tuberculosis in a Low-Prevalence Setting: a Prospective Intervention Study.

    Science.gov (United States)

    Vinuesa, Víctor; Borrás, Rafael; Briones, María Luisa; Clari, María Ángeles; Cresencio, Vicenta; Giménez, Estela; Muñoz, Carmen; Oltra, Rosa; Servera, Emilio; Scheelje, Talia; Tornero, Carlos; Navarro, David

    2018-05-01

    The potential impact of routine real-time PCR testing of respiratory specimens from patients with presumptive tuberculosis in terms of diagnostic accuracy and time to tuberculosis treatment inception in low-prevalence settings remains largely unexplored. We conducted a prospective intervention cohort study. Respiratory specimens from 1,020 patients were examined by acid-fast bacillus smear microscopy, tested by a real-time Mycobacterium tuberculosis complex PCR assay (Abbott RealTi me MTB PCR), and cultured in mycobacterial media. Seventeen patients tested positive by PCR (5 were acid-fast bacillus smear positive and 12 acid-fast bacillus smear negative), and Mycobacterium tuberculosis was recovered from cultures for 12 of them. Patients testing positive by PCR and negative by culture ( n = 5) were treated and deemed to have responded to antituberculosis therapy. There were no PCR-negative/culture-positive cases, and none of the patients testing positive for nontuberculous mycobacteria ( n = 20) yielded a positive PCR result. The data indicated that routine testing of respiratory specimens from patients with presumptive tuberculosis by the RealTi me MTB PCR assay improves the tuberculosis diagnostic yield and may reduce the time to antituberculosis treatment initiation. On the basis of our data, we propose a novel mycobacterial laboratory algorithm for tuberculosis diagnosis. Copyright © 2018 American Society for Microbiology.

  5. Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form

    Directory of Open Access Journals (Sweden)

    Fahimeh Kamarei

    2014-12-01

    Full Text Available In this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra™ C18 analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L-1 (60:40, V/V (pH 7.0 was used as the mobile phase, effluent flow rate monitored at 1.0 mL min−1, and UV detection at 205 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature were investigated showing no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 400 to 600 μg mL−1, precise (intra- and inter-day relative standard deviations <0.65, accurate (mean recovery; 99.5%. The impurities and degradation products of erythromycin ethylsuccinate were selectively determined with good resolution in both the raw material and the final suspension forms. The method could be useful for both routine analytical and quality control assays of erythromycin ethylsuccinate in commercial powder for an oral suspension dosage form and it could be a very powerful tool to investigate the chemical stability of erythromycin ethylsuccinate.

  6. Arsenic and Nitrate Removal from Drinking Water by Ion Exchange U.S. EPA Demonstration Project at Vale, OR - Final Performance Evaluation Report

    Science.gov (United States)

    As part of the EPA Arsenic Removal Technology Demonstration Program, a 540-gal/min (gpm) ion exchange (IX) system proposed by Kinetico was selected for demonstration at Vale, OR to remove arsenic and nitrate from a groundwater supply to meet their respective maximum contaminant l...

  7. Matrix effects of TRU [transuranic] assays using the SWEPP PAN assay system

    International Nuclear Information System (INIS)

    Smith, J.R.

    1990-08-01

    The Drum Assay System (DAS) at the Stored Waste Experimental Pilot Plant (SWEPP) is a second-generation active-passive neutron assay system. It has been used to assay over 5000 208-liter drums of transuranic waste from the Rocky Flats Plant (RFP). Data from these assays have been examined and compared with the assays performed at Rocky Flats, mainly utilize counting of 239 Pu gamma rays. For the most part the passive assays are in very good agreement with the Rocky Flats assays. The active assays are strongly correlated with the results of the other two methods, but require matrix-dependent correction factors beyond those provided by the system itself. A set of matrix-dependent correction factors has been developed from the study of the assay results. 3 refs., 4 figs., 3 tabs

  8. Performance of four different indirect enzyme-linked immunosorbent assays (ELISAs) to detect specific IgG, IgA, and IgM in Legionnaires' disease

    DEFF Research Database (Denmark)

    Bangsborg, Jette Marie; Shand, G H; Hansen, K

    1994-01-01

    Currently recommended methods in Legionnaires' disease serology are based upon crude whole-cell antigenic preparations. To investigate whether purified antigens would perform better in a given diagnostic test for antibodies against Legionella pneumophila, we compared the performance of three...

  9. Barcoded microchips for biomolecular assays.

    Science.gov (United States)

    Zhang, Yi; Sun, Jiashu; Zou, Yu; Chen, Wenwen; Zhang, Wei; Xi, Jianzhong Jeff; Jiang, Xingyu

    2015-01-20

    Multiplexed assay of analytes is of great importance for clinical diagnostics and other analytical applications. Barcode-based bioassays with the ability to encode and decode may realize this goal in a straightforward and consistent manner. We present here a microfluidic barcoded chip containing several sets of microchannels with different widths, imitating the commonly used barcode. A single barcoded microchip can carry out tens of individual protein/nucleic acid assays (encode) and immediately yield all assay results by a portable barcode reader or a smartphone (decode). The applicability of a barcoded microchip is demonstrated by human immunodeficiency virus (HIV) immunoassays for simultaneous detection of three targets (anti-gp41 antibody, anti-gp120 antibody, and anti-gp36 antibody) from six human serum samples. We can also determine seven pathogen-specific oligonucleotides by a single chip containing both positive and negative controls.

  10. Clinical validation of the Tempus xO assay

    Science.gov (United States)

    Beaubier, Nike; Tell, Robert; Huether, Robert; Bontrager, Martin; Bush, Stephen; Parsons, Jerod; Shah, Kaanan; Baker, Tim; Selkov, Gene; Taxter, Tim; Thomas, Amber; Bettis, Sam; Khan, Aly; Lau, Denise; Lee, Christina; Barber, Matthew; Cieslik, Marcin; Frankenberger, Casey; Franzen, Amy; Weiner, Ali; Palmer, Gary; Lonigro, Robert; Robinson, Dan; Wu, Yi-Mi; Cao, Xuhong; Lefkofsky, Eric; Chinnaiyan, Arul; White, Kevin P.

    2018-01-01

    We have developed a clinically validated NGS assay that includes tumor, germline and RNA sequencing. We apply this assay to clinical specimens and cell lines, and we demonstrate a clinical sensitivity of 98.4% and positive predictive value of 100% for the clinically actionable variants measured by the assay. We also demonstrate highly accurate copy number measurements and gene rearrangement identification. PMID:29899824

  11. Specificity of B-type natriuretic peptide assays

    DEFF Research Database (Denmark)

    Saenger, Amy K.; Rodriguez-Fraga, Olaia; Ler, Ranka

    2017-01-01

    BACKGROUND: B-type natriuretic peptides (BNPs) are used clinically to diagnose and monitor heart failure and are present in the circulation as multiple proBNP-derived fragments. We investigated the specificity of BNP immunoassays with glycosylated and nonglycosylated BNP, N-terminal proBNP (NT......-proBNP), and proBNP peptides to probe the cross-reactivity of each assay. METHODS: Nine B-type natriuretic peptides were studied, including synthetic and recombinant BNP (Shionogi, Scios, Mayo), human and synthetic glycosylated and nonglycosylated NT-proBNP (HyTest, Roche Diagnostics), and human glycosylated......-Rad, Goetze] were evaluated. Specificity was assessed by calculating the recovery between baseline and peptide-spiked human plasma pools at target concentrations of 100 ng/L BNP, 300 ng/L proBNP, or 450 ng/L NT-proBNP. All assays were performed in duplicate. RESULTS: BNP and NT-proBNP assays demonstrated...

  12. Evaluation of the Thermo Scientific SureTect Listeria monocytogenes Assay.

    Science.gov (United States)

    Cloke, Jonathan; Leon-Velarde, Carlos; Larson, Nathan; Dave, Keron; Evans, Katharine; Crabtree, David; Hughes, Annette; Hopper, Craig; Simpson, Helen; Withey, Sophie; Oleksiuk, Milena; Holopainen, Jani; Wickstrand, Nina; Kauppinen, Mikko

    2014-01-01

    The Thermo Scientific SureTect Listeria monocytogenes Assay is a new real-time PCR assay for the detection of Listeria monocytogenes in food and environmental samples. This assay was validated using the AOAC Research Institute (AOAC-RI) Performance Tested Methods program in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996, including Amendment 1:2004 with the following foods and food contact surfaces: smoked salmon, processed cheese, fresh bagged spinach, fresh cantaloupe, cooked prawns (chilled product), cooked sliced turkey meat (chilled product), ice cream, pork frankfurters, salami, ground raw beef meat (12% fat), plastic, and stainless steel. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, bagged lettuce, and stainless steel) were analyzed independently as part of the AOAC-RI controlled laboratory study by the University of Guelph, Canada. Using probability of detection (POD) statistical analysis, a significant difference was demonstrated between the candidate and reference methods for salami, cooked sliced turkey and ice cream in favor of the SureTect assay. For all other matrixes, no significant difference by POD was seen between the two methods during the study. Inclusivity and exclusivity testing was also conducted with 53 and 30 isolates, respectively, which demonstrated that the SureTect assay was able to detect all serotypes of L. monocytogenes. None of the exclusivity isolates analyzed were detected by the SureTect assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside the recommended parameters open to variation, i.e., enrichment time and temperature and lysis temperature, which demonstrated that the assay gave reliable performance. Accelerated stability testing was also conducted, validating the assay shelf life.

  13. Simultaneous detection of five different 2-hydroxyethyl-DNA adducts formed by ethylene oxide exposure, using a high-performance liquid chromatography/electrospray ionisation tandem mass spectrometry assay.

    Science.gov (United States)

    Tompkins, Elaine M; Jones, Donald J L; Lamb, John H; Marsden, Debbie A; Farmer, Peter B; Brown, Karen

    2008-01-01

    A method has been developed for the simultaneous detection and quantitation of five different 2-hydroxyethyl-DNA (HE-DNA) adducts that could be formed as a result of exposure to ethylene oxide (EO). In addition to the major N7-HE-guanine (N7-HEG) adducts this assay can also measure the less prevalent but potentially more biologically significant N1-HE-2'-deoxyadenosine (N1-HEdA), O(6)-HE-2'-deoxyguanosine (O(6)-HEdG), N(6)-HE-2'-deoxyadenosine (N(6)-HEdA) and N3-HE-2'-deoxyuridine adducts (N3-HEdU). The method involves the isolation of HE adducts from the unmodified nucleosides by either neutral thermal hydrolysis or enzymatic digestion, followed by high-performance liquid chromatographic (HPLC) purification, before detection and quantification by liquid chromatography tandem mass spectrometry (LC/MS/MS) using selective reaction monitoring (SRM). The limits of detection were in the range 0.5-25 fmol for each individual adduct, making this one of the most sensitive assays available for the detection of N7-HEG. To illustrate the possible applications of the assay, it has been employed in the measurement of endogenous/background and EO-induced HE adducts in a variety of DNA samples.

  14. Arsenic Removal from Drinking Water by Point of Entry/Point of Use Adsorptive Media U.S. EPA Demonstration Project at Oregon Institute of Technology at Klamath Falls, OR - Final Performance Evaluation Report

    Science.gov (United States)

    This report documents the activities performed during and the results obtained from the arsenic removal treatment technology demonstration project at Oregon Institute of Technology (OIT) at Klamath Falls, OR. The objectives of the project were to evaluate: (1) the effectiveness...

  15. In-house validation study of the DuPont Qualicon BAX system Q7 instrument with the BAX system PCR Assay for Salmonella (modification of AOAC Official Method 2003.09 and AOAC Research Institute Performance-Tested Method 100201).

    Science.gov (United States)

    Tice, George; Andaloro, Bridget; White, H Kirk; Bolton, Lance; Wang, Siqun; Davis, Eugene; Wallace, Morgan

    2009-01-01

    In 2006, DuPont Qualicon introduced the BAX system Q7 instrument for use with its assays. To demonstrate the equivalence of the new and old instruments, a validation study was conducted using the BAX system PCR Assay for Salmonella, AOAC Official Method 2003.09, on three food types. The foods were simultaneously analyzed with the BAX system Q7 instrument and either the U.S. Food and Drug Administration Bacteriological Analytical Manual or the U.S. Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook reference method for detecting Salmonella. Comparable performance between the BAX system and the reference methods was observed. Of the 75 paired samples analyzed, 39 samples were positive by both the BAX system and reference methods, and 36 samples were negative by both the BAX system and reference methods, demonstrating 100% correlation. Inclusivity and exclusivity for the BAX system Q7 instrument were also established by testing 50 Salmonella strains and 20 non-Salmonella isolates. All Salmonella strains returned positive results, and all non-Salmonella isolates returned a negative response.

  16. Microbead agglutination based assays

    KAUST Repository

    Kodzius, Rimantas

    2013-01-21

    We report a simple and rapid room temperature assay for point-of-care (POC) testing that is based on specific agglutination. Agglutination tests are based on aggregation of microbeads in the presence of a specific analyte thus enabling the macroscopic observation. Such tests are most often used to explore antibody-antigen reactions. Agglutination has been used for protein assays using a biotin/streptavidin system as well as a hybridization based assay. The agglutination systems are prone to selftermination of the linking analyte, prone to active site saturation and loss of agglomeration at high analyte concentrations. We investigated the molecular target/ligand interaction, explaining the common agglutination problems related to analyte self-termination, linkage of the analyte to the same bead instead of different microbeads. We classified the agglutination process into three kinds of assays: a two- component assay, a three-component assay and a stepped three- component assay. Although we compared these three kinds of assays for recognizing DNA and protein molecules, the assay can be used for virtually any molecule, including ions and metabolites. In total, the optimized assay permits detecting analytes with high sensitivity in a short time, 5 min, at room temperature. Such a system is appropriate for POC testing.

  17. Assay optimization for molecular detection of Zika virus

    NARCIS (Netherlands)

    Corman, Victor M.; Rasche, Andrea; Baronti, Cecile; Aldabbagh, Souhaib; Cadar, Daniel; Reusken, Chantal Bem; Pas, Suzan D.; Goorhuis, Abraham; Schinkel, Janke; Molenkamp, Richard; Kümmerer, Beate M.; Bleicker, Tobias; Brünink, Sebastian; Eschbach-Bludau, Monika; Eis-Hübinger, Anna M.; Koopmans, Marion P.; Schmidt-Chanasit, Jonas; Grobusch, Martin P.; de Lamballerie, Xavier; Drosten, Christian; Drexler, Jan Felix

    2016-01-01

    To examine the diagnostic performance of real-time reverse transcription (RT)-polymerase chain reaction (PCR) assays for Zika virus detection. We compared seven published real-time RT-PCR assays and two new assays that we have developed. To determine the analytical sensitivity of each assay, we

  18. Enzyme activity assays within microstructured optical fibers enabled by automated alignment.

    Science.gov (United States)

    Warren-Smith, Stephen C; Nie, Guiying; Schartner, Erik P; Salamonsen, Lois A; Monro, Tanya M

    2012-12-01

    A fluorescence-based enzyme activity assay has been demonstrated within a small-core microstructured optical fiber (MOF) for the first time. To achieve this, a reflection-based automated alignment system has been developed, which uses feedback and piezoelectric actuators to maintain optical alignment. The auto-alignment system provides optical stability for the time required to perform an activity assay. The chosen assay is based on the enzyme proprotein convertase 5/6 (PC6) and has important applications in women's health.

  19. Evaluation of the performance of Abbott m2000 and Roche COBAS Ampliprep/COBAS Taqman assays for HIV-1 viral load determination using dried blood spots and dried plasma spots in Kenya.

    Science.gov (United States)

    Zeh, Clement; Ndiege, Kenneth; Inzaule, Seth; Achieng, Rebecca; Williamson, John; Chih-Wei Chang, Joy; Ellenberger, Dennis; Nkengasong, John

    2017-01-01

    Routine HIV viral load testing is not widely accessible in most resource-limited settings, including Kenya. To increase access to viral load testing, alternative sample types like dried blood spots (DBS), which overcome the logistic barriers associated with plasma separation and cold chain shipment need to be considered and evaluated. The current study evaluated matched dried blood spots (DBS) and dried plasma spots (DPS) against plasma using the Abbott M 2000 (Abbott) and Roche Cobas Ampliprep/Cobas TaqMan (CAP/CTM) quantitative viral load assays in western Kenya. Matched plasma DBS and DPS were obtained from 200 HIV-1 infected antiretroviral treatment (ART)-experienced patients attending patient support centers in Western Kenya. Standard quantitative assay performance parameters with accompanying 95% confidence intervals (CI) were assessed at the assays lower detection limit (400cps/ml for CAP/CTM and 550cps/ml for Abbott) using SAS version 9.2. Receiver operating curves (ROC) were further used to assess viral-load thresholds with best assay performance (reference assay CAP/CTM plasma). Using the Abbott test, the sensitivity and specificity, respectively, for DPS were (97.3%, [95%CI: 93.2-99.2] and 98.1% [95%CI: 89.7-100]) and those for DBS (93.9% [95%CI: 88.8-97.2] and 88.0% [95%CI: 82.2-92.4]). The correlation and agreement using paired plasma and DPS/DBS were strong, with r2 = 90.5 and rc = 68.1. The Bland-Altman relative percent change was 95.3 for DPS, (95%CI: 90.4-97.7) and 73.6 (95%CI: 51.6-86.5) for DBS. Using the CAP/CTM assay, the sensitivity for DBS was significantly higher compared to DPS (100.0% [95% CI: 97.6-100.0] vs. 94.7% [95%CI: 89.8-97.7]), while the specificity for DBS was lower: 4%, [95% CI: 0.4-13.7] compared to DPS: 94.0%, [95% CI: 83.5-98.7]. When compared under different clinical relevant thresholds, the accuracy for the Abbott assay was 95% at the 1000cps/ml cut-off with a sensitivity and specificity of 96.6% [95% CI 91.8-98.7] and 90

  20. Radioreceptor opioid assay

    International Nuclear Information System (INIS)

    Miller, R.J.; Chang, K.-J.

    1981-01-01

    A radioreceptor assay is described for assaying opioid drugs in biological fluids. The method enables the assay of total opioid activity, being specific for opioids as a class but lacking specificity within the class. A radio-iodinated opioid and the liquid test sample are incubated with an opiate receptor material. The percentage inhibition of the binding of the radio-iodinated compound to the opiate receptor is calculated and the opioid activity of the test liquid determined from a standard curve. Examples of preparing radio-iodinated opioids and assaying opioid activity are given. A test kit for the assay is described. Compared to other methods, this assay is cheap, easy and rapid. (U.K.)

  1. Absolute nuclear material assay

    Science.gov (United States)

    Prasad, Manoj K [Pleasanton, CA; Snyderman, Neal J [Berkeley, CA; Rowland, Mark S [Alamo, CA

    2010-07-13

    A method of absolute nuclear material assay of an unknown source comprising counting neutrons from the unknown source and providing an absolute nuclear material assay utilizing a model to optimally compare to the measured count distributions. In one embodiment, the step of providing an absolute nuclear material assay comprises utilizing a random sampling of analytically computed fission chain distributions to generate a continuous time-evolving sequence of event-counts by spreading the fission chain distribution in time.

  2. Harmonization of radiobiological assays: why and how?

    International Nuclear Information System (INIS)

    Prasanna, Pataje G.

    2014-01-01

    The International Atomic Energy Agency has made available a technical manual for cytogenetic biodosimetry assays (dicentric chromosome aberration (DCA) and cytokinesis-block micronucleus (CBMN) assays) used for radiation dose assessment in radiation accidents. The International Standardization Organization, which develops standards and guidelines, also provides an avenue for laboratory accreditation, has developed guidelines and recommendations for performing cytogenetic biodosimetry assays. Harmonization of DCA and CBMN assays, has improved their accuracy. Double-blinded inter-laboratory comparison studies involving several networks have further validated DCA and CBMN assays and improved the confidence in their potential use for radiation dose assessment in mass casualties. This kind of international harmonization is lacking for pre-clinical radiobiology assays. The widely used pre-clinical assays that are relatively important to set stage for clinical trials include clonogenic assays, flow-cytometry assays, apoptotic assays, and tumor regression and growth delay assays. However, significant inter-laboratory variations occur with respect to data among laboratories. This raises concerns on the reliability and reproducibility of preclinical data that drives further development and translation. Lack of reproducibility may stem from a variety of factors such as poor scientist training, less than optimal experimental design, inadequate description of methodology, and impulse to publish only the positive data etc. Availability of technical manuals, standard operating procedures, accreditation avenues for laboratories performing such assays, inter-laboratory comparisons, and use of standardized protocols are necessary to enhance reliability and reproducibility. Thus, it is important that radiobiological assays are harmonized for laboratory protocols to ensure successful translation of pre-clinical research on radiation effect modulators to help design clinic trials with

  3. Comparison of Batch Assay and Random Assay Using Automatic Dispenser in Radioimmunoassay

    Energy Technology Data Exchange (ETDEWEB)

    Moon, Seung Hwan; Jang, Su Jin; Kang, Ji Yeon; Lee, Dong Soo; Chung, June Key; Lee, Myung Chul [Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul (Korea, Republic of); Lee, Ho Young; Shin, Sun Young; Min, Gyeong Sun; Lee, Hyun Joo [Seoul National University college of Medicine, Seoul (Korea, Republic of)

    2009-08-15

    Radioimmunoassay (RIA) was usually performed by the batch assay. To improve the efficiency of RIA without increase of the cost and time, random assay could be a choice. We investigated the possibility of the random assay using automatic dispenser by assessing the agreement between batch assay and random assay. The experiments were performed with four items; Triiodothyronine (T3), free thyroxine (fT4), Prostate specific antigen (PSA), Carcinoembryonic antigen (CEA). In each item, the sera of twenty patients, the standard, and the control samples were used. The measurements were done 4 times with 3 hour time intervals by random assay and batch assay. The coefficient of variation (CV) of the standard samples and patients' data in T3, fT4, PSA, and CEA were assessed. ICC (Intraclass correlation coefficient) and coefficient of correlation were measured to assessing the agreement between two methods. The CVs (%) of T3, fT4, PSA, and CEA measured by batch assay were 3.2+-1.7%, 3.9+-2.1%, 7.1+-6.2%, 11.2+-7.2%. The CVs by random assay were 2.1+-1.7%, 4.8+-3.1%, 3.6+-4.8%, and 7.4+-6.2%. The ICC between the batch assay and random assay were 0.9968 (T3), 0.9973 (fT4), 0.9996 (PSA), and 0.9901 (CEA). The coefficient of correlation between the batch assay and random assay were 0.9924(T3), 0.9974 (fT4), 0.9994 (PSA), and 0.9989 (CEA) (p<0.05). The results of random assay showed strong agreement with the batch assay in a day. These results suggest that random assay using automatic dispenser could be used in radioimmunoassay

  4. Comparison of Batch Assay and Random Assay Using Automatic Dispenser in Radioimmunoassay

    International Nuclear Information System (INIS)

    Moon, Seung Hwan; Jang, Su Jin; Kang, Ji Yeon; Lee, Dong Soo; Chung, June Key; Lee, Myung Chul; Lee, Ho Young; Shin, Sun Young; Min, Gyeong Sun; Lee, Hyun Joo

    2009-01-01

    Radioimmunoassay (RIA) was usually performed by the batch assay. To improve the efficiency of RIA without increase of the cost and time, random assay could be a choice. We investigated the possibility of the random assay using automatic dispenser by assessing the agreement between batch assay and random assay. The experiments were performed with four items; Triiodothyronine (T3), free thyroxine (fT4), Prostate specific antigen (PSA), Carcinoembryonic antigen (CEA). In each item, the sera of twenty patients, the standard, and the control samples were used. The measurements were done 4 times with 3 hour time intervals by random assay and batch assay. The coefficient of variation (CV) of the standard samples and patients' data in T3, fT4, PSA, and CEA were assessed. ICC (Intraclass correlation coefficient) and coefficient of correlation were measured to assessing the agreement between two methods. The CVs (%) of T3, fT4, PSA, and CEA measured by batch assay were 3.2±1.7%, 3.9±2.1%, 7.1±6.2%, 11.2±7.2%. The CVs by random assay were 2.1±1.7%, 4.8±3.1%, 3.6±4.8%, and 7.4±6.2%. The ICC between the batch assay and random assay were 0.9968 (T3), 0.9973 (fT4), 0.9996 (PSA), and 0.9901 (CEA). The coefficient of correlation between the batch assay and random assay were 0.9924(T3), 0.9974 (fT4), 0.9994 (PSA), and 0.9989 (CEA) (p<0.05). The results of random assay showed strong agreement with the batch assay in a day. These results suggest that random assay using automatic dispenser could be used in radioimmunoassay

  5. Antares: preliminary demonstrator results

    International Nuclear Information System (INIS)

    Kouchner, A.

    2000-05-01

    The ANTARES collaboration is building an undersea neutrino telescope off Toulon (Mediterranean sea) with effective area ∼ 0.1 km 2 . An extensive study of the site properties has been achieved together with software analysis in order to optimize the performance of the detector. Results are summarized here. An instrumented line, linked to shore for first time via an electro-optical cable, has been immersed late 1999. The preliminary results of this demonstrator line are reported. (author)

  6. A versatile electrowetting-based digital microfluidic platform for quantitative homogeneous and heterogeneous bio-assays

    Science.gov (United States)

    Vergauwe, Nicolas; Witters, Daan; Ceyssens, Frederik; Vermeir, Steven; Verbruggen, Bert; Puers, R