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Sample records for standard assay procedures

  1. Standard Evaluation Procedures (SEPs) and Data Entry Spreadsheet Templates (DESTs) for Endocrine Disruptor Screening Program (EDSP) Tier 1 Assays

    Science.gov (United States)

    This page provides information and access to Standard Evaluation Procedures (SEPs) and Data Entry Spreadsheet Templates (DESTs) developed by EPA's Office of Chemical Safety and Pollution Prevention (OCSPP).

  2. 42 CFR 493.1251 - Standard: Procedure manual.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Procedure manual. 493.1251 Section 493... Systems § 493.1251 Standard: Procedure manual. (a) A written procedure manual for all tests, assays, and.... (b) The procedure manual must include the following when applicable to the test procedure: (1...

  3. Radiation control standards and procedures

    Energy Technology Data Exchange (ETDEWEB)

    1956-12-14

    This manual contains the Radiation Control Standards'' and Radiation Control Procedures'' at Hanford Operations which have been established to provide the necessary control radiation exposures within Irradiation Processing Department. Provision is also made for including, in the form of Bulletins'', other radiological information of general interest to IPD personnel. The purpose of the standards is to establish firm radiological limits within which the Irradiation Processing Department will operate, and to outline our radiation control program in sufficient detail to insure uniform and consistent application throughout all IPD facilities. Radiation Control Procedures are intended to prescribe the best method of accomplishing an objective within the limitations of the Radiation Control Standards. A procedure may be changed at any time provided the suggested changes is generally agreeable to management involved, and is consistent with department policies and the Radiation Control Standards.

  4. 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

  5. Is the Comet Assay a Sensitive Procedure for Detecting Genotoxicity?

    Directory of Open Access Journals (Sweden)

    Satomi Kawaguchi

    2010-01-01

    Full Text Available Although the Comet assay, a procedure for quantitating DNA damage in mammalian cells, is considered sensitive, it has never been ascertained that its sensitivity is higher than the sensitivity of other genotoxicity assays in mammalian cells. To determine whether the power of the Comet assay to detect a low level of genotoxic potential is superior to those of other genotoxicity assays in mammalian cells, we compared the results of Comet assay with those of micronucleus test (MN test. WTK1 human lymphoblastoid cells were exposed to methyl nitrosourea (MNU, ethyl nitrosourea (ENU, methyl methanesulfonate (MMS, ethyl methanesulfonate (EMS, bleomycin (BLM, or UVC. In Comet assay, cells were exposed to each mutagen with (Comet assay/araC and without (Comet assay DNA repair inhibitors (araC and hydroxyurea. Furthermore, acellular Comet assay (acellular assay was performed to determine how single-strand breaks (SSBs as the initial damage contributes to DNA migration and/or to micronucleus formation. The lowest genotoxic dose (LGD, which is defined as the lowest dose at which each mutagen causes a positive response on each genotoxicity assay, was used to compare the power of the Comet assay to detect a low level of genotoxic potential and that of MN test; that is, a low LGD indicates a high power. Results are summarized as follows: (1 for all mutagens studied, LGDs were MN test ≦ Comet assay; (2 except for BLM, LGDs were Comet assay/araC ≦ MN test; (3 except for UVC and MNU, LGDs were acellular assay ≦ Comet assay/araC ≦ MN test ≦ Comet assay. The following is suggested by the present findings: (1 LGD in the Comet assay is higher than that in MN test, which suggests that the power of the MN test to detect a low level of genotoxic potential is superior to that of the Comet assay; (2 for the studied mutagens, all assays were able to detect all mutagens correctly, which suggests that the sensitivity of the Comet assay and that of the MN test were

  6. Multicenter Evaluation of Cystatin C Measurement after Assay Standardization.

    Science.gov (United States)

    Bargnoux, Anne-Sophie; Piéroni, Laurence; Cristol, Jean-Paul; Kuster, Nils; Delanaye, Pierre; Carlier, Marie-Christine; Fellahi, Soraya; Boutten, Anne; Lombard, Christine; González-Antuña, Ana; Delatour, Vincent; Cavalier, Etienne

    2017-04-01

    Since 2010, a certified reference material ERM-DA471/IFCC has been available for cystatin C (CysC). This study aimed to assess the sources of uncertainty in results for clinical samples measured using standardized assays. This evaluation was performed in 2015 and involved 7 clinical laboratories located in France and Belgium. CysC was measured in a panel of 4 serum pools using 8 automated assays and a candidate isotope dilution mass spectrometry reference measurement procedure. Sources of uncertainty (imprecision and bias) were evaluated to calculate the relative expanded combined uncertainty for each CysC assay. Uncertainty was judged against the performance specifications derived from the biological variation model. Only Siemens reagents on the Siemens systems and, to a lesser extent, DiaSys reagents on the Cobas system, provided results that met the minimum performance criterion calculated according to the intraindividual and interindividual biological variations. Although the imprecision was acceptable for almost all assays, an increase in the bias with concentration was observed for Gentian reagents, and unacceptably high biases were observed for Abbott and Roche reagents on their own systems. This comprehensive picture of the market situation since the release of ERM-DA471/IFCC shows that bias remains the major component of the combined uncertainty because of possible problems associated with the implementation of traceability. Although some manufacturers have clearly improved their calibration protocols relative to ERM-DA471, most of them failed to meet the criteria for acceptable CysC measurements. © 2016 American Association for Clinical Chemistry.

  7. Standardized procedure for tsunami PRA by AESJ

    International Nuclear Information System (INIS)

    Kirimoto, Yukihiro; Yamaguchi, Akira; Ebisawa, Katsumi

    2013-01-01

    After Fukushima Accident (March 11, 2011), the Atomic Energy Society of Japan (AESJ) started to develop the standard of Tsunami Probabilistic Risk Assessment (PRA) for nuclear power plants in May 2011. As Japan is one of the countries with frequent earthquakes, a great deal of efforts has been made in the field of seismic research since the early stage. To our regret, the PRA procedures guide for tsunami has not yet been developed although the importance is held in mind of the PRA community. Accordingly, AESJ established a standard to specify the standardized procedure for tsunami PRA considering the results of investigation into the concept, the requirements that should have and the concrete methods regarding tsunami PRA referring the opinions of experts in the associated fields in December 2011 (AESJ-SC-RK004:2011). (author)

  8. Standard manufacturing procedure of Tamra Bhasma.

    Science.gov (United States)

    Jagtap, Chandrashekhar Y; Prajapati, Pradeep Kumar; Patgiri, Biswajyoti; Shukla, Vinay J

    2012-10-01

    Tamra Bhasma (incinerated copper) is one of the main weapons in the archery of Ayurvedic practitioners. Though several methods of preparation of Tamra Bhasma (TB) are found in Rasashastra classics, several difficulties occur during the preparation of a good-quality Bhasma. In this study, TB was prepared and analyzed to develop the standard manufacturing procedure. Each unit operative procedure was considered as an independent processing and an attempt was made to validate each procedure. Wire used for the purpose of electrical earthing was taken for the preparation of Bhasma. Procedures of Shodhana, Marana, and Amritikarana were followed as per the classical references. Specific temperature pattern was adopted for Puta in the electrical muffle furnace. From 500 g of Tamra, 483.4 g of black colored TB was obtained after subjecting to three Putas. Final product was detected to be cupric sulfide in X-ray diffraction. In particle size distribution analysis 10% of the material was below the size of 2 μm, while in inductive coupled plasma - atomic absorption spectrometry 58.56 wt% copper and 22.48 wt% of sulfur were found present in the final product along with the elements such as arsenic, lead, zinc, mercury, and manganese in traces.

  9. Standardization of portable assay instrumentation: the neutron-coincidence tree

    International Nuclear Information System (INIS)

    Menlove, H.O.

    1983-01-01

    Standardization of portable neutron assay instrumentation has been achieved by using the neutron coincidence technique as a common basis for a wide range of instruments and applications. The electronics originally developed for the High-Level Neutron Coincidence Counter has been adapted to both passive- and active-assay instrumentation for field verification of bulk plutonium, inventory samples, pellets, powders, nitrates, high-enriched uranium, and materials-testing-reactor, light-water-reactor, and mixed-oxide fuel assemblies. The family of detectors developed at Los Alamos National Laboratory and their performance under in-field conditions are described. 16 figures, 3 tables

  10. Qualification of standard membrane-feeding assay with Plasmodium falciparum malaria and potential improvements for future assays.

    Directory of Open Access Journals (Sweden)

    Kazutoyo Miura

    Full Text Available Vaccines that interrupt malaria transmission are of increasing interest and a robust functional assay to measure this activity would promote their development by providing a biologically relevant means of evaluating potential vaccine candidates. Therefore, we aimed to qualify the standard membrane-feeding assay (SMFA. The assay measures the transmission-blocking activity of antibodies by feeding cultured P. falciparum gametocytes to Anopheles mosquitoes in the presence of the test antibodies and measuring subsequent mosquito infection. The International Conference on Harmonisation (ICH Harmonised Tripartite Guideline Q2(R1 details characteristics considered in assay validation. Of these characteristics, we decided to qualify the SMFA for Precision, Linearity, Range and Specificity. The transmission-blocking 4B7 monoclonal antibody was tested over 6 feeding experiments at several concentrations to determine four suitable concentrations that were tested in triplicate in the qualification experiments (3 additional feeds to evaluate Precision, Linearity and Range. For Specificity, 4B7 was tested in the presence of normal mouse IgG. We determined intra- and inter-assay variability of % inhibition of mean oocyst intensity at each concentration of 4B7 (lower concentrations showed higher variability. We also showed that % inhibition was dependent on 4B7 concentration and the activity is specific to 4B7. Since obtaining empirical data is time-consuming, we generated a model using data from all 9 feeds and simulated the effects of different parameters on final readouts to improve the assay procedure and analytical methods for future studies. For example, we estimated the effect of number of mosquitoes dissected on variability of % inhibition, and simulated the relationship between % inhibition in oocyst intensity and % inhibition of prevalence of infected mosquitos at different mean oocysts in the control. SMFA is one of the few biological assays used in

  11. 21 CFR 120.6 - Sanitation standard operating procedures.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Sanitation standard operating procedures. 120.6... Provisions § 120.6 Sanitation standard operating procedures. (a) Sanitation controls. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation...

  12. Standardization of Neisseria meningitidis Serogroup B Colorimetric Serum Bactericida Assay

    Science.gov (United States)

    Rodríguez, Tamara; Lastre, Miriam; Cedré, Barbara; Campo, Judith del; Bracho, Gustavo; Zayas, Caridad; Taboada, Carlos; Díaz, Miriam; Sierra, Gustavo; Pérez, Oliver

    2002-01-01

    The correlate of protection for serogroup B meningococci is not currently known, but for serogroup C it is believed to be the serum bactericidal assay (SBA). The current SBAs are labor intensive and the variations in protocols among different laboratories make interpretation of results difficult. A colorimetric SBA (cSBA), based on the ability of Neisseria meningitidis serogroup B to consume glucose, leading to acid production, was standardized by using group B strain Cu385-83 as the target. The cSBA results were compared to those obtained for a traditional colony-counting microassay (mSBA). Glucose and bromocresol purple pH indicator were added to the medium in order to estimate growth of cSBA target cell survivors through color change. Different variants of the assay parameters were optimized: growth of target cells (Mueller Hinton agar plates), target cell number (100 CFU/per well), and human complement source used at a final concentration of 25%. After the optimization, three other group B strains (H44/76, 490/91, and 511/91) were used as targets for the cSBA. The selection of the assay parameters and the standardization of cSBA were done with 13 sera from vaccinated volunteers. The titers were determined as the higher serum dilution that totally inhibited the bacterial growth marked by the color invariability of the pH indicator. This was detected visually as well as spectrophotometrically and was closely related to a significant difference in the growth of target cell survivors determined using Student’s t test. Intralaboratory reproducibility was ±1 dilution. The correlation between bactericidal median titers and specific immunoglobulin G serum concentration by enzyme immunoassay was high (r = 0.910, P < 0.01). The bactericidal titers generated by the cSBA and the mSBA were nearly identical, and there was a high correlation between the two assays (r = 0.974, P < 0.01). The standardized cSBA allows easy, fast, and efficient evaluation of samples. PMID

  13. 40 CFR 761.79 - Decontamination standards and procedures.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Decontamination standards and..., AND USE PROHIBITIONS Storage and Disposal § 761.79 Decontamination standards and procedures. (a) Applicability. This section establishes decontamination standards and procedures for removing PCBs, which are...

  14. Operability test procedure for TRUSAF assayer software upgrade

    International Nuclear Information System (INIS)

    Cejka, C.C.

    1995-01-01

    This OTP is to be used to ensure the operability of the Transuranic Waste Assay System (TRUWAS). The system was upgraded and requires a retest to assure satisfactory operation. The upgrade consists of an AST 486 computer to replace the IBM-PC/XT, and a software upgrade (CNEUT). The software calculations are performed in the same manner as in the previous system (NEUT), however, the new software is written in C Assembly Language. CNEUT is easier to use and far more powerful than the previous program. The TRUWAS is used to verify the TRU content of waste packages sent for storage in the Transuranic Storage and Assay Facility (TRUSAF). The TRUSAF is part of Westinghouse Hanford's certification program for waste to be shipped to the Waste Isolation Pilot Plant (WIPP) in New Mexico. The Transuranic Waste Assayer uses a combination passive-active neutron interrogation system to determine the TRU content of 55-gallon waste drums. The system consists of a shielded assay chamber; Deuterium-Tritium neutron generator; Helium-3 proportional counters; drum handling system; electronics including preamplifier, amplifier, and discriminator for each of the counter packages; and an AST 486 computer/printer system for data acquisition and analysis. The system can detect down to TRU levels of 10 nCi/g in the waste matrix. The equipment to be tested is: Assay Chamber Door Drum Turntable and Automatic Loading Platform Interlocks Assayer Software; and IBM computer/printer software. The objective of the test is to verify that the system is operational with the AST 486 computer, the software used in the new computer system correctly calculates TRU levels, and the new computer system is capable of storing and retrieving data

  15. Standard-E hydrogen monitoring system shop acceptance test procedure

    Energy Technology Data Exchange (ETDEWEB)

    Schneider, T.C.

    1997-10-02

    The purpose of this report is to document that the Standard-E Hydrogen Monitoring Systems (SHMS-E), fabricated by Mid-Columbia Engineering (MCE) for installation on the Waste Tank Farms in the Hanford 200 Areas, are constructed as intended by the design. The ATP performance will verify proper system fabrication.

  16. Standard manufacturing procedure of Teekshna lauha bhasma

    Directory of Open Access Journals (Sweden)

    Thakur Rakesh Singh

    2016-04-01

    Conclusion: Pharmaceutical procedures given in Ayurvedic texts are necessary to prepare pakwa jambu phala varna T. lauha bhasma that complies with all the classical bhasma pariksha and modern analytical parameters in 20 puta at a temperature of 650 °C maintained for 1 h in EMF.

  17. Analytical Tools to Improve Optimization Procedures for Lateral Flow Assays.

    Science.gov (United States)

    Hsieh, Helen V; Dantzler, Jeffrey L; Weigl, Bernhard H

    2017-05-28

    Immunochromatographic or lateral flow assays (LFAs) are inexpensive, easy to use, point-of-care medical diagnostic tests that are found in arenas ranging from a doctor's office in Manhattan to a rural medical clinic in low resource settings. The simplicity in the LFA itself belies the complex task of optimization required to make the test sensitive, rapid and easy to use. Currently, the manufacturers develop LFAs by empirical optimization of material components (e.g., analytical membranes, conjugate pads and sample pads), biological reagents (e.g., antibodies, blocking reagents and buffers) and the design of delivery geometry. In this paper, we will review conventional optimization and then focus on the latter and outline analytical tools, such as dynamic light scattering and optical biosensors, as well as methods, such as microfluidic flow design and mechanistic models. We are applying these tools to find non-obvious optima of lateral flow assays for improved sensitivity, specificity and manufacturing robustness.

  18. 77 FR 12454 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2012-03-01

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30829; Amdt. No. 3467] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule...

  19. Analytical Tools to Improve Optimization Procedures for Lateral Flow Assays

    Directory of Open Access Journals (Sweden)

    Helen V. Hsieh

    2017-05-01

    Full Text Available Immunochromatographic or lateral flow assays (LFAs are inexpensive, easy to use, point-of-care medical diagnostic tests that are found in arenas ranging from a doctor’s office in Manhattan to a rural medical clinic in low resource settings. The simplicity in the LFA itself belies the complex task of optimization required to make the test sensitive, rapid and easy to use. Currently, the manufacturers develop LFAs by empirical optimization of material components (e.g., analytical membranes, conjugate pads and sample pads, biological reagents (e.g., antibodies, blocking reagents and buffers and the design of delivery geometry. In this paper, we will review conventional optimization and then focus on the latter and outline analytical tools, such as dynamic light scattering and optical biosensors, as well as methods, such as microfluidic flow design and mechanistic models. We are applying these tools to find non-obvious optima of lateral flow assays for improved sensitivity, specificity and manufacturing robustness.

  20. 42 CFR 493.1256 - Standard: Control procedures.

    Science.gov (United States)

    2010-10-01

    ... results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Control procedures. 493.1256 Section 493... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic...

  1. JSC Design and Procedural Standards, JSC-STD-8080

    Science.gov (United States)

    Punch, Danny T.

    2011-01-01

    This document provides design and procedural requirements appropriate for inclusion in specifications for any human spaceflight program, project, spacecraft, system, or end item. The term "spacecraft" as used in the standards includes launch vehicles, orbital vehicles, non-terrestrial surface vehicles, and modules. The standards are developed and maintained as directed by Johnson Space Center (JSC) Policy Directive JPD 8080.2, JSC Design and Procedural Standards for Human Space Flight Equipment. The Design and Procedural Standards contained in this manual represent human spacecraft design and operational knowledge applicable to a wide range of spaceflight activities. These standards are imposed on JSC human spaceflight equipment through JPD 8080.2. Designers shall comply with all design standards applicable to their design effort.

  2. The use of calibration standards and the correction for sample self-attenuation in gamma-ray nondestructive assay

    International Nuclear Information System (INIS)

    Parker, J.L.

    1986-11-01

    The efficient use of appropriate calibration standards and the correction for the attenuation of the gamma rays within an assay sample by the sample itself are two important and closely related subjects in gamma-ray nondestructive assay. Much research relating to those subjects has been done in the Nuclear Safeguards Research and Development program at the Los Alamos National Laboratory since 1970. This report brings together most of the significant results of that research. Also discussed are the nature of appropriate calibration standards and the necessary conditions on the composition, size, and shape of the samples to allow accurate assays. Procedures for determining the correction for the sample self-attenuation are described at length including both general principles and several specific useful cases. The most useful concept is that knowing the linear attenuation coefficient of the sample (which can usually be determined) and the size and shape of the sample and its position relative to the detector permits the computation of the correction factor for the self-attenuation. A major objective of the report is to explain how the procedures for determining the self-attenuation correction factor can be applied so that calibration standards can be entirely appropriate without being particularly similar, either physically or chemically, to the items to be assayed. This permits minimization of the number of standards required to assay items with a wide range of size, shape, and chemical composition

  3. 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.

  4. Comparative evaluation of two radioenzymatic procedures designed to determine noradrenaline in the plasma (COMT assay and PNMT assay)

    International Nuclear Information System (INIS)

    Barth, A.

    1984-01-01

    A comparative evaluation of two radioenzymatic procedures to determine the concentration of noradrenaline in the plasma - with linearity, sensitivity, specifity and accuracy serving as test criteria - led to the following results: In view of a probability of error in the order of 2% both methods were judged to show a satisfactory sensitivity. The specific of the COMT assay, by contrast with that of the PNMT assay, was found to be wanting, as the noradrenaline measurements in the presence of other biogenic amines were biassed in such a way that the values determined were higher than the actual concentrations. During antihypertensive treatment even minimal changes in the noradrenaline concentration can be ascertained on a quantitative basis. If suitable hardware is available, the COMT assay permits up to 25 single determinations to be carried out per day, while the number of double determinations is restricted to 7 per day. One advantage, however, lies in the fact that several catecholamines in the plasma can be detected simultaneously, if required. In cases where the noradrenaline concentration alone is to be determined for clinical purposes, preference should be given to the PNMT assay, as both tests showed equal linearity and sensitivity. (TRV) [de

  5. Standard test method for nondestructive assay of radioactive material by tomographic gamma scanning

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This test method describes the nondestructive assay (NDA) of gamma ray emitting radionuclides inside containers using tomographic gamma scanning (TGS). High resolution gamma ray spectroscopy is used to detect and quantify the radionuclides of interest. The attenuation of an external gamma ray transmission source is used to correct the measurement of the emission gamma rays from radionuclides to arrive at a quantitative determination of the radionuclides present in the item. 1.2 The TGS technique covered by the test method may be used to assay scrap or waste material in cans or drums in the 1 to 500 litre volume range. Other items may be assayed as well. 1.3 The test method will cover two implementations of the TGS procedure: (1) Isotope Specific Calibration that uses standards of known radionuclide masses (or activities) to determine system response in a mass (or activity) versus corrected count rate calibration, that applies to only those specific radionuclides for which it is calibrated, and (2) Respo...

  6. Standard Review Plan Maintenance Program implementing procedures document

    International Nuclear Information System (INIS)

    1996-11-01

    The implementing Procedures Document (IPD) was developed by the Inspection Program Projects Branch, Office of Nuclear Reactor Regulation, with assistance from Pacific Northwest National Laboratory, for the Standard Review Plan Maintenance Program (SRP-MP). The SRP-MP was established to maintain the Standard Review Plan (SRP) on an on-going basis. The IPD provides guidance, including an overall approach and procedures, for SRP-MP tasks. The objective of the IPD is to ensure that modifications to SRP need to reflect current NRC requirements and guidance are identified and that a consistent methodology is used to develop and revise SRP sections

  7. Standard Review Plan Update and Development Program. Implementing Procedures Document

    Energy Technology Data Exchange (ETDEWEB)

    1992-05-01

    This implementing procedures document (IPD) was prepared for use in implementing tasks under the standard review plan update and development program (SRP-UDP). The IPD provides comprehensive guidance and detailed procedures for SRP-UDP tasks. The IPD is mandatory for contractors performing work for the SRP-UDP. It is guidance for the staff. At the completion of the SRP-UDP, the IPD will be revised (to remove the UDP aspects) and will replace NRR Office Letter No. 800 as long-term maintenance procedures.

  8. Standardized methods for photography in procedural dermatology using simple equipment.

    Science.gov (United States)

    Hexsel, Doris; Hexsel, Camile L; Dal'Forno, Taciana; Schilling de Souza, Juliana; Silva, Aline F; Siega, Carolina

    2017-04-01

    Photography is an important tool in dermatology. Reproducing the settings of before photos after interventions allows more accurate evaluation of treatment outcomes. In this article, we describe standardized methods and tips to obtain photographs, both for clinical practice and research procedural dermatology, using common equipment. Standards for the studio, cameras, photographer, patients, and framing are presented in this article. © 2017 The International Society of Dermatology.

  9. 21 CFR 58.81 - Standard operating procedures.

    Science.gov (United States)

    2010-04-01

    ... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Standard operating procedures. 58.81 Section 58.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD...

  10. Standard guide for making quality nondestructive assay measurements

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This guide is a compendium of Quality Measurement Practices for performing measurements of radioactive material using nondestructive assay (NDA) instruments. The primary purpose of the guide is to assist users in arriving at quality NDA results, that is, results that satisfy the end user’s needs. This is accomplished by providing an acceptable and uniform basis for the collection, analysis, comparison, and application of data. The recommendations are not compulsory or prerequisites to achieving quality NDA measurements, but are considered contributory in most areas. 1.2 This guide applies to the use of NDA instrumentation for the measurement of nuclear materials by the observation of spontaneous or stimulated nuclear radiations, including photons, neutrons, or the flow of heat. Recommended calibration, operating, and assurance methods represent guiding principles based on current NDA technology. The diversity of industry-wide nuclear materials measurement applications and instrumentation precludes disc...

  11. Creatinine Assay Attainment of Analytical Performance Goals Following Implementation of IDMS Standardization

    Directory of Open Access Journals (Sweden)

    Elizabeth Sunmin Lee

    2017-02-01

    Full Text Available Background: The international initiative to standardize creatinine (Cr assays by tracing reference materials to Isotope Dilution Mass Spectrometry (IDMS assigned values was implemented to reduce interlaboratory variability and improve assay accuracy. Objective: The aims of this study were to examine whether IDMS standardization has improved Cr assay accuracy (bias, interlaboratory variability (precision, total error (TE, and attainment of recommended analytical performance goals. Methods: External Quality Assessment (EQA data (n = 66 challenge vials from Ontario, Canada, were analyzed. The bias, precision, TE, and the number of EQA challenge vials meeting performance goals were determined by assay manufacturer before (n = 32 and after (n = 34 IDMS implementation. Results: The challenge vials with the worst bias and precision were spiked with known common interfering substances (glucose and bilirubin. IDMS standardization improved assay bias (10.4%-1.6%, P < .001, but precision remained unchanged (5.0%-4.7%, P = .5 with performance goals not consistently being met. Precision and TE goals based on biologic variation were attained by only 29% to 69% and 32% to 62% of challenge vials. Conclusions: While IDMS standardization has improved Cr assay accuracy and thus reduced TE, significant interlaboratory variability remains. Contemporary Cr assays do not currently meet the standards required to allow for accurate and consistent estimated glomerular filtration rate assessment and chronic kidney disease diagnosis across laboratories. Further improvements in Cr assay performance are needed.

  12. Hip arthroplasty in obese patients: rising prevalence – standard procedures?

    Directory of Open Access Journals (Sweden)

    Michael Skutek

    2016-06-01

    Full Text Available We examined our experience and, in particular, complications associated with total hip arthroplasty in obese and morbidly obese patients. We prospectively gathered 50 patients in a matched control series including 25 obese and morbidly obese patients. All patients were operated using the direct lateral approach and standard postoperative protocols. Operating room time, complications, dislocations, blood loss, cup position and clinical parameters using the Harris Hip Score and the Western Ontario and McMaster Universities Arthritis Index results were compared. Although there were some significant differences in clinical outcomes, standard procedures yielded good overall results and an acceptable rate of complications. Details approaching this patient entity are being discussed.

  13. The European Stroke Organisation Guidelines: a standard operating procedure

    DEFF Research Database (Denmark)

    Ntaios, George; Bornstein, Natan M; Caso, Valeria

    2015-01-01

    In 2008, the recently founded European Stroke Organisation published its guidelines for the management of ischemic stroke and transient ischemic attack. This highly cited document was translated in several languages and was updated in 2009. Since then, the European Stroke Organisation has published...... pace with this progress and driven by the strong determination of the European Stroke Organisation to further promote stroke management, education, and research, the European Stroke Organisation decided to delineate a detailed standard operating procedure for its guidelines. There are two important...... cornerstones in this standard operating procedure: The first is the implementation of the Grading of Recommendations Assessment, Development, and Evaluation methodology for the development of its Guideline Documents. The second one is the decision of the European Stroke Organisation to move from the classical...

  14. Inter-laboratory variation in DNA damage using a standard comet assay protocol

    DEFF Research Database (Denmark)

    Forchhammer, Lykke; Ersson, Clara; Loft, Steffen

    2012-01-01

    There are substantial inter-laboratory variations in the levels of DNA damage measured by the comet assay. The aim of this study was to investigate whether adherence to a standard comet assay protocol would reduce inter-laboratory variation in reported values of DNA damage. Fourteen laboratories ...

  15. Quality assurance: Importance of systems and standard operating procedures

    OpenAIRE

    Kishu Manghani

    2011-01-01

    It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality...

  16. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

    Science.gov (United States)

    Tuck, Melissa K; Chan, Daniel W; Chia, David; Godwin, Andrew K; Grizzle, William E; Krueger, Karl E; Rom, William; Sanda, Martin; Sorbara, Lynn; Stass, Sanford; Wang, Wendy; Brenner, Dean E

    2009-01-01

    Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

  17. 75 FR 72942 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-11-29

    ...: Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions..., SD, Rapid City Rgnl, ILS OR LOC RWY 32, Amdt 19 Newport News, VA, Newport News/Williamsburg Intl, ILS OR LOC RWY 7, Amdt 33 Newport News, VA, Newport News/Williamsburg Intl, ILS OR LOC RWY 25, Amdt 1...

  18. Standardization of SMP procedure and its impact on outcome

    Directory of Open Access Journals (Sweden)

    Rachita S Dhurat

    2017-01-01

    Full Text Available Background: Cosmetic deformities can result from various types of alopecia or even post hair transplantation procedures. Patients with such deformities seek aesthetically appealing longer-lasting options. Scalp concealers are commonly used by men and women to camouflage these deformities. Scalp micropigmentation (SMP is one of the concealers recently gaining popularity. Objectives: SMP is a novel technique wherein microdot tattoos are placed in a stippling pattern to mimic hair follicles that are cut close to the scalp and various variables affecting its outcome were evaluated. Methods: Forty-five subjects were recruited for the study. The various factors affecting outcome of SMP—angle of needle against the scalp, depth of needle into the scalp, time of the needle contact in scalp, speed of the rotor, resistance of scalp, color of pigment, viscosity of dye, needle number, needle thickness, and pattern of dot placement—were systematically studied in 15 patients through clinical photographs and trichoscopy. Ideal depth of pigment deposition was assessed through histopathological examination. After using these optimum variables, standardized SMP was performed in 30 patients with hair loss (3 patients with cicatricial and 27 patients with diffuse non-cicatricial alopecia. SMP was also used to create an aesthetically denser hairline. The outcome of the procedure was evaluated using standardized global photographs. Results: The ideal parameters were established to achieve standard reproducible results. There were great patient satisfaction and acceptance of the procedure. All the patients showed moderate to great improvement after the procedure with satisfactory scalp coverage. Adverse events were transient which were seen in the form of edema and redness. Conclusion: SMP offers a non-medical, tattoo-based cosmetically appealing and effective “cover-up” that hides the unsightly conditions. The cosmetic tattoo placement creates an illusion of

  19. Standard working procedures in production of traditionally fermented Sremska sausage

    Directory of Open Access Journals (Sweden)

    Vesković-Moračanin Slavica

    2011-01-01

    Full Text Available Investigations conducted within project "Techonological and protective characteristics of autochthonous strains of lactic acid bacteria isolated from traditional fermented sausages and possibilities for their implementation in the meat industry" (Project Number: 20127, financed on behalf of the Ministry for Science and Technology of the Republic of Serbia, have provided an answer on the characteristics of the quality of the used raw materials for the production of Sremska sausage - one of the most well-known Serbian traditionally fermented sausages (choice of meat, fatty tissue, additives and spices, and data have been registered in connection with the procedures of their processing, microclimatic conditions have been established (temperature, relative humidity, and air circulation during the entire process of production and fermentation, as well as the presence and types of microorganisms, primarily lactic acid bacteria (BMK, the carrier of lactic fermentation. The most important characteristics of the filling have been established, the smoking regimen, the regimens of fermentation, maturing, drying, as well as the parameters for quality and safety of the finished product. At the same time, the standard working procedure has been determined for the preparation of the meat, fatty tissue, the forming and inserting of the filling into the wrappers, as well as the characteristics of the finished products. The given standard working procedure should serve as a guideline for the meat industry in the production process of this traditional fermented sausage.

  20. Environmental Sciences Division Toxicology Laboratory standard operating procedures

    Energy Technology Data Exchange (ETDEWEB)

    Kszos, L.A.; Stewart, A.J.; Wicker, L.F.; Logsdon, G.M.

    1989-09-01

    This document was developed to provide the personnel working in the Environmental Sciences Division's Toxicology Laboratory with documented methods for conducting toxicity tests. The document consists of two parts. The first part includes the standard operating procedures (SOPs) that are used by the laboratory in conducting toxicity tests. The second part includes reference procedures from the US Environmental Protection Agency document entitled Short-Term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater Organisms, upon which the Toxicology Laboratory's SOPs are based. Five of the SOPs include procedures for preparing Ceriodaphnia survival and reproduction test. These SOPs include procedures for preparing Ceriodaphnia food (SOP-3), maintaining Ceriodaphnia cultures (SOP-4), conducting the toxicity test (SOP-13), analyzing the test data (SOP-13), and conducting a Ceriodaphnia reference test (SOP-15). Five additional SOPs relate specifically to the fathead minnow (Pimephales promelas) larval survival and growth test: methods for preparing fathead minnow larvae food (SOP-5), maintaining fathead minnow cultures (SOP-6), conducting the toxicity test (SOP-9), analyzing the test data (SOP-12), and conducting a fathead minnow reference test (DOP-14). The six remaining SOPs describe methods that are used with either or both tests: preparation of control/dilution water (SOP-1), washing of glassware (SOP-2), collection and handling of samples (SOP-7), preparation of samples (SOP-8), performance of chemical analyses (SOP-11), and data logging and care of technical notebooks (SOP-16).

  1. The European Stroke Organisation Guidelines: a standard operating procedure.

    Science.gov (United States)

    Ntaios, George; Bornstein, Natan M; Caso, Valeria; Christensen, Hanne; De Keyser, Jacques; Diener, Hans-Christoph; Diez-Tejedor, Exuperio; Ferro, Jose M; Ford, Gary A; Grau, Armin; Keller, Emanuella; Leys, Didier; Russell, David; Toni, Danilo; Turc, Guillaume; Van der Worp, Bart; Wahlgren, Nils; Steiner, Thorsten

    2015-10-01

    In 2008, the recently founded European Stroke Organisation published its guidelines for the management of ischemic stroke and transient ischemic attack. This highly cited document was translated in several languages and was updated in 2009. Since then, the European Stroke Organisation has published guidelines for the management of intracranial aneurysms and subarachnoidal hemorrhage, for the establishment of stroke units and stroke centers, and recently for the management of intracerebral hemorrhage. In recent years, the methodology for the development of guidelines has evolved significantly. To keep pace with this progress and driven by the strong determination of the European Stroke Organisation to further promote stroke management, education, and research, the European Stroke Organisation decided to delineate a detailed standard operating procedure for its guidelines. There are two important cornerstones in this standard operating procedure: The first is the implementation of the Grading of Recommendations Assessment, Development, and Evaluation methodology for the development of its Guideline Documents. The second one is the decision of the European Stroke Organisation to move from the classical model of a single Guideline Document about a major topic (e.g. management of ischemic stroke) to focused modules (i.e. subdivisions of a major topic). This will enable the European Stroke Organisation to react faster when new developments in a specific stroke field occur and update its recommendations on the related module rather swiftly; with the previous approach of a single large Guideline Document, its entire revision had to be completed before an updated publication, delaying the production of up-to-date guidelines. After discussion within the European Stroke Organisation Guidelines Committee and significant input from European Stroke Organisation members as well as methodologists and analysts, this document presents the official standard operating procedure for

  2. "Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

    Science.gov (United States)

    Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

    2016-01-01

    The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

  3. Standardizing electrophoresis conditions: how to eliminate a major source of error in the comet assay.

    Directory of Open Access Journals (Sweden)

    Gunnar Brunborg

    2015-06-01

    Full Text Available In the alkaline comet assay, cells are embedded in agarose, lysed, and then subjected to further processing including electrophoresis at high pH (>13. We observed very large variations of mean comet tail lengths of cell samples from the same population when spread on a glass or plastic substrate and subjected to electrophoresis. These variations might be cancelled out if comets are scored randomly over a large surface, or if all the comets are scored. The mean tail length may then be representative of the population, although its standard error is large. However, the scoring process often involves selection of 50 – 100 comets in areas selected in an unsystematic way from a large gel on a glass slide. When using our 96-sample minigel format (1, neighbouring sample variations are easily detected. We have used this system to study the cause of the comet assay variations during electrophoresis and we have defined experimental conditions which reduce the variations to a minimum. We studied the importance of various physical parameters during electrophoresis: (i voltage; (ii duration of electrophoresis; (iii electric current; (iv temperature; and (v agarose concentration. We observed that the voltage (V/cm varied substantially during electrophoresis, even within a few millimetres of distance between gel samples. Not unexpectedly, both the potential ( V/cm and the time were linearly related to the mean comet tail, whereas the current was not. By measuring the local voltage with microelectrodes a few millimetres apart, we observed substantial local variations in V/cm, and they increased with time. This explains the large variations in neighbouring sample comet tails of 25% or more. By introducing simple technology (circulation of the solution during electrophoresis, and temperature control, these variations in mean comet tail were largely abolished, as were the V/cm variations. Circulation was shown to be particularly important and optimal conditions

  4. Standard Operating Procedures for Female Genital Sexual Pain

    DEFF Research Database (Denmark)

    Fugl-Meyer, Kerstin S; Bohm-Starke, Nina; Damsted Petersen, Christina

    2012-01-01

    and psychological disorders are highlighted, and different somatic and psychological assessment and treatment modalities are discussed. Methods.  The Standard Operating Procedures (SOP) committee was composed of a chair and five additional experts. No corporate funding or remuneration was received. The authors...... therapeutic interventions. However, this international expert group will recommend guidelines for management of female GSP. Conclusions.  GSP disorders are complex. It is recommended that their evaluation and treatment are performed through comprehensive somato-psychological multidisciplinary approach. Fugl......Introduction.  Female genital sexual pain (GSP) is a common, distressing complaint in women of all ages that is underrecognized and undertreated. Definitions and terminology for female GSP are currently being debated. While some authors have suggested that GSP is not per se a sexual dysfunction...

  5. Quality assurance: Importance of systems and standard operating procedures.

    Science.gov (United States)

    Manghani, Kishu

    2011-01-01

    It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

  6. Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies

    Science.gov (United States)

    Grangeot-Keros, Liliane; Vauloup-Fellous, Christelle

    2015-01-01

    SUMMARY Rubella virus usually causes a mild infection in humans but can cause congenital rubella syndrome (CRS). Vaccination programs have significantly decreased primary rubella virus infection and CRS; however, vaccinated individuals usually have lower levels of rubella virus IgG than those with natural infections. Rubella virus IgG is quantified with enzyme immunoassays that have been calibrated against the World Health Organization (WHO) international standard and report results in international units per milliliter. It is recognized that the results reported by these assays are not standardized. This investigation into the reasons for the lack of standardization found that the current WHO international standard (RUB-1-94) fails by three key metrological principles. The standard is not a pure analyte but is composed of pooled human immunoglobulin. It was not calibrated by certified reference methods; rather, superseded tests were used. Finally, no measurement uncertainty estimations have been provided. There is an analytical and clinical consequence to the lack of standardization of rubella virus IgG assays, which leads to misinterpretation of results. The current approach to standardization of rubella virus IgG assays has not achieved the desired results. A new approach is required. PMID:26607813

  7. Standard procedures for pooling health physics data for epidemiologic studies

    International Nuclear Information System (INIS)

    Strom, D.J.; Beck, W.L.; Stansbury, P.S.; Tankersley, W.G.; Watson, J.E. Jr.

    1983-01-01

    The objectives of the study are: (1) to determine the availability of dosimetry data and supporting documentation at multiple facilities; (2) to develop criteria and methods for optimally retrieving data; (3) to evaluate and document the quality and completeness of data and dosimetry programs; (4) to put dosimetry data (e.g., external, whole body counting, and bioassay data) from various facilities in a single format for epidemiologic analysis; and (5) to document all work for peer review. To achieve these objectives, a ''Dosimetry Records and Radiation Hazards Questionnaire'' was developed to send to the facilities under study. Responses to this questionnaire are used to develop data retrieval criteria and methods, and to retrieve data. Dose data are reformatted into Standard Intermediate Dosimetry Files for editing and characterization. Evaluations of dosimetry programs are performed concurrently. Results of these steps are brought together and analysis files created. Status of this work in the context of the Department of Energy 5-Rem Study is reported. The standard procedures are applicable to single- as well as multiple-facility studies

  8. Measuring Cytotoxicity by Bioluminescence Imaging Outperforms the Standard Chromium-51 Release Assay

    Science.gov (United States)

    Karimi, Mobin A.; Lee, Eric; Bachmann, Michael H.; Salicioni, Ana Maria; Behrens, Edward M.; Kambayashi, Taku; Baldwin, Cynthia L.

    2014-01-01

    The chromium-release assay developed in 1968 is still the most commonly used method to measure cytotoxicity by T cells and by natural killer cells. Target cells are loaded in vitro with radioactive chromium and lysis is determined by measuring chromium in the supernatant released by dying cells. Since then, alternative methods have been developed using different markers of target cell viability that do not involve radioactivity. Here, we compared and contrasted a bioluminescence (BLI)-based cytotoxicity assay to the standard radioactive chromium-release assay using an identical set of effector cells and tumor target cells. For this, we stably transduced several human and murine tumor cell lines to express luciferase. When co-cultured with cytotoxic effector cells, highly reproducible decreases in BLI were seen in an effector to target cell dose-dependent manner. When compared to results obtained from the chromium release assay, the performance of the BLI-based assay was superior, because of its robustness, increased signal-to-noise ratio, and faster kinetics. The reduced/delayed detection of cytotoxicity by the chromium release method was attributable to the association of chromium with structural components of the cell, which are released quickly by detergent solubilization but not by hypotonic lysis. We conclude that the (BLI)-based measurement of cytotoxicity offers a superior non-radioactive alternative to the chromium-release assay that is more robust and quicker to perform. PMID:24586714

  9. Measuring and diagnosing unilateral neglect: a standardized statistical procedure.

    Science.gov (United States)

    Toraldo, Alessio; Romaniello, Cristian; Sommaruga, Paolo

    Unilateral neglect is usually investigated by adminstering stimuli (targets) in different positions, with targets being responded to by the patient (Hit) or omitted. In spite of this homogeneity of data type, neglect indices and diagnostic criteria vary considerably, causing inconsistencies in both clinical and experimental settings. We aimed at deriving a standard analysis which would apply to all tasks sharing this data form. A-priori theoretical reasoning demonstrated that the mean position of Hits in space (MPH) is an optimal index for correctly diagnosing and quantifying neglect. Crucially MPH eliminates the confounding effects of deficits that are different from neglect (non-lateral) but which decrease Hit rate. We ran a Monte Carlo study to assess MPH's (so far overlooked) statistical behavior as a function of numbers of targets and Hits. While average MPH was indeed insensitive to non-lateral deficits, MPH's variance (like that of all other neglect indices) increased dramatically with increasing non-lateral deficits. This instability would lead to alarmingly high false-positive rates (FPRs) when applying a classical diagnostic procedure that compares one patient with a control sample. We solved the problem by developing an equation that takes into account MPH instability and provides correct cut-offs and close-to-nominal FPRs, even without control subjects. We developed a computerized program which, given the raw data, yields the MPH, a z-score and a p-value. We provided a standard method that allows clinical and experimental neuropsychologists to diagnose and measure neglect in a consistent way across the vast majority of tasks.

  10. Standard formatted data units-control authority procedures

    Science.gov (United States)

    1991-01-01

    The purpose of this document is to establish a set of minimum and optional requirements for the implementation of Control Authority (CA) organizations within and among the Agencies participating in the Consultative Committee for Space Data Systems (CCSDS). By satisfying these requirements, the resultant cooperating set of CA organizations will produce a global CA service supporting information transfer with digital data under the Standard Formatted Data Unit (SFDU) concept. This service is primarily accomplished through the registration, permanent archiving, and dissemination of metadata in the form of Metadata Objects (MDO) that assist in the interpretation of data objects received in SFDU form. This Recommendation addresses the responsibilities, services, and interface protocols for a hierarchy of CA organizations. The top level, consisting of the CCSDS Secretariat and its operational agent, is unique and primarily provides a global coordination function. The lower levels are Agency CA organizations that have primary responsibility for the registration, archiving, and dissemination of MDOs. As experience is gained and technology evolves, the CA Procedures will be extended to include enhanced services and their supporting protocols. In particular, it is anticipated that eventually CA organizations will be linked via networks on a global basis, and will provide requestors with online automated access to CA services. While this Recommendation does not preclude such operations, it also does not recommend the specific protocols to be used to ensure global compatibility of these services. These recommendations will be generated as experience is gained.

  11. Quality assurance: Importance of systems and standard operating procedures

    Directory of Open Access Journals (Sweden)

    Kishu Manghani

    2011-01-01

    Full Text Available It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

  12. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis

    International Nuclear Information System (INIS)

    2016-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  13. 49 CFR 1111.9 - Procedural schedule in cases using simplified standards.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Procedural schedule in cases using simplified... PROCEDURES § 1111.9 Procedural schedule in cases using simplified standards. (a) Procedural schedule. Absent a specific order by the Board, the following general procedural schedules will apply in cases using...

  14. Estimating the Standard Error of the Judging in a modified-Angoff Standards Setting Procedure

    Directory of Open Access Journals (Sweden)

    Robert G. MacCann

    2004-03-01

    Full Text Available For a modified Angoff standards setting procedure, two methods of calculating the standard error of the..judging were compared. The Central Limit Theorem (CLT method is easy to calculate and uses readily..available data. It estimates the variance of mean cut scores as a function of the variance of cut scores within..a judging group, based on the independent judgements at Stage 1 of the process. Its theoretical drawback is..that it is unable to take account of the effects of collaboration among the judges at Stages 2 and 3. The..second method, an application of equipercentile (EQP equating, relies on the selection of very large stable..candidatures and the standardisation of the raw score distributions to remove effects associated with test..difficulty. The standard error estimates were then empirically obtained from the mean cut score variation..observed over a five year period. For practical purposes, the two methods gave reasonable agreement, with..the CLT method working well for the top band, the band that attracts most public attention. For some..bands in English and Mathematics, the CLT standard error was smaller than the EQP estimate, suggesting..the CLT method be used with caution as an approximate guide only.

  15. International standards and quality control procedures applied to nuclear instruments

    International Nuclear Information System (INIS)

    Urbanski, P.

    2008-01-01

    The survey of international standards related to Nuclear Instrumentation and QC tests was presented. From among the 29'336 active international standards published by such organizations as ISO, IEC, CEN and CENELEC, only 582 are devoted to nuclear instruments. The international classification of standards (ICS) is shown. Also, the list of 582 international standards related to nuclear instruments is attached. (author)

  16. Detection of systemic hypersensitivity to drugs using standard guinea pig assays.

    Science.gov (United States)

    Weaver, James L; Staten, David; Swann, Joslyn; Armstrong, George; Bates, Melissa; Hastings, Kenneth L

    2003-12-01

    The most commonly used assays designed to detect either skin or systemic immune-based hypersensitivity reactions are those using guinea pigs (GP). We obtained data from various FDA records to evaluate the correlation between GP assay results and reported post-marketing systemic hypersensitivity reactions. We examined the new drug application (NDA) reviews of approved drugs for the results of GP assays. Post-marketing human data were extracted from the FDA adverse event reporting system (AERS). Drug usage data were obtained from a commercial database maintained by IMS Health Inc. We found 83 (21%) of 396 drugs approved between 1978 and 1998 had reported GP test results. Among these 83 drugs, 14 (17%) were found to have positive results in at least one GP assay. Simple reporting index (RI) values for systemic hypersensitivity reactions were calculated from AERS data and usage to produce the index of adverse event reports per million shipping units of drug. A variety of definitions of positive human response were examined. A statistically significant association was seen for rash between post-marketing and clinical trials adverse event reports. No statistically significant associations between human data and GP test results were observed. These data suggest that standard GP assays have limited ability to predict human systemic hypersensitivity potential for pharmaceuticals.

  17. Evaluation of standard reagents for radial-immunodiffusion assays. In vitro control of rabies vaccines

    Directory of Open Access Journals (Sweden)

    MICELI Graciela S.

    2000-01-01

    Full Text Available The RID assay is one of the in vitro methods used for in-process control in the production of rabies vaccines for veterinary use. It has been shown to be very useful for determining antigen concentration in the final bulk product. The work presented in this paper, including the production and standardization of candidate standard reagents for use in the Radial Immunodiffusion Assay (RID was carried out at the Pan American Institute for Food Protection and Zoonoses (INPPAZ/PAHO/WHO. The study was completed with the cooperation of the Faculty of Veterinary Sciences, National University of La Plata (NULP, Argentina, where the validation of the proposed standards and the quality control of samples from 28 different batches of rabies vaccines produced with Pasteur strain rabies virus (PV in BHK cells were performed. The activity of the vaccines was determined by in vivo (NIH and in vitro (RIDassays. The results of the candidate reagents for the reagent standardization tests showed stability, sensitivity and reproducibility. The Relative Potency the 1.2 between the problem vaccines and the reference vaccine was estimated by variance and regression analysis. The results of our validation study show that the INPPAZ (PAHO/WHO is capable of producing and distributing the above-mentioned standard reagents, as well as of providing support for the incorporation of the RID technique (sensitive, rapid and inexpensive to the laboratories that manufacture rabies vaccines in Latin America and the Caribbean.

  18. The network formation assay: a spatially standardized neurite outgrowth analytical display for neurotoxicity screening.

    Science.gov (United States)

    Frimat, Jean-Philippe; Sisnaiske, Julia; Subbiah, Subanatarajan; Menne, Heike; Godoy, Patricio; Lampen, Peter; Leist, Marcel; Franzke, Joachim; Hengstler, Jan G; van Thriel, Christoph; West, Jonathan

    2010-03-21

    We present a rapid, reproducible and sensitive neurotoxicity testing platform that combines the benefits of neurite outgrowth analysis with cell patterning. This approach involves patterning neuronal cells within a hexagonal array to standardize the distance between neighbouring cellular nodes, and thereby standardize the length of the neurite interconnections. This feature coupled with defined assay coordinates provides a streamlined display for rapid and sensitive analysis. We have termed this the network formation assay (NFA). To demonstrate the assay we have used a novel cell patterning technique involving thin film poly(dimethylsiloxane) (PDMS) microcontact printing. Differentiated human SH-SY5Y neuroblastoma cells colonized the array with high efficiency, reliably producing pattern occupancies above 70%. The neuronal array surface supported neurite outgrowth, resulting in the formation of an interconnected neuronal network. Exposure to acrylamide, a neurotoxic reference compound, inhibited network formation. A dose-response curve from the NFA was used to determine a 20% network inhibition (NI(20)) value of 260 microM. This concentration was approximately 10-fold lower than the value produced by a routine cell viability assay, and demonstrates that the NFA can distinguish network formation inhibitory effects from gross cytotoxic effects. Inhibition of the mitogen-activated protein kinase (MAPK) ERK1/2 and phosphoinositide-3-kinase (PI-3K) signaling pathways also produced a dose-dependent reduction in network formation at non-cytotoxic concentrations. To further refine the assay a simulation was developed to manage the impact of pattern occupancy variations on network formation probability. Together these developments and demonstrations highlight the potential of the NFA to meet the demands of high-throughput applications in neurotoxicology and neurodevelopmental biology.

  19. Variability of assay methods for total and free PSA after WHO standardization.

    Science.gov (United States)

    Foj, L; Filella, X; Alcover, J; Augé, J M; Escudero, J M; Molina, R

    2014-03-01

    The variability of total PSA (tPSA) and free PSA (fPSA) results among commercial assays has been suggested to be decreased by calibration to World Health Organization (WHO) reference materials. To characterize the current situation, it is necessary to know its impact in the critical cutoffs used in clinical practice. In the present study, we tested 167 samples with tPSA concentrations of 0 to 20 μg/L using seven PSA and six fPSA commercial assays, including Access, ARCHITECT i2000, ADVIA Centaur XP, IMMULITE 2000, Elecsys, and Lumipulse G1200, in which we only measured tPSA. tPSA and fPSA were measured in Access using the Hybritech and WHO calibrators. Passing-Bablok analysis was performed for PSA, and percentage of fPSA with the Hybritech-calibrated access comparison assay. For tPSA, relative differences were more than 10 % at 0.2 μg/L for ARCHITECT i2000, and at a critical concentration of 3, 4, and 10 μg/L, the relative difference was exceeded by ADVIA Centaur XP and WHO-calibrated Access. For percent fPSA, at a critical concentration of 10 %, the 10 % relative difference limit was exceeded by IMMULITE 2000 assay. At a critical concentration of 20 and 25 %, ADVIA Centaur XP, ARCHITECT i2000, and IMMULITE 2000 assays exceeded the 10 % relative difference limit. We have shown significant discordances between assays included in this study despite advances in standardization conducted in the last years. Further harmonization efforts are required in order to obtain a complete clinical concordance.

  20. Standard interface files and procedures for reactor physics codes. Version IV

    International Nuclear Information System (INIS)

    O'Dell, R.D.

    1977-09-01

    Standards, procedures, and recommendations of the Committee on Computer Code Coordination for promoting the exchange of reactor physics codes are updated to Version IV status. Standards and procedures covering general programming, program structure, standard interface files, and file management and handling subroutines are included

  1. Reference assays for Clostridium difficile infection: one or two gold standards?

    Science.gov (United States)

    Planche, Timothy; Wilcox, Mark

    2011-01-01

    Accurate diagnosis of Clostridium difficile infection (CDI) is essential for optimal treatment, prevention and control. There are two reference assays for CDI diagnosis: the cell cytotoxicity assay (CCTA) and toxigenic culture (TC). Importantly, these tests actually detect different targets: CCTA detects the presence of C difficile toxins (primarily toxin B, but also toxin A), whereas TC detects the presence in the stool of C difficile with the potential to produce toxin. Not surprisingly studies comparing the results of these assays show imperfect agreement. Thus, a faecal sample may be CCTA negative but TC positive, and this raises the crucial question about the clinical significance of the presence of C difficile with the capacity to produce toxin but no actual detectable free toxin. A positive TC result indicates that a patient with diarrhoea is potentially infectious. TC also has the advantage that the cultured isolate is available for typing and for susceptibility testing. In general, however, CCTA has been shown to be a better test for the laboratory confirmation of CDI, although additional culture may be needed to optimise sensitivity. Crucially, when these reference assays are used to determine the accuracy of alternative diagnostic tests, care should be taken to compare methods with their appropriate standard (ie, compare tests that target equivalent end-points). Such issues have contributed to the variable and often suboptimal performance of rapid diagnostic tests for CDI. Further research is urgently needed to improve knowledge of the utility of routine diagnostic tests in CDI and the factors that influence their performance.

  2. Development of recombinant human IgA for anticardiolipin antibodies assay standardization.

    Science.gov (United States)

    Knappik, Achim; Capuano, Francesco; Frisch, Christian; Ylera, Francisco; Bonelli, Fabrizio

    2009-09-01

    Controls and calibrators in autoimmune assays are typically developed from patient sera. However, the use of sera is accompanied by a number of disadvantages, such as lack of monospecificity, lack of assay comparability, and supply limitations. Ideally, the control reagent would be an antigen-specific human monoclonal antibody preparation that is defined and pure, easy to produce without any supply limitations, and of defined isotype (IgG, IgM, or IgA). The generation of antigen-specific human monoclonal antibodies has been complicated, but recent advances in development of fully human antibodies by means of in vitro antibody gene library selection has opened a way for the isolation of human antibodies to virtually any antigen, including self-antigens. Such antibodies can be converted to any isotype by gene cloning. Here we developed a set of human monoclonal IgA antibodies specific for the cardiolipin-beta2-glycoprotein 1 complex, using the HuCAL technology. We evaluated the IgA variants of those antibodies for their use as standards in IgA anticardiolipin antibody assays and compared these reagents with serum controls. Such recombinant antibodies may ultimately replace patient sera as assay control and calibration reagents.

  3. Manual for the GAW Precipitation Chemistry Programme: Guidelines, Data Quality Objectives and Standard Operating Procedures

    National Research Council Canada - National Science Library

    Allan, Mary A

    2004-01-01

    This is a manual for the Global Atmosphere Watch Precipitation Chemistry (GAW-PC) Programme. Where possible, it describes standard operating procedures and otherwise provides guidance on methods and procedures...

  4. Guide to nondestructive assay standards: Preparation criteria, availability, and practical considerations

    International Nuclear Information System (INIS)

    Hsue, S.T.; Stewart, J.E.; Sampson, T.E.; Butler, G.W.; Rudy, C.R.; Rinard, P.M.

    1997-10-01

    For certification and measurement control, nondestructive assay (NDA) instruments and methods used for verification measurements of special nuclear materials (SNMs) require calibrations based on certified reference materials (CRMs), or working reference materials (WRMs), traceable to the national system of measurements, and adequately characteristic of the unknowns. The Department of Energy Office of Safeguards and Security is sponsoring production of a comprehensive guide to preparation of NDA standards. The scope of the report includes preparation criteria, current availability of CRMs and WRMs, practical considerations for preparation and characterization, and an extensive bibliography. In preparing the report, based primarily on experience at Los Alamos, they have found that standards preparation is highly dependent on the particular NDA method being applied. They therefore include sections that contain information specific to commonly used neutron and gamma-ray NDA techniques. They also present approaches that are alternatives to, or minimize requirements for physical standards

  5. Guide to nondestructive assay standards: Preparation criteria, availability, and practical considerations

    Energy Technology Data Exchange (ETDEWEB)

    Hsue, S.T.; Stewart, J.E.; Sampson, T.E.; Butler, G.W.; Rudy, C.R.; Rinard, P.M.

    1997-10-01

    For certification and measurement control, nondestructive assay (NDA) instruments and methods used for verification measurements of special nuclear materials (SNMs) require calibrations based on certified reference materials (CRMs), or working reference materials (WRMs), traceable to the national system of measurements, and adequately characteristic of the unknowns. The Department of Energy Office of Safeguards and Security is sponsoring production of a comprehensive guide to preparation of NDA standards. The scope of the report includes preparation criteria, current availability of CRMs and WRMs, practical considerations for preparation and characterization, and an extensive bibliography. In preparing the report, based primarily on experience at Los Alamos, they have found that standards preparation is highly dependent on the particular NDA method being applied. They therefore include sections that contain information specific to commonly used neutron and gamma-ray NDA techniques. They also present approaches that are alternatives to, or minimize requirements for physical standards.

  6. Standardization of the time for the execution of HANARO start-up and shutdown procedures

    International Nuclear Information System (INIS)

    Choi, H. Y.; Lim, I. C.; Hwang, S. R.; Kang, T. J.; Youn, D. B.

    2003-01-01

    For the standardization of the time to execute HANARO start-up and shutdown procedures, code names were assigned to the individual procedures and the work time were investigated. The data recorded by the operators during start-up and shutdown were statistically analyzed. The analysis results will be used for the standardization of start-up and shutdown procedures and it will be reflected in the procedure document

  7. 21 CFR 606.100 - Standard operating procedures.

    Science.gov (United States)

    2010-04-01

    ... blood and blood components for transfusion and further manufacturing purposes. Such procedures shall be... the site of phlebotomy to give maximum assurance of a sterile container of blood. (4) Method of... precautions taken to measure accurately the quantity of blood removed from the donor. (6) Methods of component...

  8. Creating Royal Australian Navy Standard Operating Procedures using Flow Diagrams

    Science.gov (United States)

    2015-08-01

    set it is important to determine writing and approval responsibilities, storage methods and publishing details before SOPs are written. This...5 4.1.1 Brainstorming ...managed accordingly. Key activities include scoping the set of SOPs, creating a team, developing a plan, writing , reviewing and approving procedures, and

  9. Item Disordinality with the Bookmark Standard Setting Procedure.

    Science.gov (United States)

    Skaggs, Gary; Tessema, Aster

    This paper presents an application of the bookmark procedure to a test comprised of increasing text difficulty levels. The Test of English Proficiency for Adults (TEPA) was used for this study. Three forms of the TEPA were field tested in 1999 with approximately 1,000 non-native English speaking students enrolled in English-as-a-Second-Language…

  10. Policy, Procedures and Standards for Enterprise Information Management

    Science.gov (United States)

    This policy establishes a standard approach for managing information produced by, funded by, or received per regulated reporting and/or federal-wide requirements and subsequently held or cataloged in information management systems by EPA.

  11. Surveillance evaluation of the standardization of assay values for serum total 25-hydroxyvitamin D concentration in Japan.

    Science.gov (United States)

    Ihara, Hiroshi; Kiuchi, Sachiko; Ishige, Takayuki; Nishimura, Motoi; Matsushita, Kazuyuki; Satoh, Mamoru; Nomura, Fumio; Yamashita, Mine; Kitajima, Isao; Tsugawa, Naoko; Okano, Toshio; Hirota, Kouichi; Miura, Masakazu; Totani, Masayuki; Hashizume, Naotaka

    2018-01-01

    Background To assess the vitamin D nutritional status, serum total 25-hydroxyvitamin D (25(OH)D) concentration is measured. We used six automated 25(OH)D immunoassays (AIAs) available in Japan and certified by the Vitamin D Standardization Program (VDSP) at the U.S. Center for Disease Control and Prevention to assess the concordance of the assay results. Methods Serum total 25(OH)D concentrations in SRM 972a and 20 serum samples from patients were determined using three liquid chromatography-tandem mass spectrometry (LC-MS/MS) and six AIAs (pilot study), and an additional 110 serum samples were assessed by the six AIAs (surveillance study). The assay bias from the results of LC-MS/MS by Chiba University or consensus values (i.e. average of six AIAs) was estimated using the procedure described in CLSI document EP09-A3. Results LC-MS/MS at Chiba University could completely separate 25(OH)D2, 25(OH)D3 and 3-epi-25(OH)D3, and the observed values including total 25(OH)D in SRM 972a were all within ±1·SD of the assigned values. All AIAs produced results greater than ±3·SD. In the pilot study, four of the six AIAs had an average percentage bias, as estimated by confidence interval (CI), larger than ±5% (acceptance criterion in CLSI); the bias converged from -6.5% to 3.2% after adjustment by LC-MS/MS. In the surveillance study, 25(OH)D concentrations in AIAs all adjusted to LC-MS/MS converged within ±5% from consensus values. However, some AIAs showed negative or positive bias from the consensus values. Conclusions Current AIAs in Japan continue to lack standardization. Manufacturers should implement quality assurance strategies so that their values more closely align to those of standard reference material 972a.

  12. Guide to nondestructive assay standards: Preparation criteria, availability, and practical considerations

    International Nuclear Information System (INIS)

    Stewart, J.E.; Hsue, S.T.; Sampson, T.E.

    1997-01-01

    For certification and measurement control, nondestructive assay (NDA) instruments and methods used for verification measurement of special nuclear materials (SNMs) require calibrations based on certified reference materials (CRMs), or working reference materials (WRMs), traceable to the national system of measurements, and adequately characteristic of the unknowns. The Department of Energy Office of Safeguards and Security is sponsoring production of a comprehensive guide to preparation of NDA standards. The scope of the report includes preparation criteria, current availability of CRMs and WRMs, practical considerations for preparation and characterization, and an extensive bibliography. In preparing the report, based primarily on experience at Los Alamos, we have found that standards preparation is highly dependent on the particular NDA method being applied. We therefore include sections that contain information specific to commonly used neutron and gamma-ray NDA techniques. 16 refs., 4 figs., 2 tabs

  13. Standard Operating Procedure for Accelerated Corrosion Testing at ARL

    Science.gov (United States)

    2017-11-01

    to scribe nonferrous materials so as to prevent contamination of the substrate during the process. The "X" scribe is made by scribing 2 intersecting...may include GMW14872 Cyclic Corrosion Testing (typically Exterior, Exposure C), ASTM B117 Neutral Salt Fog Testing, ASTM G50 Atmospheric Corrosion...using the same cleaning procedures, contamination of the substrate is minimized during the scribe process. All partners adhering to guidelines and

  14. A single-centre evaluation of two new anti-Mullerian hormone assays and comparison with the current clinical standard assay.

    Science.gov (United States)

    Welsh, Paul; Smith, Karen; Nelson, Scott M

    2014-05-01

    .0%, P Gen II assay and may be suitable for clinical and epidemiological use. Enhanced sensitivity of the Ansh Labs picoAMH assay enables measurement of low AMH concentrations. These results re-emphasize the need for an AMH international standard. Ansh Labs provided kits for this study free of charge. The manufacturer played no part in conducting assays or data analysis. S.M.N. has received speaker's fees and participated in advisory boards for Beckman Coulter, Merck Serono, MSD and Ferring regarding AMH. P.W. is supported by British Heart Foundation fellowship FS/12/62/29889. We declare no other financial relationship or competing interests.

  15. Standardization of the Romanowsky staining procedure: an overview.

    Science.gov (United States)

    Bentley, S A; Marshall, P N; Trobaugh, F E

    1980-01-01

    Commerically available Romanowsky blood stains are variable mixtures of thiazein dyes and brominated fluorescein derivatives with varying degrees of metallic salt contamination in a number of different solvent systems. There is a need for standardized Romanowsky stains of constant composition, which, when used in conjunction with a carefully controlled specimen preparation technique, should give consistent performance. Such a preparation system would be of great value to hematologists in general and would be essential to the validity of data obtained by the digital processing of blood cell images. It is possible to prepare standardized Romanowsky stains as mixtures of two or three dye components, namely, eosin Y, azure B and methylene blue, although azure B has only recently become commercially available at an acceptable degree of purity. The logistic problems of stain standardization are discussed.

  16. Standardization of automated 25-hydroxyvitamin D assays: How successful is it?

    Science.gov (United States)

    Elsenberg, E H A M; Ten Boekel, E; Huijgen, H; Heijboer, A C

    2017-12-01

    Multiple 25(OH)D assays have recently been aligned to improve comparibility. In this study we investigated the performance of these assays using both native single-donor sera with target values certified by a reference method as well as single donor sera from a heterogeneous patient population. 25(OH)D levels were measured in twenty reference samples (Ref!25OHD; Labquality, Finland) using five automated methods (Lumipulse, Liaison, Cobas, iSYS and Access) and one aligned ID-XLC-MS/MS method (slope: 1,00; intercept: 0,00; R=0,996). Furthermore, 25(OH)D concentrations measured in 50 pregnant women and 52 random patients using the 5 automated assays were compared to the ID-XLC-MS/MS. In addition, Vitamin D binding protein (DBP) was measured. Most automated assays showed significant differences in 25(OH)D levels measured in reference samples. Slopes varied from 1,00 to 1,33, intercepts from -5.48 to -15,81nmol/L and the R from 0,971 to 0,997. This inaccuracy was even more prominent in a heterogeneous patient population. Slopes varied from 0,75 to 1,35, intercepts from -9.02 to 11,51nmol/L and the R from 0,840 to 0,949. For most assays the deviation in 25(OH)D concentration increased with elevating DBP concentrations suggesting that DBP might be one of the factors contributing to the inaccuracy in currently used automated 25(OH)D methods. Despite the use of standardized assays, we observed significant differences in 25(OH)D concentrations in some automated methods using reference material obtained from healthy single donor sera. In sera of a patient population this inaccuracy was even worse which is highly concerning as patient samples are being investigated in clinical laboratories. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  17. The history and development of FETAX (ASTM standard guide, E-1439 on conducting the frog embryo teratogenesis Assay-Xenopus)

    Science.gov (United States)

    Dumont, J.N.; Bantle, J.A.; Linder, G.; ,

    2003-01-01

    The energy crisis of the 1970's and 1980's prompted the search for alternative sources of fuel. With development of alternate sources of energy, concerns for biological resources potentially adversely impacted by these alternative technologies also heightened. For example, few biological tests were available at the time to study toxic effects of effluents on surface waters likely to serve as receiving streams for energy-production facilities; hence, we began to use Xenopus laevis embryos as test organisms to examine potential toxic effects associated with these effluents upon entering aquatic systems. As studies focused on potential adverse effects on aquatic systems continued, a test procedure was developed that led to the initial standardization of FETAX. Other .than a limited number of aquatic toxicity tests that used fathead minnows and cold-water fishes such as rainbow trout, X. laevis represented the only other aquatic vertebrate test system readily available to evaluate complex effluents. With numerous laboratories collaborating, the test with X. laevis was refined, improved, and developed as ASTM E-1439, Standard Guide for the Conducting Frog Embryo Teratogenesis Assay-Xenopus (FETAX). Collabrative work in the 1990s yielded procedural enhancements, for example, development of standard test solutions and exposure methods to handle volatile organics and hydrophobic compounds. As part of the ASTM process, a collaborative interlaboratory study was performed to determine the repeatability and reliability of FETAX. Parallel to these efforts, methods were also developed to test sediments and soils, and in situ test methods were developed to address "lab-to-field extrapolation errors" that could influence the method's use in ecological risk assessments. Additionally, a metabolic activation system composed of rat liver microsomes was developed which made FETAX more relevant to mammalian studies.

  18. Planning and evaluating prescribed fires--a standard procedure

    Science.gov (United States)

    William C. Fischer

    1978-01-01

    Provides a standard format and checklist to guide the land manager through the important steps for prescribed burning. Describes the kind of information needed to prepare fire prescriptions and burning plans. Identifies the elements of a fire prescription, a burning plan, and a prescribed fire evaluation. A plan written for an actual prescribed burning is included as...

  19. Standardized Procedures for Use of Nucleic Acid-Based Tools

    Science.gov (United States)

    2008-08-01

    Madigan, M., J. Martinko, P. Dunlap and D. Clark (2006). Brock Biology Of Microorganisms , Benjamin Cummings. Mailloux, B. J. and M. E. Fuller...Methods for Enumeration of Microorganisms and Development of a Dhc Reference Standard...Dehalococcoides (Dhc) and other environmentally relevant microorganisms . The results of these analyses are increasingly used by site owners

  20. 12 CFR 616.6300 - Leasing policies, procedures, and underwriting standards.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Leasing policies, procedures, and underwriting standards. 616.6300 Section 616.6300 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LEASING § 616.6300 Leasing policies, procedures, and underwriting standards. The board of each institution...

  1. 7 CFR 201.67 - Seed certifying agency standards and procedures.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Seed certifying agency standards and procedures. 201...) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Certified Seed § 201.67 Seed certifying agency standards and procedures. In order to qualify as a seed certifying agency for purposes of section 101(a)(25) of the Federal...

  2. Procedures and Standards Handbook. Version 3.0. What Works Clearinghouse

    Science.gov (United States)

    What Works Clearinghouse, 2014

    2014-01-01

    This "What Works Clearinghouse Procedures and Standards Handbook (Version 3.0)" provides a detailed description of the standards and procedures of the What Works Clearinghouse (WWC). The remaining chapters of this Handbook are organized to take the reader through the basic steps that the WWC uses to develop a review protocol, identify…

  3. Standardization of a Continuous Assay for Glycosidases and Its Use for Screening Insect Gut Samples at Individual and Populational Levels

    Directory of Open Access Journals (Sweden)

    Gerson S. Profeta

    2017-05-01

    Full Text Available Glycoside Hydrolases (GHs are enzymes able to recognize and cleave glycosidic bonds. Insect GHs play decisive roles in digestion, in plant-herbivore, and host-pathogen interactions. GH activity is normally measured by the detection of a release from the substrate of products as sugars units, colored, or fluorescent groups. In most cases, the conditions for product release and detection differ, resulting in discontinuous assays. The current protocols result in using large amounts of reaction mixtures for the obtainment of time points in each experimental replica. These procedures restrain the analysis of biological materials with limited amounts of protein and, in the case of studies regarding small insects, implies in the pooling of samples from several individuals. In this respect, most studies do not assess the variability of GH activities across the population of individuals from the same species. The aim of this work is to approach this technical problem and have a deeper understanding of the variation of GH activities in insect populations, using as models the disease vectors Rhodnius prolixus (Hemiptera: Triatominae and Lutzomyia longipalpis (Diptera: Phlebotominae. Here we standardized continuous assays using 4-methylumbelliferyl derived substrates for the detection of α-Glucosidase, β-Glucosidase, α-Mannosidase, N-acetyl-hexosaminidase, β-Galactosidase, and α-Fucosidase in the midgut of R. prolixus and L. longipalpis with results similar to the traditional discontinuous protocol. The continuous assays allowed us to measure GH activities using minimal sample amounts with a higher number of measurements, resulting in data that are more reliable and less time and reagent consumption. The continuous assay also allows the high-throughput screening of GH activities in small insect samples, which would be not applicable to the previous discontinuous protocol. We applied continuous GH measurements to 90 individual samples of R. prolixus

  4. Standardization of a Continuous Assay for Glycosidases and Its Use for Screening Insect Gut Samples at Individual and Populational Levels.

    Science.gov (United States)

    Profeta, Gerson S; Pereira, Jessica A S; Costa, Samara G; Azambuja, Patricia; Garcia, Eloi S; Moraes, Caroline da Silva; Genta, Fernando A

    2017-01-01

    Glycoside Hydrolases (GHs) are enzymes able to recognize and cleave glycosidic bonds. Insect GHs play decisive roles in digestion, in plant-herbivore, and host-pathogen interactions. GH activity is normally measured by the detection of a release from the substrate of products as sugars units, colored, or fluorescent groups. In most cases, the conditions for product release and detection differ, resulting in discontinuous assays. The current protocols result in using large amounts of reaction mixtures for the obtainment of time points in each experimental replica. These procedures restrain the analysis of biological materials with limited amounts of protein and, in the case of studies regarding small insects, implies in the pooling of samples from several individuals. In this respect, most studies do not assess the variability of GH activities across the population of individuals from the same species. The aim of this work is to approach this technical problem and have a deeper understanding of the variation of GH activities in insect populations, using as models the disease vectors Rhodnius prolixus (Hemiptera: Triatominae) and Lutzomyia longipalpis (Diptera: Phlebotominae). Here we standardized continuous assays using 4-methylumbelliferyl derived substrates for the detection of α-Glucosidase, β-Glucosidase, α-Mannosidase, N-acetyl-hexosaminidase, β-Galactosidase, and α-Fucosidase in the midgut of R. prolixus and L. longipalpis with results similar to the traditional discontinuous protocol. The continuous assays allowed us to measure GH activities using minimal sample amounts with a higher number of measurements, resulting in data that are more reliable and less time and reagent consumption. The continuous assay also allows the high-throughput screening of GH activities in small insect samples, which would be not applicable to the previous discontinuous protocol. We applied continuous GH measurements to 90 individual samples of R. prolixus anterior midgut

  5. A Comparison of Standard-Setting Procedures for an OSCE in Undergraduate Medical Education.

    Science.gov (United States)

    Kaufman, David M.; Mann, Karen V.; Muijtjens, Arno M. M.; van der Vleuten, Cees P. M.

    2000-01-01

    Compared four standard-setting procedures for an objective structure clinical examination (OSCE) in medical education. Applied Angoff, borderline, relative, and holistic procedures to the data used to establish a cutoff score for a pass/fail decision. The Angoff and borderline procedures gave similar results; however, the relative and holistic…

  6. Operational procedure standard for occurrences involving radioactive materials

    Energy Technology Data Exchange (ETDEWEB)

    Piekarz, Leonardo, E-mail: leonardopbm@yahoo.com.br [Academia de Bombeiros Militar de Minas Gerais, Belo Horizonte, MG (Brazil); Rezende, Talita C.; Pinheiro, Christiano J.G., E-mail: talitacolombi@yahoo.com, E-mail: christrieste@yahoo.it [Universidade Federal do Espirito Santo (CCA/UFES), Alegre, ES (Brazil). Programa de Pós-Graduação em Engenharia Química

    2017-07-01

    This study has as objective to analyze more deeply the actions of response to emergencies involving radioactive materials, in the intent to establish a pattern to the actions performed by the military fire fighters of the Military Fire Brigade of Minas Gerais. To met these goals, it has been attempted to analyze the procedures utilized and recommended, nowadays, for the military fire fighters of CBMMG, and through directed studies, to suggest new actions possible to be executed in the local of the emergency in a way that will not expose the garrison to doses of ionizing radiation that may prejudice them. It is a study of bibliographic, exploratory, and also descriptive nature, realized through a qualitative approach. The techniques used for the research were the analysis of institutional documents, norms and other literature produced by renamed entities in the radiologic and biosafety areas. It was then concluded that CBMMG, through simple actions of response, can provide higher quality and safety in the operations involving radiologic accidents, standing out that the implemented actions nowadays are very beneath the capacity of the corporation, due to the lack of knowledge of the matter by the fire fighters. It was proposed, then, that new actions be implemented and instituted as operational procedures to be used on those emergencies, with the objective of provide a higher safety and professionalism in the attendance to emergencies involving radioactive materials. (author)

  7. Operational procedure standard for occurrences involving radioactive materials

    International Nuclear Information System (INIS)

    Piekarz, Leonardo; Rezende, Talita C.; Pinheiro, Christiano J.G.

    2017-01-01

    This study has as objective to analyze more deeply the actions of response to emergencies involving radioactive materials, in the intent to establish a pattern to the actions performed by the military fire fighters of the Military Fire Brigade of Minas Gerais. To met these goals, it has been attempted to analyze the procedures utilized and recommended, nowadays, for the military fire fighters of CBMMG, and through directed studies, to suggest new actions possible to be executed in the local of the emergency in a way that will not expose the garrison to doses of ionizing radiation that may prejudice them. It is a study of bibliographic, exploratory, and also descriptive nature, realized through a qualitative approach. The techniques used for the research were the analysis of institutional documents, norms and other literature produced by renamed entities in the radiologic and biosafety areas. It was then concluded that CBMMG, through simple actions of response, can provide higher quality and safety in the operations involving radiologic accidents, standing out that the implemented actions nowadays are very beneath the capacity of the corporation, due to the lack of knowledge of the matter by the fire fighters. It was proposed, then, that new actions be implemented and instituted as operational procedures to be used on those emergencies, with the objective of provide a higher safety and professionalism in the attendance to emergencies involving radioactive materials. (author)

  8. Muscle sparing lateral thoracotomy: the standard incision for thoracic procedures

    Directory of Open Access Journals (Sweden)

    Mihai Dumitrescu

    2017-05-01

    Full Text Available Lateral thoracotomy is a versatile approach with many variations and is currently the most widely used incision in thoracic surgery. In the current article we are presenting the muscle-sparing lateral thoracotomy in the lateral decubitus position which we consider to be the “standard” for lateral thoracotomies. Indications, surgical technique and pitfalls are described alongside our experience with thoracic drainage. Although there is no consensus regarding the name of this incision, some authors call it “axillary thoracotomy” while others call it a “modified lateral thoracotomy”, they all agree on one aspect – the importance of muscle sparing – which makes it the go-to thoracotomy for both small and large procedures involving the lung. Lateral muscle sparing thoracotomy allows for good exposure of the pulmonary hilum, fissures, apex and diaphragm. The approach is easy and quick to perform while at the same time ensuring faster postoperative recovery by sparing the latissimus dorsi muscle, better cosmetics and lower postoperative pain score when compared to the posterolateral or classical lateral thoracotomies.

  9. Standard-C hydrogen monitoring system acceptance test procedure

    Energy Technology Data Exchange (ETDEWEB)

    Schneider, T.C.

    1994-09-02

    The primary function of the standard-C hydrogen monitoring system (SHMS) is to monitor specifically for hydrogen in the waste tank atmosphere which may also contain (but not be limited to) unknown quantities of air, nitrous oxide, ammonia, water vapor, carbon dioxide, carbon monoxide, and other gaseous constituents. The SHMS will consist of hydrogen specific monitors, a grab sampler to collect samples for laboratory analysis, a gas chromatograph, and the gas sample collection system necessary to support the operation of the instrumentation. This system will be located in a cabinet placed at the tank of interest. The purpose of this document is to demonstrate that the SHMS is constructed as intended by design.

  10. Assessing the cleanliness of surfaces: Innovative molecular approaches vs. standard spore assays

    Energy Technology Data Exchange (ETDEWEB)

    Cooper, M.; Duc, M.T. La; Probst, A.; Vaishampayan, P.; Stam, C.; Benardini, J.N.; Piceno, Y.M.; Andersen, G.L.; Venkateswaran, K.

    2011-04-01

    A bacterial spore assay and a molecular DNA microarray method were compared for their ability to assess relative cleanliness in the context of bacterial abundance and diversity on spacecraft surfaces. Colony counts derived from the NASA standard spore assay were extremely low for spacecraft surfaces. However, the PhyloChip generation 3 (G3) DNA microarray resolved the genetic signatures of a highly diverse suite of microorganisms in the very same sample set. Samples completely devoid of cultivable spores were shown to harbor the DNA of more than 100 distinct microbial phylotypes. Furthermore, samples with higher numbers of cultivable spores did not necessarily give rise to a greater microbial diversity upon analysis with the DNA microarray. The findings of this study clearly demonstrated that there is not a statistically significant correlation between the cultivable spore counts obtained from a sample and the degree of bacterial diversity present. Based on these results, it can be stated that validated state-of-the-art molecular techniques, such as DNA microarrays, can be utilized in parallel with classical culture-based methods to further describe the cleanliness of spacecraft surfaces.

  11. 78 FR 14010 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2013-03-04

    ...). Issued in Washington, DC, on February 15, 2013. John M. Allen, Director, Flight Standards Service..., RNAV (GPS) RWY 36, Orig Siren, WI, Burnett County, Takeoff Minimums and Obstacle DP, Orig BILLING CODE...

  12. 75 FR 63712 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-10-18

    ... 1, 2010. John M. Allen, Director, Flight Standards Service. Adoption of the Amendment 0 Accordingly..., Takeoff Minimums and Obstacle DP, Amdt 3 Siren, WI, Burnett County, VOR OR GPS RWY 5, Amdt 2B Solon...

  13. 76 FR 40600 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2011-07-11

    ... Navigation (air). Issued in Washington, DC, on June 24, 2011. John M. Allen, Director, Flight Standards... Corinth, MS, Roscoe Turner, RNAV (GPS) RWY 36, Amdt 1 Harvey, ND, Harvey Muni, RNAV (GPS) RWY 29, Orig-A...

  14. 75 FR 25760 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-05-10

    .... John M. Allen, Director, Flight Standards Service. Adoption of the Amendment 0 Accordingly, pursuant to... Muni, Takeoff Minimums and Obstacle DP, Amdt 3 Galliano, LA, South Lafourche Leonard Miller Jr, LOC/DME...

  15. 75 FR 9098 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-03-01

    ... 19, 2010. John M. Allen, Director, Flight Standards Service. Adoption of the Amendment 0 Accordingly... GALLIANO SOUTH LAFOURCHE 0/3269 2/3/10 RNAV (GPS) RWY 18, AMDT 1. LEONARD MILLER JR. 8-Apr-10 LA JENNINGS...

  16. 16 CFR 1610.35 - Procedures for testing special types of textile fabrics under the standard.

    Science.gov (United States)

    2010-01-01

    ... textile fabrics under the standard. 1610.35 Section 1610.35 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES Rules and Regulations § 1610.35 Procedures for testing special types of textile fabrics under the standard. (a) Fabric...

  17. Standardization of CalyculinA induced PCC assay and its advantages over Okadaic acid PCC assay in Biodosimetry applications.

    Science.gov (United States)

    Nairy, Rajesha K; Yerol, Narayana; Bhat, Nagesh N; Desai, Utkarsha; Shirsath, Kapil; Yadav, Usha; K Chaurasia, Rajesh; B K, Sapra

    2016-11-29

    In the present study an attempt was made to estimate coefficients of dose response curves for PCC aberrations induced by CalyculinA and Okadaic acid, using 60 Co gamma radiation and 8 MeV pulsed electron beam for biodosimetry application. The modified method outlined by Puig et al. 2013 was used to conduct Calyculin A and Okadaic acid induced PCC assay in human blood lymphocytes.Chemical treatment was given for the last 1 h of a 48 h culture. The study was carried out in the dose range 2.5 to 20 Gy using 60 Co gamma rays and 8 MeV pulsed electron beam. Results show a linear dose dependent increase with a slope of 0.047 ± 0.001 from Calycalin A PCC and 0.048 ± 0.002 form Okadaic acid PCC. The slope of the fragments curve was 0.327 ± 0.006 from Calyculin A and 0.328 ± 0.006 from Okadaic acid PCC. Further, dose calibration studies were carried out for 8 MeV electron using Calyculin A PCC assay and the obtained slope from ring yield was 0.054 ± 0.002 and 0.427 ± 0.009 from fragment yield.

  18. Standardization of figures and assessment procedures for DTM verticalaccuracy

    Directory of Open Access Journals (Sweden)

    Vittorio Casella

    2015-07-01

    Full Text Available Digital Terrain Models (DTMs are widely used in many sectors. They play a key role in hydrological risk prevention, risk mitigation and numeric simulations. This paper deals with two questions: (i when it is stated that a DTM has a given vertical accuracy, is this assertion univocal? (ii when DTM vertical accuracy is assessed by means of checkpoints, does their location influence results? First, the paper illustrates that two vertical accuracy definitions are conceivable: Vertical Accuracy at the Nodes (VAN, the average vertical distance between the model and the terrain, evaluated at the DTM's nodes and Vertical Accuracy at the interpolated Points (VAP, in which the vertical distance is evaluated at the generic points. These two quantities are not coincident and, when they are calculated for the same DTM, different numeric values are reached. Unfortunately, the two quantities are often interchanged, but this is misleading. Second, the paper shows a simulated example of a DTM vertical accuracy assessment, highlighting that the checkpoints’ location plays a key role: when checkpoints coincide with the DTM nodes, VAN is estimated; when checkpoints are randomly located, VAP is estimated, instead. Third, an in-depth, theoretical characterization of the two considered quantities is performed, based on symbolic computation, and suitable standardization coefficients are proposed. Finally, our discussion has a well-defined frame: it doesn't deal with all the items of the DTM vertical accuracy budget, which would require a much longer essay, but only with one, usually called fundamental vertical accuracy.

  19. 78 FR 37452 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2013-06-21

    ..., 2013. John M. Allen, Director, Flight Standards Service. Adoption of the Amendment Accordingly..., Amdt 1. 7/25/13 FL Tampa Tampa Executive. 3/0405 6/6/13 ILS OR LOC RWY 23, Amdt 1. 7/25/13 FL Milton...

  20. The philosophy and limitations of FAA aeromedical standards, policies and procedures.

    Science.gov (United States)

    1971-06-01

    Designated Aviation Medical Examiners need available basic information concerning the FAA medical certification system, the philosophy which underlies standards, policy and procedures, and certain limitations of the system. It is through such informa...

  1. Trends and the determination of effective doses for standard X-ray procedures

    International Nuclear Information System (INIS)

    Johnson, H.M.; Neduzak, C.; Gallet, J.; Sandeman, J.

    2001-01-01

    Trends in the entrance skin exposures (air kerma) for standard x-ray imaging procedures are reported for the Province of Manitoba, Canada. Average annual data per procedure using standard phantoms and standard ion chambers have been recorded since 1981. For example, chest air kerma (backscatter included) has decreased from 0.14 to 0.09 mGy. Confounding factors may negate the gains unless facility quality control programs are maintained. The data were obtained for a quality assurance and regulatory compliance program. Quoting such data for risk evaluation purposes lacks rigor hence a compartment model for organ apportioning, using organ absorbed doses and weighting factors, has been applied to determine effective dose per procedure. The effective doses for the standard procedures are presented, including the value of 0.027 mSv (1999) calculated for the effective dose in PA chest imaging. (author)

  2. Development of a standard operating procedure for analysis of ammonia concentrations in coal fly ash.

    Science.gov (United States)

    2015-04-01

    Research was performed to support the development and recommendation of a standard operating : procedure (SOP) for analyzing the ammonia content in fly ash intended for use in concrete. A review : of existing ash producers found that several differen...

  3. Licensing procedure, nuclear codes and standards in the Federal Republic of Germany

    International Nuclear Information System (INIS)

    Schultheiss, G.F.

    1980-01-01

    The present paper deals with legal background of licensing in nuclear technology and atomic energy use, licensing procedures for nuclear power plants and with codes, standards and guidelines in the Federal Republic of Germany. (orig./RW)

  4. A new complementary procedure for patients affected by head and neck cancer: Chemo-predictive assay

    Directory of Open Access Journals (Sweden)

    Antonio Cortese

    2016-01-01

    Conclusions: This procedure may be useful in helping physicians choose an effective chemotherapy regimen for head and neck cancer patients and lower treatment costs by eliminating ineffective chemotherapies and unnecessary toxicity particularly in elderly patients.

  5. 9 CFR 354.210 - Minimum standards for sanitation, facilities, and operating procedures in official plants.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Minimum standards for sanitation, facilities, and operating procedures in official plants. 354.210 Section 354.210 Animals and Animal Products... sanitation, facilities, and operating procedures in official plants. The provisions of §§ 354.210 to 354.247...

  6. 40 CFR 75.38 - Standard missing data procedures for Hg CEMS.

    Science.gov (United States)

    2010-07-01

    ... Hg CEMS. 75.38 Section 75.38 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Standard missing data procedures for Hg CEMS. (a) Once 720 quality assured monitor operating hours of Hg... substitute data for Hg concentration in accordance with the procedures in ( 75.33(b)(1) through (b)(4...

  7. Establishment and intra-/inter-laboratory validation of a standard protocol of reactive oxygen species assay for chemical photosafety evaluation.

    Science.gov (United States)

    Onoue, Satomi; Hosoi, Kazuhiro; Wakuri, Shinobu; Iwase, Yumiko; Yamamoto, Toshinobu; Matsuoka, Naoko; Nakamura, Kazuichi; Toda, Tsuguto; Takagi, Hironori; Osaki, Naoto; Matsumoto, Yasuhiro; Kawakami, Satoru; Seto, Yoshiki; Kato, Masashi; Yamada, Shizuo; Ohno, Yasuo; Kojima, Hajime

    2013-11-01

    A reactive oxygen species (ROS) assay was previously developed for photosafety evaluation of pharmaceuticals, and the present multi-center study aimed to establish and validate a standard protocol for ROS assay. In three participating laboratories, two standards and 42 coded chemicals, including 23 phototoxins and 19 nonphototoxic drugs/chemicals, were assessed by the ROS assay according to the standardized protocol. Most phototoxins tended to generate singlet oxygen and/or superoxide under UV-vis exposure, but nonphototoxic chemicals were less photoreactive. In the ROS assay on quinine (200 µm), a typical phototoxic drug, the intra- and inter-day precisions (coefficient of variation; CV) were found to be 1.5-7.4% and 1.7-9.3%, respectively. The inter-laboratory CV for quinine averaged 15.4% for singlet oxygen and 17.0% for superoxide. The ROS assay on 42 coded chemicals (200 µm) provided no false negative predictions upon previously defined criteria as compared with the in vitro/in vivo phototoxicity, although several false positives appeared. Outcomes from the validation study were indicative of satisfactory transferability, intra- and inter-laboratory variability, and predictive capacity of the ROS assay. Copyright © 2012 John Wiley & Sons, Ltd.

  8. Standard testing procedures for optical fiber and unshielded twisted pair at Sandia National Laboratories

    Energy Technology Data Exchange (ETDEWEB)

    Adams, R.L.

    1993-11-01

    This document will establish a working standard for testing optical fiber and unshielded twisted pair cables included in the Lab-wide telecommunications cabling system. The purpose of these standard testing procedures is to deliver to all Sandians a reliable, low-maintenance, state-of-the-art, ubiquitous telecommunications cabling infrastructure capable of satisfying all current and future telecommunication needs.

  9. EVALUASI SANITATION STANDARD OPERATING PROCEDURES KERUPUKAMPLANG DI UD SARINA KECAMATAN KALIANGET KABUPATEN SUMENEP

    Directory of Open Access Journals (Sweden)

    Ach Triharjono

    2016-11-01

    Full Text Available Industri pangan untuk menghasilkan produk yang memenuhi standar keamanan pangan. Standar tersebut dapat dipenuhi dengan menerapkan 8 aspek kunci Sanitation Standard Operating Prosedures (SSOP. Tujuan dari penelitian ini adalah untuk memperoleh hasil penerapan 8 aspek kunci Sanitation Standard Operating Procedures (SSOP dan mengevaluasi penerapan Sanitation Standard Operating Procedures (SSOP Di UD Sarina Kecamatan Kalianget Kabupaten Sumenep. Jenis penelitian ini bersifat deskriptif dengan lokasi penelitian di UD Sarina Kecamatan Kalianget Kabupaten Sumenep. Hasil penelitian diketahui bahwa penerapan 8 aspek kunci Sanitation Standard Operating Procedures (SSOP di UD Sarina sudah terlaksana tapi terdapat 3 tahapan kunci yang belum terlaksana dengan baik yaitu pencegahan kontaminasi silang, pengawasan kondisi kesehatan personil dan menghilangkan hama dari unit pengolahan. Hal yang perlu ditingkatkan terkait dengan penerapan SSOP di UD Sarina yaitu masih perlu adanya manual prosedur untuk berbagai pelaksanaan sanitasi yang dilakukan oleh UD Sarina ini

  10. Comet assay as a procedure for detecting possible genotoxicity induced by non-ionizing radiation

    Directory of Open Access Journals (Sweden)

    Zsuzsanna Nemeth

    2015-05-01

    In our laboratory we use comet assay for testing genotoxicity of non-ionizing radiation for more than ten years. In the experiments we use whole blood samples (human or dog, cell lines (e.g. H295R cell line or 3 dimensional in vitro skin tissue (epidermis models. In our protocol a slightly modified alkaline Comet assay method of Singh et al. (1988 is used. On our poster there will be presented a brief summary of our experiments with exposure to different types of radiation (ELF, RF, and intermediate frequency. In our protocols the non-ionizing radiation was often combined with ionizing radiation to see whether the non-ionizing radiation can influence the repair of the DNA damage induced by ionizing radiation. For the evaluation of the slides mainly Komet 4.0 image analysis system software (Kinetic Imaging, Liverpool, UK was used, but as we got familiarized with other methods for slide evaluation like grading the comets by visual scoring into 5 categories or the CaspLab software, the comparison of these three methods will be also presented.

  11. An International Collaboration To Standardize HIV-2 Viral Load Assays: Results from the 2009 ACHIEV2E Quality Control Study▿

    OpenAIRE

    Damond, F.; Benard, A.; Balotta, Claudia; Böni, Jürg; Cotten, Matthew; Duque, Vitor; Ferns, Bridget; Garson, Jeremy; Gomes, Perpetua; Gonçalves, Fátima; Gottlieb, Geoffrey; Kupfer, Bernd; Ruelle, Jean; Rodes, Berta; Soriano, Vicente

    2011-01-01

    Accurate HIV-2 plasma viral load quantification is crucial for adequate HIV-2 patient management and for the proper conduct of clinical trials and international cohort collaborations. This study compared the homogeneity of HIV-2 RNA quantification when using HIV-2 assays from ACHIEV2E study sites and either in-house PCR calibration standards or common viral load standards supplied to all collaborators. Each of the 12 participating laboratories quantified blinded HIV-2 samples, using its own H...

  12. Toward an international standard for PCR-based detection of food-borne thermotolerant Campylobacters: Assay development and analytical validation

    DEFF Research Database (Denmark)

    Lübeck, Peter Stephensen; Wolffs, P.; On, Stephen L.W.

    2003-01-01

    As part of a European research project (FOOD-PCR), we developed a standardized and robust PCR detection assay specific for the three most frequently reported food-borne pathogenic Campylobacter species, C. jejuni, C. coli, and C. lari. Fifteen published and unpublished PCR primers targeting the 16S...... carcass rinse, unlike both Taq DNA polymerase and DyNAzyme. Based on these results, Tth was selected as the most suitable enzyme for the assay. The standardized PCR test described shows potential for use in large-scale screening programs for food-borne Campylobacter species under the assay conditions....... The inclusivity and exclusivity were 100 and 97%, respectively. In an attempt to find a thermostable DNA polymerase more resistant than Taq to PCR inhibitors present in chicken samples, three DNA polymerases were evaluated. The DNA polymerase Tth was not inhibited at a concentration of 2% (vol/vol) chicken...

  13. Are Fish and Standardized FETAX Assays Protective Enough for Amphibians? A Case Study on Xenopus laevis Larvae Assay with Biologically Active Substances Present in Livestock Wastes

    Directory of Open Access Journals (Sweden)

    Federica Martini

    2012-01-01

    Full Text Available Biologically active substances could reach the aquatic compartment when livestock wastes are considered for recycling. Recently, the standardized FETAX assay has been questioned, and some researchers have considered that the risk assessment performed on fish could not be protective enough to cover amphibians. In the present study a Xenopus laevis acute assay was developed in order to compare the sensitivity of larvae relative to fish or FETAX assays; veterinary medicines (ivermectin, oxytetracycline, tetracycline, sulfamethoxazole, and trimethoprim and essential metals (zinc, copper, manganese, and selenium that may be found in livestock wastes were used for the larvae exposure. Lethal (LC50 and sublethal effects were estimated. Available data in both, fish and FETAX studies, were in general more protective than values found out in the current study, but not in all cases. Moreover, the presence of nonlethal effects, caused by ivermectin, zinc, and copper, suggested that several physiological mechanisms could be affected. Thus, this kind of effects should be deeply investigated. The results obtained in the present study could expand the information about micropollutants from livestock wastes on amphibians.

  14. Improving the review of standard operating procedures: a novel electronic system for compounding pharmacies.

    Science.gov (United States)

    Brensel, Robert; Brensel, Scott; Ng, Amy

    2013-01-01

    Since the New England Compounding Center disaster in 2012, the importance of following correct procedures during every phase of customized pharmacy has been a focus of governmental interest and action as well as public scrutiny. Many pharmacies rely on the rote review of standard operating procedures to ensure that staff members understand and follow protocols that ensure the safety and potency of all compounds prepared, but that approach to continuing education can be cumbersome and needlessly time-consuming. In addition, documenting and retrieving evidence of employee competence can be difficult. In this article, we describe our use of online technology to improve our methods of educating staff about the full range of standard operating procedures that must be followed in our pharmacy. The system we devised and implemented has proven to be effective, easy to update and maintain, very inexpensive, and user friendly. Its use has reduced the time previously required for a read-over review of standard operating procedures from 30 or 40 minutes to 5 or 10 minutes in weekly staff meetings, and we can now easily document and access proof of employees' comprehension of that content. It is our hope that other small compounding pharmacies will also find this system of online standard operating procedure review helpful.

  15. Importance of 241 Am Determination in the Characterization of PuO2 Standards for Calorimetric Assay.

    Energy Technology Data Exchange (ETDEWEB)

    Sampson, Thomas E.

    2005-01-01

    Plutonium dioxide (PuO{sub 2}) standards are often used both as heat standards and isotopic standards for calorimetric assay. Calorimetric assay is the combination of the power in watts measured in a calorimeter with the effective specific power (P{sub eff}) in watts/g Pu, determined either by nondestructive gamma-ray assay or by destructive mass spectrometry, to yield the total elemental plutonium mass in the sample. To use a PuO{sub 2} sample as a heat standard for calorimetry, one must determine both the plutonium mass and P{sub eff} with very small uncertainties and then calculate the sample watts from the known plutonium mass, specific powers, and isotopic composition. Well-characterized PuO{sub 2} standards have plutonium mass values determined by analytical chemistry with a precision and accuracy on the order of 0.1%-0.2% relative to the total mass of the sample. Mass spectrometry, typically used to determine the isotopic fractions of plutonium standards, is very accurate and precise for the major isotopes but is somewhat less precise for low-abundance isotopes. The characterization of the {sup 241}Am/Pu ratio in the standard is also of great importance because {sup 241}Am can contribute significantly to P{sub eff} and to the heat output of the standard. The determination of the {sup 241}Am/Pu ratio in a plutonium-bearing sample is a process that is less standardized than mass spectrometry. There are no certified reference materials (CRMs) traceable to the national measurement system for {sup 241}Am in plutonium, and routine analytical {sup 241}Am/Pu ratio measurements often exhibit uncertainties of several percent relative to the total plutonium or greater.

  16. Evaluation of the dot enzyme-linked immunosorbent assay in comparison with standard ELISA for the immunodiagnosis of human toxocariasis

    Directory of Open Access Journals (Sweden)

    Roldán William

    2006-01-01

    Full Text Available A dot enzyme-linked immunosorbent assay (dot-ELISA was standardized using excretory-secretory antigens of Toxocara canis for the rapid immunodiagnosis of human toxocariasis. Thirty patients with clinical signs of toxocariasis, 20 cases with other parasitic diseases, and 40 healthy subjects were tested. A total of 0.2 ng of antigen per dot, serum dilution of 1:160 and dilution conjugate of 1:1000 were found optimal. The sensitivity and specificity of the assay were 100 and 95%, respectively. Comparable sensitivity of dot-ELISA and the standard ELISA was obtained, but only 3 cross-reactions occurred in the dot-ELISA, compared with 6 in the standard ELISA. Dot-ELISA is simple to perform, rapid, and low cost. Large-scale screening studies should be done to evaluate its usefulness under field conditions.

  17. The primary exposure standard for Co-60 gamma radiation: characteristics and measurements procedures

    International Nuclear Information System (INIS)

    Laitano, R.F.; Toni, M.P.

    1983-01-01

    A description is given of a cavity ionization chamber used, as a primary exposure standard, at the Laboratorio di Metrologia delle Radiazioni Ionizzanti of the ENEA in Italy. The primary standard is designed to make absolute measurements of exposure due to the Co-60 gamma radiation. The procedures for the realizationof the exposure unit are also described. Finally results of some international comparisons are reported

  18. Assessment of bone formation capacity using in vivo transplantation assays: procedure and tissue analysis

    DEFF Research Database (Denmark)

    Abdallah, Basem; Ditzel, Nicholas; Kassem, Moustapha

    2008-01-01

    In vivo assessment of bone formation (osteogenesis) potential by isolated cells is an important method for analysis of cells and factors control ling bone formation. Currently, cell implantation mixed with hydroxyapa-tite/tricalcium phosphate in an open system (subcutaneous implantation) in immun...... transplantation methods in testing bone formationpotential of human mesenchymal stem cells.......In vivo assessment of bone formation (osteogenesis) potential by isolated cells is an important method for analysis of cells and factors control ling bone formation. Currently, cell implantation mixed with hydroxyapa-tite/tricalcium phosphate in an open system (subcutaneous implantation......) in immunodeficient mice is the standard method for in vivo assessment of bone formation capacity of a particular cell type. The method is easy to perform and provides reproducible results. Assessment of the donor origin of tissue formation is possible, especially in the case of human-to-mouse transplanta tion...

  19. Diagnosis and Dosimetry of Exposure to Sulfur Mustard: Development of Standard Operating Procedures; Further Exploratory Research on Protein Adducts

    National Research Council Canada - National Science Library

    Benschop, H

    1999-01-01

    .... Both procedures could be substantially shortened, while their sensitivities were improved. Furthermore, exploratory research is performed aiming at the development of a fieldable immunochemical assay for sulfur mustard adducts with proteins, i.e...

  20. Standard operating procedures for female orgasmic disorder: consensus of the International Society for Sexual Medicine

    NARCIS (Netherlands)

    Laan, Ellen; Rellini, Alessandra H.; Barnes, Tricia

    2013-01-01

    As the field of sexual medicine evolves, it is important to continually improve patient care by developing contemporary "standard operating procedures" (SOPs), reflecting the consensus view of experts in sexual medicine. Few, if any, consensus SOPs have been developed for the diagnosis and treatment

  1. Procedure-related mortality of endovascular abdominal aortic aneurysm repair using revised reporting standards.

    NARCIS (Netherlands)

    Konig, G.G.; Vallabhneni, S.R.; Marrewijk, C.J. van; Leurs, L.J.; Laheij, R.J.F.; Buth, J.

    2007-01-01

    OBJECTIVE: The aim of this study was to evaluate the definition of Procedure-related mortality after endovascular aneurysm repair (EVAR) as defined by the Committee for Standardized Reporting Practices in Vascular Surgery. METHODS: Data on patients with an AAA were taken from the EUROSTAR database.

  2. Evolution of standardized procedures for adjusting lumber properties for change in moisture content

    Science.gov (United States)

    David W. Green; James W. Evans

    2001-01-01

    This paper documents the development of procedures in American Society for Testing and Materials standards for adjusting the allowable properties of lumber for changes in moisture content. The paper discusses the historical context of efforts to establish allowable properties on a consensus basis, beginning in the 19th century. Where possible, the reasons for proposed...

  3. Procedures and Standards for Residential Ventilation System Commissioning: An Annotated Bibliography

    Energy Technology Data Exchange (ETDEWEB)

    Stratton, J. Chris [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Wray, Craig P. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2013-04-01

    Beginning with the 2008 version of Title 24, new homes in California must comply with ANSI/ASHRAE Standard 62.2-2007 requirements for residential ventilation. Where installed, the limited data available indicate that mechanical ventilation systems do not always perform optimally or even as many codes and forecasts predict. Commissioning such systems when they are installed or during subsequent building retrofits is a step towards eliminating deficiencies and optimizing the tradeoff between energy use and acceptable IAQ. Work funded by the California Energy Commission about a decade ago at Berkeley Lab documented procedures for residential commissioning, but did not focus on ventilation systems. Since then, standards and approaches for commissioning ventilation systems have been an active area of work in Europe. This report describes our efforts to collect new literature on commissioning procedures and to identify information that can be used to support the future development of residential-ventilation-specific procedures and standards. We recommend that a standardized commissioning process and a commissioning guide for practitioners be developed, along with a combined energy and IAQ benefit assessment standard and tool, and a diagnostic guide for estimating continuous pollutant emission rates of concern in residences (including a database that lists emission test data for commercially-available labeled products).

  4. Standard operating procedures improve acute neurologic care in a sub-Saharan African setting.

    Science.gov (United States)

    Jaiteh, Lamin E S; Helwig, Stefan A; Jagne, Abubacarr; Ragoschke-Schumm, Andreas; Sarr, Catherine; Walter, Silke; Lesmeister, Martin; Manitz, Matthias; Blaß, Sebastian; Weis, Sarah; Schlund, Verena; Bah, Neneh; Kauffmann, Jil; Fousse, Mathias; Kangankan, Sabina; Ramos Cabrera, Asmell; Kronfeld, Kai; Ruckes, Christian; Liu, Yang; Nyan, Ousman; Fassbender, Klaus

    2017-07-11

    Quality of neurologic emergency management in an under-resourced country may be improved by standard operating procedures (SOPs). Neurologic SOPs were implemented in a large urban (Banjul) and a small rural (Brikama) hospital in the Gambia. As quality indicators of neurologic emergency management, performance of key procedures was assessed at baseline and in the first and second implementation years. At Banjul, 100 patients of the first-year intervention group exhibited higher rates of general procedures of emergency management than 105 control patients, such as neurologic examination (99.0% vs 91.4%; p process quality of neurologic emergency management in under-resourced settings. This study provides Class IV evidence that, for patients with suspected neurologic emergencies in sub-Saharan Africa, neurologic SOPs increase the rate of performance of guideline-recommended procedures. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  5. Standard procedures for adults in accredited sleep medicine centres in Europe

    DEFF Research Database (Denmark)

    Fischer, Jürgen; Dogas, Zoran; Bassetti, Claudio L

    2012-01-01

    The present paper describes standardized procedures within clinical sleep medicine. As such, it is a continuation of the previously published European guidelines for the accreditation of sleep medicine centres and European guidelines for the certification of professionals in sleep medicine, aimed...... and quality assurance of sleep medicine in Europe....... at creating standards of practice in European sleep medicine. It is also part of a broader action plan of the European Sleep Research Society, including the process of accreditation of sleep medicine centres and certification of sleep medicine experts, as well as publishing the Catalogue of Knowledge...... and Skills for sleep medicine experts (physicians, non-medical health care providers, nurses and technologists), which will be a basis for the development of relevant educational curricula. In the current paper, the standard operational procedures sleep medicine centres regarding the diagnostic...

  6. Partnership on Rotational ViscoElastic Test Standardization (PROVETS): evidence-based guidelines on rotational viscoelastic assays in veterinary medicine.

    Science.gov (United States)

    Goggs, Robert; Brainard, Benjamin; de Laforcade, Armelle M; Flatland, Bente; Hanel, Rita; McMichael, Maureen; Wiinberg, Bo

    2014-01-01

    To systematically examine the evidence relating to the performance of rotational viscoelastic testing in companion animals, to develop assay guidelines, and to identify knowledge gaps. Multiple questions were considered within 5 parent domains, specifically system comparability, sample handling, assay activation and test protocol, definitions and data reporting, and nonstandard assays. Standardized, systematic evaluation of the literature was performed. Relevant articles were categorized according to level of evidence and assessed for quality. Consensus was developed regarding conclusions for application of concepts to clinical practice. Academic and referral veterinary medical centers. Databases searched included Medline, Commonwealth Agricultural Bureaux abstracts, and Google Scholar. Worksheets were prepared evaluating 28 questions across the 5 domains and generating 84 assay guidelines. Evidence-based guidelines for the performance of thromboelastography in companion animals were generated through this process. Some of these guidelines are well supported while others will benefit from additional evidence. Many knowledge gaps were identified and future work should be directed to address these gaps and to objectively evaluate the impact of these guidelines on assay comparability within and between centers. © Veterinary Emergency and Critical Care Society 2014.

  7. A Guide for Developing Standard Operating Job Procedures for the Pump Station Process Wastewater Treatment Facility. SOJP No. 3.

    Science.gov (United States)

    Perley, Gordon F.

    This is a guide for standard operating job procedures for the pump station process of wastewater treatment plants. Step-by-step instructions are given for pre-start up inspection, start-up procedures, continuous routine operation procedures, and shut-down procedures. A general description of the equipment used in the process is given. Two…

  8. Toward an International Standard for PCR-Based Detection of Food-Borne Thermotolerant Campylobacters: Assay Development and Analytical Validation

    OpenAIRE

    Lübeck, P. S.; Wolffs, P.; On, S. L. W.; Ahrens, P.; Rådström, P.; Hoorfar, J.

    2003-01-01

    As part of a European research project (FOOD-PCR), we developed a standardized and robust PCR detection assay specific for the three most frequently reported food-borne pathogenic Campylobacter species, C. jejuni, C. coli, and C. lari. Fifteen published and unpublished PCR primers targeting the 16S rRNA gene were tested in all possible pairwise combinations, as well as two published primers targeting the 23S rRNA gene. A panel of 150 strains including target an...

  9. Appearance of discontinuities in spectra transformed by the piecewise direct instrument standardization procedure.

    Science.gov (United States)

    Gemperline, P J; Cho, J; Aldridge, P K; Sekulic, S S

    1996-09-01

    Several years ago, we noted that spectra transformed by the piecewise direct standardization (PDS) method may contain discontinuities. Having noticed that the problem was a recurring one, we studied it and recently diagnosed its source. Our investigations suggest that this problem also occurs in applications of window factor analysis, evolving factor analysis, and any other procedure that uses piecewise principal component models. In this work, we report the source of the problem and illustrate it with one example. A procedure is presented for eliminating the problem that is effective in PDS pattern recognition applications. Further work is needed to develop modified algorithms suitable for calibration applications.

  10. Standardizing the classification of abortion incidents: the Procedural Abortion Incident Reporting and Surveillance (PAIRS) Framework.

    Science.gov (United States)

    Taylor, Diana; Upadhyay, Ushma D; Fjerstad, Mary; Battistelli, Molly F; Weitz, Tracy A; Paul, Maureen E

    2017-07-01

    To develop and validate standardized criteria for assessing abortion-related incidents (adverse events, morbidities, near misses) for first-trimester aspiration abortion procedures and to demonstrate the utility of a standardized framework [the Procedural Abortion Incident Reporting & Surveillance (PAIRS) Framework] for estimating serious abortion-related adverse events. As part of a California-based study of early aspiration abortion provision conducted between 2007 and 2013, we developed and validated a standardized framework for defining and monitoring first-trimester (≤14weeks) aspiration abortion morbidity and adverse events using multiple methods: a literature review, framework criteria testing with empirical data, repeated expert reviews and data-based revisions to the framework. The final framework distinguishes incidents resulting from procedural abortion care (adverse events) from morbidity related to pregnancy, the abortion process and other nonabortion related conditions. It further classifies incidents by diagnosis (confirmatory data, etiology, risk factors), management (treatment type and location), timing (immediate or delayed), seriousness (minor or major) and outcome. Empirical validation of the framework using data from 19,673 women receiving aspiration abortions revealed almost an equal proportion of total adverse events (n=205, 1.04%) and total abortion- or pregnancy-related morbidity (n=194, 0.99%). The majority of adverse events were due to retained products of conception (0.37%), failed attempted abortion (0.15%) and postabortion infection (0.17%). Serious or major adverse events were rare (n=11, 0.06%). Distinguishing morbidity diagnoses from adverse events using a standardized, empirically tested framework confirms the very low frequency of serious adverse events related to clinic-based abortion care. The PAIRS Framework provides a useful set of tools to systematically classify and monitor abortion-related incidents for first

  11. Standard guidelines of care: Performing procedures in patients on or recently administered with isotretinoin

    Directory of Open Access Journals (Sweden)

    Venkataram Mysore

    2017-01-01

    Full Text Available Background: Currently, the standard protocol regarding the performance of procedures on patients receiving or having recently received isotretinoin (13-cis-retinoic acid states that the procedures should not be performed. The recommendations in standard books and drug insert require discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. These recommendations have been followed for over two decades despite little evidence for the stated increased risk of scarring. Objective: The Association of Cutaneous Surgeons (I constituted a task force to review the evidence and to recommend consensus guidelines regarding the safety of skin procedures, including resurfacing, energy-device treatments, and dermatosurgical procedures in patients with concurrent or recent isotretinoin administration. Materials and Methods: Data were extracted from the literature through a PubMed search using the keywords “isotretinoin,” “safety,” “scarring,” “keloids,” “hypertrophic scarring,” and “pigmentation.” The evidence was then labeled and circulated to all members of task force for review. Results: The task force is of the opinion that there is insufficient evidence to support the current protocol of avoiding and delaying treatments in the patient group under consideration and recommends that the current practice should be discontinued.The task force concludes that performing procedures such as laser hair removal, fractional lasers for aging and acne scarring, lasers for pigmented skin lesions, fractional radio-frequency microneedling, superficial and medium-depth peels, microdermabrasion, dermaroller, biopsies, radio-frequency ablation, and superficial excisions is safe in patients with concurrent or recent isotretinoin administration.

  12. Standard operating procedure changed pre-hospital critical care anaesthesiologists’ behaviour: a quality control study

    Science.gov (United States)

    2013-01-01

    Introduction The ability of standard operating procedures to improve pre-hospital critical care by changing pre-hospital physician behaviour is uncertain. We report data from a prospective quality control study of the effect on pre-hospital critical care anaesthesiologists’ behaviour of implementing a standard operating procedure for pre-hospital controlled ventilation. Materials and methods Anaesthesiologists from eight pre-hospital critical care teams in the Central Denmark Region prospectively registered pre-hospital advanced airway-management data according to the Utstein-style template. We collected pre-intervention data from February 1st 2011 to January 31st 2012, implemented the standard operating procedure on February 1st 2012 and collected post intervention data from February 1st 2012 until October 31st 2012. We included transported patients of all ages in need of controlled ventilation treated with pre-hospital endotracheal intubation or the insertion of a supraglottic airways device. The objective was to evaluate whether the development and implementation of a standard operating procedure for controlled ventilation during transport could change pre-hospital critical care anaesthesiologists’ behaviour and thereby increase the use of automated ventilators in these patients. Results The implementation of a standard operating procedure increased the overall prevalence of automated ventilator use in transported patients in need of controlled ventilation from 0.40 (0.34-0.47) to 0.74 (0.69-0.80) with a prevalence ratio of 1.85 (1.57-2.19) (p = 0.00). The prevalence of automated ventilator use in transported traumatic brain injury patients in need of controlled ventilation increased from 0.44 (0.26-0.62) to 0.85 (0.62-0.97) with a prevalence ratio of 1.94 (1.26-3.0) (p = 0.0039). The prevalence of automated ventilator use in patients transported after return of spontaneous circulation following pre-hospital cardiac arrest increased from 0.39 (0

  13. Worldwide review of existing standards and procedures for monitoring and analysing dam deformations

    International Nuclear Information System (INIS)

    Chrzanowski, A.; Avella, S.; Frodge, S.L.

    1993-01-01

    A study was carried out of existing standards and procedures for dam monitoring worldwide. The survey covers worldwide distribution of large dams, dam failures and dam safety legislation, required accuracy and frequency of monitoring surveys, and geometrical analysis of dam deformations. Information is tabulated, on a per-country basis, of number of dam types, actual or preferred method of monitoring, dam safety legislation in place, standards and specifications for monitoring, whether automation of monitoring is included, whether geodetic systems have been designed, and sample specifications for monitoring concrete dams as recommended by the Swiss National Committee on Large Dams. 29 refs., 3 tabs

  14. Standardized quantitative RT-PCR assays for quantitation of yellow fever and chimeric yellow fever-dengue vaccines.

    Science.gov (United States)

    Mantel, N; Aguirre, M; Gulia, S; Girerd-Chambaz, Y; Colombani, S; Moste, C; Barban, V

    2008-07-01

    Yellow fever-dengue chimeras (CYDs) are being developed currently as live tetravalent dengue vaccine candidates. Specific quantitative assays are needed to evaluate the viral load of each serotype in vaccine batches and biological samples. A quantitative real-time RT-PCR (qRT-PCR) system was developed comprising five one-step qRT-PCRs targeting the E/NS1 junction of each chimera, or the NS5 gene in the yellow fever backbone. Each assay was standardized using in vitro transcribed RNA qualified according to its size and purity, and precisely quantified. A non RNA-extracted virus sample was introduced as external quality control (EQC), as well as 2 extraction controls consisting of 2 doses, 40 and 4,000 GEQ (genomic equivalents), of this EQC extracted in parallel to the samples. Between 6 and 10 GEQ/reaction were reproducibly measured with all assays and similar titers were obtained with the two methods when chimeric virus samples were quantified with the E/NS1- or the NS5-specific assays. Reproducibility of RNA extraction was ensured by automation of the process (yield>or=50%), and infectious virus was isolated in >or=80% of PCR-positive sera from immune monkeys.

  15. Development of a standardized and safe airborne antibacterial assay, and its evaluation on antibacterial biomimetic model surfaces.

    Directory of Open Access Journals (Sweden)

    Ali Al-Ahmad

    Full Text Available Bacterial infection of biomaterials is a major concern in medicine, and different kinds of antimicrobial biomaterial have been developed to deal with this problem. To test the antimicrobial performance of these biomaterials, the airborne bacterial assay is used, which involves the formation of biohazardous bacterial aerosols. We here describe a new experimental set-up which allows safe handling of such pathogenic aerosols, and standardizes critical parameters of this otherwise intractable and strongly user-dependent assay. With this new method, reproducible, thorough antimicrobial data (number of colony forming units and live-dead-stain was obtained. Poly(oxonorbornene-based Synthetic Mimics of Antimicrobial Peptides (SMAMPs were used as antimicrobial test samples. The assay was able to differentiate even between subtle sample differences, such as different sample thicknesses. With this new set-up, the airborne bacterial assay was thus established as a useful, reliable, and realistic experimental method to simulate the contamination of biomaterials with bacteria, for example in an intraoperative setting.

  16. Bias in segmented gamma scans arising from size differences between calibration standards and assay samples

    International Nuclear Information System (INIS)

    Sampson, T.E.

    1991-01-01

    Recent advances in segmented gamma scanning have emphasized software corrections for gamma-ray self-adsorption in particulates or lumps of special nuclear material in the sample. another feature of this software is an attenuation correction factor formalism that explicitly accounts for differences in sample container size and composition between the calibration standards and the individual items being measured. Software without this container-size correction produces biases when the unknowns are not packaged in the same containers as the calibration standards. This new software allows the use of different size and composition containers for standards and unknowns, as enormous savings considering the expense of multiple calibration standard sets otherwise needed. This paper presents calculations of the bias resulting from not using this new formalism. These calculations may be used to estimate bias corrections for segmented gamma scanners that do not incorporate these advanced concepts

  17. Standard guide for the selection, training and qualification of nondestructive assay (NDA) personnel

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

    1.1 This guide contains good practices for the selection, training, qualification, and professional development of personnel performing analysis, calibration, physical measurements, or data review using nondestructive assay equipment, methods, results, or techniques. The guide also covers NDA personnel involved with NDA equipment setup, selection, diagnosis, troubleshooting, or repair. Selection, training, and qualification programs based on this guide are intended to provide assurance that NDA personnel are qualified to perform their jobs competently. This guide presents a series of options but does not recommend a specific course of action.

  18. Procedure and reference standard to determine the structural resolution in coordinate metrology

    Science.gov (United States)

    Illemann, Jens; Bartscher, Markus; Jusko, Otto; Härtig, Frank; Neuschaefer-Rube, Ulrich; Wendt, Klaus

    2014-06-01

    A new procedure and reference standards for specifying the structural resolution in coordinate metrology traceable to the SI unit the metre are proposed. With the definition of the structural resolution, a significant gap will be closed to complete ‘acceptance and verification tests’ of the coordinate measuring systems (CMSs) which are specified in the ISO 10360 series dealing with tactile sensors, optical sensors, and x-ray computed tomography measurement systems (CTs). The proposed new procedure uses reference standards with circular rounded edges. The idea is to measure the radius of curvature on a calibrated round edge structure. From the deviation between the measured and the calibrated radius, an analogue Gaussian broadening of the measurement system is determined. This value is a well-defined and easy-to-apply measure to define the structural resolution for dimensional measurements. It is applicable to CMSs which are based on different sensing principles, e.g. tactile, optical and CT systems. On the other hand, it has a physical meaning similar to the classical optical point-spread function. It makes it possible to predict which smallest details the CMS is capable of measuring reliably for an arbitrary object shape. The theoretical background of the new procedure is given, an appropriate reference standard is described and comparative, quantitative measurement data of CMSs featuring different sensors are shown.

  19. Reevaluation of the Harboe assay as a standardized method of assessment for the hemolytic performance of ventricular assist devices.

    Science.gov (United States)

    Chan, Chris H H; Hilton, Andrew; Foster, Graham; Hawkins, Karl

    2012-08-01

    The Harboe spectrophotometric assay is regarded as one of the safest and most reproducible methods for measuring plasma free hemoglobin (pfHb). However, there is still some ambiguity in the application of the assay when assessing the hemolytic performance of ventricular assist devices (VADs). The purpose of this study was to reexamine and compare values of pfHb obtained using different concentrations of plasma diluent (Na(2) CO(3) ) as cited by various studies such that a standard practice may be recommended for the application of the Harboe assay in the hemolytic evaluation of VADs, allowing reliable comparisons to be made between laboratories. As a means to examine the Harboe assay, a BioMedicus BPX-80 was tested using both whole blood and a washed suspension of red blood cells (RBCs). Results show that for whole blood, the pfHb may be underestimated by 13-23%, dependent upon the concentration of Na(2) CO(3) diluent solution. This trend was not observed for the washed suspension of RBCs. Furthermore, it is shown that the concentration of diluent influences the stability of a sample. The results of this study show that the problems associated with the incongruity of pfHb readings are a direct result of the precipitation of proteins from the plasma under alkaline conditions; as the molarity of the diluent controls pH, it becomes essential to use the appropriate concentration of Na(2) CO(3) diluent in order to avoid turbidity of the solution and the consequent misrepresentation of pfHb values. Such standardization is pertinent when measuring the very low levels of pfHb observed during the in vivo testing of modern ventricular assist devices. © 2012, Copyright the Authors. Artificial Organs © 2012, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  20. A new internal standard for HPLC assay of conjugated linoleic acid in animal tissues and milk

    Czech Academy of Sciences Publication Activity Database

    Czauderna, M.; Kowalczyk, J.; Marounek, Milan; Michalski, J. P.; Rozbicka-Wieczorek, A. J.; Krajewska, K. A.

    2011-01-01

    Roč. 56, č. 1 (2011), s. 23-29 ISSN 1212-1819 Institutional research plan: CEZ:AV0Z50450515 Keywords : sorbic acid * internal standard * CLA isomers Subject RIV: GH - Livestock Nutrition Impact factor: 1.079, year: 2011

  1. Standard test method for plutonium assay by plutonium (III) diode array spectrophotometry

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method describes the determination of total plutonium as plutonium(III) in nitrate and chloride solutions. The technique is applicable to solutions of plutonium dioxide powders and pellets (Test Methods C 697), nuclear grade mixed oxides (Test Methods C 698), plutonium metal (Test Methods C 758), and plutonium nitrate solutions (Test Methods C 759). Solid samples are dissolved using the appropriate dissolution techniques described in Practice C 1168. The use of this technique for other plutonium-bearing materials has been reported (1-5), but final determination of applicability must be made by the user. The applicable concentration range for plutonium sample solutions is 10–200 g Pu/L. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropria...

  2. Bias in segmented gamma scans arising from size differences between calibration standards and assay samples

    International Nuclear Information System (INIS)

    Sampson, T.E.

    1991-01-01

    Recent advances in segmented gamma scanning have emphasized software corrections for gamma-ray self-absorption in particulates or lumps of special nuclear material in the sample. Another feature of this software is an attenuation correction factor formalism that explicitly accounts for differences in sample container size and composition between the calibration standards and the individual items being measured. Software without this container-size correction produces biases when the unknowns are not packaged in the same containers as the calibration standards. This new software allows the use of different size and composition containers for standards and unknowns, an enormous savings considering the expense of multiple calibration standard sets otherwise needed. This report presents calculations of the bias resulting from not using this new formalism. The calculations may be used to estimate bias corrections for segmented gamma scanners that do not incorporate these advanced concepts. This paper describes this attenuation-correction-factor formalism in more detail and illustrates the magnitude of the biases that may arise if it is not used. 5 refs., 7 figs

  3. Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

    Directory of Open Access Journals (Sweden)

    Concetta Dagostino

    Full Text Available Chronic low back pain (CLBP is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on the Global Burden of Disease 2010 study. Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine. Multicentre studies are needed for such an effort, and a standardized and homogeneous approach is vital for recruitment of large numbers of participants among different centres (clinical and laboratories to obtain robust and reproducible results. To date, no validated standard operating procedures (SOPs for genetic/-omics studies in chronic pain have been developed. In this study, we validated an SOP model that will be used in the multicentre (5 centres retrospective "PainOmics" study, funded by the European Community in the 7th Framework Programme, which aims to develop new biomarkers for CLBP through three different -omics approaches: genomics, glycomics and activomics. The SOPs describe the specific procedures for (1 blood collection, (2 sample processing and storage, (3 shipping details and (4 cross-check testing and validation before assays that all the centres involved in the study have to follow. Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses. The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.

  4. Paving the way for a gold standard of care for infertility treatment: improving outcomes through standardization of laboratory procedures.

    Science.gov (United States)

    Schoolcraft, William; Meseguer, Marcos

    2017-10-01

    Infertility affects over 70 million couples globally. Access to, and interest in, assisted reproductive technologies is growing worldwide, with more couples seeking medical intervention to conceive, in particular by IVF. Despite numerous advances in IVF techniques since its first success in 1978, almost half of the patients treated remain childless. The multifactorial nature of IVF treatment means that success is dependent on many variables. Therefore, it is important to examine how each variable can be optimized to achieve the best possible outcomes for patients. The current approach to IVF is fragmented, with various protocols in use. A systematic approach to establishing optimum best practices may improve IVF success and live birth rates. Our vision of the future is that technological advancements in the laboratory setting are standardized and universally adopted to enable a gold standard of care. Implementation of best practices for laboratory procedures will enable clinicians to generate high-quality gametes, and to produce and identify gametes and embryos of maximum viability and implantation potential, which should contribute to improving take-home healthy baby rates. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. 40 CFR 75.33 - Standard missing data procedures for SO2, NOX, Hg, and flow rate.

    Science.gov (United States)

    2010-07-01

    ... SO2, NOX, Hg, and flow rate. 75.33 Section 75.33 Protection of Environment ENVIRONMENTAL PROTECTION... Procedures § 75.33 Standard missing data procedures for SO2, NOX, Hg, and flow rate. (a) Following initial...—Missing Data Procedure for SO2 CEMS, CO2 CEMS, Moisture CEMS, Hg CEMS, and Diluent (CO2 or O2) Monitors...

  6. Towards an international standard for PCR-based detection of food-borne thermotolerant Campylobacters: assay development and analytical validation.

    OpenAIRE

    Lübeck, P S; Wolffs, Petra; On, S L; Ahrens, P; Rådström, Peter; Hoorfar, J

    2003-01-01

    As part of a European research project (FOOD-PCR), we developed a standardized and robust PCR detection assay specific for the three most frequently reported food-borne pathogenic Campylobacter species, C. jejuni, C. coli, and C. lari. Fifteen published and unpublished PCR primers targeting the 16S rRNA gene were tested in all possible pairwise combinations, as well as two published primers targeting the 23S rRNA gene. A panel of 150 strains including target and nontarget strains was used in ...

  7. Standardization of specifications and inspection procedures for LEU plate-type research reactor fuels

    International Nuclear Information System (INIS)

    1988-06-01

    With the transition to high density uranium LEU fuel, fabrication costs of research reactor fuel elements have a tendency to increase because of two reasons. First, the amount of the powder of the uranium compound required increases by more than a factor of five. Second, fabrication requirements are in many cases nearer the fabrication limits. Therefore, it is important that measures be undertaken to eliminate or reduce unnecessary requirements in the specification or inspection procedures of research reactor fuel elements utilizing LEU. An additional stimulus for standardizing specifications and inspection procedures at this time is provided by the fact that most LEU conversions will occur within a short time span, and that nearly all of them will require preparation of new specifications and inspection procedures. In this sense, the LEU conversions offer an opportunity for improving the rationality and efficiency of the fuel fabrication and inspection processes. This report focuses on the standardization of specifications and inspection processes of high uranium density LEU fuels for research reactors. However, in many cases the results can also be extended directly to other research reactor fuels. 15 refs, 1 fig., 3 tabs

  8. Addendum to the procedure of KWU standard calculation for PWR fuel assembly with gadolinium

    International Nuclear Information System (INIS)

    Andrade, E.P. de

    1993-01-01

    The objective of this work is to solve a doubt appeared in the standard procedure of KWU/Siemens for fuel assembly (FA) with gadolinium. In this procedure, the σ's and form functions of such assembly are modified by his effective heterogeneity factor factor (f eff ), which is defined as the ratio between the heterogeneity factors (f het ) of FA's with and without poison. The doubt appeared at the time to calculated the f het of FA without poison: should one consider the pure FA or the FA with poison in which the concentration of gadolinium would be set to zero, but one should keep that of natural uranium? The best results were obtained considering the second hypothesis. (author)

  9. Refractory Metal Heat Pipe Life Test - Test Plan and Standard Operating Procedures

    Science.gov (United States)

    Martin, J. J.; Reid, R. S.

    2010-01-01

    Refractory metal heat pipes developed during this project shall be subjected to various operating conditions to evaluate life-limiting corrosion factors. To accomplish this objective, various parameters shall be investigated, including the effect of temperature and mass fluence on long-term corrosion rate. The test series will begin with a performance test of one module to evaluate its performance and to establish the temperature and power settings for the remaining modules. The performance test will be followed by round-the-clock testing of 16 heat pipes. All heat pipes shall be nondestructively inspected at 6-month intervals. At longer intervals, specific modules will be destructively evaluated. Both the nondestructive and destructive evaluations shall be coordinated with Los Alamos National Laboratory. During the processing, setup, and testing of the heat pipes, standard operating procedures shall be developed. Initial procedures are listed here and, as hardware is developed, will be updated, incorporating findings and lessons learned.

  10. Assessment of organ doses by standard X-ray procedures in the GDR

    International Nuclear Information System (INIS)

    Tautz, M.; Brandt, G.A.

    1986-01-01

    A modern method has been described to assess the radiation burden by X-ray procedures with consideration of the standards of our Society for Medical Radiology in the GDR. The underlying methodology is a Monte Carlo computer technique, which simulates stochastically the energy deposition of X-ray photons in a mathematically described heterogeneous anthropomorphic phantom by Rosenstein (US Department of Health, Education and Welfare). To apply the procedure specific values for the following parameters must be determined for each dose estimation: projection and view, X-ray field size and location entrance exposure at skin surface, beam quality, source-to-image receptor distance. The base data are obtained in terms of tissue-air ratio. Organ doses were calculated for chest, urography, skull, cervical spine, thoracic spine, lumbar spine, pelvis and lymphography. Concluding possibilities have been discussed for reduction of radiation burden. 9 refs., 6 figs., 9 tabs. (author)

  11. Smelling Pseudomonas aeruginosa infections using a whole-cell biosensor - An alternative for the gold-standard culturing assay.

    Science.gov (United States)

    Kviatkovski, Igor; Shushan, Sagit; Oron, Yahav; Frumin, Idan; Amir, Daniel; Secundo, Lavi; Livne, Eitan; Weissbrod, Aharon; Sobel, Noam; Helman, Yael

    2018-02-10

    Improved easy-to-use diagnostic tools for infections are in strong demand worldwide. Yet, despite dramatic advances in diagnostic technologies, the gold-standard remains culturing. Here we offer an alternative tool demonstrating that a bacterial biosensor can efficiently detect Pseudomonas aeruginosa infections in patients suffering from otitis externa. Detection was based on specific binding between the biosensor and 2-aminoacetophenone (2-AA), a volatile produced by P. aeruginosa in high amounts. We collected pus samples from ears of 26 subjects exhibiting symptoms of otitis externa. Detection of P. aeruginosa using the biosensor was compared to detection using gold-standard culturing assay and to gas-chromatograph-mass-spectrometry (GC-MS) analyses of 2-AA. The biosensor strain test matched the culture assay in 24 samples (92%) and the GC-MS analyses in 25 samples (96%). With this result in hand, we designed a device containing a whole-cell luminescent biosensor combined with a photo-multiplier tube. This device allowed detection of 2-AA at levels as low as 2 nmol, on par with detection level of GC-MS. The results of the described study demonstrate that the volatile 2-AA serves as an effective biomarker for P. aeruginosa in ear infections, and that activation of the biosensor strain by 2-AA provides a unique opportunity to design an easy-to-use device that can specifically detect P. aeruginosa infections. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Chinese consensus statement on standard procedure and perioperative management of bronchial thermoplasty.

    Science.gov (United States)

    Lin, Jiangtao; Nong, Ying; Yang, Dong; Li, Shiyue; Wang, Guangfa; Su, Nan; Zhong, Nanshan

    2017-12-01

    Bronchial thermoplasty (BT) is a non-pharmacologic therapy for severe asthma. The proper procedure and perioperative management are very important for the effectiveness and safety of BT. China Asthma Alliance assembled a group of experts in asthma and BT to review the literature, drew on their own experiences, discussed, and then finalized by consensus to establish this standard practice guideline. This practice guideline is designed to guide clinicians as to proper patients' selection, preoperative assessment, postoperative management and follow-up. This practice guideline also proposed "China Alair System Registry Study (NCT02206269)" as the real-world study to enhance clinical utility of BT.

  13. New Serbian criminal procedure: New reasons for harmonization with European legal standards

    Directory of Open Access Journals (Sweden)

    Đurđić Vojislav

    2014-01-01

    Full Text Available The new criminal procedure, set forth in 2011, represents a compilation of the inquisitive model of preliminary proceedings, on the one hand, and adversarial trial of the Anglo-American type of criminal procedure on the other. Introduction of the public prosecutor's investigation required a subtle legislative approach to the protection of human rights in criminal proceedings, in order to establish equilibrium between efficient and just procedure. Instead of the expected, the erroneous conception based on the ideas that the public prosecutor's investigation should be strictly formal as that of a court, that evidence taken by the non-judicial authorities should have the same bearing as those taken by the courts, and that the court should have no role in conducting investigation, resulted in an overly inferior position of the accuses compared to that of the public prosecutor. Beside the fact that such conception can not pass the ECJ test, the specific legal solutions referring the investigation open the question of harmonization with the European legal standards. The provisions on initiation of this phase of the proceedings, not being legally sanctioned, put in question the right of the accused to access justice, as well as his right to an effective legal remedy, and the introduced investigation against the unknown perpetrator, the right to be present at one's own trial is being jeopardized. Neither do all procedural rules pertaining to the trial support the fair procedure principle: the indirect extortion of evidence from the defense is discordant with the rule that the burden of proof lies on the prosecutor, as one of the main pillars of the assumption of innocence; as well as the broad opportunity to use non-judicial evidence at the hearing without any major legal obstacles, have demolished the principles of directness and contradictoriness. Even some of the minimal right of the defense as well as the guarantees of personal freedom in the course

  14. Assessing Immunity to Rubella Virus: a Plea for Standardization of IgG (Immuno)assays

    Science.gov (United States)

    Bouthry, Elise; Huzly, Daniela; Ogee-Nwankwo, Adaeze; Hao, LiJuan; Adebayo, Adebola; Icenogle, Joseph; Sarasini, Antonella; Revello, Maria Grazia; Grangeot-Keros, Liliane

    2016-01-01

    Immunity to rubella virus (RV) is commonly determined by measuring specific immunoglobulin G (RV IgG). However, RV IgG results and their interpretation may vary, depending on the immunoassay, even though most commercial immunoassays (CIAs) have been calibrated against an international standard and results are reported in international units per milliliter. A panel of 322 sera collected from pregnant women that tested negative or equivocal for RV IgG in a prior test (routine screening) was selected. This panel was tested with two reference tests, immunoblotting (IB) and neutralization (Nt), and with 8 CIAs widely used in Europe. IB and Nt gave concordant results on 267/322 (82.9%) sera. Of these, 85 (26.4%) sera were negative and 182 (56.5%) sera were positive for both tests. All 85 IB/Nt-negative samples were classified as negative with all CIAs. Of the 182 IB/Nt-positive samples, 25.3 to 61.5% were classified as equivocal and 6 to 64.8% were classified as positive with the CIAs. Wide variations in titers in international units per milliliter were observed. In our series, more than half of the women considered susceptible to RV based on CIA results tested positive for RV antibodies by IB/Nt. Our data suggest that (i) sensitivity of CIAs could be increased by considering equivocal results as positive and (ii) the definition of immunity to RV as the 10-IU/ml usual cutoff as well as the use of quantitative results for clinical decisions may warrant reconsideration. A better standardization of CIAs for RV IgG determination is needed. PMID:27147722

  15. Standardization and performance evaluation of mononuclear cell cytokine secretion assays in a multicenter study

    Directory of Open Access Journals (Sweden)

    Grindle Kristine

    2006-12-01

    Full Text Available Abstract Background Cryopreservation of peripheral blood mononuclear cells has been used to preserve and standardize immunologic measurements for multicenter studies, however, effects of cryopreservation on cytokine responses are incompletely understood. In designing immunologic studies for a new multicenter birth cohort study of childhood asthma, we performed a series of experiments to determine the effects of two different methods of cryopreservation on the cytokine responses of cord and peripheral blood mononuclear cells. Results Paired samples of PBMC were processed freshly, or after cryopreservation in a Nalgene container (NC or a controlled-rate freezer (CRF. Although there were some differences between the methods, cryopreservation inhibited PHA-induced IL-10 secretion and Der f 1-induced IL-2 secretion, and augmented PHA-induced IL-2 secretion and spontaneous secretion of TNF-α. In separate experiments, NC cryopreservation inhibited secretion of several cytokines (IL-13, IL-10, IFN-γ, TNF-α by PHA-stimulated cord blood mononuclear cells. With the exception of PHA-induced IL-13, results from fresh and cryopreserved cord blood samples were not significantly correlated. Finally, in reproducibility studies involving processing of identical cell samples in up to 4 separate laboratories, variances in cytokine responses of fresh cells stimulated at separate sites did not exceed those in cryopreserved cells stimulated at a central site. Conclusion Collectively, these studies indicate that cryopreservation can affect mononuclear cell cytokine response profiles, and that IL-10 secretion and antigen-induced responses may be especially vulnerable. These studies also demonstrate that mononuclear cell responses can be standardized for performance in a small number of laboratories for multicenter studies, and underscore the importance of measuring reproducibility and of testing whether cryopreservation techniques alter specific immunologic outcomes.

  16. Federal standards and procedures for the National Watershed Boundary Dataset (WBD)

    Science.gov (United States)

    ,; ,; ,

    2013-01-01

    The Watershed Boundary Dataset (WBD) is a comprehensive aggregated collection of hydrologic unit data consistent with the national criteria for delineation and resolution. This document establishes Federal standards and procedures for creating the WBD as seamless and hierarchical hydrologic unit data, based on topographic and hydrologic features at a 1:24,000 scale in the United States, except for Alaska at 1:63,360 scale, and 1:25,000 scale in the Caribbean. The data within the WBD have been reviewed for certification through the 12-digit hydrologic unit for compliance with the criteria outlined in this document. Any edits to certified data will be reviewed against this standard prior to inclusion. Although not required as part of the framework WBD, the guidelines contain details for compiling and delineating the boundaries of two additional levels, the 14- and 16-digit hydrologic units, as well as the use of higher resolution base information to improve delineations. The guidelines presented herein are designed to enable local, regional, and national partners to delineate hydrologic units consistently and accurately. Such consistency improves watershed management through efficient sharing of information and resources and by ensuring that digital geographic data are usable with other related Geographic Information System (GIS) data.Terminology, definitions, and procedural information are provided to ensure uniformity in hydrologic unit boundaries, names, and numerical codes. Detailed standards and specifications for data are included. The document also includes discussion of objectives, communications required for revising the data resolution in the United States and the Caribbean, as well as final review and data-quality criteria. Instances of unusual landforms or artificial features that affect the hydrologic units are described with metadata standards. Up-to-date information and availability of the hydrologic units are listed at http:// www

  17. Aminoglycoside detection using a universal ELISA binding procedure onto polystyrene microtiter plates in comparison with HPLC analysis and microbiological agar-diffusion assay.

    Science.gov (United States)

    Sachetelli, S; Beaulac, C; Lagacé, J

    1998-01-08

    The use of enzyme-linked immunosorbent assay for the detection of aminoglycosides has been hindered due to low molecular weight compound adsorption to solid phases. Here, we describe an enzyme-linked immunosorbent assay based on the treatment of polystyrene microtiter plates with Alcian blue prepared in acetic acid prior to coating with the antibiotic. Whereas no detection of tobramycin was possible on commercially treated or untreated enzyme-linked immunosorbent assay plates, the Alcian blue treatment permitted detection of 0.025 and 0.05 microg ml(-1) of tobramycin respectively using 0.05 and 0.1% of Alcian blue with a coefficient of variation of 1.85 and 7.69%, respectively. Comparative studies of five tobramycin samples of unknown quantity using enzyme-linked immunosorbent assay and high-performance liquid chromatography gave equivalent results while those done via microbiological agar-diffusion assay were an overestimation of the actual quantity. The use of the Alcian blue pretreatment enzyme-linked immunosorbent assay procedure has permitted, in previous studies, the measure of antibodies against synthetic peptides and phospholipids. Subsequently, our demonstration of the sensitivity and reliability of this method in the quantification of tobramycin strongly suggests that the use of Alcian blue pretreatment in enzyme-linked immunosorbent assay can be applied universally to avert molecule immobilization problems on solid phases.

  18. Improving International Standards in Surgical and Procedural Training through Comparative Operative Log Growth Charts

    Directory of Open Access Journals (Sweden)

    Vannipa Vathanophas, M.D.

    2018-03-01

    Full Text Available Objective: To use these growth charts to critically assess sufficiency of cases and parity of cases between residents, and to compare these growth charts to available international standards for minimum case numbers. Methods: Operative Log Growth Charts were developed for key indicator procedures for graduating otolaryngology residents in 2012-2014 at a large teaching hospital in the capital city of a newly industrialized country. Comparisons were made between years of training and required minimum case numbers published by the ACGME RRC for Otolaryngology. Results: Data was available to create 7 key indicator operative log growth charts to include all available data from 2012-2014 residents. These growth charts were used to assess growth in operative procedures for residents in the program compared to historical norms in the program. Graduating residents surpassed ACGME minimum case numbers in Bronchoscopy only and were below the minimum numbers for the other key indicators tested. Conclusion: There is significant heterogeneity in the standards for otolaryngology training between countries. It is possible to develop program-specific and country-specific operative log growth charts.

  19. The Cox-maze IV procedure in its second decade: still the gold standard?

    Science.gov (United States)

    Ruaengsri, Chawannuch; Schill, Matthew R; Khiabani, Ali J; Schuessler, Richard B; Melby, Spencer J; Damiano, Ralph J

    2018-04-01

    Atrial fibrillation (AF) is the most common cardiac arrhythmia and the treatment options include medical treatment and catheter-based or surgical interventions. AF is a major cause of stroke, and its prevalence is increasing. The surgical treatment of AF has been revolutionized over the past 2 decades through surgical innovation and improvements in endoscopic imaging, ablation technology and surgical instrumentation. The Cox-maze (CM) procedure, which was developed by James Cox and introduced clinically in 1987, is a procedure in which multiple incisions are created in both the left and the right atria to eliminate AF while allowing the sinus impulse to reach the atrioventricular node. This procedure became the gold standard for the surgical treatment of AF. Its latest iteration is termed the CM IV and was introduced in 2002. The CM IV replaced the previous cut-and-sew method (CM III) by replacing most of the incisions with a combination of bipolar radiofrequency and cryoablation. The use of ablation technologies, made the CM IV technically easier, faster and more amenable to minimally invasive approaches. The aims of this article are to review the indications and preoperative planning for the CM IV, to describe the operative technique and to review the literature including comparisons of the CM IV with the previous cut-and-sew method. Finally, this review explores future directions for the surgical treatment of patients with AF.

  20. Development of a standard operating procedure for mammography equipment used in calibration of ionized chambers

    International Nuclear Information System (INIS)

    Rodrigues, Yklys Santos; Potiens, Maria da Penha Albuquerque

    2011-01-01

    Mammography is one widely used technique in the detection of breast cancer. In order to optimize the results achieving better images with lower dose rates, a quality assurance programme must be applied to the equipment. Some control tests use ionization chambers to measure air kerma and other quantities. These tests can only be reliable if the ionization chambers used on them are correctly calibrated. In the present work, it was developed a standard operating procedure (SOP) for quality control tests in a commercial mammography equipment installed in the Calibration Laboratory (LCI) at IPEN - Brazilian Institute for energy and nuclear research). Seven tests were performed in the equipment: Tube voltage and exposition time accuracy and reproducibility, linearity and reproducibility of Air kerma and Half Value Layer (HVL). Then, it was made a measurement of the air kerma in the mammography equipment, using a reference ionization chamber with traceability to a primary laboratory in Germany (Physikalisch-Technische Bundesanstalt - PTB), that was later compared with the air kerma measured in an industrial irradiator. This industrial X-ray generator was recently used in the implementation of X-radiation Standards beams, mammography level, following the Standard IEC 61267. The HVL values varied from 0.36 (25kV) to 0.41 mmA1 (35kV), and the measured air kerma rates were between 9.78 and 17.97 mGy/min. (author)

  1. Primary calibration of TXRF in comparison with the standard droplet procedure

    International Nuclear Information System (INIS)

    Dobler, M.; Reus, U.; Knoth, J.; Schwenke, H.

    2000-01-01

    For the determination of contamination on wafer surfaces with total reflection x-ray fluorescence spectrometry (TXRF) normally external 1 ng Ni droplet standards were used for calibration. This method is based on several assumptions about the properties of the standard droplet which are strongly affected by the preparation of the samples. In this paper a study is resented which compares the external droplet method with a calibration procedure using the fundamental physical background of total reflection x-ray fluorescence spectrometry and the properties of Ni bulk material. The particular features of the two methods will be discussed and the obtained results compared to each other. It is demonstrated in this study that the calibration with Ni bulk material is a primary method which offers several advantages compared to the calibration based on droplet standards. These advantages are unique and enable a more reliable and reproducible quantification of contamination on wafer surfaces. This is caused by the fact that the method is standardless and only based on fundamental parameters and natural constants. It is also demonstrated that effects which could be caused by especial features of the measured samples (particle or film, e.g.) or by the degradation of the calibration sample could be excluded. (author)

  2. Influence of new customs procedures and logistic security standards on companies competiveness – a Croatian company case study

    Directory of Open Access Journals (Sweden)

    Aleksandar Erceg

    2014-12-01

    Full Text Available In today’s global market, companies are constantly confronted with the competition on the local, national and international level. Companies therefore use a variety of strategies and tools to become and/or remain competitive. Potential areas for cost reduction in companies are supply chain management and logistic and customs procedures. Implementation of various logistic standards in supply chain management can provide significant cost savings for the company’s daily operations and thus reduce overall costs and improve the competitiveness. Using different customs procedures and logistic standards to reduce their costs and become more competitive in the market is necessary for Croatian companies. The method of using these tools is not a one-time process and requires constant efforts. Companies therefore have to be ready to improve daily to be and remain competitive. Using a variety of modern customs procedures can save their money and time, not only through these procedures, but also through better use of their employee’s time, their own vehicles and other equipment. The paper analyzes various customs procedures and logistic standards that can help companies save time and money and improve their competitiveness. In the example of Croatian company, which uses various available procedures and standards the benefits of their use are shown. Apart from bringing savings in operations, all these procedures and standards allow the company to be better, cheaper and more attractive to buyers.

  3. Calibration of photon and beta ray sources used in brachytherapy. Guidelines on standardized procedures at Secondary Standards Dosimetry Laboratories

    International Nuclear Information System (INIS)

    2004-03-01

    It has generally been recognized that international harmonization in radiotherapy dosimetry is essential. Consequently, the IAEA has given much effort to this, for example by publishing a number of reports in the Technical Reports Series (TRS) for external beam dosimetry, most notably TRS-277 and more recently TRS-398. Both of these reports describe in detail the steps to be taken for absorbed dose determination in water and they are often referred to as 'dosimetry protocols'. Similar to TRS-277, it is expected that TRS-398 will be adopted or used as a model by a large number of countries as their national protocol. In 1996, the IAEA established a calibration service for low dose rate (LDR) 137 Cs brachytherapy sources, which is the most widely used source for treatment of gynecological cancer. To further enhance harmonization in brachytherapy dosimetry, the IAEA published in 1999 IAEA-TECDOC-1079 entitled 'Calibration of Brachytherapy Sources. Guidelines on Standardized Procedures for the Calibration of Brachytherapy Sources at Secondary Standard Dosimetry Laboratories (SSDLs) and Hospitals'. The report was well received and was distributed in a large number of copies to the members of the IAEA/WHO network of SSDLs and to medical physicists working with brachytherapy. The present report is an update of the aforementioned TECDOC. Whereas TECDOC-1079 described methods for calibrating brachytherapy sources with photon energies at or above those of 192 Ir, the current report has a wider scope in that it deals with standardization of calibration of all the most commonly used brachytherapy sources, including both photon and beta emitting sources. The latter sources have been in use for a few decades already, but their calibration methods have been unclear. Methods are also described for calibrating sources used in the rapidly growing field of cardiovascular angioplasty. In this application, irradiation of the vessel wall is done in an attempt to prevent restenosis after

  4. A Guide for Developing Standard Operating Job Procedures for the Grit Removal Process Wastewater Treatment Facility. SOJP No. 2.

    Science.gov (United States)

    Deal, Gerald A.; Montgomery, James A.

    This guide describes standard operating job procedures for the grit removal process of wastewater treatment plants. Step-by-step instructions are given for pre-start up inspection, start-up, continuous operation, and shut-down procedures. A description of the equipment used in the process is given. Some theoretical material is presented. (BB)

  5. Standard manufacturing procedure for syrup and tablet forms of Jwarahara Dashemani

    Science.gov (United States)

    Kalsariya, Bharat D.; Patgiri, B. J.; Prajapati, P. K.

    2010-01-01

    Jwarahara Dashemani (JHD) is mentioned by Acharya Charaka under the different categories of Mahakashayas (groups of drugs having similar pharmacological actions). For the present study, syrup and tablet forms of JHDs were prepared and analyzed. The formulations were prepared in various batches by following the standard manufacturing procedure (SMP). JHD Kwatha (2200 ml) and 1430 g sugar candy powder were heated (80–90°C) together for 3.10 hours and 2200 ml syrup was obtained, whereas an average of 446 g of tablet was obtained from the mixture of 285 g Ghana and powder of sugar candy (125 g), JHD Dravyas (55 g) and talc (18 g). These formulations were subjected to various analytical parameters and the results were observed on the basis of preparation. PMID:22131721

  6. The CIPM list of recommended frequency standard values: guidelines and procedures

    Science.gov (United States)

    Riehle, Fritz; Gill, Patrick; Arias, Felicitas; Robertsson, Lennart

    2018-04-01

    A list of standard reference frequency values (LoF) of quantum transitions from the microwave to the optical regime has been recommended by the International Committee for Weights and Measures (Comité international des poids et mesures, CIPM) for use in basic research, technology, and for the metrology of time, frequency and length. The CIPM LoF contains entries that are recommended as secondary representations of the second in the International System of Units, and entries that can be used to serve as realizations of the definition of the metre. The historical perspective that led to the CIPM LoF is outlined. Procedures have been developed for updating existing, and validating new, entries into the CIPM LoF. The CIPM LoF might serve as an entry for a future redefinition of the second by an optical transition.

  7. Standardization of the Action Verbs used in Emergency Operating Procedures of NPPs

    Energy Technology Data Exchange (ETDEWEB)

    Jang, Tong Il; Lee, Yong Hee; Park, Jae Chang [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Jeong, Yeon Seop; Chu, Gang Il [Korea Hydro and Nuclear Power, Daejeon (Korea, Republic of)

    2010-05-15

    The action verbs used in Emergency Operating Procedures (EOPs) for each nuclear power plant are translated respectively from the action verbs used in Emergency Recovery Guidelines (ERG) of the reference plants. The action verbs used in each plant are not largely different with one another. There are, however, some cases that the meanings of the same action verbs used in different plants are not consistent with each other and translations are not exact. In this study, the original English expressions of the action verbs and the translated verbs were compared and their accepted meanings analyzed. And then, standardization for the action verbs which are not exactly translated or which are used with different meanings among the plants was proposed

  8. Constructing an exposure chart: step by step (based on standard procedures)

    International Nuclear Information System (INIS)

    David, Jocelyn L; Cansino, Percedita T.; Taguibao, Angileo P.

    2000-01-01

    An exposure chart is very important in conducting radiographic inspection of materials. By using an accurate exposure chart, an inspector is able to avoid a trial and error way of determining correct time to expose a specimen, thereby producing a radiograph that has an acceptable density based on a standard. The chart gives the following information: x-ray machine model and brand, distance of the x-ray tube from the film, type and thickness of intensifying screens, film type, radiograph density, and film processing conditions. The methods of preparing an exposure chart are available in existing radiographic testing manuals. These described methods are presented in step by step procedures, covering the actual laboratory set-up, data gathering, computations, and transformation of derived data into Characteristic Curve and Exposure Chart

  9. Development of a standard test procedure for devices on thermal weed control

    Directory of Open Access Journals (Sweden)

    Verschwele, Arnd

    2016-02-01

    Full Text Available In contrast to the standard evaluation of the efficacy of pesticides and the testing of spraying equipment there are no comparable testing procedure for equipment of thermal weed control. It is the aim of the investigations described here to develop a standard procedure for assessing temperature distribution and biological efficacy. This will be the basis for quality testing which can be directly used by practical users. Also it can help engineers to improve devices if constructive gaps will be identified by these tests. The results from testing a flaming device (Green-Flame 850 E demonstrated such a potential for technical improvement: The temperature decreased from 159 °C to 89 °C by increasing driving speed from 0.35 m/s to 0.81 m/s. The variation of the temperature related to the working width was extremely high: The range was 60 °C at highest speed and 79 °C at lowest speed, respectively. The biological efficacy against the test plant species Sinapis arvensis was also affected by the driving speed and the corresponding temperature. A driving speed not higher than 0.53 m/s resulted in efficacy rates of almost 95%. However, the efficacy was only 66% at the highest tested speed of 0.81 m/s. Thus, the needed effective temperature is between 89 °C und 106 °C. In contrast, Lolium perenne was controlled by only 72% under the tested conditions. Here a dose-response relationship was not observed. The variation of the temperature, as well as the biological efficacy, was extremely heterogeneous and not satisfying in terms of an economic and safe use. Similar results were found for other devices on thermal weed control.

  10. Standard Operating Procedure (SOP) for Rapid and Efficient Production of Stevia Tissue Culture Seedlings

    International Nuclear Information System (INIS)

    Norazlina Noordin; Peng, C.S.; Rusli Ibrahim

    2015-01-01

    Stevia rebaudiana Bertoni is a non-caloric natural sweetener which is 300 times sweeter than cane sugar. Extracts from stevia leaves has vast application in food and beverages based industries, can be added to tea and coffee, cooked or baked goods, processed foods and confectionary goods. Recently, stevia attained awareness owing to its natural, non-caloric sweetness by diet/ health conscious and diabetic persons (Arpita et al., 2011). This natural sweetener has high commercial value in global market, it was estimated that global market value for stevia is be around USD11 billion by year 2015. Although stevia is being largely popularized in Malaysia and other countries but large-scale propagation procedures for the continuous supply of planting materials in commercial plantation has yet to be established, optimized and standardized. Furthermore, propagation through stevia seeds is often very difficult due to self-incompatibility which results in sterile seeds (Sakaguchi et al., 1982). Tissue culture is the only rapid process for the mass propagation of stevia and there have been few reports of in vitro growth of stevia (Miyagaya et al., 1986) and in vitro micropropagation from shoot tip and leaf (Uddin et al., 2006). Hence, study was carried out to establish a suitable protocol for in vitro propagation of S. rebaudiana Bertoni that can be further up-scaled for mass propagation of stevia seedlings. The established Standard Operating Procedure (SOP) will ensure rapid and efficient production of stevia tissue culture seedlings for continuous supply of planting materials for commercial stevia plantations in Malaysia. Preparation of growth medium, multiplication of shoots, rooting of plant lets and hardening of ex-vitro rooted plant lets is discussed in this paper. (author)

  11. The importance of strong evaluation standards and procedures in training residents.

    Science.gov (United States)

    Short, J P

    1993-07-01

    A strong evaluation process in a residency offers faculty an opportunity to strengthen the educational program, to help residents know what is expected of them, and to remove with minimum difficulties those residents who are not progressing satisfactorily and do not appear to be salvageable. Despite these advantages, the evaluation of residents during their training is often done poorly or not at all. The author describes the kinds of standards and procedures that constitute a sound, strong evaluation process, proposes criteria for academic probation and due process when a resident is performing unacceptably, and describes the role that the medical school administration should play in the evaluation process, one that is flexible enough to allow each program to comply and still have program-specific procedures. The author closes with statistics on how few residents are dismissed for incompetency or unacceptable behaviors, and inquires how many more might be found if strong evaluation processes were more widely used. Even so, in the attempt to evaluate residents and to foster protection from legal problems, residency program directors must keep in mind the importance of letting residents make mistakes and learn from them; a good evaluation system strikes a balance that fosters the learning process and benefits the residents, the medical school, and the community.

  12. Reproducibility of microbial mutagenicity assays. I. Tests with Salmonella typhimurium and Escherichia coli using a standardized protocol

    International Nuclear Information System (INIS)

    Dunkel, V.C.; Zeiger, E.; Brusick, D.; McCoy, E.; McGregor, D.; Mortelmans, K.; Rosenkranz, H.S.; Simmon, V.F.

    1984-01-01

    The Salmonella/microsome test developed by Ames and his coworkers has been widely used in the evaluation of chemicals for genotoxic potential. Although the value of this assay is well recognized, there have been no comprehensive studies on the interlaboratory reproducibility of the method using a standardized protocol. A program was therefore initiated to compare the results obtained in four laboratories from testing a series of coded mutagens and nonmutagens using a standardized protocol. Additional objectives of this study were to compare male Fisher 344 rat, B6C3F1 mouse, and Syrian hamster liver S-9 preparations for the activation of chemicals; to compare Aroclor 1254-induced liver S-9 from all three species with the corresponding non-induced liver S-9's; and to compare the response of Escherichia coli WP-2 uvrA with the Salmonella typhimurium tester strains recommended by Ames. Since a primary use of in vitro microbial mutagenesis tests is the identification of potential carcinogens by their mutagenicity, the authors decided to compare the animal species and strains used by the National Cancer Institute/National Toxicology Program (NCI/NTP) for animal carcinogenicity studies

  13. Methodology for determination of plasma cortisol in fish using Competitive Enzyme-Linked Immunosorbent Assay (ELISA)

    DEFF Research Database (Denmark)

    Velasco-Santamaría, Yohana M.; Cruz-Casallas, Pablo E.

    2007-01-01

    Objective. To determine plasma cortisol procedure in fish using competitive enzymelinked immunosorbent assay (ELISA). Materials and methods. Two plasma samples of juveniles rainbow trout Oncorhynchus mykiss were analized by using ELISA human kit for cortisol assay. For standard curve calibration ...

  14. Collection of Pyrethroids in Water and Sediment Matrices: Development and Validation of a Standard Operating Procedure

    Science.gov (United States)

    Hladik, Michelle; Orlando, James L.; Kuivila, Kathryn

    2009-01-01

    Loss of pyrethroid insecticides onto surfaces during sample collection can confound the interpretation of analytical and toxicity test results. Sample collection devices, container materials, and water matrix composition have a significant influence on the association of pyrethroids to container walls, which can be as high as 50 percent. Any sample collection method involving transfer through multiple containers or pieces of equipment increases the potential for pyrethroid loss. This loose 'surface-association' with container walls can be reversed through agitation. When sampling water matrices with pumps or autosamplers, no pyrethroids were lost as long as the water was moving continuously through the system. When collecting water matrices in containers, the material with the least amount of pyrethroid sorption is as follows: glass less than (pyrethroids were easier to re-suspend from the glass container walls. Since the amount of surface-association is proportional to the ratio of volume-to-contact-area of the sample, taking larger-volume field samples (greater than 3 liters) reduced pyrethroid losses to less than 10 percent. The amount of surface-association cannot be predicted easily because of the dependence on water matrix composition; samples with higher dissolved organic carbon or suspended-sediment concentrations were observed to have lower percent loss. Sediment samples were not affected by glass-container sorption (the only containers tested). Standardized sample-collection protocols are critical to yield accurate pyrethroid concentrations for assessment of potential effects, and have been summarized in an accompanying standard operating procedure.

  15. Enhanced Sanitation Standard Operating Procedures Have Limited Impact on Listeria monocytogenes Prevalence in Retail Delis.

    Science.gov (United States)

    Etter, Andrea J; Hammons, Susan R; Roof, Sherry; Simmons, Courtenay; Wu, Tongyu; Cook, Peter W; Katubig, Alex; Stasiewicz, Matthew J; Wright, Emily; Warchocki, Steven; Hollingworth, Jill; Thesmar, Hilary S; Ibrahim, Salam A; Wiedmann, Martin; Oliver, Haley F

    2017-10-20

    In a recent longitudinal surveillance study in 30 U.S. retail delicatessens, 9.7% of environmental surfaces were positive for Listeria monocytogenes, and we found substantial evidence of persistence. In this study, we aimed to reduce the prevalence and persistence of L. monocytogenes in the retail deli environment by developing and implementing practical and feasible intervention strategies (i.e., sanitation standard operating procedures; SSOPs). These SSOPs were standardized across the 30 delis enrolled in this study. SSOP implementation was verified by systems inherent to each retailer. Each deli also was equipped with ATP monitoring systems to verify effective sanitation. We evaluated intervention strategy efficacy by testing 28 food and nonfood contact surfaces for L. monocytogenes for 6 months in all 30 retail delis. The efficacy of the intervention on the delis compared with preintervention prevalence level was not statistically significant; we found that L. monocytogenes could persist despite implementation of enhanced SSOPs. Systematic and accurate use of ATP monitoring systems varied widely among delis. The findings indicate that intervention strategies in the form of enhanced daily SSOPs were not sufficient to eliminate L. monocytogenes from highly prevalent and persistently contaminated delis and that more aggressive strategies (e.g., deep cleaning or capital investment in redesign or equipment) may be necessary to fully mitigate persistent contamination.

  16. Leptospirosis in a small animal veterinarian: reminder to follow standardized infection control procedures.

    Science.gov (United States)

    Baer, R; Turnberg, W; Yu, D; Wohrle, R

    2010-06-01

    A small animal veterinarian in Washington State developed leptospirosis after an occupational exposure. Approximately 10 days prior to the onset of illness, he examined a healthy appearing pet rat for fleas, which urinated on his un-gloved hands. Although the veterinarian washed his hands after the examination, his hands had abrasions from gardening. The veterinarian was hospitalized for 12 days and was able to return to work part-time 1 month following discharge. This illness may have been prevented if the veterinarian had been wearing gloves during the examination as recommended by the National Association of State Public Health Veterinarians (NASPHV), Veterinary Infection Control Committee, in its Compendium of Veterinary Standard Precautions for Zoonotic Disease Prevention in Veterinary Personnel (2008). This case alerts us to the need for small animal veterinarians to minimize their infection risk by practising recommended infection control procedures. Veterinarians should establish and follow a written infection control plan based on the standardized infection control approach adopted by the NASPHV to minimize their risk of occupational zoonotic infections.

  17. CSNI international standard problem procedures - CSNI Report No. 17 - Revision 4

    International Nuclear Information System (INIS)

    Micaelli, J.C.

    2004-01-01

    . Careful consideration and planning is therefore required. After a brief recall of the ISPs' objectives, this document provides guidelines to be followed during the different phases of an ISP. Two phases are considered. The first one consists in proposing and selecting an ISP, the second one consists in performing an ISP. This revised document was prepared under the Leadership of J.-C. Micaelli (IRSN). It was reviewed and endorsed in September 2003 by the Working Group on the Analysis and Management of Accidents (GAMA), GAMA performed in 2003 a survey on updating CSNI Report No. 17, 'CSNI Standard Problem Procedures', first published in 1977, last updated in 1989. The objective of this activity was to collect proposals regarding the improvement of ISP efficiency with respect to their objectives and the improvement of the quality of the procedures document. Eleven series of questions were asked in the survey, related to: - General structure of the procedures document; - ISP objectives; - Six phases: ISP proposal, ISP specification, ISP results reporting, Preparation of the preliminary data comparison and interpretation report, Post-ISP analysis, Preparation of the final comparison and interpretation report; - Updating of the procedures; - Support to be provided by the participants

  18. A standard operating procedure for the surgical implantation of transmitters in juvenile salmonids

    Science.gov (United States)

    Liedtke, T.L.; Beeman, J.W.; Gee, L.P.

    2012-01-01

    Biotelemetry is a useful tool to monitor the movements of animals and is widely applied in fisheries research. Radio or acoustic technology can be used, depending on the study design and the environmental conditions in the study area. A broad definition of telemetry also includes the use of Passive Integrated Transponder (PIT) tags, either separately or with a radio or acoustic transmitter. To use telemetry, fish must be equipped with a transmitter. Although there are several attachment procedures available, surgical implantation of transmitters in the abdominal cavity is recognized as the best technique for long-term telemetry studies in general (Stasko and Pincock, 1977; Winter, 1996; Jepsen, 2003), and specifically for juvenile salmonids, Oncorhynchus spp. (Adams and others, 1998a, 1998b; Martinelli and others, 1998; Hall and others, 2009). Studies that use telemetry assume that the processes by which the animals are captured, handled, and tagged, as well as the act of carrying the transmitter, will have minimal effect on their behavior and performance. This assumption, commonly stated as a lack of transmitter effects, must be valid if telemetry studies are to describe accurately the movements and behavior of an entire population of interest, rather than the subset of that population that carries transmitters. This document describes a standard operating procedure (SOP) for surgical implantation of radio or acoustic transmitters in juvenile salmonids. The procedures were developed from a broad base of published information, laboratory experiments, and practical experience in tagging thousands of fish for numerous studies of juvenile salmon movements near Columbia River and Snake River hydroelectric dams. Staff from the Western Fisheries Research Center's Columbia River Research Laboratory (CRRL) frequently have used telemetry studies to evaluate new structures or operations at hydroelectric dams in the Columbia River Basin, and these evaluations typically

  19. 77 FR 65823 - Control of Air Pollution From Aircraft and Aircraft Engines; Emission Standards and Test Procedures

    Science.gov (United States)

    2012-10-31

    ... Control of Air Pollution From Aircraft and Aircraft Engines; Emission Standards and Test Procedures... titled ``Table 3 to Sec. 87.23--Tier 6 NO X Standards for New Subsonic Turbofan or Turbojet Engines with... for New Subsonic Turbofan or Turbojet Engines With Rated Output Above 26.7 kN and the rated output (in...

  20. Acucise™ endopyelotomy in a porcine model: procedure standardization and analysis of safety and immediate efficacy

    Directory of Open Access Journals (Sweden)

    Andreoni Cássio

    2004-01-01

    Full Text Available PURPOSE: The study here presented was done to test the technical reliability and immediate efficacy of the Acucise device using a standardized technique. MATERIALS AND METHODS: 56 Acucise procedures were performed in pigs by a single surgeon who used a standardized technique: insert 5F angiographic catheter bilaterally up to the midureter, perform retrograde pyelogram, Amplatz super-stiff guidewire is advanced up to the level of the renal pelvis, angiographic catheters are removed, Acucise catheter balloon is advanced to the ureteropelvic junction (UPJ level, the super-stiff guide-wire is removed and the contrast medium in the renal pelvis is aspirated and replaced with distilled water, activate Acucise at 75 watts of pure cutting current, keep the balloon fully inflated for 10 minutes, perform retrograde ureteropyelogram to document extravasation, remove Acucise catheter and pass an ureteral stent and remove guide-wire. RESULTS: In no case did the Acucise device present malfunction. The electrocautery activation time was 2.2 seconds (ranging from 2 to 4 seconds. The extravasation of contrast medium, visible by fluoroscopy, occurred in 53 of the 56 cases (94.6%. In no case there was any evidence of intraoperative hemorrhage. CONCLUSIONS: This study revealed that performing Acucise endopyelotomy routinely in a standardized manner could largely preclude intraoperative device malfunction and eliminate complications while achieving a successful incision in the UPJ. With the guidelines that were used in this study, we believe that Acucise endopyelotomy can be completed successfully and safely in the majority of selected patients with UPJ obstruction.

  1. 9 CFR 147.16 - Procedure for the evaluation of mycoplasma reactors by in vivo bio-assay (enrichment).

    Science.gov (United States)

    2010-01-01

    ... ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE LIVESTOCK IMPROVEMENT AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN Bacteriological Examination Procedure § 147.16 Procedure for... prevent the mechanical transfer of infectious avian diseases from other sources. (b) Test birds to be used...

  2. Relationship between in vitro assays and standardized ileal amino acid digestibility of animal protein meals in broilers.

    Science.gov (United States)

    Rochell, S J; Kuhlers, D L; Dozier, W A

    2013-01-01

    Two identical trials were conducted to determine the relationship of a novel digestive enzyme assay, Poultry Complete IDEA (PC IDEA), and the pepsin digestibility assay with standardized ileal amino acid digestibility (SIAAD) of 20 animal protein meals (APM) fed to broilers from 25 to 30 d of age. Animal protein meals included 10 meat and bone meals (MBM) consisting of bovine, porcine, or mixed bovine and porcine raw materials (BP), and 10 animal protein blends containing animal proteins from various species. Treatments consisted of 20 semi-purified diets containing 1 APM as the sole source of dietary amino acids (AA), and 1 N-free diet to determine endogenous ileal AA flow. With the exception of the N-free diet, diets were formulated to contain 20% CP. In each trial, 756 Ross × Ross 708 male broilers were housed in battery cages and randomly assigned to 21 dietary treatments on d 25 (12 birds per cage; 3 replicate cages), and ileal digesta were collected on d 30 for determination of SIAAD. Pepsin digestibility and PC IDEA were determined for APM samples from each experimental diet (3 replicates per trial; 6 total replicates). Pepsin digestibility and PC IDEA were both correlated (P digestibility on SIAAD resulted in the following equations: % Lys SIAAD = [-9.65 + (0.38 × % PC IDEA predicted Lys digestibility) + (0.69 × % pepsin digestibility)], % Met SIAAD = [-35.95 + (0.62 × % PC IDEA predicted Met digestibility) + (0.75 × % pepsin digestibility)], % Thr SIAAD = [-77.5 + (0.39 × % PC IDEA predicted Thr digestibility) + (1.37 × % pepsin digestibility)]. Values of R(2) were 0.46, 0.47, and 0.55 for Lys, Met, and Thr, respectively. The relatively low R(2) values may have been due to the limited range in SIAAD observed for the 20 APM, and additional data on APM varying in SIAAD are needed.

  3. A loop-mediated isothermal amplification assay and sample preparation procedure for sensitive detection of Xanthomonas fragariae in strawberry

    Science.gov (United States)

    Xanthomonas fragariae is a bacterium that causes angular leaf spot of strawberry. Asymptomatic infections are common and contribute to the difficulties in disease management. The aim of this study was to develop a loop-mediated isothermal amplification (LAMP) assay with a bacterial enrichment proced...

  4. Extraction procedure for sulfachloropyridazine in porcine tissues and detection in a sulfonamide-specific enzyme-linked immunosorbent assay (ELISA)

    NARCIS (Netherlands)

    Cliquet, P.; Cox, E.; Haasnoot, W.; Schacht, B.; Goddeeris, B.M.

    2003-01-01

    Sulfonamide-specific polyclonal rabbit antibodies were obtained after immunization with a sulfathiazole derivative (N1-[4-(carboxymethyl)-2-thiazolyl]sulfanilamide = TS) coupled to keyhole lympet hemocyanin. Using these antibodies, two sulfonamide-specific enzyme-linked immunosorbent assays (ELISAs)

  5. High accuracy/high precision determination of 235U in nondestructive assay standards by gamma-ray spectroscopy

    International Nuclear Information System (INIS)

    Greenberg, R.R.; Carpenter, B.S.

    1984-01-01

    High precision gamma spectrometry measurements have been made on five sets of five uranium isotope abundance reference materials for nondestructive assay (NDA). These sets are intended for international safeguards use as primary reference materials for the determination of the 235 U abundance in homogeneous uranium bulk material by gamma spectrometry. The measurements are to determine the counting rate uniformity of the 235 U 185.7 keV gamma as well as the 235 U isotope abundance for each sample. Since the samples are packaged such that the U 3 O 8 is infinitely thick for the 185.7 keV gamma, the measured counting rate is not dependent on the material density. In addition, the activity observed by the detector is colimated to simulate calibration conditions used to measure bulk material in the field. The results of this study indicate that accuracy of 235 U determination via gamma spectrometry, in the range of few hundredths of a percent (2sigma), is achievable. The main requirement for achieving this level of accuracy is a set of standards whose 235 U isotope abundance are known to within 0.01% (2sigma)

  6. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis (French Edition)

    International Nuclear Information System (INIS)

    2017-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  7. Standard operating procedures for quality audits of 60Co external beam radiotherapy facilities

    International Nuclear Information System (INIS)

    Larrinaga Cortina, E.F.; Dominguez Hung, L.; Campa Menendez, R.

    2001-01-01

    The use of radiotherapy implies the necessity of rigorous quality standards in its different components, aimed to provide the best possible treatment and avoid potential patients' risks, that could even cause him death. Projects of technical cooperation developed in Cuba and supported by the International Atomic Energy Agency address the implementation of Programs of Quality Assurance (PGC) in radiotherapy services. The establishment of the National Quality Audit Program (PNAC) is a superior stage. The National Control Center for Medical Devices, as the national regulator entity for the control and supervision of medical devices in the National Health System, is responsible for the making and execution of the PNAC. The audit modality selected was the inspection visit in situ due to its intrinsic advantages, our geographical extension and the number of radiotherapy services. This paper presents the methodology for the execution of the PNAC, in form of a Normalized Procedure of Operation (PNO) that defines the objectives, scope, terms and definitions, responsibilities, composition and selection of the auditor team, security's conditions, materials and equipment, steps of the audit execution, results calculation and interpretation, records, etc. (author)

  8. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis (Spanish Edition)

    International Nuclear Information System (INIS)

    2017-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  9. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  10. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.

    Science.gov (United States)

    Rapport, Frances; Storey, Mel; Porter, Alison; Snooks, Helen; Jones, Kerina; Peconi, Julie; Sánchez, Antonio; Siebert, Stefan; Thorne, Kym; Clement, Clare; Russell, Ian

    2013-02-21

    Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.

  11. Evaluation of Multiplexed Foot-and-Mouth Disease Nonstructural Protein Antibody Assay Against Standardized Bovine Serum Panel

    Energy Technology Data Exchange (ETDEWEB)

    Perkins, J; Parida, S; Clavijo, A

    2007-05-14

    Liquid array technology has previously been used to show proof-of-principle of a multiplexed non structural protein serological assay to differentiate foot-and-mouth infected and vaccinated animals. The current multiplexed assay consists of synthetically produced peptide signatures 3A, 3B and 3D and recombinant protein signature 3ABC in combination with four controls. To determine diagnostic specificity of each signature in the multiplex, the assay was evaluated against a naive population (n = 104) and a vaccinated population (n = 94). Subsequently, the multiplexed assay was assessed using a panel of bovine sera generated by the World Reference Laboratory for foot-and-mouth disease in Pirbright, UK. This sera panel has been used to assess the performance of other singleplex ELISA-based non-structural protein antibody assays. The 3ABC signature in the multiplexed assay showed comparative performance to a commercially available non-structural protein 3ABC ELISA (Cedi test{reg_sign}) and additional information pertaining to the relative diagnostic sensitivity of each signature in the multiplex is acquired in one experiment. The encouraging results of the evaluation of the multiplexed assay against a panel of diagnostically relevant samples promotes further assay development and optimization to generate an assay for routine use in foot-and-mouth disease surveillance.

  12. Instrumentation and procedures for moisture corrections to passive neutron coincidence counting assays of bulk PuO2 and MOX powders

    International Nuclear Information System (INIS)

    Stewart, J.E.; Menlove, H.O.; Ferran, R.R.; Aparo, M.; Zeppa, P.; Troiani, F.

    1993-05-01

    For passive neutron-coincidence-counting verification measurements of PuO 2 and MOX powder, assay biases have been observed that result from moisture entrained in the sample. This report describes a unique set of experiments in which MOX samples, with a range of moisture concentrations, were produced and used to calibrate and evaluate two prototype moisture monitors. A new procedure for moisture corrections to PuO 2 and MOX verification measurements yields MOX assays accurate to 1.5% (1σ) for 0.6- and 1.1-kg samples. Monte Carlo simulations were used to extend the measured moisture calibration data to higher sample masses. A conceptual design for a high-efficiency neutron coincidence counter with improved sensitivity to moisture is also presented

  13. Validity evidence for procedural competency in virtual reality robotic simulation, establishing a credible pass/fail standard for the vaginal cuff closure procedure.

    Science.gov (United States)

    Hovgaard, Lisette Hvid; Andersen, Steven Arild Wuyts; Konge, Lars; Dalsgaard, Torur; Larsen, Christian Rifbjerg

    2018-03-30

    The use of robotic surgery for minimally invasive procedures has increased considerably over the last decade. Robotic surgery has potential advantages compared to laparoscopic surgery but also requires new skills. Using virtual reality (VR) simulation to facilitate the acquisition of these new skills could potentially benefit training of robotic surgical skills and also be a crucial step in developing a robotic surgical training curriculum. The study's objective was to establish validity evidence for a simulation-based test for procedural competency for the vaginal cuff closure procedure that can be used in a future simulation-based, mastery learning training curriculum. Eleven novice gynaecological surgeons without prior robotic experience and 11 experienced gynaecological robotic surgeons (> 30 robotic procedures) were recruited. After familiarization with the VR simulator, participants completed the module 'Guided Vaginal Cuff Closure' six times. Validity evidence was investigated for 18 preselected simulator metrics. The internal consistency was assessed using Cronbach's alpha and a composite score was calculated based on metrics with significant discriminative ability between the two groups. Finally, a pass/fail standard was established using the contrasting groups' method. The experienced surgeons significantly outperformed the novice surgeons on 6 of the 18 metrics. The internal consistency was 0.58 (Cronbach's alpha). The experienced surgeons' mean composite score for all six repetitions were significantly better than the novice surgeons' (76.1 vs. 63.0, respectively, p negatives). Our study has gathered validity evidence for a simulation-based test for procedural robotic surgical competency in the vaginal cuff closure procedure and established a credible pass/fail standard for future proficiency-based training.

  14. 24 CFR 200.942 - Supplementary specific procedural requirements under HUD building product standards and...

    Science.gov (United States)

    2010-04-01

    ... the following standards: (i) AATCC 20A-81—Fiber Analysis: Quantitative; (ii) AATCC 16E-82... Energy Source; (viii) ASTM D2646-79—Standard Methods of Testing Backing Fabrics; (ix) ASTM D3936-80...-81—Standard Methods for Rubber Products—Chemical Analysis; (xi) ASTM D418-82—Standard Methods of...

  15. Staging in Patients with Small-Cell Lung Carcinoma; PET-CT versus Standard Staging Procedures

    Directory of Open Access Journals (Sweden)

    Burcu Yalçın

    2016-12-01

    Full Text Available Objective: The most important factor for accurate treatment of patients with small cell lung carcinoma (SCLC is accuracy of the initial staging. The aim of this study was to determine how often patients, staged as local or local-advanced disease by standard staging procedures (SSPs, would be staged to have a metastatic disease based on the findings of the positron emission tomography–computed tomography (PET-CT scan. Methods: Patients with SCLC who were staged as I, II, or III disease by SSPs (according to the American Joint Committee on Cancer Staging, 7th edition formed the study population. SSPs included computed tomography of chest, abdomen, brain (or magnetic resonance imaging of brain, and bone scintigraphy. These patients were re-staged with 18F-FDG PET-CT scan. Results: Between 2013 and 2015, 27 patients were prospectively studied. Of these patients, 92.5% were male and the median age was 61. Among 27 patients, distant metastasis was detected by PET-CT in 7 (25.9% patients. Two of 7 patients were determined as stage IIIA by SSPs and 5 of 17 patients that were determined as stage IIIB by SSPs were upstaged to metastatic disease by PET-CT. All of the 7 patients had bone metastasis by PET-CT. But bone metastasis could not be detected with bone scintigraphy. Conclusion: PET-CT detected distant metastasis in one quarter of SCLC stage III patients by SSPs. Patients who staged local-advanced SCLC with CT of the chest have to be assessed by PET-CT for extracranial distant metastasis.

  16. Evaluation of the surface free energy of plant surfaces: toward standardizing the procedure.

    Science.gov (United States)

    Fernández, Victoria; Khayet, Mohamed

    2015-01-01

    Plant surfaces have been found to have a major chemical and physical heterogeneity and play a key protecting role against multiple stress factors. During the last decade, there is a raising interest in examining plant surface properties for the development of biomimetic materials. Contact angle measurement of different liquids is a common tool for characterizing synthetic materials, which is just beginning to be applied to plant surfaces. However, some studies performed with polymers and other materials showed that for the same surface, different surface free energy values may be obtained depending on the number and nature of the test liquids analyzed, materials' properties, and surface free energy calculation methods employed. For 3 rough and 3 rather smooth plant materials, we calculated their surface free energy using 2 or 3 test liquids and 3 different calculation methods. Regardless of the degree of surface roughness, the methods based on 2 test liquids often led to the under- or over-estimation of surface free energies as compared to the results derived from the 3-Liquids method. Given the major chemical and structural diversity of plant surfaces, it is concluded that 3 different liquids must be considered for characterizing materials of unknown physico-chemical properties, which may significantly differ in terms of polar and dispersive interactions. Since there are just few surface free energy data of plant surfaces with the aim of standardizing the calculation procedure and interpretation of the results among for instance, different species, organs, or phenological states, we suggest the use of 3 liquids and the mean surface tension values provided in this study.

  17. Cryptic fitness advantage: diploids invade haploid populations despite lacking any apparent advantage as measured by standard fitness assays.

    Directory of Open Access Journals (Sweden)

    Aleeza C Gerstein

    Full Text Available Ploidy varies tremendously within and between species, yet the factors that influence when or why ploidy variants are adaptive remains poorly understood. Our previous work found that diploid individuals repeatedly arose within ten replicate haploid populations of Saccharomyces cerevisiae, and in each case we witnessed diploid takeover within ~1800 asexual generations of batch culture evolution in the lab. The character that allowed diploids to rise in frequency within haploid populations remains unknown. Here we present a number of experiments conducted with the goal to determine what this trait (or traits might have been. Experiments were conducted both by sampling a small number of colonies from the stocks frozen every two weeks (~ 93 generations during the original experiment, as well through sampling a larger number of colonies at the two time points where polymorphism for ploidy was most prevalent. Surprisingly, none of our fitness component measures (lag phase, growth rate, biomass production indicated an advantage to diploidy. Similarly, competition assays against a common competitor and direct competition between haploid and diploid colonies isolated from the same time point failed to indicate a diploid advantage. Furthermore, we uncovered a tremendous amount of trait variation among colonies of the same ploidy level. Only late-appearing diploids showed a competitive advantage over haploids, indicating that the fitness advantage that allowed eventual takeover was not diploidy per se but an attribute of a subset of diploid lineages. Nevertheless, the initial rise in diploids to intermediate frequency cannot be explained by any of the fitness measures used; we suggest that the resolution to this mystery is negative frequency-dependent selection, which is ignored in the standard fitness measures used.

  18. Recent advances in the characterization of HIV-1 neutralization assays for standardized evaluation of the antibody response to infection and vaccination.

    Science.gov (United States)

    Polonis, Victoria R; Brown, Bruce K; Rosa Borges, Andrew; Zolla-Pazner, Susan; Dimitrov, Dimiter S; Zhang, Mei-Yun; Barnett, Susan W; Ruprecht, Ruth M; Scarlatti, Gabriella; Fenyö, Eva-Maria; Montefiori, David C; McCutchan, Francine E; Michael, Nelson L

    2008-06-05

    In AIDS vaccine development the pendulum has swung towards a renewed emphasis on the potential role for neutralizing antibodies in a successful global vaccine. It is recognized that vaccine-induced antibody performance, as assessed in the available neutralization assays, may well serve as a "gatekeeper" for HIV-1 subunit vaccine prioritization and advancement. As a result, development of a standardized platform for reproducible measurement of neutralizing antibodies has received considerable attention. Here we review current advancements in our knowledge of the performance of different types of antibodies in a traditional primary cell neutralization assay and the newer, more standardized TZM-bl reporter cell line assay. In light of recently revealed differences (see accompanying article) in the results obtained in these two neutralization formats, parallel evaluation with both platforms should be contemplated as an interim solution until a better understanding of immune correlates of protection is achieved.

  19. A scalable assessment of Plasmodium falciparum transmission in the standard membrane-feeding assay, using transgenic parasites expressing green fluorescent protein-luciferase

    NARCIS (Netherlands)

    Stone, W.J.R.; Churcher, T.S.; Graumans, W.; Gemert, G.J.A. van; Vos, M.W.; Lanke, K.H.W.; Vegte-Bolmer, M.G. van de; Siebelink-Stoter, R.; Dechering, K.J.; Vaughan, A.M.; Camargo, N.; Kappe, S.H.; Sauerwein, R.W.; Bousema, T.

    2014-01-01

    BACKGROUND: The development of drugs and vaccines to reduce malaria transmission is an important part of eradication plans. The transmission-reducing activity (TRA) of these agents is currently determined in the standard membrane-feeding assay (SMFA), based on subjective microscopy-based readouts

  20. A Guide for Developing Standard Operating Job Procedures for the Sludge Conditioning & Dewatering Process Wastewater Treatment Facility. SOJP No. 11.

    Science.gov (United States)

    Schwing, Carl M.

    This guide describes standard operating job procedures for the sludge conditioning and dewatering process of wastewater treatment facilities. In this process, sludge is treated with chemicals to make the sludge coagulate and give up its water more easily. The treated sludge is then dewatered using a vacuum filter. The guide gives step-by-step…

  1. A Guide for Developing Standard Operating Job Procedures for the Primary Sedimentation Process Wastewater Treatment Facility. SOJP No. 4.

    Science.gov (United States)

    Charles County Community Coll., La Plata, MD.

    This guide describes standard operating job procedures for the primary sedimentation process of wastewater treatment plants. The primary sedimentation process involves removing settleable and suspended solids, in part, from wastewater by gravitational forces, and scum and other floatable solids from wastewater by mechanical means. Step-by-step…

  2. A Guide for Developing Standard Operating Job Procedures for the Screening & Grinding Process Wastewater Treatment Facility. SOJP No. 1.

    Science.gov (United States)

    Deal, Gerald A.; Montgomery, James A.

    This guide describes standard operating job procedures for the screening and grinding process of wastewater treatment facilities. The objective of this process is the removal of coarse materials from the raw waste stream for the protection of subsequent equipment and processes. The guide gives step-by-step instructions for safety inspection,…

  3. A Guide for Developing Standard Operating Job Procedures for the Sludge Thickening Process Wastewater Treatment Facility. SOJP No. 9.

    Science.gov (United States)

    Schwing, Carl M.

    This guide describes standard operating job procedures for the screening and grinding process of wastewater treatment facilities. The objective of this process is the removal of coarse materials from the raw waste stream for the protection of subsequent equipment and processes. The guide gives step-by-step instructions for safety inspection,…

  4. A Guide for Developing Standard Operating Job Procedures for the Tertiary Multimedia Filtration Process Wastewater Treatment Facility. SOJP No. 7.

    Science.gov (United States)

    Petrasek, Al, Jr.

    This guide describes the standard operating job procedures for the tertiary multimedia filtration process of wastewater treatment plants. The major objective of the filtration process is the removal of suspended solids from the reclaimed wastewater. The guide gives step-by-step instructions for pre-start up, start-up, continuous operation, and…

  5. A Guide for Developing Standard Operating Job Procedures for the Digestion Process Wastewater Treatment Facility. SOJP No. 10.

    Science.gov (United States)

    Schwing, Carl M.

    This guide describes standard operating job procedures for the digestion process of wastewater treatment facilities. This process is for reducing the volume of sludge to be treated in subsequent units and to reduce the volatile content of sludge. The guide gives step-by-step instructions for pre-startup, startup, continuous operating, shutdown,…

  6. 78 FR 4060 - Manufactured Home Construction and Safety Standards, Test Procedures for Roof Trusses

    Science.gov (United States)

    2013-01-18

    ..., such as metal connector plates or wood gussets or their equivalents, uplift testing in Wind Zone I is.... SUMMARY: This final rule amends the roof truss testing procedures in the Federal Manufactured Home... testing procedures in 2003. In response to public comments, HUD returned the proposal to MHCC for further...

  7. An international collaboration to standardize HIV-2 viral load assays: results from the 2009 ACHI(E)V(2E) quality control study.

    Science.gov (United States)

    Damond, F; Benard, A; Balotta, Claudia; Böni, Jürg; Cotten, Matthew; Duque, Vitor; Ferns, Bridget; Garson, Jeremy; Gomes, Perpetua; Gonçalves, Fátima; Gottlieb, Geoffrey; Kupfer, Bernd; Ruelle, Jean; Rodes, Berta; Soriano, Vicente; Wainberg, Mark; Taieb, Audrey; Matheron, Sophie; Chene, Genevieve; Brun-Vezinet, Francoise

    2011-10-01

    Accurate HIV-2 plasma viral load quantification is crucial for adequate HIV-2 patient management and for the proper conduct of clinical trials and international cohort collaborations. This study compared the homogeneity of HIV-2 RNA quantification when using HIV-2 assays from ACHI(E)V(2E) study sites and either in-house PCR calibration standards or common viral load standards supplied to all collaborators. Each of the 12 participating laboratories quantified blinded HIV-2 samples, using its own HIV-2 viral load assay and standard as well as centrally validated and distributed common HIV-2 group A and B standards (http://www.hiv.lanl.gov/content/sequence/HelpDocs/subtypes-more.html). Aliquots of HIV-2 group A and B strains, each at 2 theoretical concentrations (2.7 and 3.7 log(10) copies/ml), were tested. Intralaboratory, interlaboratory, and overall variances of quantification results obtained with both standards were compared using F tests. For HIV-2 group A quantifications, overall and interlaboratory and/or intralaboratory variances were significantly lower when using the common standard than when using in-house standards at the concentration levels of 2.7 log(10) copies/ml and 3.7 log(10) copies/ml, respectively. For HIV-2 group B, a high heterogeneity was observed and the variances did not differ according to the type of standard used. In this international collaboration, the use of a common standard improved the homogeneity of HIV-2 group A RNA quantification only. The diversity of HIV-2 group B, particularly in PCR primer-binding regions, may explain the heterogeneity in quantification of this strain. Development of a validated HIV-2 viral load assay that accurately quantifies distinct circulating strains is needed.

  8. Calibration of brachytherapy sources. Guidelines on standardized procedures for the calibration of brachytherapy sources at Secondary Standard Dosimetry Laboratories (SSDLs) and hospitals

    International Nuclear Information System (INIS)

    1999-04-01

    Today, irradiation by brachytherapy is considered an essential part of the treatment for almost all the sites of cancer. With the improved localization techniques and treatment planning systems, it is now possible to have precise and reproducible dose delivery. However, the desired clinical results can only be achieved with a good clinical and dosimetric practice, i.e. with the implementation of a comprehensive quality assurance (QA) programme which includes detailed quality control procedures. As summarized in the present report, accidents in brachytherapy treatments have been caused due to the lack of traceable calibration of the sources, due to the incorrect use of quantities and units, or errors made in the dose calculation procedure. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources has established a requirement on the calibration of sources used for medical exposure. For sources used in brachytherapy treatments, a calibration traceable to a standards dosimetry laboratory is required. The present report deals with the calibration of brachytherapy sources and related quality control (QC) measurements, QC of ionization chambers and safety aspects related to the calibration procedures. It does not include safety aspects related to the clinical use of brachytherapy sources, which have been addressed in a recent IAEA publication, IAEA-TECDOC-1040, 'Design and Implementation of a Radiotherapy Programme: Clinical, Medical Physics, Radiation Protection and Safety Aspects'. The procedures recommended in this report yield traceability to internationally accepted standards. It must be realized, however, that a comprehensive QA programme for brachytherapy cannot rest on source calibration alone, but must ensure QC of all the equipment and techniques that are used for the dose delivery to the patient. The present publication incorporates the reports of several consultants meetings in the field of

  9. Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457).

    Science.gov (United States)

    Lee, Ji In; Kim, Ji Young; Choi, Joon Young; Kim, Hee Kyung; Jang, Hye Won; Hur, Kyu Yeon; Kim, Jae Hyeon; Kim, Kwang-Won; Chung, Jae Hoon; Kim, Sun Wook

    2010-09-01

    Serum thyroglobulin (Tg) is essential in the follow-up of patients with differentiated thyroid carcinoma (DTC). However, interchangeability and standardization between Tg assays have not yet been achieved, even with the development of an international Tg standard (Certified Reference Material 457 [CRM-457]). Serum Tg from 30 DTC patients and serially diluted CRM-457 were measured using 3 different immunoradiometric assays (IRMA-1, IRMA-2, IRMA-3). The intraclass correlation coefficient (ICC) method was used to describe the concordance of each IRMA to CRM-457. The serum Tg measured by 3 different IRMAs correlated well (r > .85, p CRM-457, showed the best ICC (p(1) = .98) for the CRM-457. Hospitals caring for patients with DTC should either set their own cutoffs for IRMAs for Tg based on their patient pools, or adopt IRMAs standardized to CRM-457 and calibrate their laboratory using CRM-457.

  10. [Orthotopic cardiac transplantation with caval anastomosis: a comparative randomized study with standard procedure in 81 cases].

    Science.gov (United States)

    Deleuze, P; Benvenuti, C; Mazzucotelli, J P; Perdrix, C; Le Besnerais, P; Mourtada, A; Hillion, M L; Patrat, J F; Loisance, D Y

    1996-01-01

    Complete resection of the right atrium with conservation of a strip of left atrium around the 4 pulmonary veins followed by direct anastomosis on the vena cava has recently been proposed as an alternative to the standard orthotopic cardiac transplantation described by Shumway and Lower. In order to determine whether this "anatomical" transplantation should now be considered to be the procedure of choice, a prospective randomised study was undertaken in 1991 including 78 patients undergoing 81 cardiac transplantations by one of the two techniques: gr. I: classical transplantation (n = 40), gr. II: "anatomical" transplantation (n = 41). The groups were comparable in age, sex, weight, nature of the underlying cardiac disease and clinical status at the time of transplantation. Similarly, the parameters of the donors were comparable with respect to age, sex, weight and dosage of inotropic drugs at the time of explantation. All patients came of cardiopulmonary bypass with comparable ischaemia time of the graft (gr. I: 136 +/- 46 min; gr. II: 138 +/- 51 min). Immediate return to sinus rhythm occurred in 20 cases in gr. I and 36 cases in gr. II. Atrial arrhythmia persisted in 5 cases in gr. I but in no cases of gr. II. These differences were very significant (p < 0.001). There were 13 early deaths in gr. I and 8 in gr. II. Doppler echocardiography was performed two to three months after transplantation. The right atrial surface was significantly decreased in gr. II (18 +/- 4.7 cm2) compared with gr. I (24 +/- 7 cm2): the same difference was observed for the left atrium (gr. I: 24 +/- 4.5 cm2; gr. II: 20 +/- 5 cm2), p = 0.001. Tricuspid regurgitation was observed in 82% of patients in gr. I compared with 57% in gr. II (p < 0.005). Exercise stress tests during the same period showed no difference in peak oxygen consumption between the groups. Holter ECG monitoring led to permanent pacing in 2 patients of gr. I (5%). The technical simplicity and reduction of postoperative

  11. SURF: Taking Sustainable Remediation from Concept to Standard Operating Procedure (Invited)

    Science.gov (United States)

    Smith, L. M.; Wice, R. B.; Torrens, J.

    2013-12-01

    Over the last decade, many sectors of industrialized society have been rethinking behavior and re-engineering practices to reduce consumption of energy and natural resources. During this time, green and sustainable remediation (GSR) has evolved from conceptual discussions to standard operating procedure for many environmental remediation practitioners. Government agencies and private sector entities have incorporated GSR metrics into their performance criteria and contracting documents. One of the early think tanks for the development of GSR was the Sustainable Remediation Forum (SURF). SURF brings together representatives of government, industry, consultancy, and academia to parse the means and ends of incorporating societal and economic considerations into environmental cleanup projects. Faced with decades-old treatment programs with high energy outputs and no endpoints in sight, a small group of individuals published the institutional knowledge gathered in two years of ad hoc meetings into a 2009 White Paper on sustainable remediation drivers, practices, objectives, and case studies. Since then, SURF has expanded on those introductory topics, publishing its Framework for Integrating Sustainability into Remediation Projects, Guidance for Performing Footprint Analyses and Life-Cycle Assessments for the Remediation Industry, a compendium of metrics, and a call to improve the integration of land remediation and reuse. SURF's research and members have also been instrumental in the development of additional guidance through ASTM International and the Interstate Technology and Regulatory Council. SURF's current efforts focus on water reuse, the international perspective on GSR (continuing the conversations that were the basis of SURF's December 2012 meeting at the National Academy of Sciences in Washington, DC), and ways to capture and evaluate the societal benefits of site remediation. SURF also promotes and supports student chapters at universities across the US

  12. 3,3,5-Trimethylcyclohexanols and derived esters: green synthetic procedures, odour evaluation and in vitro skin cytotoxicity assays.

    Science.gov (United States)

    Gambaro, R; Villa, C; Baldassari, S; Mariani, E; Parodi, A; Bassi, A M

    2006-12-01

    The alcohols 3,3,5-trimethylcyclohexanols (cis, trans epimers, cosmetic fragrance) and some derived esters, potential and well-known actives in the cosmetic field, such as Homosalate, were synthesized using fast solvent-free methodologies with the aim of renewing and simplifying the conventional procedures. The alcohols were prepared by reduction of 3,3,5-trimethylcyclohexanone (dihydroisophorone) with sodium borohydride/alumina in solid state. The esters from propanoic, butanoic, octanoic, 10-undecenoic, cyclopropanecarboxylic, mandelic and salicylic acids were synthesized with microwave-mediated solvent-free procedures under acidic and basic catalysis. Several experiments were carried out to study advantages and limits of the selected methodologies and the results are reported. Microwave irradiation was carried out using a scientific monomode reactor. In order to evaluate the cosmetic interest of the studied compounds, the sweet-scented substances were submitted to an odour evaluation test; the most promising fragrances and the ester from 10-undecenoic acid, as an example of lipophilic derivatives, were tested to assess their in vitro skin toxicity. Résumé

  13. Rapid assays of clozapine and its metabolites in dried blood spots by liquid chromatography and microextraction by packed sorbent procedure.

    Science.gov (United States)

    Saracino, Maria Addolorata; Lazzara, Giuseppe; Prugnoli, Benedetta; Raggi, Maria Augusta

    2011-04-22

    A novel analytical approach has been developed for the determination of clozapine and its metabolites in dried blood spots on filter paper, using a chromatographic method coupled with a microextraction by packed sorbent procedure. The analytes were separated on a RP-C18 column using a mobile phase composed of 20% methanol, 16% acetonitrile and 64% aqueous phosphate buffer. Coulometric detection was used, setting the guard cell at +0.050 V, the first analytical cell at -0.200 V and the second analytical cell at +0.500 V. Clozapine and its metabolites were extracted from dried blood spots with phosphate buffer and, then, a microextraction by packed sorbent procedure for the sample clean-up was implemented obtaining good extraction yields. The calibration curve was linear over the 2.5-1000 ng mL(-1) blood concentration ranges for all the analytes. The method validation gave satisfactory results in terms of sensitivity, precision, selectivity and accuracy. The analytical method was successfully applied to dried blood spots from several psychiatric patients for therapeutic drug monitoring purpose. Copyright © 2011 Elsevier B.V. All rights reserved.

  14. 9 CFR 147.7 - Standard test procedures for mycoplasma. 5

    Science.gov (United States)

    2010-01-01

    .... Under such conditions, potency will be retained for years. There will be a rapid loss of titer if... to make 8-unit antigen.) (ii) Four-unit antigen (made by diluting surplus 8-unit antigen 1:2 with PBS...) Hemagglutination inhibition assay. (A) Label one column (A to H) of a 96-well, U-bottom microtiter plate for each...

  15. Interim radiological safety standards and evaluation procedures for subseabed high-level waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Klett, R.D.

    1997-06-01

    The Seabed Disposal Project (SDP) was evaluating the technical feasibility of high-level nuclear waste disposal in deep ocean sediments. Working standards were needed for risk assessments, evaluation of alternative designs, sensitivity studies, and conceptual design guidelines. This report completes a three part program to develop radiological standards for the feasibility phase of the SDP. The characteristics of subseabed disposal and how they affect the selection of standards are discussed. General radiological protection standards are reviewed, along with some new methods, and a systematic approach to developing standards is presented. The selected interim radiological standards for the SDP and the reasons for their selection are given. These standards have no legal or regulatory status and will be replaced or modified by regulatory agencies if subseabed disposal is implemented. 56 refs., 29 figs., 15 tabs.

  16. Interim radiological safety standards and evaluation procedures for subseabed high-level waste disposal

    International Nuclear Information System (INIS)

    Klett, R.D.

    1997-06-01

    The Seabed Disposal Project (SDP) was evaluating the technical feasibility of high-level nuclear waste disposal in deep ocean sediments. Working standards were needed for risk assessments, evaluation of alternative designs, sensitivity studies, and conceptual design guidelines. This report completes a three part program to develop radiological standards for the feasibility phase of the SDP. The characteristics of subseabed disposal and how they affect the selection of standards are discussed. General radiological protection standards are reviewed, along with some new methods, and a systematic approach to developing standards is presented. The selected interim radiological standards for the SDP and the reasons for their selection are given. These standards have no legal or regulatory status and will be replaced or modified by regulatory agencies if subseabed disposal is implemented. 56 refs., 29 figs., 15 tabs

  17. Evaluation of the ISO Standard 11063 DNA Extraction Procedure for Assessing Soil Microbial Abundance and Community Structure

    Science.gov (United States)

    Griffiths, Robert; Dequiedt, Samuel; Lelievre, Mélanie; Regnier, Tiffanie; Nowak, Virginie; Bailey, Mark; Lemanceau, Philippe; Bispo, Antonio; Chabbi, Abad; Maron, Pierre-Alain; Mougel, Christophe; Ranjard, Lionel

    2012-01-01

    Soil DNA extraction has become a critical step in describing microbial biodiversity. Historically, ascertaining overarching microbial ecological theories has been hindered as independent studies have used numerous custom and commercial DNA extraction procedures. For that reason, a standardized soil DNA extraction method (ISO-11063) was previously published. However, although this ISO method is suited for molecular tools such as quantitative PCR and community fingerprinting techniques, it has only been optimized for examining soil bacteria. Therefore, the aim of this study was to assess an appropriate soil DNA extraction procedure for examining bacterial, archaeal and fungal diversity in soils of contrasting land-use and physico-chemical properties. Three different procedures were tested: the ISO-11063 standard; a custom procedure (GnS-GII); and a modified ISO procedure (ISOm) which includes a different mechanical lysis step (a FastPrep ®-24 lysis step instead of the recommended bead-beating). The efficacy of each method was first assessed by estimating microbial biomass through total DNA quantification. Then, the abundances and community structure of bacteria, archaea and fungi were determined using real-time PCR and terminal restriction fragment length polymorphism approaches. Results showed that DNA yield was improved with the GnS-GII and ISOm procedures, and fungal community patterns were found to be strongly dependent on the extraction method. The main methodological factor responsible for differences between extraction procedure efficiencies was found to be the soil homogenization step. For integrative studies which aim to examine bacteria, archaea and fungi simultaneously, the ISOm procedure results in higher DNA recovery and better represents microbial communities. PMID:22984486

  18. Evaluation of the ISO standard 11063 DNA extraction procedure for assessing soil microbial abundance and community structure.

    Directory of Open Access Journals (Sweden)

    Pierre Plassart

    Full Text Available Soil DNA extraction has become a critical step in describing microbial biodiversity. Historically, ascertaining overarching microbial ecological theories has been hindered as independent studies have used numerous custom and commercial DNA extraction procedures. For that reason, a standardized soil DNA extraction method (ISO-11063 was previously published. However, although this ISO method is suited for molecular tools such as quantitative PCR and community fingerprinting techniques, it has only been optimized for examining soil bacteria. Therefore, the aim of this study was to assess an appropriate soil DNA extraction procedure for examining bacterial, archaeal and fungal diversity in soils of contrasting land-use and physico-chemical properties. Three different procedures were tested: the ISO-11063 standard; a custom procedure (GnS-GII; and a modified ISO procedure (ISOm which includes a different mechanical lysis step (a FastPrep ®-24 lysis step instead of the recommended bead-beating. The efficacy of each method was first assessed by estimating microbial biomass through total DNA quantification. Then, the abundances and community structure of bacteria, archaea and fungi were determined using real-time PCR and terminal restriction fragment length polymorphism approaches. Results showed that DNA yield was improved with the GnS-GII and ISOm procedures, and fungal community patterns were found to be strongly dependent on the extraction method. The main methodological factor responsible for differences between extraction procedure efficiencies was found to be the soil homogenization step. For integrative studies which aim to examine bacteria, archaea and fungi simultaneously, the ISOm procedure results in higher DNA recovery and better represents microbial communities.

  19. Standard Operating Procedures for Preparing and Handling Sterile Male Tsetse flies for Release

    International Nuclear Information System (INIS)

    Argiles-Herrero, Rafa; Leak, Stephen G.A.

    2016-01-01

    The purpose of this SOP is to describe the procedures involved in preparing tsetse flies reared in a breeding facility for release in the field for the sterile insect technique (SIT) as a component of Area-Wide Insect pest Management (AW-IPM). Following the procedures which are outlined will help to ensure that the released sterile male tsetse flies are of optimal quality.

  20. Standard operating procedure for combustion of 14C - samples with OX-500 biological material oxidizer

    International Nuclear Information System (INIS)

    Nashriyah Mat.

    1995-01-01

    This procedure is for the purpose of safe operation of OX-500 biological material oxidizer. For ease of operation, the operation flow chart (including testing the system and sample combustion) and end of day maintenance flow chart were simplified. The front view, diagrams and switches are duly copied from operating manual. Steps on sample preparation are also included for biotic and a biotic samples. This operating procedure is subjected to future reviews

  1. Evaluation of real-time PCR assays and standard curve optimisation for enhanced accuracy in quantification of Campylobacter environmental water isolates.

    Science.gov (United States)

    Gosselin-Théberge, Maxime; Taboada, Eduardo; Guy, Rebecca A

    2016-10-01

    Campylobacter is a major public health and economic burden in developed and developing countries. This study evaluated published real-time PCR (qPCR) assays for detection of Campylobacter to enable selection of the best assays for quantification of C. spp. and C. jejuni in environmental water samples. A total of 9 assays were compared: three for thermotolerant C. spp. targeting the 16S rRNA and six for C. jejuni targeting different genes. These assays were tested in the wet-lab for specificity and sensitivity against a collection of 60, genetically diverse, Campylobacter isolates from environmental water. All three qPCR assays targeting C. spp. were positive when tested against the 60 isolates, whereas, assays targeting C. jejuni differed among each other in terms of specificity and sensitivity. Three C. jejuni-specific assays that demonstrated good specificity and sensitivity when tested in the wet-lab showed concordant results with in silico-predicted results obtained against a set of 211 C. jejuni and C. coli genome sequences. Two of the assays targeting C. spp. and C. jejuni were selected to compare DNA concentration estimation, using spectrophotometry and digital PCR (dPCR), in order to calibrate standard curves (SC) for greater accuracy of qPCR-based quantification. Average differences of 0.56±0.12 and 0.51±0.11 log fold copies were observed between the spectrophotometry-based SC preparation and the dPCR preparation for C. spp. and C. jejuni, respectively, demonstrating an over-estimation of Campylobacter concentration when spectrophotometry was used to calibrate the DNA SCs. Our work showed differences in quantification of aquatic environmental isolates of Campylobacter between qPCR assays and method-specific bias in SC preparation. This study provided an objective analysis of qPCR assays targeting Campylobacter in the literature and provides a framework for evaluating novel assays. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

  2. Validation of a single nucleotide polymorphism (SNP) typing assay with 49 SNPs for forensic genetic testing in a laboratory accredited according to the ISO 17025 standard

    DEFF Research Database (Denmark)

    Børsting, Claus; Rockenbauer, Eszter; Morling, Niels

    2009-01-01

    cases and 33 twin cases were typed at least twice for the 49 SNPs. All electropherograms were analysed independently by two expert analysts prior to approval. Based on these results, detailed guidelines for analysis of the SBE products were developed. With these guidelines, the peak height ratio...... of a heterozygous allele call or the signal to noise ratio of a homozygous allele call is compared with previously obtained ratios. A laboratory protocol for analysis of SBE products was developed where allele calls with unusual ratios were highlighted to facilitate the analysis of difficult allele calls......A multiplex assay with 49 autosomal single nucleotide polymorphisms (SNPs) developed for human identification was validated for forensic genetic casework and accredited according to the ISO 17025 standard. The multiplex assay was based on the SNPforID 52plex SNP assay [J.J. Sanchez, C. Phillips, C...

  3. Development of a voltammetric procedure for assay of the antihistamine drug hydroxyzine at a glassy carbon electrode: Quantification and pharmacokinetic studies.

    Science.gov (United States)

    Beltagi, A M; Abdallah, O M; Ghoneim, M M

    2008-01-15

    An electrochemical study of hydroxyzine at a glassy carbon electrode was carried out in the Britton-Robinson universal buffer of pH 2-11. Hydroxyzine was oxidized in a single two-electron irreversible process controlled mainly by adsorption. A simple, sensitive and time-saving square-wave adsorptive anodic stripping voltammetric procedure has been developed for determination of hydroxyzine in its commercial tablets and human serum without prior extraction. The optimized procedural conditions were: frequency=120Hz, scan increment=10mV, pulse-amplitude=25mV, accumulation potential=-0.3V, accumulation time=90-300s and a Britton-Robinson universal buffer of pH 4 as a supporting electrolyte. Mean recoveries of 100.5+/-0.71 and 98.6+/-1.12% (n=5) were achieved for assay of hydroxyzine in Atarax 10 and 25mg dosage forms, respectively. Limit of detection of 1.5x10(-8)molL(-1) (5.624ngmL(-1)) and limit of quantitation of 5.0x10(-8)molL(-1) (18.746ngmL(-1)) were achieved in human serum with a mean recovery of 98.4+/-1.22%, without prior extraction of the drug. Moreover, the described procedure was applied for evaluating the pharmacokinetic parameters of hydroxyzine in plasma of two healthy volunteers after administration of a single oral dose (Atarax)-25mg).

  4. A Meta-Analytic Assessment of Empirical Differences in Standard Setting Procedures.

    Science.gov (United States)

    Bontempo, Brian D.; Marks, Casimer M.; Karabatsos, George

    Using meta-analysis, this research takes a look at studies included in a meta-analysis by R. Jaeger (1989) that compared the cut score set by one standard setting method with that set by another. This meta-analysis looks beyond Jaeger's studies to select 10 from the research literature. Each compared at least two types of standard setting method.…

  5. Malpractice claims and unintentional outcome of tonsil surgery and other standard procedures in otorhinolaryngology

    Science.gov (United States)

    Windfuhr, Jochen P.

    2015-01-01

    of malpractice after LN (16; 57%), TE (10; 37%), SP (8; 57%) and AE (2; 100%). There were 16 cases of PTH amongst 27 trials after TE resulting either in death (5) or apallic syndrome (5). Bleeding complications had occurred on the day of surgery in only 2 patients. 16 trials were based on malpractice claims following SP encompassing lack of informed consent (6), anosmia (4), septal perforation (2), frontobasal injury (2) and dry nose (2). Trials after LN procedures were associated exclusively with a lesion of the spinal accessory nerve (28), including lack of informed consent in 19 cases. 49 cases (69%) were decided for the defendant, 22 (31%) were decided for the plaintiff with monetary compensation in 7 of 29 AE/TE-trials, 9 of 28 LN-trials and 6 of 14 SP-trials. Lack of informed consent was not registered for AE/TE but LN (11) and SP (2). Conclusion: Complicated cases following TE, TT, ATE, SP and LN are not systematically collected in Germany. It can be assumed, that not every complicated case is published in the medical literature or law journals and therefore not obtainable for scientific research. Alleged medical malpracice is proven for less than 6% before trial stage. Approximately half of all cases result in a plaintiff verdict or settlement at court. Proper documentation of a thourough counselling, examination, indication, informed consent and follow-up assists the surgeon in litigation. An adequate complication management of PTH is essential, including instructions for the patients/parents, instructions for the medical staff and readily available surgical instruments. Successful outcome of life-threatening PTH is widely based on a proper airway management in an interdisciplinary approach. Electrosurgical tonsillectomy techniques were repeatedly labeled as a risk factor for bleeding complications following TE. Institutions should analyse the individual PTH rate on a yearly basis. Contradictory expert opinions and verdicts of the courts concerning spinal

  6. Comparative Study of Kaposi's Sarcoma-Associated Herpesvirus Serological Assays Using Clinically and Serologically Defined Reference Standards and Latent Class Analysis▿

    Science.gov (United States)

    Nascimento, Maria Claudia; de Souza, Vanda Akico; Sumita, Laura Masami; Freire, Wilton; Munoz, Fernando; Kim, Joseph; Pannuti, Claudio S.; Mayaud, Philippe

    2007-01-01

    Accurate determination of infection with Kaposi's sarcoma-associated herpesvirus (KSHV) has been hindered by the lack of a “gold standard” for comparison of serological assays used to estimate KSHV prevalence in serosurveys conducted in different settings. We have evaluated the performance of five in-house (developed at University College London [UCL], United Kingdom, and at the virology laboratory of the Instituto de Medicine Tropical [IMT] in Sao Paulo, Brazil) and two commercial (ABI and DIAVIR) serological assays to detect antibodies to latency-associated nuclear antigen (LANA) and to lytic KSHV antigens. We used a variety of serum samples assembled to represent populations likely to be at high, intermediate, and low risk of KSHV infection in Brazil. Composite reference standard panels were prepared based on clinical and serological parameters, against which assay performances were assessed using conventional Bayesian statistics and latent class analysis (LCA). Against the clinical reference standard, in-house immunofluorescence assays to detect anti-LANA antibodies (IFA-LANA) produced at UCL and IMT had similar performances, with sensitivities of 61% (95% confidence interval [CI], 48% to 74%) and 72% (95% CI, 58% to 83%) and specificities of 99% (95% CI, 94% to 100%) and 100% (95% CI, 96% to 100%), respectively, and only the IMT IFA-LANA was included in LCA, together with the IMT IFA-lytic and four enzyme-linked immunosorbent assays (ELISAs). The LCA indicated that the IMT whole-virus ELISA performed best (sensitivity, 87% [95% CI, 81% to 91%]; and specificity, 100% [95% CI, 98% to 100%]), confirming the results obtained with the conventional statistical approach. Commercially available ELISA-based tests yielded the lowest specificities using a spectrum of serum samples. The evaluation of KSHV serological assays is warranted before planning serosurveys in various settings. PMID:17182752

  7. Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

    Science.gov (United States)

    Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

    2018-02-23

    Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

  8. Comparison of mRNA splicing assay protocols across multiple laboratories: recommendations for best practice in standardized clinical testing.

    Science.gov (United States)

    Whiley, Phillip J; de la Hoya, Miguel; Thomassen, Mads; Becker, Alexandra; Brandão, Rita; Pedersen, Inge Sokilde; Montagna, Marco; Menéndez, Mireia; Quiles, Francisco; Gutiérrez-Enríquez, Sara; De Leeneer, Kim; Tenés, Anna; Montalban, Gemma; Tserpelis, Demis; Yoshimatsu, Toshio; Tirapo, Carole; Raponi, Michela; Caldes, Trinidad; Blanco, Ana; Santamariña, Marta; Guidugli, Lucia; de Garibay, Gorka Ruiz; Wong, Ming; Tancredi, Mariella; Fachal, Laura; Ding, Yuan Chun; Kruse, Torben; Lattimore, Vanessa; Kwong, Ava; Chan, Tsun Leung; Colombo, Mara; De Vecchi, Giovanni; Caligo, Maria; Baralle, Diana; Lázaro, Conxi; Couch, Fergus; Radice, Paolo; Southey, Melissa C; Neuhausen, Susan; Houdayer, Claude; Fackenthal, Jim; Hansen, Thomas Van Overeem; Vega, Ana; Diez, Orland; Blok, Rien; Claes, Kathleen; Wappenschmidt, Barbara; Walker, Logan; Spurdle, Amanda B; Brown, Melissa A

    2014-02-01

    Accurate evaluation of unclassified sequence variants in cancer predisposition genes is essential for clinical management and depends on a multifactorial analysis of clinical, genetic, pathologic, and bioinformatic variables and assays of transcript length and abundance. The integrity of assay data in turn relies on appropriate assay design, interpretation, and reporting. We conducted a multicenter investigation to compare mRNA splicing assay protocols used by members of the ENIGMA (Evidence-Based Network for the Interpretation of Germline Mutant Alleles) consortium. We compared similarities and differences in results derived from analysis of a panel of breast cancer 1, early onset (BRCA1) and breast cancer 2, early onset (BRCA2) gene variants known to alter splicing (BRCA1: c.135-1G>T, c.591C>T, c.594-2A>C, c.671-2A>G, and c.5467+5G>C and BRCA2: c.426-12_8delGTTTT, c.7988A>T, c.8632+1G>A, and c.9501+3A>T). Differences in protocols were then assessed to determine which elements were critical in reliable assay design. PCR primer design strategies, PCR conditions, and product detection methods, combined with a prior knowledge of expected alternative transcripts, were the key factors for accurate splicing assay results. For example, because of the position of primers and PCR extension times, several isoforms associated with BRCA1, c.594-2A>C and c.671-2A>G, were not detected by many sites. Variation was most evident for the detection of low-abundance transcripts (e.g., BRCA2 c.8632+1G>A Δ19,20 and BRCA1 c.135-1G>T Δ5q and Δ3). Detection of low-abundance transcripts was sometimes addressed by using more analytically sensitive detection methods (e.g., BRCA2 c.426-12_8delGTTTT ins18bp). We provide recommendations for best practice and raise key issues to consider when designing mRNA assays for evaluation of unclassified sequence variants.

  9. CTEPP STANDARD OPERATING PROCEDURE FOR CONDUCTING INTERNAL FIELD AUDITS AND QUALITY CONTROL (SOP-2.25)

    Science.gov (United States)

    This SOP describes the method for conducting internal field audits and quality control procedures. Internal field audits will be conducted to ensure the collection of high quality data. Internal field audits will be conducted by Field Auditors (the Field QA Officer and the Field...

  10. Effects of Computer-Based Training on Procedural Modifications to Standard Functional Analyses

    Science.gov (United States)

    Schnell, Lauren K.; Sidener, Tina M.; DeBar, Ruth M.; Vladescu, Jason C.; Kahng, SungWoo

    2018-01-01

    Few studies have evaluated methods for training decision-making when functional analysis data are undifferentiated. The current study evaluated computer-based training to teach 20 graduate students to arrange functional analysis conditions, analyze functional analysis data, and implement procedural modifications. Participants were exposed to…

  11. 42 CFR 493.1255 - Standard: Calibration and calibration verification procedures.

    Science.gov (United States)

    2010-10-01

    ... least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the... the number, type, and concentration of calibration materials, as well as acceptable limits for and the... acceptable limits for calibration verification. (b) Perform and document calibration verification procedures...

  12. HUBUNGAN ANTARA GAYA KEPEMIMPINAN PATH GOAL SUPERVISOR PABRIK BAJA DENGAN TINGKAT KEPATUHAN SOP (STANDARD OPERATIONAL PROCEDURE) PEKERJA

    OpenAIRE

    Ridho, Wahyu Fahrul

    2017-01-01

    ABSTRACTEmployee ignorance on Standard Operational Procedures (SOP) is one of the main causes of workplace accidents. This study was conducted to analyze the correlation between path goal leadership implemented by Gresik steel factory supervisors and employee obedience on company SOP. This study applied quantitative approach and cross-sectional research design. The data were collected through observation and interview on 52 respondents consisting of employees working led by 4 different superv...

  13. Comparison of the efficacy of standard bariatric surgical procedures on Saudi population using the bariatric analysis and reporting outcome system

    Directory of Open Access Journals (Sweden)

    Azzam Al Kadi

    2017-03-01

    Full Text Available Objectives: To compare the efficacy of various standard bariatric surgical procedures using the Bariatric Analysis and Reporting Outcome System (BAROS. Methods: This is a prospective, descriptive analytical study conducted in 2 medical institutions in Saudi Arabia. A total of 270 patients who had different bariatric surgery during the period between March 2010 and December 2012 were included. The data was analyzed and scored against 3 outcomes, excess weight loss, cure or improvement of comorbidities, and quality of life changes. Results: All patients who had different bariatric procedures were included in our study. Seventy-nine (29.3% underwent laparoscopic Roux-en-Y gastric bypass (LRYGBP, 159 (58.9% had laparoscopic sleeve gastrectomy (LSG, and 32 (11.9% had laparoscopic adjustable gastric banding (LAGB. Complete remission of at least one comorbidity was reported in 36% of LRYGBP, 51% in LSG, and 42% in LAGB. While all other patients have improved comorbidities. The BAROS score was good or higher in 78.5% of LRYGBP, 83.6% for the LSG, and 84.4% of LAGB patients. The average excess weight loss was 67.9% in LRYGBP, 75.8% in LSG, and 81.7% LAGB patients. Conclusion: Bariatric surgery provides a substantial reduction in excess weight, improvement and cure of comorbidities, and improvement in quality of life. Standard bariatric procedures have different degrees of outcomes that can be beneficial in selecting appropriate procedure for appropriate indications and patients.

  14. 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

  15. Aircrew Compliance with Standard Operating Procedures as a Component of Airline Safety.

    Science.gov (United States)

    1980-01-01

    typical operating environment, the crew activity associated with it is thought to be representative of habitual behavior. In contrast, the second...Most of the participants were assigned to a single aircrew domicle. The one captain who came from a different domicile is subjectively ranked between...initiations lies in the sweeping Command and Management Procedures. They affirm that responsibility for all operational activity resides in the

  16. Size- and coating-dependent cytotoxicity and genotoxicity of silver nanoparticles evaluated using in vitro standard assays.

    Science.gov (United States)

    Guo, Xiaoqing; Li, Yan; Yan, Jian; Ingle, Taylor; Jones, Margie Yvonne; Mei, Nan; Boudreau, Mary D; Cunningham, Candice K; Abbas, Mazhar; Paredes, Angel M; Zhou, Tong; Moore, Martha M; Howard, Paul C; Chen, Tao

    2016-11-01

    The physicochemical characteristics of silver nanoparticles (AgNPs) may greatly alter their toxicological potential. To explore the effects of size and coating on the cytotoxicity and genotoxicity of AgNPs, six different types of AgNPs, having three different sizes and two different coatings, were investigated using the Ames test, mouse lymphoma assay (MLA) and in vitro micronucleus assay. The genotoxicities of silver acetate and silver nitrate were evaluated to compare the genotoxicity of nanosilver to that of ionic silver. The Ames test produced inconclusive results for all types of the silver materials due to the high toxicity of silver to the test bacteria and the lack of entry of the nanoparticles into the cells. Treatment of L5718Y cells with AgNPs and ionic silver resulted in concentration-dependent cytotoxicity, mutagenicity in the Tk gene and the induction of micronuclei from exposure to nearly every type of the silver materials. Treatment of TK6 cells with these silver materials also resulted in concentration-dependent cytotoxicity and significantly increased micronucleus frequency. With both the MLA and micronucleus assays, the smaller the AgNPs, the greater the cytotoxicity and genotoxicity. The coatings had less effect on the relative genotoxicity of AgNPs than the particle size. Loss of heterozygosity analysis of the induced Tk mutants indicated that the types of mutations induced by AgNPs were different from those of ionic silver. These results suggest that AgNPs induce cytotoxicity and genotoxicity in a size- and coating-dependent manner. Furthermore, while the MLA and in vitro micronucleus assay (in both types of cells) are useful to quantitatively measure the genotoxic potencies of AgNPs, the Ames test cannot.

  17. Proposal evaluation tool of standards and procedures for breast cancer in the province of Cienfuegos

    International Nuclear Information System (INIS)

    Fraga Suarez, Omayda; Sabates Llerandi, Teresita; Arnot Silvera, Rogelio; Torres Aja, Lidia

    2009-01-01

    Breast cancer is one of the most frequent malignancies Although Cuba and be a program with rules and procedures established a high number of women will die from cause. Objectives, design an instrument to assess compliance with the rules and procedures of breast cancer in Cienfuegos Province. Methodological design, a study was conducted descriptive, during the time period from January 2007 to January 2008, whose study group consisted of 55 women diagnosed with breast cancer at the 'Hospital Universitario Dr. Gustavo Lima Aldereguia' of Cienfuegos, the research was divided into three stages: general characterization, design of an assessment tool, criterion validation by external evaluators. Methods were used theoretical, empirical and mathematical statistics. Results, the stadiums most representative were II and III, there are delays in the performance definitive surgery, radical surgical treatments prevail, delays in the initiation of chemotherapy. Findings, there difficulties in adherence and compliance and therapeutic procedures established in the province of Cienfuegos, by which an instrument was designed for evaluation. (Author)

  18. The advantages of using standardized review procedures in certifying type B radioactive material packages

    International Nuclear Information System (INIS)

    Easton, E.P.; Faille, S.

    2004-01-01

    This paper presents the advantages of adopting well-documented standardized review practices for reviewing Type B package designs. The US experience using standardized review plans and guidance has shown them to be a valuable tool in achieving more consistent and efficient package reviews, in training and qualifying technical reviewers, and in enhancing public and industry understanding of the package certification process. In addition, the standardized review practices, as living documents, have proven to be an effective method of incorporating new technical advances into the review process, and have provided a vehicle to make that knowledge widely available to fellow reviewers, the public and industry. Canada implemented a new internal review process in early 2003 to standardize the review of applications for certification of Type B Packages. Based on the similarity of these approaches, the United States and Canada have started discussions on a A North American System for the unilateral approval of Type B (U) packages. This initiative is looking into how each country is currently reviewing transportation package applications to see if agreement can be reached on accepting Type B certifications on a reciprocal basis, i.e., without additional review. Based on the experience in Canada and the United States, the authors believe that the use of standardized review processes, coupled with the knowledge and experience resident in IAEA's Transportation Advisory Material (TS-G-1.1) and series of TECDOCS, could also be used to develop a standard internationally accepted review process that could enhance the acceptance of unilateral approvals for Type B packages

  19. 78 FR 54655 - Center for Devices and Radiological Health: Draft Standard Operating Procedure for Level 1...

    Science.gov (United States)

    2013-09-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... challenging for the Center to communicate the change and its basis to all affected parties in a meaningful and... communication on regulatory matters, including establishing a standard practice for communicating to all...

  20. Study on Design and Implementation of JAVA Programming Procedural Assessment Standard

    Science.gov (United States)

    Tingting, Xu; Hua, Ma; Xiujuan, Wang; Jing, Wang

    2015-01-01

    The traditional JAVA course examination is just a list of questions from which we cannot know students' skills of programming. According to the eight abilities in curriculum objectives, we designed an assessment standard of JAVA programming course that is based on employment orientation and apply it to practical teaching to check the teaching…

  1. Preliminary Guidelines and Standard Operating Procedure for Drainage and Erosion Control at McMurdo Station

    Science.gov (United States)

    2014-12-01

    along the impermeable frozen soil layer. Soil freeze–thaw action disrupts soil structures, displaces soils particles, and creates voids both in...appropriate culvert replacement type (e.g., metal or plastic or concrete , etc.) and to try to standardize culverts around the Station. ER D C

  2. CTEPP STANDARD OPERATING PROCEDURE FOR HANDLING SAMPLE AND DATA CUSTODY (SOP-2.26)

    Science.gov (United States)

    This SOP describes the method for handling sample custody. A standardized Chain-of-Custody (CoC) Record is used to document the sample/data custody. Each participant is assigned one CoC Record for the samples/data collected at their home and/or day care center.

  3. Incorporation of biomagnification in procedures for environmental risk assessment and standard setting

    NARCIS (Netherlands)

    Luttik R; Traas TP; de Greef J

    1992-01-01

    Recently methods have been developed in the Netherlands to assess quality standards for the environment. Maximum permissible concentrations have been derived for direct exposure to environmental media. In 1991 two simple foodchains were analyzed at the RIVM. - Water --> Fish --> Fish-eating

  4. Documentation for assessment of modal pushover-based scaling procedure for nonlinear response history analysis of "ordinary standard" bridges

    Science.gov (United States)

    Kalkan, Erol; Kwong, Neal S.

    2010-01-01

    The earthquake engineering profession is increasingly utilizing nonlinear response history analyses (RHA) to evaluate seismic performance of existing structures and proposed designs of new structures. One of the main ingredients of nonlinear RHA is a set of ground-motion records representing the expected hazard environment for the structure. When recorded motions do not exist (as is the case for the central United States), or when high-intensity records are needed (as is the case for San Francisco and Los Angeles), ground motions from other tectonically similar regions need to be selected and scaled. The modal-pushover-based scaling (MPS) procedure recently was developed to determine scale factors for a small number of records, such that the scaled records provide accurate and efficient estimates of 'true' median structural responses. The adjective 'accurate' refers to the discrepancy between the benchmark responses and those computed from the MPS procedure. The adjective 'efficient' refers to the record-to-record variability of responses. Herein, the accuracy and efficiency of the MPS procedure are evaluated by applying it to four types of existing 'ordinary standard' bridges typical of reinforced-concrete bridge construction in California. These bridges are the single-bent overpass, multi span bridge, curved-bridge, and skew-bridge. As compared to benchmark analyses of unscaled records using a larger catalog of ground motions, it is demonstrated that the MPS procedure provided an accurate estimate of the engineering demand parameters (EDPs) accompanied by significantly reduced record-to-record variability of the responses. Thus, the MPS procedure is a useful tool for scaling ground motions as input to nonlinear RHAs of 'ordinary standard' bridges.

  5. Standardization of solvent extraction procedure for determination of uranium in seawater

    International Nuclear Information System (INIS)

    Sukanta Maity; Sahu, S.K.; Pandit, G.G.

    2015-01-01

    Solvent extraction procedure using ammonium pyrolidine dithiocarbamate complexing agent in methyl isobutyl ketone organic phase and acid exchange back-extraction is described for the simultaneous quantitative pre-concentration of uranium in seawater followed by its determination by differential pulse adsorptive stripping voltammetry. Solvent extraction time is optimized for extraction of uranium from seawater. Solvent extraction efficiency for uranium in seawater at different pH was carried out. The method gives a recovery of 98 ± 2 % for 400 mL sample at pH 3.0 ± 0.02, facilitating the rapid and interference free analysis of seawater samples. (author)

  6. A Standardized Procedure for a Pre-evaluation of the IED Instance

    Science.gov (United States)

    Panepinto, Deborah; Ruffino, Barbara; Zanetti, Mariachiara; Genon, Giuseppe

    2016-04-01

    This study presents a procedure, called EICS (Enterprise IPPC Compatibility Study) aimed at evaluating, by means of the calculation of three indexes, the compliance of the processes performed in an industrial plant with the guidelines provided by BREFs (BAT References) Documents. In fact, according to European Directive 2010/75/EU (concerning the Integrated Pollution Prevention and Control and repealing European Directive 2008/01/EC), industrial plants must require authorizations to the competent authority stating the conformity of their activity, in order to obtain this conformity they are advised to Best Available Technologies (BAT). The aim of the BATs is to avoid or minimize the impact of an industrial activity on the environment through the prevention of the atmospheric emissions, wastewater discharge and energetic consumption, and the correct waste management thus improving the efficiency of the plant. The procedure shown in the present paper has been tested on several types of industrial plant (cement plants, secondary smelt foundries, paper-mill, and automotive industries as regards their paint lines). In this paper, the application of EICS method to a cement plant is presented: the obtained results highlight a good correlation between the index values and the real situation of the plant.

  7. Developing standard performance testing procedures for MC and A components at a site

    International Nuclear Information System (INIS)

    Scherer, Carolynn

    2010-01-01

    The condition of a nuclear material control and accountability system (MC and A) and its individual components, as with any system combining technical elements, documentation and the human factor, may be characterized through an aggregate of values for the various parameters that determine the system's ability to perform. The MC and A system's status may be functioning effectively, marginally or not functioning based on a summary of the values of the individual parameters. This work included a review of the following elements and subsystems or components for a material control and accountability system: (1) MC and A Elements: Information subsystem, Measurement subsystem, NM access subsystem, including a tamper-indicating device (TID) program, and Automated information-gathering subsystem; and (2) Detecting NM Loses Elements: Inventory differences, Shipper/receiver differences, Confirmatory measurements and differences with accounting data, and TID or seal violations. In order to detect the absence or loss of nuclear material there must be appropriate interactions among the elements and their respective subsystems (from the list above). Additionally this work includes a review of the status of regulatory requirements for the MC and A system components and potential criteria that support the evaluation of the performance of the listed components. The listed components had performance testing algorithms and procedures developed that took into consideration the regulatory criteria. The developed MC and A performance-testing procedures were the basis for a pilot Guide for MC and A Performance Testing at the MBAs of SSC RF IPPE.

  8. A semi-automated luminescence based standard membrane feeding assay identifies novel small molecules that inhibit transmission of malaria parasites by mosquitoes.

    Science.gov (United States)

    Vos, Martijn W; Stone, Will J R; Koolen, Karin M; van Gemert, Geert-Jan; van Schaijk, Ben; Leroy, Didier; Sauerwein, Robert W; Bousema, Teun; Dechering, Koen J

    2015-12-21

    Current first-line treatments for uncomplicated falciparum malaria rapidly clear the asexual stages of the parasite, but do not fully prevent parasite transmission by mosquitoes. The standard membrane feeding assay (SMFA) is the biological gold standard assessment of transmission reducing activity (TRA), but its throughput is limited by the need to determine mosquito infection status by dissection and microscopy. Here we present a novel dissection-free luminescence based SMFA format using a transgenic Plasmodium falciparum reporter parasite without resistance to known antimalarials and therefore unrestricted in its utility in compound screening. Analyses of sixty-five compounds from the Medicines for Malaria Venture validation and malaria boxes identified 37 compounds with high levels of TRA (>80%); different assay modes allowed discrimination between gametocytocidal and downstream modes of action. Comparison of SMFA data to published assay formats for predicting parasite infectivity indicated that individual in vitro screens show substantial numbers of false negatives. These results highlight the importance of the SMFA in the screening pipeline for transmission reducing compounds and present a rapid and objective method. In addition we present sixteen diverse chemical scaffolds from the malaria box that may serve as a starting point for further discovery and development of malaria transmission blocking drugs.

  9. 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

  10. Pet Food Palatability Evaluation: A Review of Standard Assay Techniques and Interpretation of Results with a Primary Focus on Limitations.

    Science.gov (United States)

    Aldrich, Gregory C; Koppel, Kadri

    2015-01-16

    The pet food industry continues to grow steadily as a result of new innovative products. Quality control and product development tests for pet foods are typically conducted through palatability testing with dogs and cats. Palatability is the measure of intake of a food that indicates acceptance or the measure of preference of one food over another. Pet food palatability is most commonly measured using a single-bowl or a two-bowl assay. While these tests answer some questions about the animals' perception of the food, there are many limitations as well. This review addresses some of these limitations and indicates opportunities for future research.

  11. Pet Food Palatability Evaluation: A Review of Standard Assay Techniques and Interpretation of Results with a Primary Focus on Limitations

    Directory of Open Access Journals (Sweden)

    Gregory C. Aldrich

    2015-01-01

    Full Text Available The pet food industry continues to grow steadily as a result of new innovative products. Quality control and product development tests for pet foods are typically conducted through palatability testing with dogs and cats. Palatability is the measure of intake of a food that indicates acceptance or the measure of preference of one food over another. Pet food palatability is most commonly measured using a single-bowl or a two-bowl assay. While these tests answer some questions about the animals’ perception of the food, there are many limitations as well. This review addresses some of these limitations and indicates opportunities for future research.

  12. Biobanking human endometrial tissue and blood specimens: standard operating procedure and importance to reproductive biology research and diagnostic development.

    Science.gov (United States)

    Sheldon, Elizabeth; Vo, Kim Chi; McIntire, Ramsey A; Aghajanova, Lusine; Zelenko, Zara; Irwin, Juan C; Giudice, Linda C

    2011-05-01

    To develop a standard operating procedure (SOP) for collection, transport, storage of human endometrial tissue and blood samples, subject and specimen annotation, and establishing sample priorities. The SOP synthesizes sound scientific procedures, the literature on ischemia research, sample collection and gene expression profiling, good laboratory practices, and the authors' experience of workflow and sample quality. The National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. Women undergoing endometrial biopsy or hysterectomy for nonmalignant indications. Collecting, processing, storing, distributing endometrial tissue and blood samples under approved institutional review board protocols and written informed consent from participating subjects. Standard operating procedure. The SOP addresses rigorous and consistent subject annotation, specimen processing and characterization, strict regulatory compliance, and a reference for researchers to track collection and storage times that may influence their research. The comprehensive and systematic approach to the procurement of human blood and endometrial tissue in this SOP ensures the high quality, reliability, and scientific usefulness of biospecimens made available to investigators by the National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. The detail and perspective in this SOP also provides a blueprint for implementation of similar collection programs at other institutions. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  13. Comparison of isolated cranberry (Vaccinium macrocarpon Ait.) proanthocyanidins to catechin and procyanidins A2 and B2 for use as standards in the 4-(dimethylamino)cinnamaldehyde assay.

    Science.gov (United States)

    Feliciano, Rodrigo P; Shea, Michael P; Shanmuganayagam, Dhanansayan; Krueger, Christian G; Howell, Amy B; Reed, Jess D

    2012-05-09

    The 4-(dimethylamino)cinnamaldehyde (DMAC) assay is currently used to quantify proanthocyanidin (PAC) content in cranberry products. However, this method suffers from issues of accuracy and precision in the analysis and comparison of PAC levels across a broad range of cranberry products. Current use of procyanidin A2 as a standard leads to an underestimation of PACs content in certain cranberry products, especially those containing higher molecular weight PACs. To begin to address the issue of accuracy, a method for the production of a cranberry PAC standard, derived from an extraction of cranberry (c-PAC) press cake, was developed and evaluated. Use of the c-PAC standard to quantify PAC content in cranberry samples resulted in values that were 2.2 times higher than those determined by procyanidin A2. Increased accuracy is critical for estimating PAC content in relationship to research on authenticity, efficacy, and bioactivity, especially in designing clinical trials for determination of putative health benefits.

  14. The use of faces as stimuli in neuroimaging and psychological experiments: a procedure to standardize stimulus features.

    Science.gov (United States)

    Gronenschild, Ed H B M; Smeets, Floortje; Vuurman, Eric F P M; van Boxtel, Martin P J; Jolles, Jelle

    2009-11-01

    In psychological experiments involving facial stimuli, it is of great importance that the basic perceptual or psychological characteristics that are investigated are not confounded by factors such as brightness and contrast, head size, hair cut and color, skin color, and the presence of glasses and earrings. Standardization of facial stimulus materials reduces the effect of these confounding factors. We therefore employed a set of basic image processing techniques to deal with this issue. The processed images depict the faces in grayscale, all at the same size, brightness, and contrast, and confined to an oval mask revealing only the basic features such as the eyes, nose, and mouth. The standardization was successfully applied to four different face databases, consisting of male and female faces and including neutral as well as happy facial expressions. An important advantage of the proposed standardization is that featural as well as configurational information is retained. We also consider the procedure to be a major contribution to the development of a de facto standard for the use of facial stimuli in psychological experiments. Such methodological standardization would allow a better comparison of the results of these studies.

  15. Developing standard performance testing procedures for material control and accounting components at a site

    International Nuclear Information System (INIS)

    Scherer, Carolynn P.; Bushlya, Anatoly V.; Efimenko, Vladimir F.; Ilyanstev, Anatoly; Regoushevsky, Victor I.

    2010-01-01

    The condition of a nuclear material control and accountability system (MC and A) and its individual components, as with any system combining technical elements and documentation, may be characterized through an aggregate of values for the various parameters that determine the system's ability to perform. The MC and A system's status may be functioning effectively, marginally or not functioning based on a summary of the values of the individual parameters. This work included a review of the following subsystems, MC and A and Detecting Material Losses, and their respective elements for the material control and accountability system: (a) Elements of the MC and A Subsystem - Information subsystem (Accountancy/Inventory), Measurement subsystem, Nuclear Material Access subsystem, including tamper-indicating device (TID) program, and Automated Information-gathering subsystem; (b) Elements for Detecting Nuclear Material Loses Subsystem - Inventory Differences, Shipper/receiver Differences, Confirmatory Measurements and differences with accounting data, and TID or Seal Violations. In order to detect the absence or loss of nuclear material there must be appropriate interactions among the elements and their respective subsystems from the list above. Additionally this work includes a review of regulatory requirements for the MC and A system component characteristics and criteria that support the evaluation of the performance of the listed components. The listed components had performance testing algorithms and procedures developed that took into consideration the regulatory criteria. The developed MC and A performance-testing procedures were the basis for a Guide for MC and A Performance Testing at the material balance areas (MBAs) of State Scientific Center of the Russian Federation - Institute for Physics and Power Engineering (SSC RF-IPPE).

  16. [Nomenclature and classification of complications. Standard procedure at the Heidelberg University Orthopedic Clinic].

    Science.gov (United States)

    Krämer, K L; Clauss, M

    1999-03-01

    In order to get a better data management of complications in orthopedic surgery and in order to get comparable statistics a standardisation of nomenclature and classification of complications is demanded since 1.1.1997. The Orthopedic University Clinic of Heidelberg started with a register of all early complications of all inpatients. According to a standardized nomenclature all occurred complications the doctors put in the data of complications in a database. These data were controlled, complemented and classified by members of the quality management group. This guideline consists of five parts: catalogue of diagnoses, general and special definitions, classification and an allocation table of diagnoses to grades of severity.

  17. Assessment of modal-pushover-based scaling procedure for nonlinear response history analysis of ordinary standard bridges

    Science.gov (United States)

    Kalkan, E.; Kwong, N.

    2012-01-01

    The earthquake engineering profession is increasingly utilizing nonlinear response history analyses (RHA) to evaluate seismic performance of existing structures and proposed designs of new structures. One of the main ingredients of nonlinear RHA is a set of ground motion records representing the expected hazard environment for the structure. When recorded motions do not exist (as is the case in the central United States) or when high-intensity records are needed (as is the case in San Francisco and Los Angeles), ground motions from other tectonically similar regions need to be selected and scaled. The modal-pushover-based scaling (MPS) procedure was recently developed to determine scale factors for a small number of records such that the scaled records provide accurate and efficient estimates of “true” median structural responses. The adjective “accurate” refers to the discrepancy between the benchmark responses and those computed from the MPS procedure. The adjective “efficient” refers to the record-to-record variability of responses. In this paper, the accuracy and efficiency of the MPS procedure are evaluated by applying it to four types of existing Ordinary Standard bridges typical of reinforced concrete bridge construction in California. These bridges are the single-bent overpass, multi-span bridge, curved bridge, and skew bridge. As compared with benchmark analyses of unscaled records using a larger catalog of ground motions, it is demonstrated that the MPS procedure provided an accurate estimate of the engineering demand parameters (EDPs) accompanied by significantly reduced record-to-record variability of the EDPs. Thus, it is a useful tool for scaling ground motions as input to nonlinear RHAs of Ordinary Standard bridges.

  18. Microspectrophotometric studies of Romanowsky stained blood cells. I. Subtraction analysis of a standardized procedure.

    Science.gov (United States)

    Galbraith, W; Marshall, P N; Bacus, J W

    1980-08-01

    This paper describes a microspectrophotometric study of blood smears stained by a simple, standardized Romanowsky technique, using only the dyes azure B and cosin. Absorbance spectra are presented for twenty-two classes of cellular object, and for the two dyes in solution, together with tabulations of spectral maxima, and suitable wavelengths for use in automated image processing. The colours of objects stained with azure B/eosin are discussed in terms of absorbance spectra. By a spectral subtraction technique, it is shown that the differential colouration of various cell structures may be explained satisfactorily in terms of the varying proportions of only four dye components. These are the monomers and dimers of azure B and eosin. Polymerization was found to occur both in solution and on binding to biopolymers. A similar analysis of a conventional Romanowsky stain would present much greater difficulties, due to the greater number of dye components, which, however, contribute little to the colours observed.

  19. STANDARDIZATION OF PROCEDURES OF Plasmodium falciparum ANTIGEN PREPARATION FOR SEROLOGIC TESTS

    Directory of Open Access Journals (Sweden)

    Sandra L.M. AVILA

    1998-09-01

    Full Text Available The objective of the present study is to standardize the technical variables for preparation and storage of Plasmodium falciparum and of antigen components extracted with the amphoteric detergent Zwittergent. P. falciparum obtained from in vitro culture was stored at different temperatures and for different periods of time. For each variable, antigen components of the parasite were extracted in the presence or absence of protease inhibitors and submitted or not to later dialysis. Products were stored for 15, 30 and 60 days at different temperatures and immunological activity of each extract was determined by SDS-PAGE and ELISA using positive or negative standard sera for the presence of IgG directed to blood stage antigens of P. falciparum. Antigen extracts obtained from parasites stored at -20oC up to 10 days or at -70oC for 2 months presented the best results, showing well-defined bands on SDS-PAGE and Western blots and presenting absorbance values in ELISA that permitted safe differentiation between positive and negative sera.O objetivo deste estudo foi padronizar variáveis técnicas para o armazenamento de Plasmodium falciparum e de seus componentes antigênicos. Sedimentos de parasitas foram obtidos do cultivo in vitro de P.falciparum e estocados em diferentes temperaturas por diferentes períodos de tempo. De cada variável, foram extraídos os componentes antigênicos com detergente anfótero Zwittergent na presença e na ausência de inibidores de proteases e submetidos ou não a posterior diálise. Os produtos foram estocados por 15, 30 e 60 dias em diferentes temperaturas e caracterizados por SDS-PAGE. A atividade antigênica de cada extrato foi determinada por ELISA e Western blotting usando soros positivos e negativos para anticorpos IgG anti-formas eritrocitárias de P.falciparum. Os extratos antigênicos obtidos de parasitas estocados até 10 dias a _20ºC ou por 2 meses a _70ºC e tratados com inibidores de proteases, sob as

  20. A comparison of titers of anti-Brucella antibodies of naturally infected and healthy vaccinated cattle by standard tube agglutination test, microtiter plate agglutination test, indirect hemagglutination assay, and indirect enzyme-linked immunosorbent assay

    Directory of Open Access Journals (Sweden)

    Anju Mohan

    2016-07-01

    Full Text Available Aim: We determined the antibody response in cattle naturally infected with brucellosis and normal healthy adult cattle vaccinated during calf hood with strain 19. Materials and Methods: The antibody titers were measured by standard tube agglutination test (STAT, microtiter plate agglutination test (MAT, indirect hemagglutination assay (IHA, and indirect enzyme-linked immunosorbent assay (iELISA as per standard protocols. Results: The mean STAT titers were 1.963±0.345 in infected cattle and 1.200±0.155 in healthy vaccinated cattle. The difference was extremely significant (p<0.0001. The mean MAT titers were 2.244±0.727 in infected cattle and 1.200±0.155 in healthy vaccinated cattle. The difference was very significant (p<0.005. The mean IHA titers in infected cattle were 2.284±0.574, and those in healthy vaccinated cattle were 1.200±0.155. The difference was extremely significant (p=0.0002. However, the difference in mean iELISA titers of infected cattle (1.3678±0.014 and healthy vaccinated cattle (1.367±0.014 was non-significant. The infected animals showed very high titers of agglutinating antibodies compared to the vaccinated animals. However, it cannot be ascertained whether these antibodies are due to vaccine or response to infection. Since the infected animals had been vaccinated earlier, the current infection may suggest that vaccination was unable to induce protective levels of antibody. The heightened antibody response after infection may also indicate a secondary immune response to the antigens common to the vaccine strain and wild Brucella organisms. Conclusion: The brucellosis infected animals showed very high titers of agglutinating antibodies compared to the vaccinated animals.

  1. Two-loop renormalization in the standard model, part II. Renormalization procedures and computational techniques

    Energy Technology Data Exchange (ETDEWEB)

    Actis, S. [Deutsches Elektronen-Synchrotron (DESY), Zeuthen (Germany); Passarino, G. [Torino Univ. (Italy). Dipt. di Fisica Teorica; INFN, Sezione di Torino (Italy)

    2006-12-15

    In part I general aspects of the renormalization of a spontaneously broken gauge theory have been introduced. Here, in part II, two-loop renormalization is introduced and discussed within the context of the minimal Standard Model. Therefore, this paper deals with the transition between bare parameters and fields to renormalized ones. The full list of one- and two-loop counterterms is shown and it is proven that, by a suitable extension of the formalism already introduced at the one-loop level, two-point functions suffice in renormalizing the model. The problem of overlapping ultraviolet divergencies is analyzed and it is shown that all counterterms are local and of polynomial nature. The original program of 't Hooft and Veltman is at work. Finite parts are written in a way that allows for a fast and reliable numerical integration with all collinear logarithms extracted analytically. Finite renormalization, the transition between renormalized parameters and physical (pseudo-)observables, are discussed in part III where numerical results, e.g. for the complex poles of the unstable gauge bosons, are shown. An attempt is made to define the running of the electromagnetic coupling constant at the two-loop level. (orig.)

  2. OIE philosophy, policy and procedures for the development of food safety standards.

    Science.gov (United States)

    Droppers, W F G L

    2006-08-01

    Food safety was identified as a high priority area in the 2001-2005 World Organisation for Animal Health (OIE) Strategic Plan. Member Countries of the OIE considered that the organisation should be more active in issues of public health and consumer protection and that this should include more involvement in the area of diseases or pathogens transmissible through food, whether or not animals are affected by such diseases or pathogens. A permanent Working Group on Animal Production Food Safety was established in 2002 to coordinate the OIE's activities in food safety. The Working Group was requested to focus on food safety measures applicable at farm level and to monitor the ongoing cooperation between the OIE and Codex Alimentarius. More emphasis is now placed on the public health aspects of a disease when OIE standards are developed or revised. For example, the revised chapter on bovine tuberculosis in the Terrestrial Animal Health Code includes food safety recommendations for meat and meat products and for milk and milk products. The revised chapter was approved by the OIE International Committee of Member Countries at their 73rd General Session in May 2005. More chapters will follow, beginning with a chapter addressing bovine brucellosis.

  3. A scalable assessment of Plasmodium falciparum transmission in the standard membrane-feeding assay, using transgenic parasites expressing green fluorescent protein-luciferase.

    Science.gov (United States)

    Stone, Will J R; Churcher, Thomas S; Graumans, Wouter; van Gemert, Geert-Jan; Vos, Martijn W; Lanke, Kjerstin H W; van de Vegte-Bolmer, Marga G; Siebelink-Stoter, Rianne; Dechering, Koen J; Vaughan, Ashley M; Camargo, Nelly; Kappe, Stefan H I; Sauerwein, Robert W; Bousema, Teun

    2014-11-01

    The development of drugs and vaccines to reduce malaria transmission is an important part of eradication plans. The transmission-reducing activity (TRA) of these agents is currently determined in the standard membrane-feeding assay (SMFA), based on subjective microscopy-based readouts and with limitations in upscaling and throughput. Using a Plasmodium falciparum strain expressing the firefly luciferase protein, we present a luminescence-based approach to SMFA evaluation that eliminates the requirement for mosquito dissections in favor of a simple approach in which whole mosquitoes are homogenized and examined directly for luciferase activity. Analysis of 6860 Anopheles stephensi mosquitoes across 68 experimental feeds shows that the luminescence assay was as sensitive as microscopy for infection detection. The mean luminescence intensity of individual and pooled mosquitoes accurately quantifies mean oocyst intensity and generates comparable TRA estimates. The luminescence assay presented here could increase SMFA throughput so that 10-30 experimental feeds could be evaluated in a single 96-well plate. This new method of assessing Plasmodium infection and transmission intensity could expedite the screening of novel drug compounds, vaccine candidates, and sera from malaria-exposed individuals for TRA. Luminescence-based estimates of oocyst intensity in individual mosquitoes should be interpreted with caution. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  4. Development and Evaluation of a Duplex Real-Time PCR Assay With a Novel Internal Standard for Precise Quantification of Plasma DNA.

    Science.gov (United States)

    Chen, Dan; Pan, Shiyang; Xie, Erfu; Gao, Li; Xu, Huaguo; Xia, Wenying; Xu, Ting; Huang, Peijun

    2017-01-01

    Circulating levels of cell-free DNA increase in many pathologic conditions. However, notable discrepancies in the quantitative analysis of cell-free DNA from a large number of laboratories have become a considerable pitfall, hampering its clinical application. We designed a novel recombinant DNA fragment that could be applied as an internal standard in a newly developed and validated duplex real-time PCR assay for the quantitative analysis of total cell-free plasma DNA, which was tested in 5,442 healthy adults and 200 trauma patients. Compared with two traditional methods, this novel assay showed a lower detection limit of 0.1 ng/mL, lower intra- and inter-assay CVs, and higher accuracy in the recovery test. The median plasma DNA concentration of healthy males (20.3 ng/mL, n=3,092) was significantly higher than that of healthy females (16.1 ng/mL, n=2,350) (Mann-Whitney two-sample rank sum test, PDNA concentration were 0-45.8 ng/mL and 0-52.5 ng/mL for healthy females and males, respectively. The plasma DNA concentrations of the majority of trauma patients (96%) were higher than the upper normal cutoff values and were closely related to the corresponding injury severity scores (R²=0.916, PDNA, showing promising application in clinical diagnosis.

  5. Novel femoral artery terminology: integrating anatomy and clinical procedures leading to standardized intuitive nomenclature.

    Science.gov (United States)

    Benninger, Brion

    2014-10-01

    The objective of this study is to investigate the terminology of the femoral artery and recommended alternative terminology that satisfies both anatomy and clinical arenas.The femoral artery (FA) is often defined as the continuation of the external iliac artery. Specifically, when the external iliac artery reaches directly beneath the inguinal ligament, it becomes the FA. Currently, Terminologia Anatomica (TA) records the profunda femoris or deep femoral as a terminal branch. Clinicians often use superficial femoral artery (SFA) rather than FA and profunda or deep FA. SFA is actually very deep and well protected for most of its journey. On observation, the terminology in current use is not intuitive. The objective of this study was to investigate the terminology associated with the anatomical and clinical anatomical interpretations of the FA and its terminal branches and to suggest a more appropriate terminology that addresses the points of view of the macro anatomist, as well as that of the clinician. Literature search was conducted regarding the nomenclature of the FA and its terminal branches. Dissection of 89 embalmed cadavers (49F, 40M, ages 47-89) was conducted to analyze the morphology of the FA and its branches. Perusal of the literature revealed a difference in terminology between anatomical and clinical textbooks/atlases/journals regarding the FA and its terminal branch. Our dissections suggested that the FA may be better defined vis-à-vis its relationship to the anterior and posterior compartments of the thigh. A difference in terminology exists between the anatomical and clinical arenas. A need for a standardized terminology is necessary because clinicians and their publishers have not adopted TA. This study suggests that the current FA be considered the common FA and the continuation of the FA, the SFA be renamed the anterior FA and the current profunda (the deep FA) be renamed the posterior FA, respectively. The proposed terminology mirrors the lower

  6. Electroluminescent TCC, C3dg and fB/Bb epitope assays for profiling complement cascade activation in vitro using an activated complement serum calibration standard.

    Science.gov (United States)

    van Vuuren, B Jansen; Bergseth, G; Mollnes, T E; Shaw, A M

    2014-01-15

    Electroluminescent assays for epitopes on the complement components C3dg, terminal complement complex (TCC) and factor B/Bb (fB/Bb) have been developed with capture and detection antibodies to produce detection limits C3dg=91±9ng/mL, TCC=3±0.1ng/mL and fB=55.7±0.1ng/mL. The assay performance was assessed against a series of zymosan and heat aggregated IgG (HAIgG) in vitro activations of complement using a calibrated activated complement serum (ACS) as calibration standard. The ACS standard was stable within 20% accuracy over a 6-month period with freeze-thaw cycles as required. Differential activation of the complement cascade was observed for TCC showing a pseudo-first order formation half-life of 3.5h after activation with zymosan. The C3dg activation fragment indicates a 10% total activation for both activation agents. The kinetic-epitope analysis for fB indicates that the capture epitope is on the fB/Bb protein fragment which can then become covered by the formation of C3bBb or C3bBbP complexes during the time course of the cascade. Copyright © 2013 Elsevier B.V. All rights reserved.

  7. Standardization and optimization of core sampling procedure for carbon isotope analysis in eucalyptus and variation in carbon isotope ratios across species and growth conditions

    CSIR Research Space (South Africa)

    Raju, M

    2011-11-01

    Full Text Available 13C is a well established surrogate for water use efficiency (WUE). However, variation due to aspect, length of branch and position In canopy can cause potential errors. Hence, experiments were conducted to standardize the sampling procedures...

  8. A Guide for Developing Standard Operating Job Procedures for the Tertiary Chemical Treatment - Lime Precipitation Process Wastewater Treatment Facility. SOJP No. 6.

    Science.gov (United States)

    Petrasek, Al, Jr.

    This guide describes the standard operating job procedures for the tertiary chemical treatment - lime precipitation process of wastewater treatment plants. Step-by-step instructions are given for pre-start up, start-up, continuous operation, and shut-down procedures. In addition, some theoretical material is presented along with some relevant…

  9. Sexual Desire and Hypoactive Sexual Desire Disorder in Women. Introduction and Overview. Standard Operating Procedure (SOP Part 1)

    DEFF Research Database (Denmark)

    Bitzer, Johannes; Giraldi, Annamaria; Pfaus, Jim

    2013-01-01

    Introduction.  Hypoactive sexual desire disorder (HSDD) is defined in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition as persistent or recurrent deficiency (or absence) of sexual fantasies/thoughts, and/or desire for or receptivity to sexual activity, which causes personal......-factor models (e.g., excitation-inhibition, appetitive-consummatory) or more specific multifactorial models (in which the different components of sexual activity and their interaction are delineated). The etiology of the disorder is generally considered as multifactorial. Biomedical factors like diseases, drugs...... must be based on a biopsychosocial, multidimensional, and integrative perspective. Bitzer J, Giraldi A, and Pfaus J. Sexual desire and hypoactive sexual desire disorder in women. Introduction and overview. Standard operating procedure (SOP part 1). J Sex Med **;**:**-**....

  10. Removal of foot-and-mouth disease virus infectivity in salted natural casings by minor adaptation of standardized industrial procedures.

    Science.gov (United States)

    Wijnker, J J; Haas, B; Berends, B R

    2007-04-10

    Intestines are used for the production of natural casings as edible sausage containers. Derived from animals (pigs and sheep) experimentally infected with FMDV (initial dosage 10(7.3) PFU/ml, strain O(1Kaufbeuren)), these natural casings were treated with sodium chloride or a phosphate salts/sodium chloride mixture and the residual FMDV titres measured. After storage at about 20 degrees C, no remaining infectivity was found after either treatment, whereas casings stored at 4 degrees C still contained infectivity. Storage of salted casings at about 20 degrees C for 30 days is already part of the Standard Operating Procedures (included in HACCP) of the international casing industry and can therefore be considered as a protective measure for the international trade in natural casings.

  11. Design of standard operating procedure production proceses (case study on the home industry Bedugul Baturiti Tabanan Bali)

    Science.gov (United States)

    Kasiani; Suhantono, Djoko; Mirah Kencanawati, AAA

    2018-01-01

    Candikuning is part of the district of Baturiti, tourism village, better known by the name of Bedugul. No less interesting is the variety of chips produced by two partner groups as a souvenir after the tour, such as Chips: Spinach; beans; Tempeh. The purpose of this research were to design a Standard Operating Procedure (SOP): Production Processes on the Home Industry Bedugul Baturiti Tabanan Bali. The data technic collected use: observation; Documentation; and then interview to collect information. The data analysis technic done by using the Miles & Huberman. Result this research that the draft SOP: Production Processes Chips (Menu). The conclusion in this research SOP Production Processes use with flowchart and description on the Home Industry Bedugul Baturiti Tabanan Bali.

  12. Assessment of macrofungal diversity in a Silver Fir plantation in Sardinia (Italy using a standardized sampling procedure

    Directory of Open Access Journals (Sweden)

    Elia Ambrosio

    2015-12-01

    Full Text Available The knowledge of macrofungal diversity associated with Silver Fir forests in Italy is quite scarce. Only a little information is available about macrofungal communities from some Ligurian and Tuscan Silver Fir sites. This study aims to assess the macrofungal diversity of a Silver Fir plantation in Sardinia by the application of a standardized sampling procedure. A total of 606 sporomata were collected and 52 Basidiomycota were identified. The high value of the Shannon Index indicated a considerable level of macrofungal diversity in this plantation. The results were also compared with the diversity indices obtained by a previous 3-years long sampling methodology in the same site. The comparison of the macrofungal diversity values of the Sardinian site with those of the Ligurian Silver Fir forest revealed interesting similarities among natural versus planted coniferous forests.

  13. Standardization of digestion procedure for the determination of heavy metals in biological materials by atomic absorption spectrometry

    International Nuclear Information System (INIS)

    Khalid, N.; Chaudhri, S.A.

    1999-01-01

    Proper decomposition of the sample is one of the basic requirements of the atomic absorption spectroscopic analysis. In the present studies, heavy metals (Cu, Fe, Mn and Zn) were determined in biological samples by designating them in a mixture of nitric acid and perchloric acid. The quantification was made with atomic absorption spectrometry using an air-acetylene flame. The reliability of the procedure used was checked by analysing standard reference materials from NBS and IAEA, such as Rice flour (NBS-SRM-1568), Horse Kidney (IAEA H-8), Mixed Human diet(IAEA H-9), Copepod (IAEA MA-A-1) and fish flesh (IAEA MA-A-2) under identical conditions. A good agreement was observed between determined and the certified values reported by NBS and IAEA. (author)

  14. Standard operating procedures for pre-analytical handling of blood and urine for metabolomic studies and biobanks

    International Nuclear Information System (INIS)

    Bernini, Patrizia; Bertini, Ivano; Luchinat, Claudio; Nincheri, Paola; Staderini, Samuele; Turano, Paola

    2011-01-01

    1 H NMR metabolic profiling of urine, serum and plasma has been used to monitor the impact of the pre-analytical steps on the sample quality and stability in order to propose standard operating procedures (SOPs) for deposition in biobanks. We analyzed the quality of serum and plasma samples as a function of the elapsed time (t = 0−4 h) between blood collection and processing and of the time from processing to freezing (up to 24 h). The stability of the urine metabolic profile over time (up to 24 h) at various storage temperatures was monitored as a function of the different pre-analytical treatments like pre-storage centrifugation, filtration, and addition of the bacteriostatic preservative sodium azide. Appreciable changes in the profiles, reflecting changes in the concentration of a number of metabolites, were detected and discussed in terms of chemical and enzymatic reactions for both blood and urine samples. Appropriate procedures for blood derivatives collection and urine preservation/storage that allow maintaining as much as possible the original metabolic profile of the fresh samples emerge, and are proposed as SOPs for biobanking.

  15. Standard operating procedures for pre-analytical handling of blood and urine for metabolomic studies and biobanks

    Energy Technology Data Exchange (ETDEWEB)

    Bernini, Patrizia; Bertini, Ivano, E-mail: bertini@cerm.unifi.it; Luchinat, Claudio [University of Florence, Magnetic Resonance Center (CERM) (Italy); Nincheri, Paola; Staderini, Samuele [FiorGen Foundation (Italy); Turano, Paola [University of Florence, Magnetic Resonance Center (CERM) (Italy)

    2011-04-15

    {sup 1}H NMR metabolic profiling of urine, serum and plasma has been used to monitor the impact of the pre-analytical steps on the sample quality and stability in order to propose standard operating procedures (SOPs) for deposition in biobanks. We analyzed the quality of serum and plasma samples as a function of the elapsed time (t = 0-4 h) between blood collection and processing and of the time from processing to freezing (up to 24 h). The stability of the urine metabolic profile over time (up to 24 h) at various storage temperatures was monitored as a function of the different pre-analytical treatments like pre-storage centrifugation, filtration, and addition of the bacteriostatic preservative sodium azide. Appreciable changes in the profiles, reflecting changes in the concentration of a number of metabolites, were detected and discussed in terms of chemical and enzymatic reactions for both blood and urine samples. Appropriate procedures for blood derivatives collection and urine preservation/storage that allow maintaining as much as possible the original metabolic profile of the fresh samples emerge, and are proposed as SOPs for biobanking.

  16. Revisiting olfactory classical conditioning of the proboscis extension response in honey bees: a step toward standardized procedures.

    Science.gov (United States)

    Matsumoto, Yukihisa; Menzel, Randolf; Sandoz, Jean-Christophe; Giurfa, Martin

    2012-10-15

    The honey bee Apis mellifera has emerged as a robust and influential model for the study of classical conditioning thanks to the existence of a powerful Pavlovian conditioning protocol, the olfactory conditioning of the proboscis extension response (PER). In 2011, the olfactory PER conditioning protocol celebrated its 50 years since it was first introduced by Kimihisa Takeda in 1961. In this protocol, individually harnessed honey bees are trained to associate an odor with sucrose solution. The resulting olfactory learning is fast and induces robust olfactory memories that have been characterized at the behavioral, neuronal and molecular levels. Despite the success of this protocol for studying the bases of learning and memory at these different levels, innumerable procedural variants have arisen throughout the years, which render comparative analyses of behavioral performances difficult. Moreover, because even slight variations in conditioning procedures may introduce significant differences in acquisition and retention performances, we revisit olfactory PER conditioning and define here a standardized framework for experiments using this behavioral protocol. To this end, we present and discuss all the methodological steps and details necessary for successful implementation of olfactory PER conditioning. Copyright © 2012 Elsevier B.V. All rights reserved.

  17. The development of standard samples with a defined number of antigen-specific T cells to harmonize T cell assays: a proof-of-principle study.

    Science.gov (United States)

    Singh, Satwinder Kaur; Tummers, Bart; Schumacher, Ton N; Gomez, Raquel; Franken, Kees L M C; Verdegaal, Els M; Laske, Karoline; Gouttefangeas, Cécile; Ottensmeier, Christian; Welters, Marij J P; Britten, Cedrik M; van der Burg, Sjoerd H

    2013-03-01

    The validation of assays that quantify antigen-specific T cell responses is critically dependent on cell samples that contain clearly defined measurable numbers of antigen-specific T cells. An important requirement is that such cell samples are handled and analyzed in a comparable fashion to peripheral blood mononuclear cells (PBMC). We performed a proof-of-principle study to show that retrovirally TCR-transduced T cells spiked at defined numbers in autologous PBMC can be used as standard samples for HLA/peptide multimer staining. NY-ESO-1157-165-specific, TCR-transduced CD8+ T cell batches were successfully generated from PBMC of several HLA-A*0201 healthy donors, purified by magnetic cell sorting on the basis of HLA tetramer (TM) staining and expanded with specific antigen in vitro. When subsequently spiked into autologous PBMC, the detection of these CD3+CD8+TM+ T cells was highly accurate with a mean accuracy of 91.6 %. The standard cells can be preserved for a substantial period of time in liquid nitrogen. Furthermore, TM staining of fresh and cryopreserved standard samples diluted at decreasing concentrations into autologous cryopreserved unspiked PBMC revealed that the spiked CD3+CD8+TM+ T cells could be accurately detected at all dilutions in a linear fashion with a goodness-of-fit of over 0.99 at a frequency of at least 0.02 % among the CD3+CD8+ T cell population. Notably, the CD3+CD8+TM+ cells of the standard samples were located exactly within the gates used to analyze patient samples and displayed a similar scatter pattern. The performance of the cryopreserved standard samples in the hands of 5 external investigators was good with an inter-laboratory variation of 32.9 % and the doubtless identification of one outlier.

  18. Random assay in radioimmunoassay: Feasibility and application compared with batch assay

    International Nuclear Information System (INIS)

    Lee, Jung Min; Lee, Hwan Hee; Park, Sohyun; Kim, Tae Sung; Kim, Seok Ki

    2016-01-01

    The batch assay has been conventionally used for radioimmunoassay (RIA) because of its technical robustness and practical convenience. However, it has limitations in terms of the relative lag of report time due to the necessity of multiple assays in a small number of samples compared with the random assay technique. In this study, we aimed to verify whether the random assay technique can be applied in RIA and is feasible in daily practice. The coefficients of variation (CVs) of eight standard curves within a single kit were calculated in a CA-125 immunoradiometric assay (IRMA) for the reference of the practically ideal CV of the CA-125 kit. Ten standard curves of 10 kits from 2 prospectively collected lots (pLot) and 85 standard curves of 85 kits from 3 retrospectively collected lots (Lot) were obtained. Additionally, the raw measurement data of both 170 control references and 1123 patients' sera were collected retrospectively between December 2015 and January 2016. A standard curve of the first kit of each lot was used as a master standard curve for a random assay. The CVs of inter-kits were analyzed in each lot, respectively. All raw measurements were normalized by decay and radioactivity. The CA-125 values from control samples and patients' sera were compared using the original batch assay and random assay. In standard curve analysis, the CVs of inter-kits in pLots and Lots were comparable to those within a single kit. The CVs from the random assay with normalization were similar to those from the batch assay in the control samples (CVs % of low/high concentration; Lot1 2.71/1.91, Lot2 2.35/1.83, Lot3 2.83/2.08 vs. Lot1 2.05/1.21, Lot2 1.66/1.48, Lot3 2.41/2.14). The ICCs between the batch assay and random assay using patients' sera were satisfactory (Lot1 1.00, Lot2 0.999, Lot3 1.00). The random assay technique could be successfully applied to the conventional CA-125 IRMA kits. The random assay showed strong agreement with the batch assay. The

  19. Random assay in radioimmunoassay: Feasibility and application compared with batch assay

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Min; Lee, Hwan Hee; Park, Sohyun; Kim, Tae Sung; Kim, Seok Ki [Dept. of Nuclear MedicineNational Cancer Center, Goyang (Korea, Republic of)

    2016-12-15

    The batch assay has been conventionally used for radioimmunoassay (RIA) because of its technical robustness and practical convenience. However, it has limitations in terms of the relative lag of report time due to the necessity of multiple assays in a small number of samples compared with the random assay technique. In this study, we aimed to verify whether the random assay technique can be applied in RIA and is feasible in daily practice. The coefficients of variation (CVs) of eight standard curves within a single kit were calculated in a CA-125 immunoradiometric assay (IRMA) for the reference of the practically ideal CV of the CA-125 kit. Ten standard curves of 10 kits from 2 prospectively collected lots (pLot) and 85 standard curves of 85 kits from 3 retrospectively collected lots (Lot) were obtained. Additionally, the raw measurement data of both 170 control references and 1123 patients' sera were collected retrospectively between December 2015 and January 2016. A standard curve of the first kit of each lot was used as a master standard curve for a random assay. The CVs of inter-kits were analyzed in each lot, respectively. All raw measurements were normalized by decay and radioactivity. The CA-125 values from control samples and patients' sera were compared using the original batch assay and random assay. In standard curve analysis, the CVs of inter-kits in pLots and Lots were comparable to those within a single kit. The CVs from the random assay with normalization were similar to those from the batch assay in the control samples (CVs % of low/high concentration; Lot1 2.71/1.91, Lot2 2.35/1.83, Lot3 2.83/2.08 vs. Lot1 2.05/1.21, Lot2 1.66/1.48, Lot3 2.41/2.14). The ICCs between the batch assay and random assay using patients' sera were satisfactory (Lot1 1.00, Lot2 0.999, Lot3 1.00). The random assay technique could be successfully applied to the conventional CA-125 IRMA kits. The random assay showed strong agreement with the batch assay. The

  20. Standard Operating Procedure

    National Research Council Canada - National Science Library

    1997-01-01

    ...) plastic collection bag system. Red blood cell concentrates stored at 4 C in the 800 ml primary plastic collection bag can be biochemically modified to increase the red cell 2,3 DPG and ATP levels...

  1. Design reinforced concrete structures: Differences in procedure, formula, and results between Eurocode 2 and British Standard 8110

    Science.gov (United States)

    Rahim, Mustaqqim Abdul; Ying, Lum Chui; Shahidan, Shahiron; Ghazaly, Zuhayr Md.; Anudai, Shamilah; Bawadi, Nor Faizah; Isa, Nur Fitriah; Hassan, Zulkarnain; Habulat, Afifuddin; Ismail, Zul-Atfi

    2017-09-01

    This research is mainly about comparisons of reinforced concrete structure design based on Eurocode 2 and British Standard 8110. The reinforcement concrete element is designed by referring Eurocode 2 (EN1992-1-1) and British Standard 8110 (BS8110-1:1997) for comparing purpose. The work examples of the structural elements has been done in this research to obtain the area of reinforcement required. The differences in procedure, formula and result of area of steel required for the elements based on both of the codes are compared and tabulated. In this research, there are five part of reinforced concrete structure elements are designed which are continuous beams, one way slabs, braced and short column, pile cap, and cantilever retaining wall. From the result acquired, it shows that area of reinforcement required based on EC 2 is lesser than BS 8110 and the dimension required based on BS8110 is larger than EC 2. Meanwhile, the design based on Eurocode 2 came out with more economical structural elements compare to BS 8110 as lesser steel and concrete volume required.

  2. Assessment of the standard forensic procedure for the evaluation of psychological injury in intimate-partner violence.

    Science.gov (United States)

    Fariña, Francisca; Arce, Ramón; Vilariño, Manuel; Novo, Mercedes

    2014-01-01

    In judicial terms, a victim refers to any person who has suffered injury arising from an action or omission of an action that constitutes an offence, and the burden of proof lies with the prosecution. A review of Spanish judicial judgements underscored that the lack of evidence of psychological injury in cases of intimate-partner violence (IPV) accounted for approximately 40% of acquittals. Thus, the Spanish standard of proof for the forensic evaluation of psychological injury i.e., the MMPI-2 and the unstructured interview were assessed in order to determine if they met the statutory requirement for the assessment of psychological injury and the differential diagnosis of feigning. The results of the comparison of 51 women victims of IPV with firm convictions against their aggressors, and 54 women mock victims of IPV showed that the F, K, Fb, Fp and Ds scales, and the F-K index discriminated significantly and with medium and large effect sizes, between adjudicated and mock victims. However, the results did not provide a valid decision criterion for forensic settings i.e., false negatives (identifying feigner as honest protocols) were not classified correctly. In conclusion, the standard forensic procedure for the evaluation of psychological injury in cases of IPV did not constitute valid proof for judges who acquitted defendants on the grounds of not proven due to the lack of evidence of psychological injury.

  3. Influence of oxygen on asexual blood cycle and susceptibility of Plasmodium falciparum to chloroquine: requirement of a standardized in vitro assay

    Directory of Open Access Journals (Sweden)

    Minodier Philippe

    2007-04-01

    Full Text Available Abstract Objective The main objective of this study was to assess the influence of gas mixtures on in vitro Plasmodium falciparum growth and 50% inhibitory concentration (IC50 for chloroquine. Methods The study was performed between February 2004 and December 2005. 136 Plasmodium falciparum isolates were used to evaluate gas mixtures effect on IC50 for chloroquine by isotopic microtest. The oxygen effect on asexual blood cycle of 3D7 and W2 clones was determined by thin blood smears examination and tritiated hypoxanthine uptake. Results From 5% O2 to 21% O2 conditions, no parasiticide effect of O2 concentration was observed in vitro on the clones 3D7 and W2. A parasitostatic effect was observed during the exposure of mature trophozoïtes and schizonts at 21% O2 with an increase in the length of schizogony. The chloroquine IC50 at 10% O2 were significantly higher than those at 21% O2, means of 173.5 nM and 121.5 nM respectively (p in vitro resistant to chloroquine (IC50 > 100 nM at 10% O2, 17 were sensitive to chloroquine (IC50 2. Conclusion Based on these results, laboratories should use the same gas mixture to realize isotopic microtest. Further studies on comparison of isotopic and non-isotopic assays are needed to establish a standardized in vitro assay protocol to survey malaria drug resistance.

  4. Raising the quality of rheumatology management recommendations: lessons from the EULAR process 10 years after provision of standard operating procedures.

    Science.gov (United States)

    Colebatch-Bourn, Alexandra N; Conaghan, Philip G; Arden, Nigel K; Cooper, Cyrus; Dougados, Maxime; Edwards, Christopher J

    2015-08-01

    To increase understanding of how to raise the quality of rheumatology guidelines by reviewing European League Against Rheumatism (EULAR) management recommendations, using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, 10 years after publication of the EULAR standardized operating procedures (SOP) for the production of recommendations. It was hoped that this work could help inform improvements in guideline development by other societies and organizations. The SOP were published in 2004 to ensure the quality of EULAR-endorsed recommendations. We reviewed 27 published EULAR recommendations for management using the AGREE II tool. This provides a framework to assess the quality of guidelines across six broad domains using 23 specific questions. Overall the EULAR recommendations reviewed have been performed to a high standard. There are particular strengths in the methodology and presentation of the guidelines; however, the results indicate areas for development in future recommendations: in particular, stakeholder involvement and applicability of the recommendations. Improvements in quality were evident in recent years, with patient representation in 9 of 15 (60.0%) recommendations published 2010-14 compared with 4 of 12 (33.3%) published 2000-09. In the last 10 years the overall quality of recommendations was good, with standards improving over the decade following publication of the SOP. However, this review process has identified potential areas for improvement, especially in patient representation and provision of implementation tools. The lessons from this work can be applied to the development of rheumatology guidelines by other societies and organizations. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  5. External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe.

    Science.gov (United States)

    Perich, C; Ricós, C; Alvarez, V; Biosca, C; Boned, B; Cava, F; Doménech, M V; Fernández-Calle, P; Fernández-Fernández, P; García-Lario, J V; Minchinela, J; Simón, M; Jansen, R

    2014-05-15

    Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. Imprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. Of the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. Results obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Comparison of Test Procedures and Energy Efficiency Criteria in Selected International Standards & Labeling Programs for Copy Machines, External Power Supplies, LED Displays, Residential Gas Cooktops and Televisions

    Energy Technology Data Exchange (ETDEWEB)

    Zheng, Nina [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Zhou, Nan [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fridley, David [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2012-03-01

    This report presents a technical review of international minimum energy performance standards (MEPS), voluntary and mandatory energy efficiency labels and test procedures for five products being considered for new or revised MEPS in China: copy machines, external power supply, LED displays, residential gas cooktops and flat-screen televisions. For each product, an overview of the scope of existing international standards and labeling programs, energy values and energy performance metrics and description and detailed summary table of criteria and procedures in major test standards are presented.

  7. Harmonization of immune biomarker assays for clinical studies.

    Science.gov (United States)

    van der Burg, Sjoerd H; Kalos, Michael; Gouttefangeas, Cécile; Janetzki, Sylvia; Ottensmeier, Christian; Welters, Marij J P; Romero, Pedro; Britten, Cedrik M; Hoos, Axel

    2011-11-09

    Assays that measure a patient's immune response play an increasingly important role in the development of immunotherapies. The inherent complexity of these assays and independent protocol development between laboratories result in high data variability and poor reproducibility. Quality control through harmonization--based on integration of laboratory-specific protocols with standard operating procedures and assay performance benchmarks--is one way to overcome these limitations. Harmonization guidelines can be widely implemented to address assay performance variables. This process enables objective interpretation and comparison of data across clinical trial sites and also facilitates the identification of relevant immune biomarkers, guiding the development of new therapies.

  8. Neutron interrogator assay system for the Idaho Chemical Processing Plant waste canisters and spent fuel: preliminary description and operating procedures manual

    International Nuclear Information System (INIS)

    Menlove, H.O.; Eccleston, G.; Close, D.A.; Speir, L.G.

    1978-05-01

    A neutron interrogation assay system is being designed for the measurement of waste canisters and spent fuel packages at the new Idaho Chemical Processing Plant to be operated by Allied Chemical Corp. The assay samples consist of both waste canisters from the fluorinel dissolution process and spent fuel assemblies. The assay system is a 252 Cf ''Shuffler'' that employs a cyclic sequence of fast-neutron interrogation with a 252 Cf source followed by delayed-neutron counting to determine the 235 U content

  9. Transfer of a two-tiered keratinocyte assay: IL-18 production by NCTC2544 to determine the skin sensitizing capacity and epidermal equivalent assay to determine sensitizer potency

    DEFF Research Database (Denmark)

    Teunis, Marc; Corsini, Emanuela; Smits, Mieke

    2013-01-01

    in a non-coded fashion. Here we describe the transferability to naïve laboratories, the establishment of the standard operating procedure, critical points, acceptance criteria and project management. Both assays were successfully transferred to laboratories that had not performed the assays previously...

  10. Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

    Science.gov (United States)

    Ravid, Rivka

    2008-06-01

    The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP's which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, "financial gain" and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

  11. Enumeration of heterotrophs, fecal coliforms and Escherichia coli in water: comparison of 3M Petrifilm plates with standard plating procedures.

    Science.gov (United States)

    Schraft, H; Watterworth, L A

    2005-03-01

    A total of 177 naturally contaminated water samples were analyzed by membrane filtration according to the Standard Methods for the Examination of Water and Wastewater published by the American Public Health Association. Filters were incubated in parallel on mHPC-agar and 3M Petrifilm Aerobic Count Plates (Petrifilm AC plates) for heterotrophic counts. Fecal coliforms and Escherichia coli were enumerated on mFC-agar and 3M Petrifilm E. coli/Coliform Count Plates (Petrifilm EC plates). Typical colonies on each media type were confirmed following standard procedures. Heterotrophic counts were between 10(3) and 10(4) CFU/mL and the average log10 counts obtained on Petrifilm AC plates were about two-fold lower than on mHPC-agar. Counts for fecal coliforms and E. coli were between 10(2) and 10(3) CFU/mL. Average log10 counts for confirmed fecal coliforms obtained on Petrifilm EC plates were slightly lower than on mFC agar with a correlation coefficient of 0.949. The average log10 counts for confirmed E. coli on Petrifilm EC plates and on mFC agar were statistically not different (P=0.126) with a correlation coefficient of 0.879. Specificity of Petrifilm EC plates and mFC agar was evaluated by comparing typical colony counts with confirmed counts. On mFC agar, counts for typical colonies were by 2 log10 CFU higher than the actual confirmed counts. In contrast, on Petrifilm EC plates typical colony counts were almost identical to confirmed colony counts for both fecal coliforms and E. coli. This comparison illustrates the high specificity of Petrifilm EC plates for enumeration of both fecal coliforms and E. coli in water.

  12. Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

    Science.gov (United States)

    Ravid, Rivka

    2008-09-01

    The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP's which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, "financial gain" and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

  13. Calibration of photon and beta ray sources used in brachytherapy. Guidelines on standardized procedures at Secondary Standards Dosimetry Laboratories (SSDLs) and hospitals

    International Nuclear Information System (INIS)

    2002-03-01

    It has generally been recognized that international harmonization in radiotherapy dosimetry is essential. Consequently, the IAEA has given much effort to this, for example by publishing a number of reports in the Technical Reports Series (TRS) for external beam dosimetry, most notably TRS-277 and more recently TRS-398. Both of these reports describe in detail the steps to be taken for absorbed dose determination in water and they are often referred to as 'dosimetry protocols'. Similar to TRS-277, it is expected that TRS-398 will be adopted or used as a model by a large number of countries as their national protocol. In 1996, the IAEA established a calibration service for low dose rate (LDR) 137 Cs brachytherapy sources, which is the most widely used source for treatment of gynecological cancer. To further enhance harmonization in brachytherapy dosimetry, the IAEA published in 1999 IAEA-TECDOC-1079 entitled 'Calibration of Brachytherapy Sources. Guidelines on Standardized Procedures for the Calibration of Brachytherapy Sources at Secondary Standard Dosimetry Laboratories (SSDLs) and Hospitals'. The report was well received and was distributed in a large number of copies to the members of the IAEA/WHO network of SSDLs and to medical physicists working with brachytherapy. The present report is an update of the aforementioned TECDOC. Whereas TECDOC-1079 described methods for calibrating brachytherapy sources with photon energies at or above those of 192 Ir, the current report has a wider scope in that it deals with standardization of calibration of all the most commonly used brachytherapy sources, including both photon and beta emitting sources. The latter sources have been in use for a few decades already, but their calibration methods have been unclear. Methods are also described for calibrating sources used in the rapidly growing field of cardiovascular angioplasty. In this application, irradiation of the vessel wall is done in an attempt to prevent restenosis after

  14. Evaluasi Penerapan Standard Operating Procedure-Good Agriculture Practice (SOP-GAP pada Usahatani Padi Organik di Kabupaten Bantul

    Directory of Open Access Journals (Sweden)

    Sriyadi Sriyadi

    2016-02-01

    Full Text Available Food security has meaning not only the availability of adequate food, but also providing security for producers and consumers and ensuring environmental sustainability for sustainable production. Organic farming systems are expected to solve the problem for realizing food security and enhancement of people's welfare. The results of research indicated that, (1 The implementation level of Standard Operating Procedure-Good Agriculture Practice (SOP-GAP of Organic Rice Farming in Bantul district was quite high, (2 The implementation level of SOP-GAP of Organic Rice Farming related to the availability of capital, the selling price and the purchase price of inputs (seeds and fertilizers, (3 The level of the farmer's decision related to the implementation level of SOP-GAP of organic rice farming, and (4 development of organic rice farming required availability of sufficient capital. In this regard the government, particularly the agriculture authority and food security agency need to disburse or facilitate capital for farmers in revolving as well as low interest loans.

  15. Standard operating procedure for air quality stationary source management at Air Force installations in the Air Force Materiel Command

    Energy Technology Data Exchange (ETDEWEB)

    Powell, C.M.; Ryckman, S.J. [Headquarters Air Force Materiel Command, Wright-Patterson AFB, OH (United States). Environmental Compliance Branch

    1997-12-31

    To sustain compliance and avoid future enforcement actions associated with air quality stationary sources and to provide installation commanders with a certification process for Title V permitting, and Air Force Materiel Command (AFMC) Standard Operating Procedure (SOP) for Stationary Source Management has been developed. The SOP consists of two major sections: Stationary Source Planning and Administration, and Stationary Source Operations These two main sections are further subdivided into twelve subsections which delineate requirements (e.g. maintaining inventories, applying for and maintaining permits, keeping records, reporting and certifying compliance) and assign ownership of processes and responsibilities (e.g. appointing a manager/alternate for each identified stationary air source). In addition, the SOP suggests training that should be provided from operator to commander levels to ensure that all personnel involved with a stationary air source are aware of their responsibilities. Implementation of the SOP should provide for the essential control necessary for installation commanders to eliminate stationary air source non-compliance and to certify compliance in accordance with the Title V Operating Permit requirements. This paper will discuss: the background and purpose for the SOPs content, the twelve subsections of the SOP, the success of implementation at various installations, the relevance or the recommended training, the success of negotiating with various labor unions for SOP implementation and the success of the SOP in reference to its intended purpose.

  16. Test Standard Revision Update: JESD57, "Procedures for the Measurement of Single-Event Effects in Semiconductor Devices from Heavy-Ion Irradiation"

    Science.gov (United States)

    Lauenstein, Jean-Marie

    2015-01-01

    The JEDEC JESD57 test standard, Procedures for the Measurement of Single-Event Effects in Semiconductor Devices from Heavy-Ion Irradiation, is undergoing its first revision since 1996. In this talk, we place this test standard into context with other relevant radiation test standards to show its importance for single-event effect radiation testing for space applications. We show the range of industry, government, and end-user party involvement in the revision. Finally, we highlight some of the key changes being made and discuss the trade-space in which setting standards must be made to be both useful and broadly adopted.

  17. Final Rule for Control of Air Pollution from Aircraft and Aircraft Engines: Emission Standards and Test Procedures

    Science.gov (United States)

    EPA is amending the existing emission standards for oxides of nitrogen (NOx) for new commercial aircraft engines. These standards are equivalent to the NOx emission standards of the United Nations International Civil Aviation Organization (ICAO).

  18. Direct Final Rule for Control of Air Pollution From Aircraft and Aircraft Engines; Emission Standards and Test Procedures

    Science.gov (United States)

    This rule will adopt the current voluntary NOx and CO emissions standards of the United Nations International Civil Aviation Organization (ICAO), bringing the United States aircraft standards into alignment with the international standards.

  19. Development and operation of a quality assurance system for deviations from standard operating procedures in a clinical cell therapy laboratory.

    Science.gov (United States)

    McKenna, D; Kadidlo, D; Sumstad, D; McCullough, J

    2003-01-01

    Errors and accidents, or deviations from standard operating procedures, other policy, or regulations must be documented and reviewed, with corrective actions taken to assure quality performance in a cellular therapy laboratory. Though expectations and guidance for deviation management exist, a description of the framework for the development of such a program is lacking in the literature. Here we describe our deviation management program, which uses a Microsoft Access database and Microsoft Excel to analyze deviations and notable events, facilitating quality assurance (QA) functions and ongoing process improvement. Data is stored in a Microsoft Access database with an assignment to one of six deviation type categories. Deviation events are evaluated for potential impact on patient and product, and impact scores for each are determined using a 0- 4 grading scale. An immediate investigation occurs, and corrective actions are taken to prevent future similar events from taking place. Additionally, deviation data is collectively analyzed on a quarterly basis using Microsoft Excel, to identify recurring events or developing trends. Between January 1, 2001 and December 31, 2001 over 2500 products were processed at our laboratory. During this time period, 335 deviations and notable events occurred, affecting 385 products and/or patients. Deviations within the 'technical error' category were most common (37%). Thirteen percent of deviations had a patient and/or a product impact score > or = 2, a score indicating, at a minimum, potentially affected patient outcome or moderate effect upon product quality. Real-time analysis and quarterly review of deviations using our deviation management program allows for identification and correction of deviations. Monitoring of deviation trends allows for process improvement and overall successful functioning of the QA program in the cell therapy laboratory. Our deviation management program could serve as a model for other laboratories in

  20. PFGE standard operating procedures for Listeria monocytogenes: harmonizing the typing of food and clinical strains in Europe.

    Science.gov (United States)

    Michelon, Damien; Félix, Benjamin; Vingadassalon, Noemie; Mariet, Jean-François; Larsson, Jonas T; Møller-Nielsen, Eva; Roussel, Sophie

    2015-03-01

    Listeria monocytogenes is a foodborne pathogen responsible for a severe disease known as listeriosis. The European Centre for Disease Prevention and Control (ECDC) coordinates a network of national public health laboratories (NPHLs) in charge of typing clinical strains. In food, it is the European Union Reference Laboratory for L. monocytogenes (EURL Lm), which manages a network of National Reference Laboratories (NRLs). A pulsed-field gel electrophoresis (PFGE) standard operating procedure (EURL SOP) has been used routinely at the EURL Lm since 2007. The EURL Lm has recommended that NRLs use the EURL SOP, whereas the Statens Serum Institut (SSI), under contract for ECDC, requested that NPHLs use Halpins' SOP (HSOP) published in 2010 for the PulseNet USA network. An update of Halpins' SOP (uHSOP) was published in 2013. To facilitate the exchange of profiles among human and food European reference laboratories, it is crucial to ensure that the PFGE profiles obtained with these different SOPs are comparable. The aim here was to compare the EURL SOP with HSOP and uHSOP. The panel comprised 114 well-characterized SSI/EURL strains. All were characterized at the EURL using both the EURL SOP and uHSOP. Seventy of the 114 strains were also characterized at the SSI using HSOP. The EURL SOP and uHSOP produced indistinguishable combined (ApaI/AscI) profiles for the 114 strains tested. The EURL SOP and HSOP produced indistinguishable combined profiles for 69 of the 70 strains tested. One strain displayed for the AscI profile an additional low-intensity band at 184 kbp with HSOP. For this strain, SSI and EUR Lm had already observed the same profile from NPHLs and NRLs. However, this deviation is minor as it accounted for about 1% of all the 114 combined profiles. This study should facilitate the exchange of reproducible PFGE profiles among human and food reference laboratories.

  1. Quantitative monitoring of HCMV DNAlactia in human milk by real time PCR assay: Implementation of internal control contributes to standardization and quality control.

    Science.gov (United States)

    Hartleif, Steffen; Göhring, Katharina; Goelz, Rangmar; Jahn, Gerhard; Hamprecht, Klaus

    2016-11-01

    For cytomegalovirus screening of breastfeeding mothers of preterm infants under risk, we present a rapid, quantitative real-time PCR protocol using the hybridization format of the viral gB target region. For quantification, we used an external gB fragment cloned into a vector system. For standardization, we created an internal control-plasmid by site-directed mutagenesis with an exchange of 9 nucleotides. Spiked with internal control, patient wildtype amplicons could be discriminated from internal controls by hybridization probes using two-channel fluorescence detection. Potential bias of formerly reported false nucleotide sequence data of gB-hybridization probes was excluded. Using this approach, we could demonstrate excellent analytical performance and high reproducibility of HCMV detection during lactation. This assay shows very good correlation with a commercial quantitative HCMV DNA PCR and may help to identify rapidly HCMV shedding mothers of very low birth weight preterm infants to prevent HCMV transmission. On the other hand, negative DNA amplification results allow feeding of milk samples of seropositive mothers to their preterm infants under risk (<30 weeks of gestational age, <1000g birth weight) during the onset and late stage of HCMV shedding during lactation. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. [Falling Short of Minimum Volume Standards, Exemptions and Their Consequences from 2018 Onwards. Complex Procedures on Oesophagus and Pancreas in German Hospitals from 2006 to 2014].

    Science.gov (United States)

    de Cruppé, Werner; Geraedts, Max

    2018-03-16

    The minimum volume standards for hospitals in Germany, in force since 2004, provide four exemptions for non-complying hospitals. This study investigates the extent and importance of these exemptions for complex procedures on the oesophagus and pancreas for all non-complying hospitals and for the revised minimum volume regulations in force since the beginning of 2018. Longitudinal, descriptive analyses of data on minimum volume standards and their exemptions for complex procedures on the oesophagus and pancreas, as presented by the hospital quality report cards of the reporting years from 2006 to 2014. For each year and both procedures, about 120 hospitals with some 500 cases report non-compliance with the minimum volume standards. Of these a third report no exemptions (with 180 procedures), a third state emergencies (110), and another third report exemptions due to internal hospital restructuring (210). Ensuring geographical access to care as an exemption is of no importance. After the three year exemption period for installation of a new service line, 20% of the hospitals with procedures on the oesophagus and 30% on the pancreas complied with the minimum volume standards. After the two-year period for staff realignment, the figures were 40 and 50%, respectively. Exemptions do not entirely explain all procedures performed by hospitals not complying with the minimum volume standards. The revised minimum volume regulations' restructuring of exemptions to "emergencies" and "new or renewed service lines" with a two year exemption period, are concordant with the empirical findings of this study. Georg Thieme Verlag KG Stuttgart · New York.

  3. The tsunami probabilistic risk assessment (PRA). Example of accident sequence analysis of tsunami PRA according to the standard for procedure of tsunami PRA for nuclear power plants

    International Nuclear Information System (INIS)

    Ohara, Norihiro; Hasegawa, Keiko; Kuroiwa, Katsuya

    2013-01-01

    After the Fukushima Daiichi nuclear power plant (NPP) accident, standard for procedure of tsunami PRA for NPP had been established by the Standardization Committee of AESJ. Industry group had been conducting analysis of Tsunami PRA for PWR based on the standard under the cooperation with electric utilities. This article introduced overview of the standard and examples of accident sequence analysis of Tsunami PRA studied by the industry group according to the standard. The standard consisted of (1) investigation of NPP's composition, characteristics and site information, (2) selection of relevant components for Tsunami PRA and initiating events and identification of accident sequence, (3) evaluation of Tsunami hazards, (4) fragility evaluation of building and components and (5) evaluation of accident sequence. Based on the evaluation, countermeasures for further improvement of safety against Tsunami could be identified by the sensitivity analysis. (T. Tanaka)

  4. Detection of Salmonella enterica serovar Enteritidis using real time PCR, immunocapture assay, PNA FISH and standard culture methods in different types of food samples.

    Science.gov (United States)

    Almeida, C; Cerqueira, L; Azevedo, N F; Vieira, M J

    2013-01-15

    Several methods for the rapid and specific detection of Salmonella in food samples have been described. Here, we compare 4 of those methods in terms of assay time, procedure complexity, detection limit, sensitivity, specificity and accuracy. Milk, eggs and mayonnaise samples were artificially contaminated with Salmonella enterica serovar Enteritidis cell concentrations ranging from 1×10(-2) to 1×10(2) CFU per 25 g or ml of food. Samples were then pre-enriched and analyzed by either: i) real-time PCR, using the iQ-Check Salmonella kit; ii) immunocapture, using the RapidChek SELECT Salmonella; iii) a peptide nucleic acid fluorescence in situ hybridization (PNA FISH) method and iv) the traditional bacteriological method ISO 6579:2002. All methods were able to detect Salmonella in the different types of food matrixes and presented a similar detection level of 1CFU per 25 g or ml of food sample. The immunocapture and the PNA FISH methods proved to be very reliable, as their results were 100% in agreement with the ISO method. However, real-time PCR presented a significant number of false positives, which resulted in a specificity of 55.6% (CI 95%, 31.3-77.6) and an accuracy of 82.2% (CI 95%, 63.2-91.4) for this method. Sensitivity was 100% since no false negative results were observed. In conclusion, the implementation of these molecular techniques, mainly the immunocapture and PNA-FISH methods, provides a reliable and less time-consuming alternative for the detection of Salmonella spp. in food samples. Copyright © 2012 Elsevier B.V. All rights reserved.

  5. U.S. Geological Survey Noble Gas Laboratory’s standard operating procedures for the measurement of dissolved gas in water samples

    Science.gov (United States)

    Hunt, Andrew G.

    2015-08-12

    This report addresses the standard operating procedures used by the U.S. Geological Survey’s Noble Gas Laboratory in Denver, Colorado, U.S.A., for the measurement of dissolved gases (methane, nitrogen, oxygen, and carbon dioxide) and noble gas isotopes (helium-3, helium-4, neon-20, neon-21, neon-22, argon-36, argon-38, argon-40, kryton-84, krypton-86, xenon-103, and xenon-132) dissolved in water. A synopsis of the instrumentation used, procedures followed, calibration practices, standards used, and a quality assurance and quality control program is presented. The report outlines the day-to-day operation of the Residual Gas Analyzer Model 200, Mass Analyzer Products Model 215–50, and ultralow vacuum extraction line along with the sample handling procedures, noble gas extraction and purification, instrument measurement procedures, instrumental data acquisition, and calculations for the conversion of raw data from the mass spectrometer into noble gas concentrations per unit mass of water analyzed. Techniques for the preparation of artificial dissolved gas standards are detailed and coupled to a quality assurance and quality control program to present the accuracy of the procedures used in the laboratory.

  6. Standardization and validation of real time PCR assays for the diagnosis of histoplasmosis using three molecular targets in an animal model.

    Directory of Open Access Journals (Sweden)

    Luisa F López

    Full Text Available Histoplasmosis is considered one of the most important endemic and systemic mycoses worldwide. Until now few molecular techniques have been developed for its diagnosis. The aim of this study was to develop and evaluate three real time PCR (qPCR protocols for different protein-coding genes (100-kDa, H and M antigens using an animal model. Fresh and formalin-fixed and paraffin-embedded (FFPE lung tissues from BALB/c mice inoculated i.n. with 2.5x106 Histoplasma capsulatum yeast or PBS were obtained at 1, 2, 3, 4, 8, 12 and 16 weeks post-infection. A collection of DNA from cultures representing different clades of H. capsulatum (30 strains and other medically relevant pathogens (36 strains of related fungi and Mycobacterium tuberculosis were used to analyze sensitivity and specificity. Analytical sensitivity and specificity were 100% when DNAs from the different strains were tested. The highest fungal burden occurred at first week post-infection and complete fungal clearance was observed after the third week; similar results were obtained when the presence of H. capsulatum yeast cells was demonstrated in histopathological analysis. In the first week post-infection, all fresh and FFPE lung tissues from H. capsulatum-infected animals were positive for the qPCR protocols tested except for the M antigen protocol, which gave variable results when fresh lung tissue samples were analyzed. In the second week, all qPCR protocols showed variable results for both fresh and FFPE tissues. Samples from the infected mice at the remaining times post-infection and uninfected mice (controls were negative for all protocols. Good agreement was observed between CFUs, histopathological analysis and qPCR results for the 100-kDa and H antigen protocols. We successfully standardized and validated three qPCR assays for detecting H. capsulatum DNA in fresh and FFPE tissues, and conclude that the 100-kDa and H antigen molecular assays are promising tests for diagnosing this

  7. Standardization and validation of real time PCR assays for the diagnosis of histoplasmosis using three molecular targets in an animal model.

    Science.gov (United States)

    López, Luisa F; Muñoz, César O; Cáceres, Diego H; Tobón, Ángela M; Loparev, Vladimir; Clay, Oliver; Chiller, Tom; Litvintseva, Anastasia; Gade, Lalitha; González, Ángel; Gómez, Beatriz L

    2017-01-01

    Histoplasmosis is considered one of the most important endemic and systemic mycoses worldwide. Until now few molecular techniques have been developed for its diagnosis. The aim of this study was to develop and evaluate three real time PCR (qPCR) protocols for different protein-coding genes (100-kDa, H and M antigens) using an animal model. Fresh and formalin-fixed and paraffin-embedded (FFPE) lung tissues from BALB/c mice inoculated i.n. with 2.5x106 Histoplasma capsulatum yeast or PBS were obtained at 1, 2, 3, 4, 8, 12 and 16 weeks post-infection. A collection of DNA from cultures representing different clades of H. capsulatum (30 strains) and other medically relevant pathogens (36 strains of related fungi and Mycobacterium tuberculosis) were used to analyze sensitivity and specificity. Analytical sensitivity and specificity were 100% when DNAs from the different strains were tested. The highest fungal burden occurred at first week post-infection and complete fungal clearance was observed after the third week; similar results were obtained when the presence of H. capsulatum yeast cells was demonstrated in histopathological analysis. In the first week post-infection, all fresh and FFPE lung tissues from H. capsulatum-infected animals were positive for the qPCR protocols tested except for the M antigen protocol, which gave variable results when fresh lung tissue samples were analyzed. In the second week, all qPCR protocols showed variable results for both fresh and FFPE tissues. Samples from the infected mice at the remaining times post-infection and uninfected mice (controls) were negative for all protocols. Good agreement was observed between CFUs, histopathological analysis and qPCR results for the 100-kDa and H antigen protocols. We successfully standardized and validated three qPCR assays for detecting H. capsulatum DNA in fresh and FFPE tissues, and conclude that the 100-kDa and H antigen molecular assays are promising tests for diagnosing this mycosis.

  8. Random access procedures and radio access network (RAN) overload control in standard and advanced long-term evolution (LTE and LTE-A) networks

    DEFF Research Database (Denmark)

    Kiilerich Pratas, Nuno; Thomsen, Henning; Popovski, Petar

    2015-01-01

    In this chapter, we describe and discuss the current LTE random access procedure and the Radio Access Network Load Control solution within LTE/LTE-A. We provide an overview of the several considered load control solutions and give a detailed description of the standardized Extended Access Class B...

  9. Diagnosis and dosimetry of exposure to sulfur mustard: Development of a standard operating procedure for hemoglobin adducts: Exploratory research on albumin and keratin adducts

    NARCIS (Netherlands)

    Noort, D.; Fidder, A.; Jong, L.P.A. de; Schans, G.P. van der; Benschop, H.P.

    2000-01-01

    A standard operating procedure (SOP) for determination of the sulfur mustard adduct to the N-terminal valine in hemoglobin was developed. By using this SOP, it was found that the Nterminal valine adduct in globin of hairless guinea pigs and marmosets which had been exposed to sulfur mustard (0.5

  10. An umbrella protocol for standardized data collection (SDC) in rectal cancer: a prospective uniform naming and procedure convention to support personalized medicine.

    Science.gov (United States)

    Meldolesi, Elisa; van Soest, Johan; Dinapoli, Nicola; Dekker, Andre; Damiani, Andrea; Gambacorta, Maria Antonietta; Valentini, Vincenzo

    2014-07-01

    Predictive models allow treating physicians to deliver tailored treatment moving from prescription by consensus to prescription by numbers. The main features of an umbrella protocol for standardizing data and procedures to create a consistent dataset useful to obtain a trustful analysis for a Decision Support System for rectal cancer are reported. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  11. Diagnosis and dosimetry of exposure to sulfur mustard: Development of a standard operating procedure for mass spectrometric analysis of haemoglobin adducts - Exploratory research on albumin and keratin adducts

    NARCIS (Netherlands)

    Noort, D.; Fidder, A.; Hulst, A.G.; Jong, L.P.A. de; Benschop, H.P.

    2000-01-01

    Experiments were carried out to develop a standard operating procedure for analysis of sulfur mustard adducts to the N-terminal valine in haemoglobin and to explore adduct formation with albumin and keratin. In the first approach, gas chromatography-negative chemical ionization/mass spectrometry

  12. A Guide for Developing Standard Operating Job Procedures for the Activated Sludge - Aeration & Sedimentation Process Wastewater Treatment Facility. SOJP No. 5.

    Science.gov (United States)

    Mason, George J.

    This guide for developing standard operating job procedures for wastewater treatment facilities is devoted to the activated sludge aeration and sedimentation process. This process is for conversion of nonsettleable and nonfloatable materials in wastewater to settleable, floculated biological groups and separation of the settleable solids from the…

  13. Transfer of near-infrared calibration model for determining fiber content in flax: effects of transfer samples and standardization procedure.

    Science.gov (United States)

    Sohn, Miryeong; Barton, Franklin E; Himmelsbach, David S

    2007-04-01

    The transfer of a calibration model for determining fiber content in flax stem was accomplished between two near-infrared spectrometers, which are the same brand but which require a standardization. In this paper, three factors, including transfer sample set, spectral type, and standardization method, were investigated to obtain the best standardization result. Twelve standardization files were produced from two sets of the transfer sample (sealed reference standards and a subset of the prediction set), two types of the transfer sample spectra (raw and preprocessed spectra), and three standardization methods (direct standardization (DS), piecewise direct standardization (PDS), and double window piecewise direct standardization (DWPDS)). The efficacy of the model transfer was evaluated based on the root mean square error of prediction, calculated using the independent prediction samples. Results indicated that the standardization using the sealed reference standards was unacceptable, but the standardization using the prediction subset was adequate. The use of the preprocessed spectra of the transfer samples led to the calibration transfers that were successful, especially for the PDS and the DWPDS correction. Finally, standardization using the prediction subset and their preprocessed spectra with DWPDS correction proved to be the best method for transferring the model.

  14. 16 CFR 1616.35 - Use of alternate apparatus, procedures, or criteria for testing under the standard.

    Science.gov (United States)

    2010-01-01

    ... SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR... converter) initially introducing items subject to the Standard into commerce to group items into production units, and to test samples from each production unit. See 16 CFR 1616.4. The Standard prescribes an...

  15. 16 CFR 1615.35 - Use of alternate apparatus, procedures, or criteria for testing under the standard.

    Science.gov (United States)

    2010-01-01

    ... SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR... converter) initially introducing items subject to the Standard into commerce to group items into production units, and to test samples from each production unit. See 16 CFR 1615.4 (b), (c) and (d). The Standard...

  16. Enzyme assays.

    Science.gov (United States)

    Brodelius, P E

    1991-02-01

    The past year or so has seen the development of new enzyme assays, as well as the improvement of existing ones. Assays are becoming more rapid and sensitive as a result of modifications such as amplification of the enzyme product(s). Recombinant DNA technology is now being recognized as a particularly useful tool in the search for improved assay systems.

  17. PENYUSUNAN DRAFT STANDARD OPERATING PROCEDURE (SOP PENGOLAHAN KERIPIK PISANG (STUDI KASUS DI SALAH SATU INDUSTRI RUMAH TANGGA KERIPIK PISANG BANDAR LAMPUNG

    Directory of Open Access Journals (Sweden)

    Didit Haryanto

    2013-09-01

    Full Text Available Standard operating procedure (SOP is a procedure or steps which is standardized and must be passed to complete a particular work process. Arranging SOP draft is based on a review of Good Manufacture Practice. SOP is made for being a guide line in doing process in an industry. Purposes of this research is arranging SOP draft for home industries of banana chips making, so the product will meet the standard. In this research, drafting standard operating procedure (SOP of the banana chips industry was begun with observating and recording every detail process. The research was conducted through four steps. Firstly, field observation to observate  process, including sanitation, tools specification, and description about step of processing banana chips. Second step was determining the critical point and optimating the condition. The next step was arranging the SOP draft. The last was the testing of SOP draft. Then the data were compared and discussed descriptively.  The result was a SOP draft which was used as in processing banana chips the products consistenly had meet the standard quality of SNI 01-4315-1996, they include moisture content, ash content, fat content, wholeness, with flavor, aroma, color, and texture.  The analysis data are, Moisture content (0,17%, ash content (1,35%, fat content (27,90% and wholeness (88,00%. Otherwise the data analysis for banana chips that produce without SOP are, moisture content (0,15%, ash content (1,88%, fat content (39,41% and wholeness (83,00%. Keywords: standard operating procedure (SOP, banana chips, consistency of quality

  18. 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.)

  19. Effective reduction of fluoroscopy duration by using an advanced electroanatomic-mapping system and a standardized procedural protocol for ablation of atrial fibrillation: 'the unleaded study'.

    Science.gov (United States)

    Knecht, Sven; Sticherling, Christian; Reichlin, Tobias; Pavlovic, Nikola; Mühl, Aline; Schaer, Beat; Osswald, Stefan; Kühne, Michael

    2015-11-01

    It is recommended to keep exposure to ionizing radiation as low as reasonably achievable. The aim of this study was to determine whether fluoroscopy-free mapping and ablation using a standardized procedural protocol is feasible in patients undergoing pulmonary vein isolation (PVI). Sixty consecutive patients were analysed: Thirty consecutive patients undergoing PVI using Carto3 were treated using a standardized procedural fluoroscopy protocol with X-ray being disabled after transseptal puncture (Group 1) and compared with a set of previous 30 consecutive patients undergoing PVI without a specific recommendation regarding the use of fluoroscopy (Group 2). The main outcome measures were the feasibility of fluoroscopy-free mapping and ablation, total fluoroscopy time, total dose area product (DAP), and procedure time. Sixty patients (age 60 ± 10 years, 73% male, ejection fraction 0.55 ± 0.09, left atrium 42 ± 8 mm) were included. In Group 1, total fluoroscopy time was 4.2 (2.6-5.6) min and mapping and ablation during PVI without using fluoroscopy was feasible in 29 of 30 patients (97%). In Group 2, total fluoroscopy time was 9.3 (6.4-13.9) min (P fluoroscopy after transseptal puncture using a standardized procedural protocol is feasible in almost all patients and is associated with markedly decreased total fluoroscopy duration and DAP. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  20. Assessing the reliability of the borderline regression method as a standard setting procedure for objective structured clinical examination

    Directory of Open Access Journals (Sweden)

    Sara Mortaz Hejri

    2013-01-01

    Full Text Available Background: One of the methods used for standard setting is the borderline regression method (BRM. This study aims to assess the reliability of BRM when the pass-fail standard in an objective structured clinical examination (OSCE was calculated by averaging the BRM standards obtained for each station separately. Materials and Methods: In nine stations of the OSCE with direct observation the examiners gave each student a checklist score and a global score. Using a linear regression model for each station, we calculated the checklist score cut-off on the regression equation for the global scale cut-off set at 2. The OSCE pass-fail standard was defined as the average of all station′s standard. To determine the reliability, the root mean square error (RMSE was calculated. The R2 coefficient and the inter-grade discrimination were calculated to assess the quality of OSCE. Results: The mean total test score was 60.78. The OSCE pass-fail standard and its RMSE were 47.37 and 0.55, respectively. The R2 coefficients ranged from 0.44 to 0.79. The inter-grade discrimination score varied greatly among stations. Conclusion: The RMSE of the standard was very small indicating that BRM is a reliable method of setting standard for OSCE, which has the advantage of providing data for quality assurance.

  1. Controlling variation in the comet assay

    Directory of Open Access Journals (Sweden)

    Andrew Richard Collins

    2014-10-01

    Full Text Available Variability of the comet assay is a serious issue, whether it occurs from experiment to experiment in the same laboratory, or between different laboratories analysing identical samples. Do we have to live with high variability, just because the comet assay is a biological assay rather than analytical chemistry? Numerous attempts have been made to limit variability by standardising the assay protocol, and the critical steps in the assay have been identified; agarose concentration, duration of alkaline incubation, and electrophoresis conditions (time, temperature and voltage gradient are particularly important. Even when these are controlled, variation seems to be inevitable. It is helpful to include in experiments reference standards, i.e. cells with a known amount of specific damage to the DNA. They can be aliquots frozen from a single large batch of cells, either untreated (negative controls or treated with, for example, H2O2 or X-rays to induce strand breaks (positive control for the basic assay, or photosensitiser plus light to oxidise guanine (positive control for Fpg- or OGG1-sensitive sites. Reference standards are especially valuable when performing a series of experiments over a long period - for example, analysing samples of white blood cells from a large human biomonitoring trial - to check that the assay is performing consistently, and to identify anomalous results necessitating a repeat experiment. The reference values of tail intensity can also be used to iron out small variations occurring from day to day. We present examples of the use of reference standards in human trials, both within one laboratory and between different laboratories, and describe procedures that can be used to control variation.

  2. Comparison of Test Procedures and Energy Efficiency Criteria in Selected International Standards and Labeling Programs for Clothes Washers, Water Dispensers, Vending Machines and CFLs

    Energy Technology Data Exchange (ETDEWEB)

    Fridley, David; Zheng, Nina; Zhou, Nan

    2010-06-01

    Since the late 1970s, energy labeling programs and mandatory energy performance standards have been used in many different countries to improve the efficiency levels of major residential and commercial equipment. As more countries and regions launch programs covering a greater range of products that are traded worldwide, greater attention has been given to harmonizing the specific efficiency criteria in these programs and the test methods for measurements. For example, an international compact fluorescent light (CFL) harmonization initiative was launched in 2006 to focus on collaboration between Australia, China, Europe and North America. Given the long history of standards and labeling programs, most major energy-consuming residential appliances and commercial equipment are already covered under minimum energy performance standards (MEPS) and/or energy labels. For these products, such as clothes washers and CFLs, harmonization may still be possible when national MEPS or labeling thresholds are revised. Greater opportunity for harmonization exists in newer energy-consuming products that are not commonly regulated but are under consideration for new standards and labeling programs. This may include commercial products such as water dispensers and vending machines, which are only covered by MEPS or energy labels in a few countries or regions. As China continues to expand its appliance standards and labeling programs and revise existing standards and labels, it is important to learn from recent international experiences with efficiency criteria and test procedures for the same products. Specifically, various types of standards and labeling programs already exist in North America, Europe and throughout Asia for products in China's 2010 standards and labeling programs, namely clothes washers, water dispensers, vending machines and CFLs. This report thus examines similarities and critical differences in energy efficiency values, test procedure specifications and

  3. Development and evaluation of Standard Operating Procedures (SOPs) for quality control tests and radiological protection activities in a Nuclear Medicine Service

    International Nuclear Information System (INIS)

    Krempser, Alexandre R.; Soares, Alexandre B.; Corbo, Rossana

    2011-01-01

    The quality management in Nuclear Medicine Services is a requirement of national and international standards. The Brazilian regulatory agency in health surveillance, the Agencia Nacional de Vigilancia Sanitaria (ANVISA), in its Resolucao de Diretoria Colegiada (Collegiate Directory Resolution) no. 38, requires the elaboration of documents describing the technical and clinical routine activities. This study aimed to elaborate, implement and evaluate Standard Operating Procedures (SOPs) for quality control tests and radiological protection activities in the Nuclear Medicine Service of a university hospital. Eighteen SOPs were developed, involving tasks related to dose calibrator, gamma camera, Geiger-Muller detectors and radiological protection activities. The performance of its application was evaluated for a period of six months. It was observed a reduction in 75% of reported operational errors and 42% of the number of reported incidents with contamination by radioactive material. The SOPs were adequate and successful in its application. New procedures involving clinical activities will also be developed and evaluated. (author)

  4. Coracoid bone graft osteolysis after Latarjet procedure: A comparison study between two screws standard technique vs mini-plate fixation

    Science.gov (United States)

    Giacomo, Giovanni Di; Costantini, Alberto; de Gasperis, Nicola; De Vita, Andrea; Lin, Bernard K. H.; Francone, Marco; Beccaglia, Mario A. Rojas; Mastantuono, Marco

    2013-01-01

    Aims: One of the reason for Latarjet procedure failure may be coracoid graft osteolysis. In this study, we aimed to understand if a better compression between the coracoid process and the glenoid, using a mini-plate fixation during the Latarjet procedure, could reduce the amount of coracoid graft osteolysis. Materials and Methods: A computed tomography scan analysis of 26 prospectively followed-up patients was conducted after modified Latarjet procedure using mini-plate fixation technique to determine both the location and the amount of coracoid graft osteolysis in them. We then compared our current results with results from that of our previous study without using mini-plate fixation to determine if there is any statistical significant difference in terms of corcacoid bone graft osteolysis between the two surgical techniques. Results: The most relevant osteolysis was represented by the superficial part of the proximal coracoid, whereas the deep part of the proximal coracoid graft is least involved in osteolysis and has best bone healing. The current study showed a significant difference only for the deep part of the distal coracoid with our previous study (P Latarjet procedure. Conclusion: Our study suggests that there is a significant difference only for the deep part of the distal coracoid in terms of osteolysis. At clinical examination, this difference did not correspond with any clinical findings. Level of Evidence: Level 4. Clinical Relevance: Prospective case series, Treatment study. PMID:23858288

  5. Enhancing Title Ix Due Process Standards in Campus Sexual Assault Adjudication: Considering the Roles of Distributive, Procedural, and Restorative Justice

    Science.gov (United States)

    Harper, Shannon; Maskaly, Jon; Kirkner, Anne; Lorenz, Katherine

    2017-01-01

    Title IX prohibits sex discrimination--including sexual assault--in higher education. The Department of Education Office for Civil Rights' 2011 "Dear Colleague Letter" outlines recommendations for campus sexual assault adjudication allowing a variety of procedures that fail to protect accused students' due process rights and victims'…

  6. 40 CFR 1045.515 - What are the test procedures related to not-to-exceed standards?

    Science.gov (United States)

    2010-07-01

    ... emissions with one of the following procedures: (1) Remove the selected engines for testing in a laboratory....075 (5) For two-stroke engines not equipped with a catalyst, the NTE zone described in paragraph (c)(3... cycle: (i) Mode 1: Operate the engine at wide open throttle. For laboratory testing, this may involve...

  7. Final Rule for Control of Air Pollution From Aircraft and Aircraft Engines; Emission Standards and Test Procedures

    Science.gov (United States)

    EPA adopted emission standards and related provisions for aircraft gas turbine engines with rated thrusts greater than 26.7 kilonewtons. These engines are used primarily on commercial passenger and freight aircraft.

  8. Development of a set of multiplex standard polymerase chain reaction assays for the identification of infectious agents from aborted bovine clinical samples.

    Science.gov (United States)

    Tramuta, Clara; Lacerenza, Daniela; Zoppi, Simona; Goria, Mariella; Dondo, Alessandro; Ferroglio, Ezio; Nebbia, Patrizia; Rosati, Sergio

    2011-07-01

    The current study describes the development of a set of 5 multiplex polymerase chain reaction (mPCR) assays for the simultaneous detection of abortive infection agents in bovine fetal tissues, including Brucella spp., Leptospira spp., and Campylobacter fetus (mPCR1); Hammondia heydorni, Neospora caninum, and Toxoplasma gondii (mPCR2); Coxiella burnetii and Chlamydophila psittaci (mPCR3); Mycoplasma bovis, Mycoplasma bovigenitalium, and Ureaplasma diversum (mPCR4); and Bovine viral diarrhea virus (BVDV) and Bovine herpesvirus-1 (BoHV-1; mPCR5). The protocol was tested on different tissue samples collected from 50 aborted bovine fetuses, and it showed that out of the 50 fetuses, 7 (14%, mPCR2) were PCR-positive for N. caninum, 4 (8%, mPCR5) were PCR-positive for BVDV, and 2 (4%, mPCR4) were PCR-positive for U. diversum. The results obtained by using each multiplex PCR were 100% concordant with those obtained by using the respective PCR assays targeting single genes on the same specimens. Moreover, all multiplex PCR assays on clinical samples were compared with reference methods, obtaining a perfect accordance in all samples and confirming the validity of the set of multiplex PCR assays. The proposed set of multiplex PCR assays is, therefore, suitable for the simultaneous detection of the main infectious agents responsible for bovine abortion.

  9. Assay of ribulose bisphosphate carboxylase

    International Nuclear Information System (INIS)

    Pike, C.; Berry, J.

    1987-01-01

    Assays of ribulose bisphosphate carboxylase (rubisco) can be used to illustrate many properties of photosynthetic systems. Many different leaves have been assayed with this standard procedure. The tissue is ground with a mortar and pestle in extraction buffer. The supernatant after centrifugation is used as the source of enzyme. Buffer, RuBP, [ 14 C]-NaHCO 3 , and enzyme are combined in a scintillation vial; the reaction is run for 1 min at 30 0 . The acid-stable products are counted. Reproducibility in student experiments has been excellent. The assay data can be combined with analyses of leaf properties such as fresh and dry weight, chlorophyll and protein content, etc. Students have done projects such as the response of enzyme to temperature and to various inhibitors. They also report on the use of a transition state analog, carboxyarabinitol bisphosphate, to titrate the molar concentration of rubisco molecules (active sites) in an enzyme sample. Thus, using crude extracts the catalytic activity of a sample can be compared to the absolute quantity of enzyme or to the turnover number

  10. [Requirement of standardizing anti-HBs assay methods in Japan for HBV infection-preventing strategy--discrepancy of anti-HBs measurements among three different kits widely used in Japan].

    Science.gov (United States)

    Ogata, Norio

    2006-09-01

    The strategy to eliminate hepatitis B virus (HBV) infection by administrating an HB vaccine is changing worldwide; however, this is not the case in Japan. An important concern about the HBV infection-preventing strategy in Japan may be that the assay methods for the antibody to hepatitis B surface antigen (anti-HBs) are not standardized. The minimum protective anti-HBs titer against HBV infection has been established as 10 mIU/ml by World Health Organization (WHO) -standardized assay methods worldwide, but that is still determined as a "positive" test result by the passive hemagglutination (PHA) method in Japan. We compared anti-HBs measurements in given samples among PHA(Mycell II, Institute of Immunology), chemiluminescent enzyme immunoassay (CLEIA) (Lumipulse, Fujirebio), and chemiluminescent immunoassay (CLIA) (Architect, Abbott), all of which are currently in wide use in Japan. First, anti-HBs measurements in serum from individuals who received a yeast-derived recombinant HB vaccine composed of the major surface protein of either subtype adr or subtype ayw were compared. The results clearly showed that in subtype adr-vaccinees CLIA underestimated the anti-HBs amount compared with CLEIA and PHA, but in ayw-vaccinees, the discordance in the measurements among the three kits was not prominent. Second, anti-HBs measurements in standard or calibration solutions of each assay kit were compared. Surprisingly, CLEIA showed higher measurements in all three kit-associated standard or calibration solutions than CLIA. Thus, the anti-HBs titer of 10 mIU/ml is difficult to introduce in Japan as the minimum protective level against HBV infection. Efforts to standardize anti-HBs assay methods are expected to share international evidence about the HBV infection-preventing strategy.

  11. The development of SRM assays is transforming proteomics research.

    Science.gov (United States)

    Manes, Nathan P; Nita-Lazar, Aleksandra

    2017-04-01

    Bottom-up targeted proteomics using SRM is a powerful analytical technology, but it requires the development of SRM assays, which is a complex procedure. Whereas proteome-wide SRM assays have recently been developed for a small number of species, this is not so for the mouse. In this issue, Percy et al. report the development of hundreds of mouse SRM assays. Their development required shotgun MS to identify proteotypic peptides, synthesis, and LC-MS characterization of peptide standards, and interlaboratory SRM to robustly assess the quality of the assays. The resulting SRM assays are intended to be used to analyze mouse plasma and cardiac tissue, primarily for cardiovascular disease and cancer research. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

  12. Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms.

    Science.gov (United States)

    Pomeroy, Eoghan; Shaarani, Shahril; Kenyon, Robert; Cashman, James

    2017-08-25

    Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications. Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

  13. A proposal of Brazilian Society of Surgical Oncology for standardizing cytoreductive surgery plus hypertermic intraperitoneal chemotherapy procedures in Brazil: pseudomixoma peritonei, appendiceal tumors and malignant peritoneal mesothelioma

    Directory of Open Access Journals (Sweden)

    Thales Paulo Batista

    Full Text Available ABSTRACT Cytoreductive surgery plus hypertermic intraperitoneal chemotherapy has emerged as a major comprehensive treatment of peritoneal malignancies and is currently the standard of care for appendiceal epithelial neoplasms and pseudomyxoma peritonei syndrome as well as malignant peritoneal mesothelioma. Unfortunately, there are some worldwide variations of the cytoreductive surgery and hypertermic intraperitoneal chemotherapy techniques since no single technique has so far demonstrated its superiority over the others. Therefore, standardization of practices might enhance better comparisons between outcomes. In these settings, the Brazilian Society of Surgical Oncology considered it important to present a proposal for standardizing cytoreductive surgery plus hypertermic intraperitoneal chemotherapy procedures in Brazil, with a special focus on producing homogeneous data for the developing Brazilian register for peritoneal surface malignancies.

  14. A Randomized Controlled Trial to Compare e-Feedback Versus "Standard" Face-to-Face Verbal Feedback to Improve the Acquisition of Procedural Skill.

    Science.gov (United States)

    Al-Jundi, Wissam; Elsharif, Mohamed; Anderson, Melanie; Chan, Phillip; Beard, Jonathan; Nawaz, Shah

    Constructive feedback plays an important role in learning during surgical training. Standard feedback is usually given verbally following direct observation of the procedure by a trained assessor. However, such feedback requires the physical presence of expert faculty members who are usually busy and time-constrained by clinical commitments. We aim to evaluate electronic feedback (e-feedback) after video observation of surgical suturing in comparison with standard face-to-face verbal feedback. A prospective, blinded, randomized controlled trial comparing e-feedback with standard verbal feedback was carried out in February 2015 using a validated pro formas for assessment. The study participants were 38 undergraduate medical students from the University of Sheffield, UK. They were recorded on video performing the procedural skill, completed a self-evaluation form, and received e-feedback on the same day (group 1); observed directly by an assessor, invited to provide verbal self-reflection, and then received standard verbal feedback (group 2). In both groups, the feedback was provided after performing the procedure. The participants returned 2 days later and performed the same skill again. Poststudy questionnaire was used to assess the acceptability of each feedback among the participants. Overall, 19 students in group 1 and 18 students in group 2 completed the study. Although there was a significant improvement in the overall mean score on the second performance of the task for all participants (first performance mean 11.59, second performance mean 15.95; p ≤ 0.0001), there was no difference in the overall mean improvement score between group 1 and group 2 (4.74 and 3.94, respectively; p = 0.49). The mean overall scores for the e-feedback group at baseline recorded by 2 independent investigators showed good agreement (mean overall scores of 12.84 and 11.89; Cronbach α = 0.86). Poststudy questionnaire demonstrated that both e-feedback and standard verbal feedback

  15. 77 FR 36341 - Control of Air Pollution From Aircraft and Aircraft Engines; Emission Standards and Test Procedures

    Science.gov (United States)

    2012-06-18

    ... normally expressed as shaft horsepower (hp) or shaft kilowatt (kW). \\5\\ This includes turbofan and turbojet... Organization (ICAO). The requirements contained in this final rule bring the United States into alignment with... brought the U.S. standards closer to alignment with ICAO CAEP/4 requirements that were effective in 2004...

  16. 20 CFR 627.604 - Alternative procedure for handling labor standards violations under section 143 of the Act...

    Science.gov (United States)

    2010-04-01

    ... standards violations under section 143 of the Act-binding arbitration. 627.604 Section 627.604 Employees... UNDER TITLES I, II, AND III OF THE ACT Federal Handling of Noncriminal Complaints and Other Allegations...—binding arbitration. (a) A person alleging a violation of section 143 of the Act, as an alternative to...

  17. Standard Procedure for Dose Assessment using the film holder NRPB/AERE and the film AGFA Monitoring 2/10

    International Nuclear Information System (INIS)

    Guillen, J.A.

    1998-07-01

    This paper describes the calculation method to assess dose and energy using the film holder from NRPB/AERE and the film Agfa Monitoring 2/10. Also includes all the steps since preparing the standard curve, fitting of calibration curve, dose assesment, description of filtration of the film holder and the form of the calibration curve

  18. Test of mutagenicity of an irradiated standard diet for laboratory animals in the host-mediated assay with salmonella typhimurium TA 1530

    International Nuclear Information System (INIS)

    Muenzner, R.; Renner, H.W.

    1976-01-01

    Feed irradiated at a dose of 3 Mrad was tested for mutagenic activity in the host-mediated assay with the mouse as host and Salmonella typhimurium TA 1530 as indicator organism. In the in vivo and in the in vitro comparative test the irradiated feed showed no mutagenic effect. (orig.) [de

  19. Conscious sedation for endoscopic and non-endoscopic interventional gastrointestinal procedures: meeting patients' expectations, missing the standard

    Energy Technology Data Exchange (ETDEWEB)

    Marriott, P.; Laasch, H.-U.; Wilbraham, L.; Marriott, A.; England, R.E.; Martin, D.F. E-mail: derrick.martin@smtr.nhs.uk

    2004-02-01

    AIM: To assess the level of sedation, patient satisfaction and frequency of unplanned events with conscious sedation for interventional procedures. MATERIALS AND METHODS: One hundred and seventeen patients were assessed prospectively before, during and after procedures. Blood pressure, pulse, oxygen saturation and sedation level were monitored and patients followed up after 24 h. Sedation was scored after drugs were given in accordance with an established protocol. Doses were recorded, as were patients' weight, age and ASA grade and any unplanned events and their management. RESULTS: Seventy-six of the 117 patients (65%) had no unplanned event, 20 (17.1%) became agitated, 15 (12.8%) hypotensive, three (2.6%) hypoxic and three (2.6%) had more than one response. Twelve patients required active management. Fifty-two (44.4%) had a sedation level of {<=}3 (responsive to verbal commands), but 39 (33.3%) reached level 6. Median doses were midazolam 6 mg (1-20 mg) and pethidine 50 mg (12.5-100 mg). Ninety-three percent were satisfied with their sedation. No adverse effects were observed after 24 h. CONCLUSION: Despite using a sedation protocol, unplanned events occurred in 35% (95% CI=27-44%) of patients, although not all required active management. The sedation levels reached in some exceeded guidelines. Unplanned events were commoner with increased sedation level. Patient satisfaction was high and no permanent damage was observed.

  20. Conscious sedation for endoscopic and non-endoscopic interventional gastrointestinal procedures: meeting patients' expectations, missing the standard

    International Nuclear Information System (INIS)

    Marriott, P.; Laasch, H.-U.; Wilbraham, L.; Marriott, A.; England, R.E.; Martin, D.F.

    2004-01-01

    AIM: To assess the level of sedation, patient satisfaction and frequency of unplanned events with conscious sedation for interventional procedures. MATERIALS AND METHODS: One hundred and seventeen patients were assessed prospectively before, during and after procedures. Blood pressure, pulse, oxygen saturation and sedation level were monitored and patients followed up after 24 h. Sedation was scored after drugs were given in accordance with an established protocol. Doses were recorded, as were patients' weight, age and ASA grade and any unplanned events and their management. RESULTS: Seventy-six of the 117 patients (65%) had no unplanned event, 20 (17.1%) became agitated, 15 (12.8%) hypotensive, three (2.6%) hypoxic and three (2.6%) had more than one response. Twelve patients required active management. Fifty-two (44.4%) had a sedation level of ≤3 (responsive to verbal commands), but 39 (33.3%) reached level 6. Median doses were midazolam 6 mg (1-20 mg) and pethidine 50 mg (12.5-100 mg). Ninety-three percent were satisfied with their sedation. No adverse effects were observed after 24 h. CONCLUSION: Despite using a sedation protocol, unplanned events occurred in 35% (95% CI=27-44%) of patients, although not all required active management. The sedation levels reached in some exceeded guidelines. Unplanned events were commoner with increased sedation level. Patient satisfaction was high and no permanent damage was observed

  1. Standard procedure for testing acute toxic effects on bioluminescent bacteria; Saggio di tossicita` acuta con batteri bioluminescenti

    Energy Technology Data Exchange (ETDEWEB)

    Guzzella, L. [CNR, Brugherio, Milan (Italy). Istituto di Ricerca Sulle Acque

    1996-06-01

    A standardized method for the determination of 15-30 min toxicity of `Vibrio fisheri` bioluminescent bacteria is evaluated. The proposed method can be applied for the analysis of liquid (superficial and drinking waters, eluates and wastes) and solid (sediments and muds) samples and permits the quantification of the EC50 and EC20 values and of the no-effective sample dilution. The results of a interlaboratory ring tests conducted with reference substances are illustrated.

  2. MATLAB-implemented estimation procedure for model-based assessment of hepatic insulin degradation from standard intravenous glucose tolerance test data.

    Science.gov (United States)

    Di Nardo, Francesco; Mengoni, Michele; Morettini, Micaela

    2013-05-01

    Present study provides a novel MATLAB-based parameter estimation procedure for individual assessment of hepatic insulin degradation (HID) process from standard frequently-sampled intravenous glucose tolerance test (FSIGTT) data. Direct access to the source code, offered by MATLAB, enabled us to design an optimization procedure based on the alternating use of Gauss-Newton's and Levenberg-Marquardt's algorithms, which assures the full convergence of the process and the containment of computational time. Reliability was tested by direct comparison with the application, in eighteen non-diabetic subjects, of well-known kinetic analysis software package SAAM II, and by application on different data. Agreement between MATLAB and SAAM II was warranted by intraclass correlation coefficients ≥0.73; no significant differences between corresponding mean parameter estimates and prediction of HID rate; and consistent residual analysis. Moreover, MATLAB optimization procedure resulted in a significant 51% reduction of CV% for the worst-estimated parameter by SAAM II and in maintaining all model-parameter CV% MATLAB-based procedure was suggested as a suitable tool for the individual assessment of HID process. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  3. PLAN-TA9-2443(U), Rev. B Remediated Nitrate Salt (RNS) Surrogate Formulation and Testing Standard Procedure

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Geoffrey Wayne [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-03-16

    This document identifies scope and some general procedural steps for performing Remediated Nitrate Salt (RNS) Surrogate Formulation and Testing. This Test Plan describes the requirements, responsibilities, and process for preparing and testing a range of chemical surrogates intended to mimic the energetic response of waste created during processing of legacy nitrate salts. The surrogates developed are expected to bound1 the thermal and mechanical sensitivity of such waste, allowing for the development of process parameters required to minimize the risk to worker and public when processing this waste. Such parameters will be based on the worst-case kinetic parameters as derived from APTAC measurements as well as the development of controls to mitigate sensitivities that may exist due to friction, impact, and spark. This Test Plan will define the scope and technical approach for activities that implement Quality Assurance requirements relevant to formulation and testing.

  4. The ageing and myasthenic thymus: a morphometric study validating a standard procedure in the histological workup of thymic specimens.

    Science.gov (United States)

    Ströbel, Philipp; Moritz, Regina; Leite, Maria Isabel; Willcox, Nick; Chuang, Wen-Yu; Gold, Ralf; Nix, Wilfred; Schalke, Berthold; Kiefer, Reinhard; Müller-Hermelink, Hans-Konrad; Jaretzki Iii, Alfred; Newsom-Davis, John; Marx, Alexander

    2008-09-15

    The thymus is believed to play an important role in the pathogenesis of myasthenia gravis (MG). The 80% of MG patients with anti-acetylcholine receptor autoantibodies fall into three clinical subgroups: 1) thymoma; 2) early-onset MG (standardized histological workup and reporting system used in this trial.

  5. Standard test method for non-destructive assay of nuclear material in waste by passive and active neutron counting using a differential Die-away system

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method covers a system that performs nondestructive assay (NDA) of uranium or plutonium, or both, using the active, differential die-away technique (DDT), and passive neutron coincidence counting. Results from the active and passive measurements are combined to determine the total amount of fissile and spontaneously-fissioning material in drums of scrap or waste. Corrections are made to the measurements for the effects of neutron moderation and absorption, assuming that the effects are averaged over the volume of the drum and that no significant lumps of nuclear material are present. These systems are most widely used to assay low-level and transuranic waste, but may also be used for the measurement of scrap materials. The examples given within this test method are specific to the second-generation Los Alamos National Laboratory (LANL) passive-active neutron assay system. 1.1.1 In the active mode, the system measures fissile isotopes such as 235U and 239Pu. The neutrons from a pulsed, 14-MeV ne...

  6. Randomized trial of one-hour sodium bicarbonate vs standard periprocedural saline hydration in chronic kidney disease patients undergoing cardiovascular contrast procedures.

    Science.gov (United States)

    Kooiman, Judith; de Vries, Jean-Paul P M; Van der Heyden, Jan; Sijpkens, Yvo W J; van Dijkman, Paul R M; Wever, Jan J; van Overhagen, Hans; Vahl, Antonie C; Aarts, Nico; Verberk-Jonkers, Iris J A M; Brulez, Harald F H; Hamming, Jaap F; van der Molen, Aart J; Cannegieter, Suzanne C; Putter, Hein; van den Hout, Wilbert B; Kilicsoy, Inci; Rabelink, Ton J; Huisman, Menno V

    2018-01-01

    Guidelines advise periprocedural saline hydration for prevention of contrast induced-acute kidney injury (CI-AKI). We analysed whether 1-hour sodium bicarbonate hydration administered solely prior to intra-arterial contrast exposure is non-inferior to standard periprocedural saline hydration in chronic kidney disease (CKD) patients undergoing elective cardiovascular diagnostic or interventional contrast procedures. We performed an open-label multicentre non-inferiority trial between 2011-2014. Patients were randomized to 1 hour pre-procedure sodium bicarbonate hydration (250 ml 1.4%, N = 168) or 4-12 hours saline hydration (1000 ml 0.9%, N = 165) prior to and following contrast administration (2000 ml of saline total). Primary outcome was the relative serum creatinine increase (%) 48-96 hours post contrast exposure. Secondary outcomes were: incidence of CI-AKI (serum creatinine increase>25% or >44μmol/L), recovery of renal function, the need for dialysis, and hospital costs within two months follow-up. Mean relative creatinine increase was 3.1% (95%CI 0.9 to 5.2%) in the bicarbonate and 1.1% (95%CI -1.2 to 3.5%) in the saline arm, mean difference 1.9% (95%CI -1.2 to 5.1%, p-non-inferiority sodium bicarbonate and 12 (7.5%) to saline (p = 0.79). Renal function did not fully recover in 40.0% and 44.4% of CI-AKI patients, respectively (p = 0.84). No patient required dialysis. Mean costs for preventive hydration and clinical preparation for the contrast procedure were $1158 for sodium bicarbonate vs. $1561 for saline (p sodium bicarbonate prior to elective cardiovascular diagnostic or therapeutic contrast procedures is non-inferior to standard periprocedural saline hydration in CKD patients with respect to renal safety and results in considerable healthcare savings. Netherlands Trial Register (http://www.trialregister.nl/trialreg/index.asp), Nr NTR2699.

  7. Standardization of a Protocol for Obtaining Platelet Rich Plasma from blood Donors; a Tool for Tissue Regeneration Procedures.

    Science.gov (United States)

    Gómez, Lina Andrea; Escobar, Magally; Peñuela, Oscar

    2015-01-01

    To develop a protocol for obtaining autologous platelet rich plasma in healthy individuals and to determine the concentration of five major growth factors before platelet activation. This protocol could be integrated into the guidelines of good clinical practice and research in regenerative medicine. Platelet rich plasma was isolated by centrifugation from 38 healthy men and 42 women ranging from 18 to 59 years old. The platelet count and quantification of growth factors were analyzed in eighty samples, stratified for age and gender of the donor. Analyses were performed using parametric the t-test or Pearson's analysis for non-parametric distribution. P platelet counts from 1.6 to 4.9 times (mean = 2.8). There was no correlation between platelet concentration and the level of the following growth factors: VEGF-D (r = 0.009, p = 0.4105), VEGF-A (r = 0.0068, p = 0.953), PDGF subunit AA (p = 0.3618; r = 0.1047), PDGF-BB (p = 0.5936; r = 0.6095). In the same way, there was no correlation between donor gender and growth factor concentrations. Only TGF-β concentration was correlated to platelet concentration (r = 0.3163, p = 0.0175). The procedure used allowed us to make preparations rich in platelets, low in leukocytes and red blood cells, and sterile. Our results showed biological variations in content of growth factors in PRP. The factors influencing these results should be further studied.

  8. Evaluation and assessment methodology, standards, and procedures manual of the United States Federal Radiological Monitoring and Assessment Center

    International Nuclear Information System (INIS)

    Kerns, K.C.; Burson, Z.G.; Smith, J.M.; Blanchard, R.L.

    2000-01-01

    In the event of a major radiological emergency, the U.S. Federal Radiological Emergency Response Plan authorises the creation of the Federal Radiological Monitoring and Assessment Center (FRMAC). The FRMAC is established to co-ordinate the Federal off-site monitoring and assessment activities, and is comprised of representatives from several Federal agencies and Department of Energy contractors who provide assistance to the state(s) and Lead Federal Agency. The Evaluation and Assessment (E and A) Division of the FRMAC is responsible for receiving, storing, and interpreting environmental surveillance data to estimate the potential health consequences to the population in the vicinity of the accident site. The E and A Division has commissioned the preparation of a methodology and procedures manual which will result in a consistent approach by Division members in carrying out their duties. The first edition of this manual is nearing completion. In this paper, a brief review of the structure of the FRMAC is presented, with emphasis on the E and A Division. The contents of the E and A manual are briefly described, as are future plans for its expansion. (author)

  9. International Cooperation to Establish Standard Operating Procedure (SOP) for Quarantine Management of Irradiated Foods in International Trade

    International Nuclear Information System (INIS)

    Lee, J. W.; Byun, M. W.; Kim, J. H.; Choi, J. I.; Song, B. S.; Yoon, Y. H.; Kim, D. H.; Kim, W. G.; Kim, K. P.

    2010-02-01

    · Development of SOPs through various research activities such as building international cooperation, and analysing current status of food irradiation in domestic and international markets, export and import, international market size, and of R and D - Analysis of examples for quarantine management in agricultural product exporting countries and use of irradiation technology for agricultural product quarantine, and changes in international quarantine management - Analysis of SOPs for food irradiation quarantine in international organization (CODEX, IPPC, WHO). U.S, EU, China, India, and Australia. - Collaborative researches of India/Korea and China/Korea entered into an agreement for market trials · Publishment of irradiation quarantine management SOPs agreed to CODEX standards - Collaborative researches for quarantine management, avoiding Technical Barrier to Trade (TBT), and Sanitary Phytosanitary Measures were conducted, and advanced SOPs agreed with WTO/FTA system were published

  10. Radioimmunoassay procedure using a stabilized complex

    International Nuclear Information System (INIS)

    Sultanian, I.V.; Irani, J.H.

    1978-01-01

    An improved radioimmunoassay procedure involves the use of a stabilized complex of labelled antigen and antibody which has an extended shelf life as compared to the same complex absent the stabilizers. Since the time needed to incubate the mixture of labelled antigen and antibody is eliminated, the time for completing the assay is considerably shortened and simplified. The components for carrying out the procedure are packaged in a kit basically including standard antigen for generation of a standard curve, a stabilized labelled antigen-antibody complex and reference serum, if used. A plurality of stabilizers are used in the complex to provide a shelf life of six weeks or more. 10 claims

  11. Mutagenic treatments towards increasing the frequency of day-neutral mutations and standardization of procedures for tissue culture, in potato

    International Nuclear Information System (INIS)

    Upadhya, M.D.; Chandra, R.; Abraham, M.J.

    1976-01-01

    Various chemical mutagens and gamma radiation have been used on single dormant eyes and true seeds with a view to finding effective mutagenic treatment for the induction of day-length neutral mutants in potato using an effective screening technique for the isolation of day-length neutral mutants. Sodium meta bisulphite (SMS) was found to be an efficient mutagen in inducing mutations for this trait in true seeds although the same concentrations, when used for treating the single tuber eyes proved lethal. Pre-soaking the seeds for 24 hrs prior to treatment with 0.0025M SMS gave highest frequency of the mutants followed by 48 hrs presoaking, indicating a sensitive stage during the cell cycle in true seeds. Other mutagen treatments gave different frequencies of mutations. The highest frequency of day-length neutral mutants was observed when seeds irradiated with 40 Kr of gamma radiation were treated with 0.05M hydrazinium dichloride solution. Screening procedures have also been standardised with the development of synethetic media for the isolation of biochemical mutants at the true seed level. Initial efforts have yielded mutants resistant to LD 100 doses of ethionine. Another aspect of the study was to develop a proper potato callus culture technique. A medium has been developed to produce and maintain callus from potato leaf strips. Efforts on the regeneration of shoot and roots from callus, have so far lead to differentiation of callus to form roots. The ultimate aim of these studies is to develop plantlets from single cell which would form the units of mutation induction and isolation. (author)

  12. Powered bone marrow biopsy procedures produce larger core specimens, with less pain, in less time than with standard manual devices

    Directory of Open Access Journals (Sweden)

    Larry J. Miller

    2011-07-01

    Full Text Available Bone marrow sampling remains essential in the evaluation of hematopoietic and many non-hematopoietic disorders. One common limitation to these procedures is the discomfort experienced by patients. To address whether a Powered biopsy system could reduce discomfort while providing equivalent or better results, we performed a randomized trial in adult volunteers. Twenty-six subjects underwent bilateral biopsies with each device. Core samples were obtained in 66.7% of Manual insertions; 100% of Powered insertions (P=0.002. Initial mean biopsy core lengths were 11.1±4.5 mm for the Manual device; 17.0±6.8 mm for the Powered device (P<0.005. Pathology assessment for the Manual device showed a mean length of 6.1±5.6 mm, width of 1.0±0.7 mm, and volume of 11.0±10.8 mm3. Powered device measurements were mean length of 15.3±6.1 mm, width of 2.0±0.3 mm, and volume of 49.1±21.5 mm3 (P<0.001. The mean time to core ejection was 86 seconds for Manual device; 47 seconds for the Powered device (P<0.001. The mean second look overall pain score was 33.3 for the Manual device; 20.9 for the Powered (P=0.039. We conclude that the Powered biopsy device produces superior sized specimens, with less overall pain, in less time.

  13. Hyaluronic Acid Assays

    DEFF Research Database (Denmark)

    Itenov, Theis Skovsgaard; Kirkby, Nikolai S; Bestle, Morten H

    2016-01-01

    BACKGROUD: Hyaluronic acid (HA) is proposed as a marker of functional liver capacity. The aim of the present study was to compare a new turbidimetric assay for measuring HA with the current standard method. METHODS: HA was measured by a particle-enhanced turbidimetric immunoassay (PETIA) and enzyme...

  14. 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...

  15. Philosophy, policy and procedures of the World Organisation for Animal Health for the development of standards in animal welfare.

    Science.gov (United States)

    Petrini, A; Wilson, D

    2005-08-01

    Animal welfare was identified as a priority for the World Organisation for Animal Health (OIE) in the 2001-2005 OIE Strategic Plan. Member Countries recognised that, as animal protection is a complex, multi-faceted public policy issue which includes important scientific, ethical, economic and political dimensions, the OIE needed to develop a detailed vision and strategy incorporating and balancing these dimensions. A permanent working group on animal welfare was established in order to provide guidance to the OIE in its work on the development of science-based standards and guidelines. The Working Group decided to give priority to the welfare of animals used in agriculture and aquaculture, and that, within those groups, the topics of transportation, slaughter for human consumption and killing for disease control purposes would be addressed first. Some guiding principles were approved by the International Committee of OIE Member Countries during the 72nd General Session in May 2004, and these have been followed by four specific guidelines on the priority topics listed above.

  16. Preparation procedure and certification of uranous-uranic oxide and nitric acid solution of neptunium as standard specimens of plant

    International Nuclear Information System (INIS)

    Bulyanitsa, L.S.; Lipovskij, A.A.; Ryzhinskij, M.V.; Preobrazhensskaya, L.D.; Aleksandruk, V.M.; Alekseeva, N.A.; Gromova, E.A.; Solntseva, L.F.; Shereshevskaya, I.I.

    1981-01-01

    Two techniques of certification of standard specimens of plant (SSP) are considered. The first technique-comparison with initial SS-metallic uranium NBS-960 - is used for certification of uranium. protoxide-oxide. The mass part of the sum of analyzed impurities in prepared initial SS is (8.4+-0.8)x10 -3 %. For certification according to mass uranium part the method of gravimetric potentiometric titration with semiautomatic titrator is used; the mean quadratic deviation of the method is s=0.0002-0.0003, certified value of uranium mass part in SSP (taking account of the error of initial SS) is (84.80+-0.02)%. The second technigue - a simplified circular experiment - is used for certification of SSP-nitric acid solution of neptunium as to Np mass part. Coulometry at controlled potential and coulometry at controlled current and two variants of potentiometric titration are used as certification methods of analysis. Relative mean quadratic deviations of the methods are ssub(r)=0.0014-0.0023. When calculating total error of certified value of neptunium mass part constituents of both accidental and unremoved systematic errors of the methods were included. The final certification result of SSP is (5.707+-0.018)% [ru

  17. Chapter 1. Introduction. Recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza epidemic or mass disaster.

    Science.gov (United States)

    Sprung, Charles L; Cohen, Robert; Adini, Bruria

    2010-04-01

    In December 2007, the European Society of Intensive Care Medicine established a Task Force to develop standard operating procedures (SOPs) for operating intensive care units (ICU) during an influenza epidemic or mass disaster. To provide direction for health care professionals in the preparation and management of emergency ICU situations during an influenza epidemic or mass disaster, standardize activities, and promote coordination and communication among the medical teams. Based on a literature review and contributions of content experts, a list of essential categories for managing emergency situations in the ICU were identified. Based on three cycles of a modified Delphi process, consensus was achieved regarding the categories. A primary author along with an expert group drafted SOPs for each category. Based on the Delphi cycles, the following key topics were found to be important for emergency preparedness: triage, infrastructure, essential equipment, manpower, protection of staff and patients, medical procedures, hospital policy, coordination and collaboration with interface units, registration and reporting, administrative policies and education. The draft SOPs serve as benchmarks for emergency preparedness and response of ICUs to emergencies or outbreak of pandemics.

  18. Changes in the biochemical oxygen demand procedure in the 21st edition of Standard Methods for the Examination of Water and Wastewater.

    Science.gov (United States)

    Young, James C; Clesceri, Lenore S; Kamhawy, Sabry M

    2005-01-01

    The dilution biochemical oxygen demand (BOD) test has widespread application for design and operation of wastewater treatment processes, evaluating the quality of natural waters, and assessing the effect of wastewater discharges on these waters. While standardization of the BOD-measuring method has become of prime importance in maintaining dependable data acquisition, changes are made as needed in response to questions raised by analysts and to accommodate new applications. The purpose of this article is to describe changes that have been incorporated in the 20th and 21st editions of Standard Methods for the Examination of Water and Wastewater (APHA et al., 1998 and 2004). These changes include changes in text format to clarify the procedural steps, allowance for use of bottle sizes ranging from 60 mL or larger, improvements in quality-control procedures, and improvements in the method of calculating BOD. Other changes include allowance for the use of allylthiourea for nitrification inhibition and broadening the source of seed that can be used for inoculation of BOD samples.

  19. [Advantages and disadvantages of different methods for the implementation and the support of standard operating procedures: From PDF files to an app- and webbased SOP management system].

    Science.gov (United States)

    Bauer, M; Riech, S; Brandes, I; Waeschle, R M

    2015-11-01

    The quality assurance of care and patient safety, with increasing cost pressure and performance levels is of major importance in the high-risk and high cost area of the operating room (OR). Standard operating procedures (SOP) are an established tool for structuring and standardization of the clinical treatment pathways and show multiple benefits for quality assurance and process optimization. An internal project was initiated in the department of anesthesiology and a continuous improvement process was carried out to build up a comprehensive SOP library. In the first step the spectrum of procedures in anesthesiology was transferred to PDF-based SOPs. The further development to an app-based SOP library (Aesculapp) was due to the high resource expenditure for the administration and maintenance of the large PDF-based SOP collection and to deficits in the mobile availability. The next developmental stage, the SOP healthcare information assistant (SOPHIA) included a simplified and advanced update feature, an archive feature previously missing and notably the possibility to share the SOP library with other departments including the option to adapt each SOP to the individual situation. A survey of the personnel showed that the app-based allocation of SOPs (Aesculapp, SOPHIA) had a higher acceptance than the PDF-based developmental stage SOP form. The SOP management system SOPHIA combines the benefits of the forerunner version Aesculapp with improved options for intradepartmental maintenance and administration of the SOPs and the possibility of an export and editing function for interinstitutional exchange of SOPs.

  20. Standard test method for nondestructive assay of nuclear material in scrap and waste by passive-Active neutron counting using 252Cf shuffler

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This test method covers the nondestructive assay of scrap and waste items for U, Pu, or both, using a 252Cf shuffler. Shuffler measurements have been applied to a variety of matrix materials in containers of up to several 100 L. Corrections are made for the effects of matrix material. Applications of this test method include measurements for safeguards, accountability, TRU, and U waste segregation, disposal, and process control purposes (1, 2, 3). 1.1.1 This test method uses passive neutron coincidence counting (4) to measure the 240Pu-effective mass. It has been used to assay items with total Pu contents between 0.03 g and 1000 g. It could be used to measure other spontaneously fissioning isotopes such as Cm and Cf. It specifically describes the approach used with shift register electronics; however, it can be adapted to other electronics. 1.1.2 This test method uses neutron irradiation with a moveable Cf source and counting of the delayed neutrons from the induced fissions to measure the 235U equiva...

  1. 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)

  2. Standard test method for nondestructive assay of special nuclear material in low density scrap and waste by segmented passive gamma-Ray scanning

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This test method covers the transmission-corrected nondestructive assay (NDA) of gamma-ray emitting special nuclear materials (SNMs), most commonly 235U, 239Pu, and 241Am, in low-density scrap or waste, packaged in cylindrical containers. The method can also be applied to NDA of other gamma-emitting nuclides including fission products. High-resolution gamma-ray spectroscopy is used to detect and measure the nuclides of interest and to measure and correct for gamma-ray attenuation in a series of horizontal segments (collimated gamma detector views) of the container. Corrections are also made for counting losses occasioned by signal processing limitations (1-3). 1.2 There are currently several systems in use or under development for determining the attenuation corrections for NDA of radioisotopic materials (4-8). A related technique, tomographic gamma-ray scanning (TGS), is not included in this test method (9, 10, 11). 1.2.1 This test method will cover two implementations of the Segmented Gamma Scanning ...

  3. Evaluation and standardization of different purification procedures for fish bile and liver metallothionein quantification by spectrophotometry and SDS-PAGE analyses.

    Science.gov (United States)

    Tenório-Daussat, Carolina Lyrio; Resende, Marcia Carolina Martinho; Ziolli, Roberta L; Hauser-Davis, Rachel Ann; Schaumloffel, Dirk; Saint'Pierre, Tatiana D

    2014-03-01

    Fish bile metallothioneins (MT) have been recently reported as biomarkers for environmental metal contamination; however, no studies regarding standardizations for their purification are available. Therefore, different procedures (varying centrifugation times and heat-treatment temperatures) and reducing agents (DTT, β-mercaptoethanol and TCEP) were applied to purify MT isolated from fish (Oreochromis niloticus) bile and liver. Liver was also analyzed, since these two organs are intrinsically connected and show the same trend regarding MT expression. Spectrophotometrical analyses were used to quantify the resulting MT samples, and SDS-PAGE gels were used to qualitatively assess the different procedure results. Each procedure was then statistically evaluated and a multivariate statistical analysis was then applied. A response surface methodology was also applied for bile samples, in order to further evaluate the responses for this matrix. Heat treatment effectively removes most undesired proteins from the samples, however results indicate that temperatures above 70 °C are not efficient since they also remove MTs from both bile and liver samples. Our results also indicate that the centrifugation times described in the literature can be decreased in order to analyze more samples in the same timeframe, of importance in environmental monitoring contexts where samples are usually numerous. In an environmental context, biliary MT was lower than liver MT, as expected, since liver accumulates MT with slower detoxification rates than bile, which is released from the gallbladder during feeding, and then diluted by water. Therefore, bile MT seems to be more adequate in environmental monitoring scopes regarding recent exposure to xenobiotics that may affect the proteomic and metalloproteomic expression of this biological matrix. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. 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

  5. Radioreceptor assays

    International Nuclear Information System (INIS)

    Lapka, R.

    1985-01-01

    Radioreceptor assay (RRA) is an analytical method using the specific interaction of some pharmaceuticals and endogenic substances (ligands) with specific receptors present in certin tissues of living organisms. RRA uses the principle of isotope dilution. The method is described in detail of the preparation of receptors, samples and radioligands, conditions of incubation, the separation of free and bound radioligand, and the mathematical evaluation of RRA. The sensitivity of RRA is measured in units to tens of pg. The specificity of RRA relates to a group of substances with similar pharmacological effect. RRA may be used for identifying neuroleptics, antidepressants, anxiolytics, ergot alkaloids, beta blockers, anticholinergic drugs, certain hormones and neuropeptides. (M.D.)

  6. Methodology of Isochronal and Isothermal Anneals applied to Irradiated MOS Structures. Application to Post-Irradiation Effects (in Space, Accelerators) and Standard Test Procedures

    International Nuclear Information System (INIS)

    Chabrerie, Christian

    1997-01-01

    We report the development of a methodology using isochronal and isothermal anneals for the characterization of MOS (Metal - Oxide - Semiconductor) Transistors irradiated electronic components. We study the recovery kinetics of the post-irradiation effects and the modeling of the recovery temperature activated phenomena. This allows us to understand the basic physical mechanisms that have led to the definition of standard test procedures. The fields of application are numerous (space, military, accelerators for high energy physics, civilian nuclear and harsh environment robotics). We begin by outlining the context of our study and by presenting the actual standard test procedures (TM1019.4 and BS22900) used for the qualification of integrated circuits. We then review the different theories of the temperature activated phenomena. The link between the foundations of the normalized procedures and the thermally activated phenomena is clarified. From this analysis, we propose a new approach, mainly based on the use of isochronal anneals. During this work, we have developed two tools with this aim: - the first tool is software, it is a numerical simulation program for thermally activated phenomena. - The second is composed of a specific automated annealing bench (in particular isochronal), that we have designed. The applications and results are then presented in four parts: - the first presents simulation results computed using our calculation code, - the second concerns experimental results obtained with thin oxides from different rad-hard technologies and their application to study gate oxides of transistors, - the third develops results on non-hardened technological thick oxides and their consequences on the lateral leakage currents due to parasitic MOS structures in the 'commercial' components, - the fourth concerns the post-irradiation evolution of interface states during isochronal anneals. We conclude with a number of recommendations concerning the post

  7. A prospective case control comparison of the ZeroGravity system versus a standard lead apron as radiation protection strategy in neuroendovascular procedures.

    Science.gov (United States)

    Haussen, Diogo C; Van Der Bom, Imramsjah Martijn John; Nogueira, Raul G

    2016-10-01

    We aimed to compare the performance of the ZeroGravity (ZG) system (radiation protection system composed by a suspended lead suit) against the use of standard protection (lead apron (LA), thyroid shield, lead eyeglasses, table skirts, and ceiling suspended shield) in neuroangiography procedures. Radiation exposure data were prospectively collected in consecutive neuroendovascular procedures between December 2014 and February 2015. Operator No 1 was assigned to the use of an LA (plus lead glasses, thyroid shield, and a 1 mm hanging shield at the groin) while operator No 2 utilized the ZG system. Dosimeters were used to measure peak skin dose for the head, thyroid, and left foot. The two operators performed a total of 122 procedures during the study period. The ZG operator was more commonly the primary operator compared with the LA operator (85% vs 71%; p=0.04). The mean anterior-posterior (AP), lateral, and cumulative dose area product (DAP) radiation exposure as well as the mean fluoroscopy time were not statistically different between the operators' cases. The peak skin dose to the head of the operator with LA was 2.1 times higher (3380 vs 1600 μSv), while the thyroid was 13.9 (4460 vs 320 μSv), the mediastinum infinitely (520 vs 0 μSv), and the foot 3.3 times higher (4870 vs 1470 μSv) compared with the ZG operator, leading to an overall accumulated dose 4 times higher. The ratio of cumulative operator received dose/total cumulative DAP was 2.5 higher on the LA operator. The ZG radiation protection system leads to substantially lower radiation exposure to the operator in neurointerventional procedures. However, substantial exposure may still occur at the level of the lens and thyroid to justify additional protection. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  8. Procedimientos Comunes de Operacion Para Juntas Responsabilidades y Derechos del Presidente, Vice Presidente, Secretaria, y Miembros (Standard Procedures of Operation for Meetings, Rights, and Responsibilities of the President, Vice President, Secretary, and Members).

    Science.gov (United States)

    Gonzalez, Ramon

    Of use to Parent Advisory Committees, this Spanish-English handout briefly describes the standard procedures used to conduct meetings and outlines the duties of committee officers and members. The pamphlet describes the standard order of business at a meeting, including calling a meeting to order, roll call, minutes, reports, unfinished and new…

  9. Sepsis and Critical Illness Research Center investigators: protocols and standard operating procedures for a prospective cohort study of sepsis in critically ill surgical patients.

    Science.gov (United States)

    Loftus, Tyler J; Mira, Juan C; Ozrazgat-Baslanti, Tezcan; Ghita, Gabriella L; Wang, Zhongkai; Stortz, Julie A; Brumback, Babette A; Bihorac, Azra; Segal, Mark S; Anton, Stephen D; Leeuwenburgh, Christiaan; Mohr, Alicia M; Efron, Philip A; Moldawer, Lyle L; Moore, Frederick A; Brakenridge, Scott C

    2017-08-01

    Sepsis is a common, costly and morbid cause of critical illness in trauma and surgical patients. Ongoing advances in sepsis resuscitation and critical care support strategies have led to improved in-hospital mortality. However, these patients now survive to enter state of chronic critical illness (CCI), persistent low-grade organ dysfunction and poor long-term outcomes driven by the persistent inflammation, immunosuppression and catabolism syndrome (PICS). The Sepsis and Critical Illness Research Center (SCIRC) was created to provide a platform by which the prevalence and pathogenesis of CCI and PICS may be understood at a mechanistic level across multiple medical disciplines, leading to the development of novel management strategies and targeted therapies. Here, we describe the design, study cohort and standard operating procedures used in the prospective study of human sepsis at a level 1 trauma centre and tertiary care hospital providing care for over 2600 critically ill patients annually. These procedures include implementation of an automated sepsis surveillance initiative, augmentation of clinical decisions with a computerised sepsis protocol, strategies for direct exportation of quality-filtered data from the electronic medical record to a research database and robust long-term follow-up. This study has been registered at ClinicalTrials.gov, approved by the University of Florida Institutional Review Board and is actively enrolling subjects. Dissemination of results is forthcoming. © 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 granted.

  10. Effectiveness of facilitated introduction of a standard operating procedure into routine processes in the operating theatre: a controlled interrupted time series.

    Science.gov (United States)

    Morgan, Lauren; New, Steve; Robertson, Eleanor; Collins, Gary; Rivero-Arias, Oliver; Catchpole, Ken; Pickering, Sharon P; Hadi, Mohammed; Griffin, Damian; McCulloch, Peter

    2015-02-01

    Standard operating procedures (SOPs) should improve safety in the operating theatre, but controlled studies evaluating the effect of staff-led implementation are needed. In a controlled interrupted time series, we evaluated three team process measures (compliance with WHO surgical safety checklist, non-technical skills and technical performance) and three clinical outcome measures (length of hospital stay, complications and readmissions) before and after a 3-month staff-led development of SOPs. Process measures were evaluated by direct observation, using Oxford Non-Technical Skills II for non-technical skills and the 'glitch count' for technical performance. All staff in two orthopaedic operating theatres were trained in the principles of SOPs and then assisted to develop standardised procedures. Staff in a control operating theatre underwent the same observations but received no training. The change in difference between active and control groups was compared before and after the intervention using repeated measures analysis of variance. We observed 50 operations before and 55 after the intervention and analysed clinical data on 1022 and 861 operations, respectively. The staff chose to structure their efforts around revising the 'whiteboard' which documented and prompted tasks, rather than directly addressing specific task problems. Although staff preferred and sustained the new system, we found no significant differences in process or outcome measures before/after intervention in the active versus the control group. There was a secular trend towards worse outcomes in the postintervention period, seen in both active and control theatres. SOPs when developed and introduced by frontline staff do not necessarily improve operative processes or outcomes. The inherent tension in improvement work between giving staff ownership of improvement and maintaining control of direction needs to be managed, to ensure staff are engaged but invest energy in appropriate change

  11. Analytical method for the identification and assay of 12 phthalates in cosmetic products: application of the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques".

    Science.gov (United States)

    Gimeno, Pascal; Maggio, Annie-Françoise; Bousquet, Claudine; Quoirez, Audrey; Civade, Corinne; Bonnet, Pierre-Antoine

    2012-08-31

    Esters of phthalic acid, more commonly named phthalates, may be present in cosmetic products as ingredients or contaminants. Their presence as contaminant can be due to the manufacturing process, to raw materials used or to the migration of phthalates from packaging when plastic (polyvinyl chloride--PVC) is used. 8 phthalates (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP, and DiBP), classified H360 or H361, are forbidden in cosmetics according to the European regulation on cosmetics 1223/2009. A GC/MS method was developed for the assay of 12 phthalates in cosmetics, including the 8 phthalates regulated. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of phthalates is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30 m × 0.25 mm (i.d.) × 0.25 mm film thickness using a temperature gradient. Phthalate quantification is performed by external calibration using an internal standard. Validation elements obtained on standard solutions, highlight a satisfactory system conformity (resolution>1.5), a common quantification limit at 0.25 ng injected, an acceptable linearity between 0.5 μg mL⁻¹ and 5.0 μg mL⁻¹ as well as a precision and an accuracy in agreement with in-house specifications. Cosmetic samples ready for analytical injection are analyzed after a dilution in ethanol whereas more complex cosmetic matrices, like milks and creams, are assayed after a liquid/liquid extraction using ter-butyl methyl ether (TBME). Depending on the type of cosmetics analyzed, the common limits of quantification for the 12 phthalates were set at 0.5 or 2.5 μg g⁻¹. All samples were assayed using the analytical approach described in the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques". This analytical protocol is particularly adapted when it is not possible to make reconstituted sample matrices. Copyright © 2012

  12. Mathematical models of cytotoxic effects in endpoint tumor cell line assays: critical assessment of the application of a single parametric value as a standard criterion to quantify the dose-response effects and new unexplored proposal formats.

    Science.gov (United States)

    Calhelha, Ricardo C; Martínez, Mireia A; Prieto, M A; Ferreira, Isabel C F R

    2017-10-23

    The development of convenient tools for describing and quantifying the effects of standard and novel therapeutic agents is essential for the research community, to perform more precise evaluations. Although mathematical models and quantification criteria have been exchanged in the last decade between different fields of study, there are relevant methodologies that lack proper mathematical descriptions and standard criteria to quantify their responses. Therefore, part of the relevant information that can be drawn from the experimental results obtained and the quantification of its statistical reliability are lost. Despite its relevance, there is not a standard form for the in vitro endpoint tumor cell lines' assays (TCLA) that enables the evaluation of the cytotoxic dose-response effects of anti-tumor drugs. The analysis of all the specific problems associated with the diverse nature of the available TCLA used is unfeasible. However, since most TCLA share the main objectives and similar operative requirements, we have chosen the sulforhodamine B (SRB) colorimetric assay for cytotoxicity screening of tumor cell lines as an experimental case study. In this work, the common biological and practical non-linear dose-response mathematical models are tested against experimental data and, following several statistical analyses, the model based on the Weibull distribution was confirmed as the convenient approximation to test the cytotoxic effectiveness of anti-tumor compounds. Then, the advantages and disadvantages of all the different parametric criteria derived from the model, which enable the quantification of the dose-response drug-effects, are extensively discussed. Therefore, model and standard criteria for easily performing the comparisons between different compounds are established. The advantages include a simple application, provision of parametric estimations that characterize the response as standard criteria, economization of experimental effort and enabling

  13. A new reliable, transposable and cost-effective assay for absolute quantification of total plasmatic bevacizumab by LC-MS/MS in human plasma comparing two internal standard calibration approaches.

    Science.gov (United States)

    Legeron, Rachel; Xuereb, Fabien; Chaignepain, Stephane; Gadeau, Alain-Pierre; Claverol, Stephane; Dupuy, Jean-William; Djabarouti, Sarah; Couffinhal, Thierry; Schmitter, Jean-Marie; Breilh, Dominique

    2017-12-01

    The quantification of monoclonal antibodies (mAbs) such as bevacizumab, a recombinant humanized immunoglobulin G1 (hIgG1), in biological fluids, is an essential prerequisite to any pharmacokinetic preclinical and clinical study. To date, reference techniques used to quantify mAbs rely on enzyme-linked immunosorbent assay (ELISA) lacking specificity. Furthermore, the commercially available ELISA kit to quantify bevacizumab in human plasma only assesses the free fraction of the drug. However, the conditions of storage and analysis of plasma samples could alter the physiological equilibrium between the free, bound and partially bound forms of bevacizumab and this could result in over- or underestimation of drug concentration. We developed a new assay for absolute quantification of total fraction of bevacizumab by liquid chromatography tandem mass spectrometry (LC-MS/MS) basing identification and quantification of bevacizumab on two specific peptides. In this report we compare our assay with two internal standard (IS) calibration approaches: one using a different human mAb (Trastuzumab) and the other using a stable isotope labeled specific peptide. After enrichment by affinity chromatography on protein A and concentration by ultrafiltration, human plasma samples were proteolyzed by trypsin. Linearity was established from 12.5 to 500μg/mL with an interday accuracy ranging from 101.7 to 110.6% and precision from 7.0% to 9.9%. This study demonstrates the importance of the choice of the IS in quantifying bevacizumab in human plasma and highlights the difficulty of reaching a reliable proteolysis with a sufficient recovery. We developed a reliable and cost-effective LC-MS/MS method to quantify total plasmatic fraction of bevacizumab in human plasma. Through our development we proposed a generic methodology easily transposable to quantify all IgG1 subclass very useful for clinical pharmacokinetics studies. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. New approaches for the standardization and validation of a real-time qPCR assay using TaqMan probes for quantification of yellow fever virus on clinical samples with high quality parameters.

    Science.gov (United States)

    Fernandes-Monteiro, Alice G; Trindade, Gisela F; Yamamura, Anna M Y; Moreira, Otacilio C; de Paula, Vanessa S; Duarte, Ana Cláudia M; Britto, Constança; Lima, Sheila Maria B

    2015-01-01

    The development and production of viral vaccines, in general, involve several steps that need the monitoring of viral load throughout the entire process. Applying a 2-step quantitative reverse transcription real time PCR assay (RT-qPCR), viral load can be measured and monitored in a few hours. In this context, the development, standardization and validation of a RT-qPCR test to quickly and efficiently quantify yellow fever virus (YFV) in all stages of vaccine production are extremely important. To serve this purpose we used a plasmid construction containing the NS5 region from 17DD YFV to generate the standard curve and to evaluate parameters such as linearity, precision and specificity against other flavivirus. Furthermore, we defined the limits of detection as 25 copies/reaction, and quantification as 100 copies/reaction for the test. To ensure the quality of the method, reference controls were established in order to avoid false negative results. The qRT-PCR technique based on the use of TaqMan probes herein standardized proved to be effective for determining yellow fever viral load both in vivo and in vitro, thus becoming a very important tool to assure the quality control for vaccine production and evaluation of viremia after vaccination or YF disease.

  15. Radioimmunoassay and related procedures in medicine 1982

    International Nuclear Information System (INIS)

    1982-01-01

    Of the 77 papers submitted, 69 were included in INIS. The papers included in the proceedings cover the following sessions: reagents and separation procedures; assay for free hormones; assay for biological substances; assay for drugs; data processing; intralaboratory quality control; external surveillance of assay performance; assay service in developing countries; public health applications; clinical applications; alternatives to radioassay

  16. Standard procedure of operation for the accomplishment of audit of quality in facilities of teletherapy with isotopic units of 60Co

    International Nuclear Information System (INIS)

    Larrinaga Cortina, Eduardo F.; Dominguez Hung, Lourdes; Campa Menendez, Raudel

    2001-01-01

    The use of the radiotherapy implies the necessity of rigorous quality standards in its different components, aiming to provide the best possible treatment and avoid potential patient's risks, that could even cause his/her death. Projects of technical cooperation have been developed in Cuba support by the International Atomic Energy Agency addresses to the implementation of Programs of Quality Assurance in radiotherapy services. The establishment of the National Quality Audit Program (PNAC) is a superior stage. The National Control Center for Medical Devices as the national regulator entity for the control and supervision of medical devices in the National Health System is the responsible for the making and execution of the PNAC. The audit modality selected was the inspection visit in situ due to its intrinsic advantages, our geographical extension and the number of radiotherapy services. This paper presents the methodology for the execution of the PNAC, in form of a Normalized Procedure of Operation that defines the objectives, scope, terms and definitions, responsibilities, composition and selection of the auditor team, security's conditions, materials and equipment, steps of the audit execution, results calculation and interpretation, records, etc. (author)

  17. Kynetic resazurin assay (KRA) for bacterial quantification of foodborne pathogens

    Science.gov (United States)

    Arenas, Yaxal; Mandel, Arkady; Lilge, Lothar

    2012-03-01

    Fast detection of bacterial concentrations is important for the food industry and for healthcare. Early detection of infections and appropriate treatment is essential since, the delay of treatments for bacterial infections tends to be associated with higher mortality rates. In the food industry and in healthcare, standard procedures require the count of colony-forming units in order to quantify bacterial concentrations, however, this method is time consuming and reports require three days to be completed. An alternative is metabolic-colorimetric assays which provide time efficient in vitro bacterial concentrations. A colorimetric assay based on Resazurin was developed as a time kinetic assay (KRA) suitable for bacterial concentration measurements. An optimization was performed by finding excitation and emission wavelengths for fluorescent acquisition. A comparison of two non-related bacteria, foodborne pathogens Escherichia coli and Listeria monocytogenes, was performed in 96 well plates. A metabolic and clonogenic dependence was established for fluorescent kinetic signals.

  18. Postoperative pain medication requirements in patients undergoing computer-assisted (“Robotic”) and standard laparoscopic procedures for newly diagnosed endometrial cancer.

    Science.gov (United States)

    Leitao, Mario M; Malhotra, Vivek; Briscoe, Gabriel; Suidan, Rudy; Dholakiya, Priyal; Santos, Kevin; Jewell, Elizabeth L; Brown, Carol L; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Gardner, Ginger J

    2013-10-01

    patients who had undergone an RBT hysterectomy compared to a standard total LSC hysterectomy for benign indications.13 A recent cost analysis suggested that patients experienced less pain and required less pain medication use after RBT procedures compared to LSC for endometrial cancer.14 Based on these reports, we sought to analyze postoperative pain and the use of pain medication in patients undergoing RBT compared to standard transperitoneal LSC procedures for newly diagnosed endometrial cancer during a concurrent time period. Of note, current RBT surgery is not truly robotic in that it is not autonomous. A more appropriate term is “computer-assisted surgery,” but to satisfy current convention, we refer to it as “robotic surgery” in this manuscript.

  19. Standard operating procedures for collection of soil and sediment samples for the Sediment-bound Contaminant Resiliency and Response (SCoRR) strategy pilot study

    Science.gov (United States)

    Fisher, Shawn C.; Reilly, Timothy J.; Jones, Daniel K.; Benzel, William M.; Griffin, Dale W.; Loftin, Keith A.; Iwanowicz, Luke R.; Cohl, Jonathan A.

    2015-12-17

    An understanding of the effects on human and ecological health brought by major coastal storms or flooding events is typically limited because of a lack of regionally consistent baseline and trends data in locations proximal to potential contaminant sources and mitigation activities, sensitive ecosystems, and recreational facilities where exposures are probable. In an attempt to close this gap, the U.S. Geological Survey (USGS) has implemented the Sediment-bound Contaminant Resiliency and Response (SCoRR) strategy pilot study to collect regional sediment-quality data prior to and in response to future coastal storms. The standard operating procedure (SOP) detailed in this document serves as the sample-collection protocol for the SCoRR strategy by providing step-by-step instructions for site preparation, sample collection and processing, and shipping of soil and surficial sediment (for example, bed sediment, marsh sediment, or beach material). The objectives of the SCoRR strategy pilot study are (1) to create a baseline of soil-, sand-, marsh sediment-, and bed-sediment-quality data from sites located in the coastal counties from Maine to Virginia based on their potential risk of being contaminated in the event of a major coastal storm or flooding (defined as Resiliency mode); and (2) respond to major coastal storms and flooding by reoccupying select baseline sites and sampling within days of the event (defined as Response mode). For both modes, samples are collected in a consistent manner to minimize bias and maximize quality control by ensuring that all sampling personnel across the region collect, document, and process soil and sediment samples following the procedures outlined in this SOP. Samples are analyzed using four USGS-developed screening methods—inorganic geochemistry, organic geochemistry, pathogens, and biological assays—which are also outlined in this SOP. Because the SCoRR strategy employs a multi-metric approach for sample analyses, this

  20. Comparison of a standardized procedure with current laboratory practices for the detection of lupus anticoagulant in France. Working Group on Hemostasis of the Société Française de Biologie Clinique.

    Science.gov (United States)

    1993-11-15

    A multicenter study involving 13 laboratories was designed to compare a common procedure for screening lupus anticoagulants (LA) to the different practices currently in use in these laboratories. The common procedure combined 3 phospholipid-dependent assays, including mixing studies and a phospholipid neutralizing test. Due to the heterogeneity of LA expression, an abnormal result in at least one of the tests was sufficient to classify a sample as positive for LA. Consecutive samples referred for LA diagnosis were evaluated in parallel by each participant and the data found using the common procedure were analyzed independently according to mutually agreed cut-offs and criteria for sample classification. Within a period of 3 months, 535 samples were included, of which 147 were judged LA positive, 29 undetermined and 359 negative by the respective laboratories using their current practice. When using the common procedure, 149 plasmas were said to be positive, 38 undetermined and 348 negative. Absolute concordance occurred for 81% of the specimen population and absolute discordance (positive versus negative) for 7%. The level of agreement between the common procedure and the current practices, assessed by kappa indexes, indicated noticeable variations in the rates of detection from laboratory to laboratory. Among the different tests used in the common procedure, regular APTT was the least sensitive (about 50% detection) but none of the other tests alone recognized more than 73% of specimens from the LA positive population. This yield increased to about 90% with any combination of 2 sensitive tests.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Technical Note: Anatomic identification of isolated modern human molars: testing Procrustes aligned outlines as a standardization procedure for elliptic fourier analysis.

    Science.gov (United States)

    Corny, Julien; Détroit, Florent

    2014-02-01

    The determination of the precise position of permanent first and second modern human molars, following standard tooth identification criteria, is often difficult because of their morphological similarities. Here, we proposed to evaluate the suitability of two-dimensional crown contour shape analysis in achieving this objective. The method was tested separately on 180 first and second maxillary molars (UM) and 180 first and second mandibular molars (LM) securely identified (in anatomical position in their sockets). Generalized Procrustes superimposition is used to normalize the outlines prior to applying elliptic Fourier analyses ("EFAproc" method). Reliability and effectiveness of this morphometric procedure was evaluated by comparing the results obtained for the same dataset with four other morphometric methods of contour analysis. Cross-validated ("leave one individual out") percentages of misclassification yielded by linear discriminant analyses were used for determining the anatomic position of modern human molars. The percentages of misclassifications obtained from every method of contour analysis were low (1.67% to 3.33% for the UM, 5.56% to 6.67% for the LM) indicating the high suitability of crown contour analyses in correctly identifying molars. A reliable protocol, based on predictive linear discriminant analyses, was then proposed for identification of isolated molars. In addition, our results confirmed that the EFAproc method is suitable for normalizing outlines prior to undertaking elliptic Fourier analyses, especially in the case of nearly circular outlines: it obtained better classification than the classic method of normalization of Fourier descriptors for UM and provided also some advantages over the three landmarks-based methods tested here. Copyright © 2013 Wiley Periodicals, Inc.

  2. Chapter 2. Surge capacity and infrastructure considerations for mass critical care. Recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza epidemic or mass disaster

    NARCIS (Netherlands)

    Hick, John L.; Christian, Michael D.; Sprung, Charles L.; Camargo, Ruben; Ceraso, Daniel; Azoulay, Elie; Duguet, Alexandre; Guery, Benoit; Reinhart, Konrad; Adini, Bruria; Barlavie, Yaron; Benin-Goren, Odeda; Cohen, Robert; Klein, Motti; Leoniv, Yuval; Margalit, Gila; Rubinovitch, Bina; Sonnenblick, Moshe; Steinberg, Avraham; Weissman, Charles; Wolff, Donna; Kesecioglu, Jozef; de Jong, Menno; Moreno, Rui; An, Youzhong; Du, Bin; Joynt, Gavin M.; Colvin, John; Loo, Shi; Richards, Guy; Artigas, Antonio; Pugin, Jerome; Amundson, Dennis; Devereaux, Asha; Beigel, John; Danis, Marion; Farmer, Chris; Maki, Dennis; Masur, Henry; Rubinson, Lewis; Sandrock, Christian; Talmor, Daniel; Truog, Robert; Zimmerman, Janice; Brett, Steve; Montgomery, Hugh; Rhodes, Andrew; Sanderson, Frances; Taylor, Bruce; Monrgomery, Hugh

    2010-01-01

    To provide recommendations and standard operating procedures for intensive care unit (ICU) and hospital preparations for a mass disaster or influenza epidemic with a specific focus on surge capacity and infrastructure considerations. Based on a literature review and expert opinion, a Delphi process

  3. Liquid chromatography-tandem mass spectrometric assay for the nucleoside reverse transcriptase inhibitor emtricitabine in human plasma

    NARCIS (Netherlands)

    Sparidans, Rolf W.; Prins, Jan M.; Schellens, Jan H. M.; Beijnen, Jos H.

    2007-01-01

    A liquid chromatography-tandem mass spectrometric assay for the determination of the antiretroviral nucleoside emtricitabine in human plasma was developed and validated using a simple sample pre-treatment procedure. After addition of 5'-deoxy-5-fluorocytidine as the internal standard and protein

  4. Do English NHS Microbiology laboratories offer adequate services for the diagnosis of UTI in children? Healthcare Quality Improvement Partnership (HQIP) Audit of Standard Operational Procedures.

    Science.gov (United States)

    McNulty, Cliodna A M; Verlander, Neville Q; Moore, Philippa C L; Larcombe, James; Dudley, Jan; Banerjee, Jaydip; Jadresic, Lyda

    2015-09-01

    The National Institute of Care Excellence (NICE) 2007 guidance CG54, on urinary tract infection (UTI) in children, states that clinicians should use urgent microscopy and culture as the preferred method for diagnosing UTI in the hospital setting for severe illness in children under 3 years old and from the GP setting in children under 3 years old with intermediate risk of severe illness. NICE also recommends that all 'infants and children with atypical UTI (including non-Escherichia coli infections) should have renal imaging after a first infection'. We surveyed all microbiology laboratories in England with Clinical Pathology Accreditation to determine standard operating procedures (SOPs) for urgent microscopy, culture and reporting of children's urine and to ascertain whether the SOPs facilitate compliance with NICE guidance. We undertook a computer search in six microbiology laboratories in south-west England to determine urine submissions and urine reports in children under 3 years. Seventy-three per cent of laboratories (110/150) participated. Enterobacteriaceae that were not E. coli were reported only as coliforms (rather than non-E. coli coliforms) by 61% (67/110) of laboratories. Eighty-eight per cent of laboratories (97/110) provided urgent microscopy for hospital and 54% for general practice (GP) paediatric urines; 61% of laboratories (confidence interval 52-70%) cultured 1 μl volume of urine, which equates to one colony if the bacterial load is 106 c.f.u. l(-1). Only 22% (24/110) of laboratories reported non-E. coli coliforms and provided urgent microscopy for both hospital and GP childhood urines; only three laboratories also cultured a 5 μl volume of urine. Only one of six laboratories in our submission audit had a significant increase in urine submissions and urines reported from children less than 3 years old between the predicted pre-2007 level in the absence of guidance and the 2008 level following publication of the NICE guidance. Less than a

  5. The Salmonella Mutagenicity Assay: The Stethoscope of Genetic Toxicology for the 21st Century

    Science.gov (United States)

    Claxton, Larry D.; de A. Umbuzeiro, Gisela; DeMarini, David M.

    2010-01-01

    Objectives According to the 2007 National Research Council report Toxicology for the Twenty-First Century, modern methods (e.g., “omics,” in vitro assays, high-throughput testing, computational methods) will lead to the emergence of a new approach to toxicology. The Salmonella mammalian microsome mutagenicity assay has been central to the field of genetic toxicology since the 1970s. Here we document the paradigm shifts engendered by the assay, the validation and applications of the assay, and how the assay is a model for future in vitro toxicology assays. Data sources We searched PubMed, Scopus, and Web of Knowledge using key words relevant to the Salmonella assay and additional genotoxicity assays. Data extraction We merged the citations, removing duplicates, and categorized the papers by year and topic. Data synthesis The Salmonella assay led to two paradigm shifts: that some carcinogens were mutagens and that some environmental samples (e.g., air, water, soil, food, combustion emissions) were mutagenic. Although there are > 10,000 publications on the Salmonella assay, covering tens of thousands of agents, data on even more agents probably exist in unpublished form, largely as proprietary studies by industry. The Salmonella assay is a model for the development of 21st century in vitro toxicology assays in terms of the establishment of standard procedures, ability to test various agents, transferability across laboratories, validation and testing, and structure–activity analysis. Conclusions Similar to a stethoscope as a first-line, inexpensive tool in medicine, the Salmonella assay can serve a similar, indispensable role in the foreseeable future of 21st century toxicology. PMID:20682480

  6. Salmonella detection in poultry meat and meat products by the Vitek immunodiagnostic assay system easy Salmonella method, a LightCycler polymerase chain reaction system, and the International Organization for Standardization method 6579.

    Science.gov (United States)

    Temelli, S; Eyigor, A; Carli, K T

    2012-03-01

    This study was conducted to evaluate the capability of the Vitek immunodiagnostic assay system easy Salmonella (VIDAS ESLM) method and a specific real-time PCR system (LightCycler, LCPCR) to complement the International Organization for Standardization Method 6579 (ISO) in detecting Salmonella from a total of 105 naturally contaminated samples comprised of poultry meat and poultry meat products. The detection limit of ISO and LCPCR was 9 cfu/mL for both poultry meat and poultry meat products, whereas that of VIDAS ESLM with both sample types was determined to be 90 cfu/mL. Twelve (33.33%), 11 (30.55%), and 18 (50.00%) out of 36 poultry meat samples were positive for Salmonella by ISO, VIDAS ESLM, and LCPCR, respectively. Salmonella detection rates from poultry meat products were 5.80% for ISO and 8.69% for LCPCR, whereas none of these products tested positive by VIDAS ESLM. In poultry meat samples, VIDAS ESLM and LCPCR detection results were in substantial agreement with ISO, with the relative accuracy, sensitivity, and specificity rates of 97.2, 91.7, and 100%, respectively, for VIDAS ESLM and 83.3, 100, and 75%, respectively, for LCPCR. This is the first report on the evaluation of both VIDAS ESLM and LCPCR to complement ISO for the rapid detection of Salmonella in poultry meat and meat products. We determined that both VIDAS ESLM and LCPCR have the potential to complement the ISO standard culture method in the rapid screening of Salmonella from naturally contaminated poultry meats. For the poultry meat products, VIDAS ESLM and LCPCR can be used for rapid primary screening, and they should be complemented absolutely by ISO. Although LCPCR can preferentially be used for initial screening poultry meat products, the results should definitely be confirmed by ISO. Also, the VIDAS ESLM did not seem to be a suitable method for detecting Salmonella in poultry meat products.

  7. Comparison of IEEE383-2003 and IEC60505-2004 standards for harmonization of environmental qualification procedure of electric cable

    International Nuclear Information System (INIS)

    Kim, Jong Seog; Jeong, Sun Chul; Park, Kyung Heum; Jang, Kyung Nam

    2010-01-01

    Needs for harmonization of international equipment qualification(EQ) standards have been raised several years due to purchasing problem of nuclear equipment supplied from abroad country. To meet the regulatory requirement of domestic nuclear power plant, manufacturers have to qualify their equipment in accordance with each standard such as IEEE, IEC and RCC-E. Double qualification increase the equipment cost, which result in high construction cost. Even the unification of each standard have been discussed several years, we have got the long way to go yet. Comparison and harmonization of each international standard will give help to purchase the equipment qualified by not endorsed standard. Environmental qualification, seismic qualification and EMI/EMC qualification are major targets for harmonization. Since concern about cable qualification of 60 years life has been raised recently, harmonization of cable qualification standard also needs to be discussed. KEPRI launched a project for harmonization of EQ relative standards such as IEEE, IEC and RCC-E. A study for harmonization of IEEE323 and IEC60780 is known in progress by IEEE committee. In this paper, harmonization of international standards for cable qualification will be discussed. IEEE383 standard is qualification standard for electric cable broadly used in Asian pacific area while IEC60505 is mostly used in European area. Since these two standards have different requirements for environmental qualification of cable, problem can be happened in the plant site when they purchase cable qualified by not endorsed standard. IEEE383-2003 and IEC60505-2004 is the latest version of each standard. Comparison results and recommendations for harmonization of these two standards are introduced herein

  8. Assay of oestrogen

    International Nuclear Information System (INIS)

    Edwards, J.C.

    1981-01-01

    A particular problem with the direct radioimmunoassay of unconjugated oestriol in pregnancy is caused by the increased amount of steroid-binding proteins present in pregnancy serum and plasma. The steroid-binding proteins react with oestriol and 125 I-labelled oestriol during the assay procedure and the steroid-protein bound 125 I-labelled oestriol is precipitated along with the antibody-bound 125 I-labelled oestriol by the ammonium sulphate solution separation system. A novel method is described whereby progesterone (1-20 μg/ml) is used to block the action of steroid-binding proteins in pregnancy serum and plasma samples, thus minimizing interference in a direct radioimmunoassay for unconjugated oestriol using a specific anti-oestriol serum. (U.K.)

  9. Development of a solid-phase assay for measurement of proteolytic enzyme activity

    International Nuclear Information System (INIS)

    Varani, J.; Johnson, K.; Kaplan, J.

    1980-01-01

    A solid-phase, plate assay was developed for the measurement of proteolytic enzyme activity. In this assay procedure, radiolabeled substrates were dried onto the surface of microtiter wells. Following drying, the wells were washed two times with saline to remove the nonadherent substrate. When proteolytic enzymes were added to the wells, protein hydrolysis occurred, releasing radioactivity into the supernatant fluid. The amount of protein hydrolysis that occurred was reflected by the amount of radioactivity in the supernatant fluid. When 125 I-hemoglobin was used as the substrate, it was as susceptible to hydrolysis by trypsin in the solid-phase assay as it was in solution in a standard assay procedure. Protease activity from a variety of sources (including from viable cells as well as from extracellular sources) were also able to hydrolyze the hemoglobin on the plate. 125 I-Labeled serum albumen, fibrinogen, and rat pulmonary basement membrane were also susceptible to hydrolysis by trypsin in the solid phase. When [ 14 C]elastin was dried onto the plate, it behaved in a similar manner to elastin in solution. It was resistant to hydrolysis by nonspecific proteases such as trypsin and chymotrypsin but was highly susceptible to hydrolysis by elastase. The solid-phase plate assay has several features which recommended it for routine use. It is as sensitive as standard tube assays (and much more sensitive than routinely used colormetric assays). It is quick and convenient; there are no precipitation, centrifugation, or filtration steps. In addition, very small volumes of radioactive wastes are generated. Another advantage of the solid-phase plate assay is the resistance of the dried substrates to spontaneous breakdown and to microbial contamination. Finally, this assay is suitable for use with viable cells as well as for extracellular proteases

  10. A fluorimetric assay for cortisol.

    Science.gov (United States)

    Appel, Daniel; Schmid, Rolf D; Dragan, Calin-Aurel; Bureik, Matthias; Urlacher, Vlada B

    2005-09-01

    A simple, rapid and sensitive fluorimetric assay for the quantitative determination of cortisol is reported. The assay is based on the formation of a fluorescent dye when cortisol is incubated with a mixture of sulfuric acid and acetic acid. The fluorescence spectrum recorded for the resulting dye shows a maximum extinction at 475 nm and a maximum emission at 525 nm. The solvent 2-methyl-4-pentanone was used for extraction and was found to act as a fluorescence amplifier. A limit of detection of 2.7 muM was achieved, making it possible to forego solvent evaporation. The assay suffers minor interference from 11-deoxycortisol which exhibits low fluorescence at lambda (ex): 460 nm; lambda (em): 505 nm. Typical standard deviations were below 4%. We validated the assay using a biotransformation with recombinant Schizosaccharomyces pombe which regioselectively hydroxylates 11-deoxycortisol to cortisol. The method described herein is suitable for preliminary screening of microorganisms capable of steroid hydroxylation.

  11. Standards for holdup measurement

    International Nuclear Information System (INIS)

    Zucker, M.S.

    1982-01-01

    Holdup measurement, needed for material balance, depend intensively on standards and on interpretation of the calibration procedure. More than other measurements, the calibration procedure using the standard becomes part of the standard. Standards practical for field use and calibration techniques have been developed. While accuracy in holdup measurements is comparatively poor, avoidance of bias is a necessary goal

  12. Standard Operating Procedures and Field Methods Used for Conducting Ecological Risk Assessment Case Studies. Naval Construction Battalion Center, Davisville, Rhode Island, and Naval Shipyard, Portsmouth, Kittery, Maine.

    Science.gov (United States)

    1992-05-01

    Volume, ASTM STP 1027, U-M. Cowgill and L.R. Williams, Eds., American Society for Testing and Materials, Philadelphia, PA. Scott, K.J., Redmond, M.S...Assessment: Seventh Symposium, ASTM STP 854, R.D. Cardwell, R.Purdy, and R.C. Bahner (Eds.), American Society for Testing and Materials, Philadelphia, PA...method referred to as the Phagocytic Index and Killing Ability ( PIKA ) assay. This test is designed to quantify the level of activity, capacity, and

  13. Radiosotopic assay and binder therefor

    International Nuclear Information System (INIS)

    Caston, J.D.; Kamen, B.A.

    1976-01-01

    A rapid and less costly radioisotopic assay for measuring the concentration of folate in blood serum is described. This procedure utilizes 3 H-pteroylmonoglutamate, unlabeled 5-methyltetrahydrofolic acid, and a partially purified folate binder, such as for example a folate binder extracted from hog kidney. The procedure involves radioisotopically relating the bound amounts of a labeled folate and a known folate at various concentrations of the known folate in a system containing a predetermined amount of the labeled folate, a predetermined amount of the binder factor for the folates, and a predetermined amount of defolated test serum. 16 claims, 8 drawing figures

  14. Investigation into the dissolution and direct assay of high-fired plutonium dioxide

    International Nuclear Information System (INIS)

    Patterson, J.K.

    1976-01-01

    A fusion-melt and dissolution assay method has been developed and tested for the quantitative analysis of high-fired plutonium dioxide. The method employs fusion of the plutonium dioxide at temperatures greater than the melting point of an eutectic mixture of potassium pyrosulfate plus sodium peroxide. The resultant melt is then titrated directly by either controlled potential coulometry or a gravimetric titration, using standardized ceric sulfate as the titrant. It has been concluded from these investigations that by using the techniques described, high-fired plutonium dioxide (stochiometric) can be quantitatively dissolved and assayed to a degree heretofore beyond the state-of-the-art, while showing direct traceability to the Federal standards. After fusion, the dissolution and direct assay is applicable to existing routine analytical procedures. The method was designed so as to minimize physical handling, simplify the chemical operations, and maximize the personal safety of the analyst at an appreciable cost savings per analysis

  15. Standardization of biodosimetry operations

    International Nuclear Information System (INIS)

    Dainiak, Nicholas

    2016-01-01

    Methods and procedures for generating, interpreting and scoring the frequency of dicentric chromosomes vary among cytogenetic biodosimetry laboratories (CBLs). This variation adds to the already considerable lack of precision inherent in the dicentric chromosome assay (DCA). Although variability in sample collection, cell preparation, equipment and dicentric frequency scoring can never be eliminated with certainty, it can be substantially minimized, resulting in reduced scatter and improved precision. Use of standard operating procedures and technician exchange may help to mitigate variation. Although the development and adoption of international standards (ISO 21243 and ISO 19238) has helped to reduce variation in standard operating procedures (SOPs), all CBLs must maintain process improvement, and those with challenges may require additional assistance. Sources of variation that may not be readily apparent in the SOPs for sample collection and processing include variability in ambient laboratory conditions, media, serum lot and quantity and the use of particular combinations of cytokines. Variability in maintenance and calibration of metafer equipment, and in scoring criteria, reader proficiency and personal factors may need to be addressed. The calibration curve itself is a source of variation that requires control, using the same known-dose samples among CBLs, measurement of central tendency, and generation of common curves with periodic reassessment to detect drifts in dicentric yield. Finally, the dose estimate should be based on common scoring criteria, using of the z-statistic. Although theoretically possible, it is practically impossible to propagate uncertainty over the entire calibration curve due to the many factors contributing to variance. Periodic re-evaluation of the curve is needed by comparison with newly published curves (using statistical analysis of differences) and determining their potential causes. (author)

  16. Tools, harmonization and standardization procedures of the impact and outcome evaluation indices obtained during a kindergarten-based, family-involved intervention to prevent obesity in early childhood: the ToyBox-study.

    Science.gov (United States)

    Mouratidou, T; Miguel, M L; Androutsos, O; Manios, Y; De Bourdeaudhuij, I; Cardon, G; Kulaga, Z; Socha, P; Galcheva, S; Iotova, V; Payr, A; Koletzko, B; Moreno, L A

    2014-08-01

    The ToyBox-intervention is a kindergarten-based, family-involved intervention targeting multiple lifestyle behaviours in preschool children, their teachers and their families. This intervention was conducted in six European countries, namely Belgium, Bulgaria, Germany, Greece, Poland and Spain. The aim of this paper is to provide a descriptive overview of the harmonization and standardization procedures of the baseline and follow-up evaluation of the study (and substudies). Steps related to the study's operational, standardization and harmonization procedures as well as the impact and outcome evaluation assessment tools used are presented. Experiences from the project highlight the importance of safeguarding the measurement process to minimize data heterogeneity derived from potential measurement error and country-by-country differences. In addition, it was made clear that continuing quality control and support is an important component of such studies. For this reason, well-supported communication channels, such as regular email updates and teleconferences, and regular internal and external meetings to ensure smooth and accurate implementation were in place during the study. The ToyBox-intervention and its harmonized and standardized procedures can serve as a successful case study for future studies evaluating the efficacy of similar interventions. © 2014 World Obesity.

  17. Study of verification and validation of standard welding procedure specifications guidelines for API 5L X-70 grade line pipe welding

    Directory of Open Access Journals (Sweden)

    Qazi H. A. A.

    2017-12-01

    Full Text Available Verification and validation of welding procedure specifications for X-70 grade line pipe welding was performed as per clause 8.2, Annexure B and D of API 5L, 45th Edition to check weld integrity in its future application conditions. Hot rolled coils were imported from China, de-coiling, strip edge milling, three roller bending to from pipe, inside and outside submerged arc welding of pipe, online ultrasonic testing of weld, HAZ and pipe body, cutting at fixed random length of pipe, visual inspection of pipe, Fluoroscopic inspection of pipe, welding procedure qualification test pieces marking at weld portion of the pipe, tensile testing, guided bend testing, CVN Impact testing were performed. Detailed study was conducted to explore possible explanations and variation in mechanical properties, WPS is examined and qualified as per API 5L 45th Edition.

  18. Development and Monte Carlo Study of a Procedure for Correcting the Standardized Mean Difference for Measurement Error in the Independent Variable

    Science.gov (United States)

    Nugent, William Robert; Moore, Matthew; Story, Erin

    2015-01-01

    The standardized mean difference (SMD) is perhaps the most important meta-analytic effect size. It is typically used to represent the difference between treatment and control population means in treatment efficacy research. It is also used to represent differences between populations with different characteristics, such as persons who are…

  19. The procedure of evaluating the practical adhesion strength of new biocompatible nano- and micro-thin films in accordance with international standards

    Czech Academy of Sciences Publication Activity Database

    Kutílek, P.; Mikšovský, Jan

    2011-01-01

    Roč. 13, č. 3 (2011), s. 87-94 ISSN 1509-409X Institutional research plan: CEZ:AV0Z10100522 Keywords : practical adhesion * strength * nano-layer * micro-layer * international standards * scratch test Subject RIV: BM - Solid Matter Physics ; Magnetism Impact factor: 0.449, year: 2011 http://382.indexcopernicus.com/abstracted.php?level=5&ICID=962671

  20. Procedure for the standardized measure of the detective quantum efficiency in digital mammography; Procedimiento para la medida estandarizada de la Eficiencia Cuantica de Deteccion en un mamografo digital

    Energy Technology Data Exchange (ETDEWEB)

    Rodriguez Martin, G.; Garcia Castano, P.; Bermudez Luna, R.; Fernandez Bedoya, V.; Espana Lopez, M. L.; Miquelez Alonso, S.

    2011-07-01

    The objective of this work is to develop a simple guide for determining the DQE, according to the CEI, in those having mammography flat panel detectors, and highlight the main difficulties that may be in the process of the standardized measurement.

  1. Collaborative study for the calibration of a replacement International Standard for Tetanus Toxoid Adsorbed.

    Science.gov (United States)

    Tierney, Rob; Stickings, Paul; Hockley, Jason; Rigsby, Peter; Iwaki, Masaaki; Sesardic, Dorothea

    2011-11-01

    We present the results of a collaborative study for the establishment of a replacement International Standard (IS) for Tetanus Toxoid Adsorbed. Two candidate preparations were included in the study, one of which was established as the 4th IS for Tetanus Toxoid Adsorbed at the WHO Expert Committee on Biological Standardization meeting in October 2010. This preparation was found to have a unitage of 490 IU/ampoule, based on calibration in guinea pig challenge assays. Results from mouse challenge assays suggest that the relative performance of two candidate preparations may differ significantly between guinea pigs and mice. The authors note that the number of laboratories that performed guinea pig challenge assays, which are used to calibrate and assign IU, is much lower than in previous collaborative studies and this may have implications for calibration of replacement standards in the future. The issue of assigning separate units to the IS for guinea pig and mouse assays is discussed. The study also assessed performance of the replacement standard in serological assays which are used as alternative procedures to challenge assays for tetanus potency testing. Results suggest that the replacement standard is suitable for use as the reference vaccine in serological assays. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  2. Relevant Standards

    Indian Academy of Sciences (India)

    .86: Ethernet over LAPS. Standard in China and India. G.7041: Generic Framing Procedure (GFP). Supports Ethernet as well as other data formats (e.g., Fibre Channel); Protocol of ... IEEE 802.3x for flow control of incoming Ethernet data ...

  3. Developing policies and procedures.

    Science.gov (United States)

    Randolph, Susan A

    2006-11-01

    The development of policies and procedures is an integral part of the occupational health nurse's role. Policies and procedures serve as the foundation for the occupational health service and are based on its vision, mission, culture, and values. The design and layout selected for the policies and procedures should be simple, consistent, and easy to use. The same format should be used for all existing and new policies and procedures. Policies and procedures should be reviewed periodically based on a specified time frame (i.e., annually). However, some policies may require a more frequent review if they involve rapidly changing external standards, ethical issues, or emerging exposures.

  4. Ecogenotoxicity testing of aquatic environment by comet assay in plants

    Directory of Open Access Journals (Sweden)

    Anita Mukherjee

    2015-05-01

    Full Text Available One of the goals of environmental monitoring is the detection of potentially hazardous compounds in water. We have set up a standard method to apply the Comet assay in aquatic plants that could be of great interest to evaluate cytotoxicity, genotoxicity and oxidative stress on the same species regarded as most sensitive to environmental pollutants. The aim of the present study was to set up of standardized procedure to evaluate genotoxicity in aquatic plants- Ceratophyllum demersum one that is submerged free floating and the other is Lemna minor - a fresh water floating plant by Comet assay. Electrophoresis and unwinding times were adapted to obtain minimum DNA migration evaluated as tail intensity % or tail moment in the control group and, at the same time maximum sensitivity for DNA damage with known genotoxicants. We further investigated the cytotoxicity and oxidative stress induced in the same species. Based on the repeatability of results obtained we suggest that Ceratophyllum, Lemna can serve as model species and Comet assay could be adopted to monitor the eco-genotoxicity of water pollutants.

  5. An improved method for staining cell colonies in clonogenic assays.

    Science.gov (United States)

    Guda, Kishore; Natale, Leanna; Markowitz, Sanford D

    2007-06-01

    Clonogenic assay is a widely used experimental approach to test for the effects of drugs/genes on the growth and proliferative characteristics of cells in vitro. Accurate quantitation of treatment effects in clonogeneic assays depends on the ability to visualize and count cell colonies precisely. We report a novel method (referred as ETeB) for staining cell colonies grown on plastic and specially coated substrates like collagen. Using colon cancer cell lines grown on plastic and collagen, we compared the colony staining efficiencies of the widely used methylene blue, and Ethidium bromide (ETeB) stains. Results show that the ETeB protocol works well on plastic and is extremely effective for staining colonies on collagen when compared to methylene blue. The key features and advantages of ETeB technique are; (a) reduction in background for colonies grown on collagen and possibly other substrates, (b) the whole procedure takes less than a minute, (c) no post-stain washing step is required which eliminates colony losses for cell lines that are loosely adherent, (d) colony visualization and counting can be done immediately following the staining procedure using a standard UV illuminator and software, and (e) the method works across a wide variety of cell lines. The simplicity and robustness of this procedure should warrant its usage in both small and large-scale clonogenic experiments.

  6. Consent for routine neonatal procedures: A study of practices in Irish neonatal units. How do we compare with the gold standard BAPM guidelines?

    LENUS (Irish Health Repository)

    Ryan, M A

    2017-06-01

    The Irish National Consent Policy (NCP)¹ proposes that the legal requirement for consent extends to all forms of interventions, investigations and treatment, carried out on or behalf of the Health Service Executive (HSE). This study employs a quantitative descriptive approach to investigate the practices for obtaining consent for an identified group of routine neonatal procedures in neonatal facilities throughout Ireland. The BAPM (British Association of Perinatal Medicine)² guidelines were identified as ‘gold standard’ for the purposes of this study. The results indicated a lack of consistency between participating units pertaining to the modes of consent utilised and notable variances from ‘gold standard’ guidelines. Unanimity was evident for 3 procedures only (administering BCG, 6-in-1, and donor breast milk to infant). Significant findings related to EEG with video recordings, MRI\\/CT and gastro intestinal imaging, screening of an infant with suspected substance abuse or retinopathy of prematurity screening (ROP), administration of Vitamin K, and the carrying out of a lumbar puncture.

  7. 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

  8. Elaboration and implementation of standard operational procedure for quality assurance of cone beam CT image in radiotherapy; Elaboracao e implementacao de procedimentos operacionais padrao para controle de qualidade da imagem CBCT em radioterapia

    Energy Technology Data Exchange (ETDEWEB)

    Bonatto, Larisse N.; Estacio, Daniela R.; Lopes, Juliane S.; Sansson, Angela; Duarte, Lucas O.; Sbaraini, Patricia; Silva, Ana M. Marques da; Streck, Elaine E., E-mail: larisse.neumann@pucrs.br [Pontificia Universidade Catolica do Rio Grande do Sul (PUC-RS), Porto Alegre, RS (Brazil)

    2016-07-01

    The objective of this article is to present the implementation of the quality Control of Cone Beam Computed Tomography (CBCT) image, generated by the On-Board Imager, integrated with the linear accelerator Trilogy. Standard operating procedures (POPs) have been developed based on the literature and manuals of the simulator object Catphan 504 and the On-Board Imager. The following POPs were developed: acquisition of the CBCT image; linearity of CT number; uniformity; spatial resolution; low contrast resolution; spatial linearity; thickness of the cut. The validation of the elaborated procedures was done from an experimental acquisition of the simulator object. The results obtained in the validation of the POPs are in compliance with the parameters established by the manufacturer of the simulator object, as well as those obtained in the acceptance of the On-Board Imager device.

  9. Elaboration and implementation of standard operational procedure for quality assurance of cone beam CT image in radiotherapy; Elaboracao e implementacao de procedimentos operacionais padrao para controle de qualidade da imagem CBCT em radioterapia

    Energy Technology Data Exchange (ETDEWEB)

    Bonatto, Larisse N.; Estacio, Daniela R.; Lopes, Juliane S.; Sansson, Angela; Duarte, Lucas O.; Sbaraini, Patricia, E-mail: larisse.neumann@pucrs.br [Hospital Sao Lucas (PUC-RS), Porto Alegre, RS (Brazil). Servico de Radioterapia; Silva, Ana M. Marques da; Streck, Elaine E. [Pontificia Universidade Catolica do Rio Grande do Sukl (PUC-RS), Porto Alegre, RS (Brazil). Faculdade de Fisica

    2016-07-01

    The aim of this paper is to present the implementation of image quality control of the computed tomography cone beam (CBCT), generated by the On-Board Imager device, and integrated into the linear accelerator Trilogy. To this end, standard operating procedures (SOP) based on the literature and Catphan 504 phantom and On-Board Imager manuals were drafted. The following SOPs were prepared: acquisition of CBCT image; CT number linearity; uniformity; spatial resolution; low contrast resolution; spatial linearity; slice thickness. The validation of the procedures from an experimental acquisition of the phantom was performed. The results, obtained in the SOP validation, are in accordance with the parameters established by the phantom manufacturer, as well as those obtained in the On-Board Imager device acceptance. (author)

  10. Balancing energy conservation and occupant needs in ventilation rate standards for Big Box stores and other commercial buildings in California. Issues related to the ASHRAE 62.1 Indoor Air Quality Procedure

    Energy Technology Data Exchange (ETDEWEB)

    Mendell, Mark J. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Apte, Mike G. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2010-10-31

    This report considers the question of whether the California Energy Commission should incorporate the ASHRAE 62.1 ventilation standard into the Title 24 ventilation rate (VR) standards, thus allowing buildings to follow the Indoor Air Quality Procedure. This, in contrast to the current prescriptive standard, allows the option of using ventilation rate as one of several strategies, which might include source reduction and air cleaning, to meet specified targets of indoor air concentrations and occupant acceptability. The research findings reviewed in this report suggest that a revised approach to a ventilation standard for commercial buildings is necessary, because the current prescriptive ASHRAE 62.1 Ventilation Rate Procedure (VRP) apparently does not provide occupants with either sufficiently acceptable or sufficiently healthprotective air quality. One possible solution would be a dramatic increase in the minimum ventilation rates (VRs) prescribed by a VRP. This solution, however, is not feasible for at least three reasons: the current need to reduce energy use rather than increase it further, the problem of polluted outdoor air in many cities, and the apparent limited ability of increasing VRs to reduce all indoor airborne contaminants of concern (per Hodgson (2003)). Any feasible solution is thus likely to include methods of pollutant reduction other than increased outdoor air ventilation; e.g., source reduction or air cleaning. The alternative 62.1 Indoor Air Quality Procedure (IAQP) offers multiple possible benefits in this direction over the VRP, but seems too limited by insufficient specifications and inadequate available data to provide adequate protection for occupants. Ventilation system designers rarely choose to use it, finding it too arbitrary and requiring use of much non-engineering judgment and information that is not readily available. This report suggests strategies to revise the current ASHRAE IAQP to reduce its current limitations. These

  11. BTS statistical standards manual

    Science.gov (United States)

    2005-10-01

    The Bureau of Transportation Statistics (BTS), like other federal statistical agencies, establishes professional standards to guide the methods and procedures for the collection, processing, storage, and presentation of statistical data. Standards an...

  12. Solid phase inclusive immunoradiometric assay for human chorionic gonadotropin using monoclonal antibodies

    International Nuclear Information System (INIS)

    Vrinda, P.C.; Paradkar, S.N.; Nagvekar, U.H.; Samuel, G.; Sivaprasad, N.

    2005-01-01

    A simple, one step, inclusive immunoradiometric assay for human chorionic gonadotropin (hCG) employing monoclonal antibodies is described. Commercially available monoclonal antibodies from various commercial sources were screened. Identified 'detection' antibody was radiolabeled with 125 I and the selected 'capture' antibody was chemically coupled to magnetizable cellulose to form a solid phase. In the procedure developed, standard/sample, radiolabeled antibody and capture antibody were incubated together for 3 hours at room temperature with shaking. After incubation, the bound complex was quantitated for the associated radioactivity. The analytical sensitivity observed was 1.0 mIU/ml with a wide concentration range up to 1000 mIU/ml of hCG. 'High dose hook' of the developed assay was observed beyond 2000 mIU/ml. Results showed that the developed assay had a good precision: intra-assay CV less than 8%, inter-assay CV less than 10% and good analytical recovery of 97-109%. The clinical samples analyzed by the developed procedure showed a good correlation with that of the commercial kit (r = 0.92; y = 0.99x+0.51). (author)

  13. 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.

  14. Development of a Cell-Based Functional Assay for the Detection of Clostridium botulinum Neurotoxin Types A and E

    Directory of Open Access Journals (Sweden)

    Uma Basavanna

    2013-01-01

    Full Text Available The standard procedure for definitive detection of BoNT-producing Clostridia is a culture method combined with neurotoxin detection using a standard mouse bioassay (MBA. The mouse bioassay is highly sensitive and specific, but it is expensive and time-consuming, and there are ethical concerns due to use of laboratory animals. Cell-based assays provide an alternative to the MBA in screening for BoNT-producing Clostridia. Here, we describe a cell-based assay utilizing a fluorescence reporter construct expressed in a neuronal cell model to study toxin activity in situ. Our data indicates that the assay can detect as little as 100 pM BoNT/A activity within living cells, and the assay is currently being evaluated for the analysis of BoNT in food matrices. Among available in vitro assays, we believe that cell-based assays are widely applicable in high-throughput screenings and have the potential to at least reduce and refine animal assays if not replace it.

  15. Novel double-isotope technique for enzymatic assay of catecholamines, permitting high precision, sensitivity and plasma sample capacity

    International Nuclear Information System (INIS)

    Brown, M.J.; Jenner, D.A.

    1981-01-01

    A novel use of a double-isotope method is described which allows radioenzymatic assays to combine precision and sensitivity. In the catechol O-methyltransferase assay separate portions of each plasma sample are incubated with either S-[ 3 H]- or S-[ 14 C]-adenosyl-L-methionine. Standards of noradrenaline and adrenaline are added to the latter portions and are thus converted into standards of [ 14 C]metadrenalines. These are added to the 3 H-labelled portions after the incubation, where they function as tracers. The final recovery of 14 C radioactivity corrects for (a) the efficiency of methylation in the plasma sample concerned and (b) the recovery of metadrenalines during the extraction procedures. The 3 H/ 14 C ratio is constant in each assay for a given catecholamine concentration and is determined for samples to which standards of noradrenaline and adrenaline are added to the 3 H- (as well as the 14 C-) labelled portions before the initial incubation. The sensitivity of the assay is increased by using high specific radioactivity S-[ 3 H]adenosyl-L-methionine, and low backgrounds are maintained by catecholamine depletion in vivo in the rats used for enzyme preparation. Both catecholamines (1.5 pg/ml; 10 pmol/l) may be detected; the coefficients of variation are 3.0 and 3.2% for noradrenaline and adrenaline respectively (intra-assay) and 4.6 and 5.0% (inter-assay). (author)

  16. Radiometric assays for glycerol, glucose, and glycogen

    International Nuclear Information System (INIS)

    Bradley, D.C.; Kaslow, H.R.

    1989-01-01

    We have developed radiometric assays for small quantities of glycerol, glucose and glycogen, based on a technique described by Thorner and Paulus for the measurement of glycerokinase activity. In the glycerol assay, glycerol is phosphorylated with [32P]ATP and glycerokinase, residual [32P]ATP is hydrolyzed by heating in acid, and free [32P]phosphate is removed by precipitation with ammonium molybdate and triethylamine. Standard dose-response curves were linear from 50 to 3000 pmol glycerol with less than 3% SD in triplicate measurements. Of the substances tested for interference, only dihydroxyacetone gave a slight false positive signal at high concentration. When used to measure glycerol concentrations in serum and in media from incubated adipose tissue, the radiometric glycerol assay correlated well with a commonly used spectrophotometric assay. The radiometric glucose assay is similar to the glycerol assay, except that glucokinase is used instead of glycerokinase. Dose response was linear from 5 to 3000 pmol glucose with less than 3% SD in triplicate measurements. Glucosamine and N-acetylglucosamine gave false positive signals when equimolar to glucose. When glucose concentrations in serum were measured, the radiometric glucose assay agreed well with hexokinase/glucose-6-phosphate dehydrogenase (H/GDH)-based and glucose oxidase/H2O2-based glucose assays. The radiometric method for glycogen measurement incorporates previously described isolation and digestion techniques, followed by the radiometric assay of free glucose. When used to measure glycogen in mouse epididymal fat pads, the radiometric glycogen assay correlated well with the H/GDH-based glycogen assay. All three radiometric assays offer several practical advantages over spectral assays

  17. Lack of standardization in the procedures for mycological examination of sputum samples from CF patients: a possible cause for variations in the prevalence of filamentous fungi.

    Science.gov (United States)

    Borman, Andrew M; Palmer, Michael D; Delhaes, Laurence; Carrère, Jacqueline; Favennec, Loïc; Ranque, Stéphane; Gangneux, Jean-Pierre; Horré, Regine; Bouchara, Jean-Philippe

    2010-11-01

    Filamentous fungi and yeasts are increasingly isolated from respiratory secretions of patients with cystic fibrosis (CF), and persistent fungal colonization of the airways of such patients is thought to exacerbate lung damage. While many independent studies have identified Aspergillus fumigatus complex as the principal colonizing fungus in CF, increased awareness of the role of fungi in CF pathology coupled with improved mycological culture and identification methods have resulted in a number of other fungi being isolated and reported from CF sputum samples, including A. terreus, members of the Pseudallescheria boydii/Scedosporium apiospermum complex, Exophiala dermatitidis, Paecilomyces and Penicillium species. However, the range of fungal pathogens isolated and the relative prevalence of individual species vary widely between reports from different geographical CF centres, and as yet no standardized method for the mycological examination of CF sputum samples has been adopted. Here, we examine the potential contribution of the mycological methods employed to examine CF respiratory secretions relative to the variability in the fungal biota reported. The role of direct microscopic examination of respiratory samples and the impact of the culture conditions used on the detection of specific fungal pathogens are addressed, and the potential significance of isolation of yeast species from CF patient airways is discussed.

  18. Problems with the PTH assays.

    Science.gov (United States)

    Cavalier, Etienne; Delanaye, Pierre; Nyssen, Laurent; Souberbielle, Jean-Claude

    2015-05-01

    Even if the first assay for parathyroid hormone (PTH) was published in the early 1960s, its determination remains a challenge even today. Indeed, in the circulation, PTH is present in its active form (PTH 1-84), but many PTH fragments can also be present. These fragments accumulate when renal function declines and are recognized, at different extents, by the 2nd generation ("intact") PTH assays that are widely used in the clinical laboratories. Some assays, called "3rd generation PTH" do not recognize these fragments, but are not available everywhere. Hence, different problems are also linked with PTH determination. Among them, one can cite the lack of a reference method, the lack of standardization of the assays and, sometimes, the lack of consistent reference range. We can also point out stability problems and a large intra-individual variation. A workgroup is working on these problems under the auspices of the IFCC and we hope that some of these problems will be resolved in the next years. In this article, we will discuss all the possible issues of PTH determination. Copyright © 2015. Published by Elsevier Masson SAS.

  19. Automation of the dicentric chromosome assay and related assays

    International Nuclear Information System (INIS)

    Balajee, Adayabalam S.; Dainiak, Nicholas

    2016-01-01

    Dicentric Chromosome Assay (DCA) is considered to be the 'gold standard' for personalized dose assessment in humans after accidental or incidental radiation exposure. Although this technique is superior to other cytogenetic assays in terms of specificity and sensitivity, its potential application to radiation mass casualty scenarios is highly restricted because DCA is time consuming and labor intensive when performed manually. Therefore, it is imperative to develop high throughput automation techniques to make DCA suitable for radiological triage scenarios. At the Cytogenetic Biodosimetry Laboratory in Oak Ridge, efforts are underway to develop high throughput automation of DCA. Current status on development of various automated cytogenetic techniques in meeting the biodosimetry needs of radiological/nuclear incident(s) will be discussed

  20. Radiometric--microbiologic assay of vitamin B-6: application to food analysis

    International Nuclear Information System (INIS)

    Guilarte, T.R.; Shane, B.; McIntyre, P.A.

    1981-01-01

    A radiometric microbiologic assay for vitamin B-6 was applied to food analysis. The method was shown to be specific, reproducible and simpler than the standard turbidimetric microbiologic technique. The analysis of seven commercially available breakfast cereals was compared to a high performance liquid chromatography method. Three out of the seven cereals agreed when assayed with both methods (P greater than 0.1). Four cereals, however, differed in value considerably (P less than 0.05). Further studies are required to determine whether these differences were due to different extraction procedures used. The study showed that the new radiometric-microbiologic method can be used to measure total vitamin B-6 or, combined with a column separation procedure, to analyze for specific forms of the vitamin

  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. Absolute nuclear material assay

    Science.gov (United States)

    Prasad, Manoj K [Pleasanton, CA; Snyderman, Neal J [Berkeley, CA; Rowland, Mark S [Alamo, CA

    2012-05-15

    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.

  3. Tricyclic antidepressant radioreceptor assay

    International Nuclear Information System (INIS)

    Innis, R.B.; Tune, L.; Rock, R.; Depaulo, R.; U'Prichard, D.C.; Snyder, S.M.

    1979-01-01

    A receptor assay for tricyclic antidepressants described here is based on the ability of these drugs to compete with [ 3 H]-3-guinuclidnyl benzilate ( 3 H-QNB) for binding to muscarinic cholinergic receptors in rat brain membranes. The assay is sensitive, in that it can detect, for example, 2ng/ml nortriptyline in plasma. Seven plasma samples from depressed patients treated with nortriptyline were assayed with the radioreceptor and gas liquid chromatographic methods, and the results from these two methods were almost identical. This assay should be used cautiously, if at all, in patients treated with other drugs that have potent anticholinergic effects. (Auth.)

  4. Application of radioimmunoassay procedures to the control of therapy and to the detection of pre-clinical stages in diabetes mellitus. Part of a coordinated programme on in vitro assay techniques

    International Nuclear Information System (INIS)

    Yorukoglu, S.N.; Cambazoglu, A.M.

    1975-12-01

    Radioimmunoassay was used in early detection of pre- and latent diabetes mellitus in cases of parental diabetes, and for diabetes screening of pregnant women with a history of large babies, habitual abortus, and parental diabetes. A total of 106 cases (28 men and 78 women, of whom 26 were pregnant, belonging to various age groups) were investigated. They were grouped as follows: normal, obese with no familial history of diabetes, pre-diabetes suspected in obese and normal weight cases, and latent diabetic obese and normal weight cases. The standard OGTT was applied throughout, and serum IRI values at fasting were determined after 30, 60, 120 and 180 minutes, using a double antibody technique (Hales and Nandle). The serum IRI values on fasting and during OGTT were considerably higher in obese cases, whether diabetic or not, than in normal and non-diabetic groups. Similar results were observed for the pregnant group

  5. Optimized in vitro procedure for assessing the cytocompatibility of magnesium-based biomaterials.

    Science.gov (United States)

    Jung, Ole; Smeets, Ralf; Porchetta, Dario; Kopp, Alexander; Ptock, Christoph; Müller, Ute; Heiland, Max; Schwade, Max; Behr, Björn; Kröger, Nadja; Kluwe, Lan; Hanken, Henning; Hartjen, Philip

    2015-09-01

    Magnesium (Mg) is a promising biomaterial for degradable implant applications that has been extensively studied in vitro and in vivo in recent years. In this study, we developed a procedure that allows an optimized and uniform in vitro assessment of the cytocompatibility of Mg-based materials while respecting the standard protocol DIN EN ISO 10993-5:2009. The mouse fibroblast line L-929 was chosen as the preferred assay cell line and MEM supplemented with 10% FCS, penicillin/streptomycin and 4mM l-glutamine as the favored assay medium. The procedure consists of (1) an indirect assessment of effects of soluble Mg corrosion products in material extracts and (2) a direct assessment of the surface compatibility in terms of cell attachment and cytotoxicity originating from active corrosion processes. The indirect assessment allows the quantification of cell-proliferation (BrdU-assay), viability (XTT-assay) as well as cytotoxicity (LDH-assay) of the mouse fibroblasts incubated with material extracts. Direct assessment visualizes cells attached to the test materials by means of live-dead staining. The colorimetric assays and the visual evaluation complement each other and the combination of both provides an optimized and simple procedure for assessing the cytocompatibility of Mg-based biomaterials in vitro. Copyright © 2015 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

  6. 21 CFR 864.7415 - Abnormal hemoglobin assay.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864... hemoglobin assay. (a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents... hemoglobin types. (b) Classification. Class II (performance standards). [45 FR 60618, Sept. 12, 1980] ...

  7. Statistical Evaluation of HTS Assays for Enzymatic Hydrolysis of β-Keto Esters.

    Directory of Open Access Journals (Sweden)

    O Buß

    Full Text Available β-keto esters are used as precursors for the synthesis of β-amino acids, which are building blocks for some classes of pharmaceuticals. Here we describe the comparison of screening procedures for hydrolases to be used for the hydrolysis of β-keto esters, the first step in the preparation of β-amino acids. Two of the tested high throughput screening (HTS assays depend on coupled enzymatic reactions which detect the alcohol released during ester hydrolysis by luminescence or absorption. The third assay detects the pH shift due to acid formation using an indicator dye. To choose the most efficient approach for screening, we assessed these assays with different statistical methods-namely, the classical Z'-factor, standardized mean difference (SSMD, the Kolmogorov-Smirnov-test, and t-statistics. This revealed that all three assays are suitable for HTS, the pH assay performing best. Based on our data we discuss the explanatory power of different statistical measures. Finally, we successfully employed the pH assay to identify a very fast hydrolase in an enzyme-substrate screening.

  8. Quantization Procedures

    International Nuclear Information System (INIS)

    Cabrera, J. A.; Martin, R.

    1976-01-01

    We present in this work a review of the conventional quantization procedure, the proposed by I.E. Segal and a new quantization procedure similar to this one for use in non linear problems. We apply this quantization procedures to different potentials and we obtain the appropriate equations of motion. It is shown that for the linear case the three procedures exposed are equivalent but for the non linear cases we obtain different equations of motion and different energy spectra. (Author) 16 refs

  9. Endogenous Locus Reporter Assays.

    Science.gov (United States)

    Liu, Yaping; Hermes, Jeffrey; Li, Jing; Tudor, Matthew

    2018-01-01

    Reporter gene assays are widely used in high-throughput screening (HTS) to identify compounds that modulate gene expression. Traditionally a reporter gene assay is built by cloning an endogenous promoter sequence or synthetic response elements in the regulatory region of a reporter gene to monitor transcriptional activity of a specific biological process (exogenous reporter assay). In contrast, an endogenous locus reporter has a reporter gene inserted in the endogenous gene locus that allows the reporter gene to be expressed under the control of the same regulatory elements as the endogenous gene, thus more accurately reflecting the changes seen in the regulation of the actual gene. In this chapter, we introduce some of the considerations behind building a reporter gene assay for high-throughput compound screening and describe the methods we have utilized to establish 1536-well format endogenous locus reporter and exogenous reporter assays for the screening of compounds that modulate Myc pathway activity.

  10. [Standardizing the manipulation procedure of acupuncture-moxibustion, reinforcing the training of' clinical skill: learning experience of Acupuncture-moxibustion Clinical Skills Training: Chapter of Commonly Used Needling and Moxibustion Techniques].

    Science.gov (United States)

    Tian, Hongfang; Yang, Chao; Tang, Jie; Qin, Qiuguo; Zhao, Mingwen; Zhao, Jiping

    2015-07-01

    The book Acupuncture-moxibustion Clinical Skills Training is one of "Twelfth Five-Year Plan" in novative teaching materials, which is published by People's Medical Publishing House. Through learning the first half of the book commonly used needling and moxibustion techniques, it is realized that the selection of book content is reasonable and much attention is paid to needling and moxibustion techniques; the chapter arrangement is well-organized, and the form is novel, which is concise and intuitive; for every technique, great attention is paid to standardize the manipulation procedure and clarify the technique key, simultaneously the safety of acupuncture and moxibustion is also emphasized. The characteristics of the book, including innovativeness, practicability, are highlighted, and it greatly helps to improve students' clinical skills and examination ability.

  11. Mortalidade relacionada ao tratamento endovascular do aneurisma da aorta abdominal com o uso dos modelos revisados Procedure-related mortality of endovascular abdominal aortic aneurysm repair using revised reporting standards

    Directory of Open Access Journals (Sweden)

    Gosen Gabriel Konig

    2007-03-01

    Full Text Available OBJETIVO: O objetivo do estudo foi avaliar a definição da mortalidade relacionada ao procedimento após tratamento endovascular do aneurisma de aorta abdominal (EVAR como definido pelo Committee for Standardized Reporting Practices in Vascular Surgery. MÉTODO: Dados de pacientes com aneurisma de aorta abdominal foram analisados do banco de dados EUROSTAR. Os pacientes foram submetidos ao EVAR entre junho de 1996 a fevereiro de 2004 e foram estudados retrospectivamente. A probabilidade explicita da causa de morte foi registrada. O intervalo entre a operação, alta hospitalar ou intervenção secundária até a morte foi registrado. RESULTADOS: De um total de 5612 pacientes, 589 (10,5% faleceram após o EVAR em acompanhamento total e qualquer causa de morte foi inclusa. Cento e quarenta e um pacientes (12,5% morreram devido a causa relacionada ao aneurisma, sendo que 28 (4,8% foram rupturas, 25 (4,2% infecções do implante e 88 (14,9% foram pacientes que morreram num prazo de 30 dias após o procedimento inicial (definição atualmente utilizada, também conhecido como resultado clínico a curto prazo. Além disso, 25 pacientes faleceram após 30 dias, mas continuavam ainda hospitalizados (ou transferidos a home-care para reavaliação posterior, ou necessitaram intervenção secundária. Levando em conta a duração da admissão ao hospital e a mortalidade imediata após o procedimento relacionada a intervenções secundárias, 49 mortes tardias também podem ser relacionadas ao EVAR. CONCLUSÃO: Morte tardia compõe uma proporção considerável da mortalidade relacionada ao EVAR dentro do tempo de análise revisado.OBJECTIVE: The aim of this study was to evaluate the definition of Procedure-related mortality after endovascular aneurysm repair (EVAR as defined by the Committee for Standardized Reporting Practices in Vascular Surgery. METHODS: Data on patients with an AAA were taken from the EUROSTAR database. The patients underwent EVAR

  12. 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)

  13. Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [LISA-TRACKER® enzyme-linked immunosorbent assay (ELISA) kits, TNF-α-Blocker ELISA kits and Promonitor® ELISA kits] versus standard care in patients with Crohn's disease: systematic reviews and economic modelling.

    Science.gov (United States)

    Freeman, Karoline; Connock, Martin; Auguste, Peter; Taylor-Phillips, Sian; Mistry, Hema; Shyangdan, Deepson; Court, Rachel; Arasaradnam, Ramesh; Sutcliffe, Paul; Clarke, Aileen

    2016-11-01

    Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER ® enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor ® ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn's disease (CD). Multiple electronic databases were searched from inception to December 2014 in order to identify primary studies and meta-analyses. Patients with moderate to severe active CD treated with infliximab (IFX) (Remicade ® , Merck Sharp & Dohme Ltd, Kenilworth, NJ, USA) or adalimumab (ADA) (Humira ® , AbbVie Inc., North Chicago, IL, USA). Monitoring of serum anti-TNF-α (IFX or ADA) and/or of anti-drug antibody levels using test assays with a test-treatment algorithm. Standard care. Any patient-related outcome, test agreement and cost-effectiveness estimates. The quality assessments used recognised checklists (Quality Assessment of Diagnostic Accuracy Studies-2, Cochrane, Philips and Consolidated Health Economic Evaluation Reporting Standards). Evidence was synthesised using narrative review and meta-analysis. A Markov model was built in TreeAge Pro 2013 (TreeAge Software, Inc., Williamstown, MA, USA). The model had a 4-week cycle and a 10-year time horizon, adopted a NHS and Personal Social Services perspective and used a linked evidence approach. Costs were adjusted to 2013/14 prices and discounted at 3.5%. We included 68 out of 2434 and 4 out of 2466 studies for the clinical effectiveness and cost-effectiveness reviews, respectively. Twenty-three studies comparing test methods were identified. Evidence on test concordance was sparse and contradictory, offering scant data for a linked evidence approach. Three studies [two randomised controlled trials (RCTs) and one

  14. Effective implementation of novel MET pharmacodynamic assays in translational studies.

    Science.gov (United States)

    Srivastava, Apurva K; Navas, Tony; Herrick, William G; Hollingshead, Melinda G; Bottaro, Donald P; Doroshow, James H; Parchment, Ralph E

    2017-01-01

    MET tyrosine kinase (TK) dysregulation is significantly implicated in many types of cancer. Despite over 20 years of drug development to target MET in cancers, a pure anti-MET therapeutic has not yet received market approval. The failure of two recently concluded phase III trials point to a major weakness in biomarker strategies to identify patients who will benefit most from MET therapies. The capability to interrogate oncogenic mutations in MET via circulating tumor DNA (ctDNA) provides an important advancement in identification and stratification of patients for MET therapy. However, a wide range in type and frequency of these mutations suggest there is a need to carefully link these mutations to MET dysregulation, at least in proof-of-concept studies. In this review, we elaborate how we can utilize recently developed and validated pharmacodynamic biomarkers of MET not only to show target engagement, but more importantly to quantitatively measure MET dysregulation in tumor tissues. The MET assay endpoints provide evidence of both canonical and non-canonical MET signaling, can be used as "effect markers" to define biologically effective doses (BEDs) for molecularly targeted drugs, confirm mechanism-of-action in testing combination of drugs, and establish whether a diagnostic test is reporting MET dysregulation. We have established standard operating procedures for tumor biopsy collections to control pre-analytical variables that have produced valid results in proof-of-concept studies. The reagents and procedures are made available to the research community for potential implementation on multiple platforms such as ELISA, quantitative immunofluorescence assay (qIFA), and immuno-MRM assays.

  15. Lateral flow assays.

    Science.gov (United States)

    Koczula, Katarzyna M; Gallotta, Andrea

    2016-06-30

    Lateral flow assays (LFAs) are the technology behind low-cost, simple, rapid and portable detection devices popular in biomedicine, agriculture, food and environmental sciences. This review presents an overview of the principle of the method and the critical components of the assay, focusing on lateral flow immunoassays. This type of assay has recently attracted considerable interest because of its potential to provide instantaneous diagnosis directly to patients. The range and interpretation of results and parameters used for evaluation of the assay will also be discussed. The main advantages and disadvantages of LFAs will be summarized and relevant future improvements to testing devices and strategies will be proposed. Finally, the major recent advances and future diagnostic applications in the LFA field will be explored. © 2016 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

  16. Lateral flow assays

    Science.gov (United States)

    Koczula, Katarzyna M.

    2016-01-01

    Lateral flow assays (LFAs) are the technology behind low-cost, simple, rapid and portable detection devices popular in biomedicine, agriculture, food and environmental sciences. This review presents an overview of the principle of the method and the critical components of the assay, focusing on lateral flow immunoassays. This type of assay has recently attracted considerable interest because of its potential to provide instantaneous diagnosis directly to patients. The range and interpretation of results and parameters used for evaluation of the assay will also be discussed. The main advantages and disadvantages of LFAs will be summarized and relevant future improvements to testing devices and strategies will be proposed. Finally, the major recent advances and future diagnostic applications in the LFA field will be explored. PMID:27365041

  17. Accreditation Criteria: Policies, Procedures, and Standards

    Science.gov (United States)

    Accrediting Council for Independent Colleges and Schools, 2010

    2010-01-01

    The Accrediting Council for Independent Colleges and Schools ("ACICS" or "Council") supports the concept that periodic evaluation entered into voluntarily by institutions and their peers enhances the quality of the educational process and demonstrates that self regulation of a profession is superior to outside regulation. This has been the…

  18. Adaptive Standard Operating Procedures for Complex Disasters

    Science.gov (United States)

    2017-03-01

    applies. Additionally, the predictive aspect of the SOP model provides policy makers and emergency planners a “ shopping list” for various types of...the complex crisis environment on September 11 as the needs of the moment inspired improvisational solutions in the absence of SOP guidance. The...three-minute window of opportunity for the military aircraft to intercept Flight 175 before it strikes the South Tower. In simulation terms, the goal

  19. Emergency Support Function 15 Standard Operating Procedures

    Science.gov (United States)

    2013-08-01

    offices, and various field offices to coordinate federal messaging.  Outreach materials were translated in 22 languages to ensure information was...effective formats. The function is also responsible for managing the translation of information into languages other than English which have been...of Defense and Deputy Secretary of Defense for public information, internal information, community relations, information training, and audiovisual

  20. MILSTRIP. MILitary, STandard, Requisitioning and Issue Procedures.

    Science.gov (United States)

    1987-05-01

    DTA Asset Support Request submitted for obsolete/inactive NSN which cannot be supported. (Applies to reference (cc) DZG trans- action rejects only...Republic of CV Cayman Islands CJ Chad CD Chile CI China (People’s Republic of) CH Colombia CO Colombia (International Narcotics Control) D5 Comoros CR...Liechtenstein LS Lithuania LH Luxembourg LX Macau MC Madagascar MA Malawi MI Malaysia MF Maldives MV Mali RM Malta MT Martinique MB Mauritania MR Mauritius

  1. Standardization of Code on Dental Procedures

    Science.gov (United States)

    1992-02-13

    such as dental implants . Credit one per patient examined. 0141 6.2 Postmortem Examination or Bite Mark Analysis for Identification. Postmortem dental ... endodontic therapy , or sensitivity testing. 0420 0.8 Oral Mucosal Smear. Credit one per specimen collected for cytological, DNA identification... Endodontic Interim Treatment. Treatment accomplished during the course of root canal therapy . Do not take credit for this code on the first or last

  2. Standard operating procedure for computing pangenome trees

    DEFF Research Database (Denmark)

    Snipen, L.; Ussery, David

    2010-01-01

    We present the pan-genome tree as a tool for visualizing similarities and differences between closely related microbial genomes within a species or genus. Distance between genomes is computed as a weighted relative Manhattan distance based on gene family presence/absence. The weights can be chose...

  3. Standardization of a rearing procedure of Tetranychus urticae Koch (Acari: Tetranychidae) on bean (Phaseolus vulgaris): plant age and harvest time; Padronizacao da criacao de Tetranychus urticae Koch (Acari: Tetranychidae) em feijoeiro (Phaseolus vulgaris): idade da planta e tempo de colheita

    Energy Technology Data Exchange (ETDEWEB)

    Bustos, Alexander; Cantor, Fernando; Cure, Jose R; Rodriguez, Daniel [Universidade Militar Nueva Granada, Bogota (Colombia). Facutad de Ciencias. Programa de Biologia Aplicada], e-mail: fernando.cantor@unimilitar.edu.co

    2009-09-15

    A rearing technique was standardized to produce Tetranychus urticae Koch on Phaseolus vulgaris (ICA Cerinza variety) as a prey of the predatory mite Phytoseiulus persimilis Athias-Henriot. Two assays were conducted to assess the following variables: the most suitable plant age for mite infestation, and the best time to harvest the mites and re infest the plants. In the first experiment, four, five, six, and seven-week-old plants of P. vulgaris were infested with six T. urticae per foliole. The lower plant stratum exhibited the largest number of mites regardless of plant age. However, four-week old plants had the larger average number of individuals. In the second experiment four-week-old plants were infested with 0.5 female mite/cm{sup 2} of leaf. The number of individuals per instar of T. urticae was recorded weekly. The highest mite production occurred between four and five weeks after infestation, indicating this to be the most suitable for mite harvesting and for plant reinfestation. (author)

  4. Civil Procedure.

    Science.gov (United States)

    Byer, Robert

    1997-01-01

    Briefly reviews the historical development of civil procedure (the rules that dictate how a civil case can proceed through the courts) and identifies some of its main components. Discusses procedures such as subject matter jurisdiction, personal jurisdiction, venue, discovery, motions practice, pleadings, pretrial conference, and trials. (MJP)

  5. Comparison of in-house biotin-avidin tetanus IgG enzyme-linked-immunosorbent assay (ELISA) with gold standard in vivo mouse neutralization test for the detection of low level antibodies.

    Science.gov (United States)

    Sonmez, Cemile; Coplu, Nilay; Gozalan, Aysegul; Akin, Lutfu; Esen, Berrin

    2017-06-01

    Detection of anti-tetanus antibody levels is necessary for both determination of the immune status of individuals and also for planning preventive measures. ELISA is the preferred test among in vitro tests however it can be affected by the cross reacting antibodies. A previously developed in-house ELISA test was found not reliable for the antibody levels ≤1.0IU/ml. A new method was developed to detect low antibody levels correctly. The aim of the present study was to compare the results of the newly developed in-house biotin-avidin tetanus IgG ELISA test with the in vivo mouse neutralization test, for the antibody levels ≤1.0IU/ml. A total of 54 serum samples with the antibody levels of three different levels, =0.01IU/ml, 0.01-0.1IU/ml, 0.1-1IU/ml, which were detected by in vivo mouse neutralization test were studied by the newly developed in-house biotin-avidin tetanus IgG ELISA test. Test was validated by using five different concentrations (0.01IU/ml, 0.06IU/ml, 0.2IU/ml, 0.5IU/ml, 1.0IU/ml). A statistically significant correlation (r 2 =0.9967 p=0,001) between in vivo mouse neutralization test and in-house biotin-avidin tetanus IgG ELISA test, was observed. For the tested concentrations intra-assay, inter-assay, accuracy, sensitivity, specificity and coefficients of variations were determined as ≤15%. In-house biotin-avidin tetanus IgG ELISA test can be an alternative method to in vivo mouse neutralization method for the detection of levels ≤1.0IU/ml. By using in-house biotin-avidin tetanus IgG ELISA test, individuals with non protective levels, will be reliably detected. Copyright © 2017. Published by Elsevier B.V.

  6. Towards an international standard for detection and typing botulinum neurotoxin-producing Clostridia types A, B, E and F in food, feed and environmental samples: a European ring trial study to evaluate a real-time PCR assay.

    Science.gov (United States)

    Fenicia, Lucia; Fach, Patrick; van Rotterdam, Bart J; Anniballi, Fabrizio; Segerman, Bo; Auricchio, Bruna; Delibato, Elisabetta; Hamidjaja, Raditijo A; Wielinga, Peter R; Woudstra, Cedric; Agren, Joakim; De Medici, Dario; Knutsson, Rickard

    2011-03-01

    A real-time PCR method for detection and typing of BoNT-producing Clostridia types A, B, E, and F was developed on the framework of the European Research Project "Biotracer". A primary evaluation was carried out using 104 strains and 17 clinical and food samples linked to botulism cases. Results showed 100% relative accuracy, 100% relative sensitivity, 100% relative specificity, and 100% selectivity (inclusivity on 73 strains and exclusivity on 31 strains) of the real-time PCR against the reference cultural method combined with the standard mouse bioassay. Furthermore, a ring trial study performed at four different European laboratories in Italy, France, the Netherlands, and Sweden was carried out using 47 strains, and 30 clinical and food samples linked to botulism cases. Results showed a concordance of 95.7% among the four laboratories. The reproducibility generated a relative standard deviation in the range of 2.18% to 13.61%. Considering the high level of agreement achieved between the laboratories, this real-time PCR is a suitable method for rapid detection and typing of BoNT-producing Clostridia in clinical, food and environmental samples and thus support the use of it as an international standard method. Copyright © 2011 Elsevier B.V. All rights reserved.

  7. Evaluation of the Diagnostic Accuracy of a Typhoid IgM Flow Assay for the Diagnosis of Typhoid Fever in Cambodian Children Using a Bayesian Latent Class Model Assuming an Imperfect Gold Standard

    Science.gov (United States)

    Moore, Catrin E.; Pan-Ngum, Wirichada; Wijedoru, Lalith P. M.; Sona, Soeng; Nga, Tran Vu Thieu; Duy, Pham Thanh; Vinh, Phat Voong; Chheng, Kheng; Kumar, Varun; Emary, Kate; Carter, Michael; White, Lisa; Baker, Stephen; Day, Nicholas P. J.; Parry, Christopher M.

    2014-01-01

    Rapid diagnostic tests are needed for typhoid fever (TF) diagnosis in febrile children in endemic areas. Five hundred children admitted to the hospital in Cambodia between 2009 and 2010 with documented fever (≥ 38°C) were investigated using blood cultures (BCs), Salmonella Typhi/Paratyphi A real-time polymerase chain reactions (PCRs), and a Typhoid immunoglobulin M flow assay (IgMFA). Test performance was determined by conventional methods and Bayesian latent class modeling. There were 32 cases of TF (10 BC- and PCR-positive cases, 14 BC-positive and PCR-negative cases, and 8 BC-negative and PCR-positive cases). IgMFA sensitivity was 59.4% (95% confidence interval = 41–76), and specificity was 97.8% (95% confidence interval = 96–99). The model estimate sensitivity for BC was 81.0% (95% credible interval = 54–99). The model estimate sensitivity for PCR was 37.8% (95% credible interval = 26–55), with a specificity of 98.2% (95% credible interval = 97–99). The model estimate sensitivity for IgMFA (≥ 2+) was 77.9% (95% credible interval = 58–90), with a specificity of 97.5% (95% credible interval = 95–100). The model estimates of IgMFA sensitivity and specificity were comparable with BCs and better than estimates using conventional analysis. PMID:24218407

  8. Microplate assay for quantitation of neutral lipids in extracts from microalgae.

    Science.gov (United States)

    Higgins, Brendan T; Thornton-Dunwoody, Alexander; Labavitch, John M; VanderGheynst, Jean S

    2014-11-15

    Lipid quantitation is widespread in the algae literature, but popular methods such as gravimetry, gas chromatography and mass spectrometry (GC-MS), and Nile red cell staining suffer drawbacks, including poor quantitation of neutral lipids, expensive equipment, and variable results among algae species, respectively. A high-throughput microplate assay was developed that uses Nile red dye to quantify neutral lipids that have been extracted from algae cells. Because the algal extracts contained pigments that quenched Nile red fluorescence, a mild bleach solution was used to destroy pigments, resulting in a nearly linear response for lipid quantities in the range of 0.75 to 40 μg. Corn oil was used as a standard for quantitation, although other vegetable oils displayed a similar response. The assay was tested on lipids extracted from three species of Chlorella and resulted in close agreement with triacylglycerol (TAG) levels determined by thin layer chromatography. The assay was found to more accurately measure algal lipids conducive to biodiesel production and nutrition applications than the widely used gravimetric assay. Assay response was also consistent among different species, in contrast to Nile red cell staining procedures. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Anthelmintic activity procedure The anthelmintic assay was carried ...

    Indian Academy of Sciences (India)

    Indian adult earthworms Pheretima posthuma. The worms were procured from local supplier at Shimoga at the time of carrying out the experiment. The worms were washed with normal saline to remove all fecal matter used for the anthelmintic study. The earthworms of 4 -6 cm in length and 0.3-0.4 cm in width were used for ...

  10. 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.)

  11. Photodigitizing procedures

    Science.gov (United States)

    Kilgore, P. D.; Gottbrath, J. H.

    1984-02-01

    This report documents procedures and programs for efficiently running the Photo Digitizing System at the Naval Biodynamics Laboratory. Procedures have been tested and have been found to be effective. Any future acquisitions of programs or changes to current programs should be incorporated in these procedures. On-going research programs use high speed instrumentation cameras to record the motion of test subjects during biodynamic experiments. The films are digitized and the 3-dimensional motion is reconstructed and analyzed. Experimental research is performed to determine the effects of aircraft crashes, ship motion, vibration, aircraft ejection and parachute opening forces on the health and performance of Navy personnel.

  12. Radioreceptor assay for insulin

    International Nuclear Information System (INIS)

    Suzuki, Kazuo

    1975-01-01

    Radioreceptor assay of insulin was discussed from the aspects of the measuring method, its merits and problems to be solved, and its clinical application. Rat liver 10 x g pellet was used as receptor site, and enzymatic degradation of insulin by the system contained in this fraction was inhibited by adding 1 mM p-CMB. 125 I-labelled porcine insulin was made by lactoperoxidase method under overnight incubation at 4 0 C and later purification by Sephadex G-25 column and Whatman CF-11 cellulose powder. Dog pancreatic vein serum insulin during and after the glucose load was determined by radioreceptor assay and radioimmunoassay resulting that both measurements accorded considerably. Radioreceptor assay would clarify the pathology of disorders of glucose metabolism including diabetes. (Tsukamoto, Y.)

  13. Radioreceptor assay for GH

    International Nuclear Information System (INIS)

    Tsushima, Toshio; Matsuzaki, Fukashi

    1975-01-01

    Radioreceptor assay (RRA) of growth hormone (GH) was studied using the protein which specifically bound to GH presenting in the liver of rabbits. 100,000g pellet of the liver homogenate was used as receptor source. The factors which affected the results of RRA such as salt, temperature and incubation time, were discussed. As same as in other RRA methods, serum protein inhibited non-specifically 125 I-GH binding in this method. In this assay, serum GH less than 5ng/ml could not be detected. The difference between the value obtained by RRA and that by radioimmunoassay was compared with reference to the patients with acromegalia. (Tsukamoto, Y.)

  14. Lateral flow strip assay

    Science.gov (United States)

    Miles, Robin R [Danville, CA; Benett, William J [Livermore, CA; Coleman, Matthew A [Oakland, CA; Pearson, Francesca S [Livermore, CA; Nasarabadi, Shanavaz L [Livermore, CA

    2011-03-08

    A lateral flow strip assay apparatus comprising a housing; a lateral flow strip in the housing, the lateral flow strip having a receiving portion; a sample collection unit; and a reagent reservoir. Saliva and/or buccal cells are collected from an individual using the sample collection unit. The sample collection unit is immersed in the reagent reservoir. The tip of the lateral flow strip is immersed in the reservoir and the reagent/sample mixture wicks up into the lateral flow strip to perform the assay.

  15. Oculoplastic procedures

    Science.gov (United States)

    ... procedures may be done on the: Eyelids Eye sockets Eyebrows Cheeks Tear ducts Face or forehead These ... eyes. These lenses help protect your eyes and shield them from the bright lights of the surgical ...

  16. European Organisation for Research and Treatment of Cancer (EORTC) Pathobiology Group standard operating procedure for the preparation of human tumour tissue extracts suited for the quantitative analysis of tissue-associated biomarkers.

    Science.gov (United States)

    Schmitt, Manfred; Mengele, Karin; Schueren, Elisabeth; Sweep, Fred C G J; Foekens, John A; Brünner, Nils; Laabs, Juliane; Malik, Abha; Harbeck, Nadia

    2007-03-01

    With the new concept of 'individualized treatment and targeted therapies', tumour tissue-associated biomarkers have been given a new role in selection of cancer patients for treatment and in cancer patient management. Tumour biomarkers can give support to cancer patient stratification and risk assessment, treatment response identification, or to identifying those patients who are expected to respond to certain anticancer drugs. As the field of tumour-associated biomarkers has expanded rapidly over the last years, it has become increasingly apparent that a strong need exists to establish guidelines on how to easily disintegrate the tumour tissue for assessment of the presence of tumour tissue-associated biomarkers. Several mechanical tissue (cell) disruption techniques exist, ranging from bead mill homogenisation and freeze-fracturing through to blade or pestle-type homogenisation, to grinding and ultrasonics. Still, only a few directives have been given on how fresh-frozen tumour tissues should be processed for the extraction and determination of tumour biomarkers. The PathoBiology Group of the European Organisation for Research and Treatment of Cancer therefore has devised a standard operating procedure for the standardised preparation of human tumour tissue extracts which is designed for the quantitative analysis of tumour tissue-associated biomarkers. The easy to follow technical steps involved require 50-300 mg of deep-frozen cancer tissue placed into small size (1.2 ml) cryogenic tubes. These are placed into the shaking flask of a Mikro-Dismembrator S machine (bead mill) to pulverise the tumour tissue in the capped tubes in the deep-frozen state by use of a stainless steel ball, all within 30 s of exposure. RNA is isolated from the pulverised tissue following standard procedures. Proteins are extracted from the still frozen pulverised tissue by addition of Tris-buffered saline to obtain the cytosol fraction of the tumour or by the Tris buffer supplemented with

  17. Bioactivity and laundering resistance of five commercially available, factory-treated permethrin-impregnated fabrics for the prevention of mosquito-borne diseases: the need for a standardized testing and licensing procedure.

    Science.gov (United States)

    Faulde, Michael K; Pages, Frederic; Uedelhoven, Waltraud

    2016-04-01

    Personal protective measures against hematophagous vectors constitute the first line of defense against arthropod-borne diseases. In this regard, a major advance has been the development of residual insecticides that can be impregnated into clothing. Currently, however, information on specific treatment procedures, initial insecticide concentrations, arthropod toxicity, residual activity, and laundering resistance is either fragmentary or non-existent, and no World Health Organization Pesticides Evaluation Scheme or other guidelines exist for the standardized testing and licensing of insecticide-treated clothing. The aim of this study was to analyze the insecticide content, contact toxicity, laundering resistance, and residual activity of five commercially available and commonly used permethrin-treated fabrics-Insect Shield, ExOfficio, Sol's Monarch T-shirts, battle dress uniforms (BDUs), and Labonal socks-against vector-competent Aedes aegypti, Anopheles stephensi, and Culex pipiens mosquitoes under laboratory conditions. Prior to laundering, permethrin concentrations ranged from 4300 to 870 mg/m(2) whereas, after 100 defined machine launderings, the remaining permethrin content fell to between 1800 and 20 mg/m(2), a percentage permethrin loss of 58.1 to 98.5 %. The highest 99 % knockdown (KD99) efficacy of permethrin was detected in Ae. aegypti, followed by An. stephensi and Cx. pipiens demonstrating that Ae. aegypti is the most sensitive species and Cx. pipiens the least sensitive. After 100 launderings, the remaining biocidal efficacy differed markedly among the five brands, with KD99 times varying from 38.8 ± 2.9 to >360 min for Ae. aegypti, from 44 ± 3.5 to >360 min for An. stephensi, and from 98 ± 10.6 to >360 min for Cx. pipiens. Overall, the ranking of the residual biocidal efficacies within the five brands tested was as follows: BDU ≈ Labonal > Sol's Monarch > ExOfficio > Insect Shield. When applying German Armed Forces

  18. Quantitative colorimetric assay for total protein applied to the red wine Pinot noir.

    Science.gov (United States)

    Smith, Mark R; Penner, Mike H; Bennett, Samuel E; Bakalinsky, Alan T

    2011-07-13

    A standard method for assaying protein in red wine is currently lacking. The method described here is based on protein precipitation followed by dye binding quantification. Improvements over existing approaches include minimal sample processing prior to protein precipitation with cold trichloroacetic acid/acetone and quantification based on absorbance relative to a commercially available standard representative of proteins likely to be found in wine, the yeast mannoprotein invertase. The precipitation method shortened preparation time relative to currently published methods and the mannoprotein standard yielded values comparable to those obtained by micro-Kjeldahl analysis. The assay was used to measure protein in 48 Pinot noir wines from 6 to 32 years old. The protein content of these wines was found to range from 50 to 102 mg/L with a mean value of 70 mg/L. The availability of a simple and relatively rapid procedure for assaying protein provides a practical tool to quantify a wine component that has been overlooked in routine analyses of red wines.

  19. Comparison of methodologies for enumerating and detecting the viability of Ascaris eggs in sewage sludge by standard incubation-microscopy, the BacLight Live/Dead viability assay and other vital dyes.

    Science.gov (United States)

    Karkashan, Alaa; Khallaf, Basma; Morris, Jacqueline; Thurbon, Nerida; Rouch, Duncan; Smith, Stephen R; Deighton, Margaret

    2015-01-01

    The aim of this study was to evaluate the Live/Dead BacLight viability kit as a method for enumerating viable eggs of Ascaris suum in sewage sludge as a surrogate for the human roundworm. The number and viability status of eggs of A. suum were accurately measured directly in sewage sludge samples by the BacLight method, compared to the conventional incubation-microscopy procedure. BacLight stains were not toxic to A. suum eggs, in contrast to some conventional vital dyes which disrupted viable eggs. The method was effective for the direct examination of eggs in heavily contaminated samples or seeded sludge containing ∼200 eggs/g DS in sludge with 5% DS content. However, a recovery method would be necessary to examine samples with small numbers of eggs, for instance in sludge from regions where the prevalence of infection with Ascaris lumbricoides is low. The BacLight technique may therefore be an effective alternative to conventional incubation-microscopy for enumerating Ascaris eggs in contaminated field samples or to validate sludge treatment processes by examining decay rates of inoculated A. suum eggs in laboratory simulations. Most field samples would require recovery from an appropriate number of composite samples prior to vital staining.

  20. Lateral flow assays

    NARCIS (Netherlands)

    Posthuma-Trumpie, G.A.; Amerongen, van A.

    2012-01-01

    A simple version of immunochemical-based methods is the Lateral Flow Assay (LFA). It is a dry chemistry technique (reagents are included); the fluid from the sample runs through a porous membrane (often nitrocellulose) by capillary force. Typically the membrane is cut as a strip of 0.5*5 cm. In most

  1. Trueness verification of actual creatinine assays in the European market demonstrates a disappointing variability that needs substantial improvement. An international study in the framework of the EC4 creatinine standardization working group.

    Science.gov (United States)

    Delanghe, Joris R; Cobbaert, Christa; Galteau, Marie-Madeleine; Harmoinen, Aimo; Jansen, Rob; Kruse, Rolf; Laitinen, Päivi; Thienpont, Linda M; Wuyts, Birgitte; Weykamp, Cas; Panteghini, Mauro

    2008-01-01

    The European In Vitro Diagnostics (IVD) directive requires traceability to reference methods and materials of analytes. It is a task of the profession to verify the trueness of results and IVD compatibility. The results of a trueness verification study by the European Communities Confederation of Clinical Chemistry (EC4) working group on creatinine standardization are described, in which 189 European laboratories analyzed serum creatinine in a commutable serum-based material, using analytical systems from seven companies. Values were targeted using isotope dilution gas chromatography/mass spectrometry. Results were tested on their compliance to a set of three criteria: trueness, i.e., no significant bias relative to the target value, between-laboratory variation and within-laboratory variation relative to the maximum allowable error. For the lower and intermediate level, values differed significantly from the target value in the Jaffe and the dry chemistry methods. At the high level, dry chemistry yielded higher results. Between-laboratory coefficients of variation ranged from 4.37% to 8.74%. Total error budget was mainly consumed by the bias. Non-compensated Jaffe methods largely exceeded the total error budget. Best results were obtained for the enzymatic method. The dry chemistry method consumed a large part of its error budget due to calibration bias. Despite the European IVD directive and the growing needs for creatinine standardization, an unacceptable inter-laboratory variation was observed, which was mainly due to calibration differences. The calibration variation has major clinical consequences, in particular in pediatrics, where reference ranges for serum and plasma creatinine are low, and in the estimation of glomerular filtration rate.

  2. Nijmegen-Bethesda assay to measure factor VIII inhibitors.

    Science.gov (United States)

    Duncan, Elizabeth; Collecutt, Margaret; Street, Alison

    2013-01-01

    Hemophilia A is an inherited bleeding disorder caused by a deficiency of factor VIII coagulant activity (FVIII:C). Patients are treated with infusions of either plasma-derived or recombinant factor VIII. However, some patients develop inhibitory antibodies (inhibitors) to infused factor VIII which render it ineffective. The original Bethesda method was developed to standardize measurement of inhibitors in a factor VIII neutralization assay. One Bethesda unit is defined as that amount of inhibitor that results in 50% residual FVIII:C activity of a defined test mixture. In the Nijmegen modification of the original Bethesda method, the pH and the protein concentration of the test mixture is further standardized. As a result, the FVIII:C in the test mixture is less prone to artifactual deterioration and the test has improved specificity. Even with a standardized procedure a number of factors can affect the performance of the test and it is important for laboratory staff to be aware of their impact on the result outcome.

  3. Variation in assessment of oxidatively damaged DNA in mononuclear blood cells by the comet assay with visual scoring

    DEFF Research Database (Denmark)

    Forchhammer, Lykke; Bräuner, Elvira Vaclavik; Folkmann, Janne Kjaersgaard

    2008-01-01

    The comet assay is popular for assessments of genotoxicity, but the comparison of results between studies is challenging because of differences in experimental procedures and reports of DNA damage in different units. We investigated the variation of DNA damage in mononuclear blood cells (MNBCs......) measured by the comet assay with focus on the variation related to alkaline unwinding and electrophoresis time, number of cells scored, as well as the putative benefits of transforming the primary end points to common units by the use of reference standards and calibration curves. Eight experienced......, our results indicate that inter-investigator difference in scoring is a strong determinant of DNA damage levels measured by the comet assay....

  4. New Insights into Butyrylcholinesterase Activity Assay: Serum Dilution Factor as a Crucial Parameter.

    Directory of Open Access Journals (Sweden)

    Joanna Jońca

    Full Text Available Butyrylcholinesterase (BChE activity assay and inhibitor phenotyping can help to identify patients at risk of prolonged paralysis following the administration of neuromuscular blocking agents. The assay plays an important role in clinical chemistry as a good diagnostic marker for intoxication with pesticides and nerve agents. Furthermore, the assay is also commonly used for in vitro characterization of cholinesterases, their toxins and drugs. There is still lack of standardized procedure for measurement of BChE activity and many laboratories use different substrates at various concentrations. The purpose of this study was to validate the BChE activity assay to determine the best dilution of human serum and the most optimal concentration of substrates and inhibitors. Serum BChE activity was measured using modified Ellman's method applicable for a microplate reader. We present our experience and new insights into the protocol for high-throughput routine assays of human plasma cholinesterase activities adapted to a microplate reader. During our routine assays used for the determination of BChE activity, we have observed that serum dilution factor influences the results obtained. We show that a 400-fold dilution of serum and 5mM S-butyrylthiocholine iodide can be successfully used for the accurate measurement of BChE activity in human serum. We also discuss usage of various concentrations of dibucaine and fluoride in BChE phenotyping. This study indicates that some factors of such a multicomponent clinical material like serum can influence kinetic parameters of the BChE. The observed inhibitory effect is dependent on serum dilution factor used in the assay.

  5. Radioligand purification prior to routine receptor assays

    International Nuclear Information System (INIS)

    Le Goff, J.-M.; Berthois, Y.; Martin, P.-M.

    1988-01-01

    The need to repurify the commercially available radioligands [ 3 H]estradiol and [ 3 H]testosterone before use in routine assays was investigated. Storage of these products for 2 months after delivery led to appreciable degradation of [ 3 H]estradiol compared to [ 3 H]testosterone. Unexpectedly, TLC and even HPLC procedures were ineffective in completely restoring the purity of [ 3 H]-estradiol and the unremoved polar products induced important variations in our estrogen receptor assays. An increase in non-specific binding and a concomitant decrease in total binding were observed resulting in an underestimation of specific binding sites and of the affinity constant. In some cases Scatchard analysis was not possible. The authors therefore strongly recommend the repurification of low-stability radioligands and propose an economic time-saving procedure for the purification of [ 3 H]estradiol by solvent differential partition which requires no high-cost investment in apparatus. (author)

  6. Reporter Gene Assays in Ecotoxicology.

    Science.gov (United States)

    Elad, Tal; Belkin, Shimshon

    The need for simple and rapid means for evaluating the potential toxic effects of environmental samples has prompted the development of reporter gene assays, based on tester cells (bioreporters) genetically engineered to report on sample toxicity by producing a readily quantifiable signal. Bacteria are especially suitable to serve as bioreporters owing to their fast responses, low cost, convenient preservation, ease of handling, and amenability to genetic manipulations. Various bacterial bioreporters have been introduced for general toxicity and genotoxicity assessment, and the monitoring of endocrine disrupting and dioxin-like compounds has been mostly covered by similarly engineered eukaryotic cells. Some reporter gene assays have been validated, standardized, and accredited, and many others are under constant development. Efforts are aimed at broadening detection spectra, lowering detection thresholds, and combining toxicity identification capabilities with characterization of the toxic effects. Taking advantage of bacterial robustness, attempts are also being made to incorporate bacterial bioreporters into field instrumentation for online continuous monitoring or on-site spot checks. However, key hurdles concerning test validation, cell preservation, and regulatory issues related to the use of genetically modified organisms still remain to be overcome.

  7. Bacteriophage amplification assay for detection of Listeria spp. using virucidal laser treatment

    Directory of Open Access Journals (Sweden)

    I.C. Oliveira

    2012-09-01

    Full Text Available A protocol for the bacteriophage amplification technique was developed for quantitative detection of viable Listeria monocytogenes cells using the A511 listeriophage with plaque formation as the end-point assay. Laser and toluidine blue O (TBO were employed as selective virucidal treatment for destruction of exogenous bacteriophage. Laser and TBO can bring a total reduction in titer phage (ca. 10(8 pfu/mL without affecting the viability of L. monocytogenes cells. Artificially inoculated skimmed milk revealed mean populations of the bacteria as low as between 13 cfu/mL (1.11 log cfu/mL, after a 10-h assay duration. Virucidal laser treatment demonstrated better protection of Listeria cells than the other agents previously tested. The protocol was faster and easier to perform than standard procedures. This protocol constitutes an alternative for rapid, sensitive and quantitative detection of L. monocytogenes.

  8. Silver (nano)materials cause genotoxicity in Enchytraeus crypticus, as determined by the comet assay

    DEFF Research Database (Denmark)

    Maria, Vera L; Ribeiro, Maria João; Guilherme, Sofia

    2018-01-01

    d the effects were either reduced or repaired, whereas Ag NM300K caused higher genotoxicity after 7d for the lowest concentration (EC20), highlighting a potential non-monotone dose-response effect. Overall, the comet assay showed the power to discriminate effects between materials and also toxicity...... not been used; hence, the goals of the current study included the optimization of the in vivo alkaline comet assay in Enchytraeus crypticus. Further, the effect of silver nanomaterial (Ag NM300K, dispersed, 15 nm) was tested and compared with AgNO3 . Hydrogen peroxide (H2 O2 ) was used as a positive...... control. The various steps were optimized. The fully detailed standard operating procedure (SOP) is presented here. Ag materials caused genotoxicity, this being differentiated for the nano and non-nano forms. AgNO3 caused genotoxicity after 3 days (d) of exposure in a dose related manner, although after 7...

  9. Adequate procedures for specific exams

    International Nuclear Information System (INIS)

    Staevie, G.L.G.; Gattringer, D.K.; Dal Mas, C.R.; Tessman, M.

    1996-01-01

    Some ideal procedures for specific radiographic exams are briefly presented. The aim is to improve the quality standard, establishing a specific method for each exam in order to decrease films waste and reduce the patient dose exposure

  10. Application of the KeratinoSens™ assay for assessing the skin sensitization potential of agrochemical active ingredients and formulations.

    Science.gov (United States)

    Settivari, Raja S; Gehen, Sean C; Amado, Ricardo Acosta; Visconti, Nicolo R; Boverhof, Darrell R; Carney, Edward W

    2015-07-01

    Assessment of skin sensitization potential is an important component of the safety evaluation process for agrochemical products. Recently, non-animal approaches including the KeratinoSens™ assay have been developed for predicting skin sensitization potential. Assessing the utility of the KeratinoSens™ assay for use with multi-component mixtures such as agrochemical formulations has not been previously evaluated and is a significant need. This study was undertaken to evaluate the KeratinoSens™ assay prediction potential for agrochemical formulations. The assay was conducted for 8 agrochemical active ingredients (AIs) including 3 sensitizers (acetochlor, meptyldinocap, triclopyr), 5 non-sensitizers (aminopyralid, clopyralid, florasulam, methoxyfenozide, oxyfluorfen) and 10 formulations for which in vivo sensitization data were available. The KeratinoSens™ correctly predicted the sensitization potential of all the AIs. For agrochemical formulations it was necessary to modify the standard assay procedure whereby the formulation was assumed to have a common molecular weight. The resultant approach correctly predicted the sensitization potential for 3 of 4 sensitizing formulations and all 6 non-sensitizing formulations when compared to in vivo data. Only the meptyldinocap-containing formulation was misclassified, as a result of high cytotoxicity. These results demonstrate the promising utility of the KeratinoSens™ assay for evaluating the skin sensitization potential of agrochemical AIs and formulations. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. 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)

  12. Cytotoxicity assay automation

    Science.gov (United States)

    Levinthal, E. C.; Payne, R. O.

    1971-01-01

    The design and construction of a system to automatically test HLP antigens are described. Major efforts were made to test and evaluate the performance of such a system, and compare its performance with nonautomatic tissue typing techniques. The system is based on the fluorochromatic cytotoxicity assay. Results show the system will work but is subject to malfunctions after a few samplings, and poses problems in showing correctly the necessary readings.

  13. Environmental procedures

    International Nuclear Information System (INIS)

    1992-01-01

    The European Bank has pledged in its Agreement to place environmental management at the forefront of its operations to promote sustainable economic development in central and eastern Europe. The Bank's environmental policy is set out in the document titled, Environmental Management: The Bank's Policy Approach. This document, Environmental Procedures, presents the procedures which the European Bank has adopted to implement this policy approach with respect to its operations. The environmental procedures aim to: ensure that throughout the project approval process, those in positions of responsibility for approving projects are aware of the environmental implications of the project, and can take these into account when making decisions; avoid potential liabilities that could undermine the success of a project for its sponsors and the Bank; ensure that environmental costs are estimated along with other costs and liabilities; and identify opportunities for environmental enhancement associated with projects. The review of environmental aspects of projects is conducted by many Bank staff members throughout the project's life. This document defines the responsibilities of the people and groups involved in implementing the environmental procedures. Annexes contain Environmental Management: The Bank's Policy Approach, examples of environmental documentation for the project file and other ancillary information

  14. Immune chromatography: a quantitative radioimmunological assay

    International Nuclear Information System (INIS)

    Davis, J.W.; Demetriades, M.; Bowen, J.M.

    1984-01-01

    Immune chromatography, a radioimmunological binding assay, employs paper chromatography to separate immune complexes from free antigen and antibodies. During chromatography free antigen and antibodies become distributed throughout the paper, while immune complexes remain near the bottoms of the strips. The chromatographic differences can be made quantitative by using either iodinated antigens or antibodies. Under these conditions nanogram quantities of antigen can be detected or antibodies in sera diluted several 1000-fold. The immune chromatography assay can also be performed as an indirect assay, since the paper strips are cut from nitrocellulose paper. In this case the immune components are absorbed by the paper during chromatography. Antigen is then detected with an iodinated second antibody. The indirect immune chromatography assay is particularly useful for identifying different sera that react with the same antigen. Reaction with the first serum before chromatography reduces the amount of antigen available to the second serum following chromatography. In addition to characterizing the immune chromatography procedure, we discuss the possible applications of chromatography assays for the quantitation of other types of molecular binding interactions. (Auth.)

  15. 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.

  16. Standardization of Laboratory Methods for the PERCH Study

    Science.gov (United States)

    Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

    2017-01-01

    Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

  17. HBA1c: clinical and biological agreement for standardization of assay methods. Report by the experts of ALFEDIAM (Association de Langue Française pour lEtude du Diabète et des Maladies Métabolique) and SFBC (Société Française de Biologie Clinique).

    Science.gov (United States)

    Gillery, P; Bordas-Fonfrède, M; Chapelle, J P; Drouin, P; Hue, G; Lévy-Marchal, C; Périer, C; Sélam, J L; Slama, G; Thivolet, C; Vialettes, B

    1999-09-01

    Glycohaemoglobin, and particularly haemoglobin A1c(HbA1c), assays have been used for many years to retrospectively evaluate the glycaemic control of diabetic patients. Cut-off values have been established for deciding treatment modifications. The techniques used in the laboratories however exhibit varying quality, and all of them are not yet standardized. The consequence is an under-utilization of this test, especially in non-hospital practice. In this context, working groups of Société Française de Biologie Clinique (SFBC), Association de Langue Française pour l'Etude du Diabète et des Maladies Métaboliques (ALFEDIAM) and Société Française d'Endocrinologie (SFE) have met together, in order to analyze the national status, and to propose practical recommendations for implementing a standardization process on the basis of international experiences. It is recommended to exclusively express results as HbA1c percentage, using methods standardized and certified by comparison to reference methods such as those using Diabetes Control and Complications Trial (DCCT) values. Simultaneously, contacts have been established with manufacturers, and the realisation of periodic quality control surveys was encouraged.

  18. Colorimetric micro-assay for accelerated screening of mould inhibitors

    Science.gov (United States)

    Carol A. Clausen; Vina W. Yang

    2013-01-01

    Since current standard laboratory methods are time-consuming macro-assays that rely on subjective visual ratings of mould growth, rapid and quantitative laboratory methods are needed to screen potential mould inhibitors for use in and on cellulose-based products. A colorimetric micro-assay has been developed that uses XTT tetrazolium salt to enzymatically assess...

  19. Electronic Procedures for Medical Operations

    Science.gov (United States)

    2015-01-01

    Electronic procedures are replacing text-based documents for recording the steps in performing medical operations aboard the International Space Station. S&K Aerospace, LLC, has developed a content-based electronic system-based on the Extensible Markup Language (XML) standard-that separates text from formatting standards and tags items contained in procedures so they can be recognized by other electronic systems. For example, to change a standard format, electronic procedures are changed in a single batch process, and the entire body of procedures will have the new format. Procedures can be quickly searched to determine which are affected by software and hardware changes. Similarly, procedures are easily shared with other electronic systems. The system also enables real-time data capture and automatic bookmarking of current procedure steps. In Phase II of the project, S&K Aerospace developed a Procedure Representation Language (PRL) and tools to support the creation and maintenance of electronic procedures for medical operations. The goal is to develop these tools in such a way that new advances can be inserted easily, leading to an eventual medical decision support system.

  20. Optimization of cell motility evaluation in scratch assay

    Directory of Open Access Journals (Sweden)

    Gotsulyak N. Ya.

    2014-05-01

    Full Text Available A scratch test is one of the most popular methods of classical cell migration assay in a monolayer culture. At the same time, the scratch assay has some disadvantages that can be easily corrected. Aim. Optimization the existent scratch assay on the base of detection of scratch wound surface area and the length of the field of observation which is more objective and less time consuming. Methods. Scratch assay. Results. The modification of scratch assay enables to perform measurement more accurately and rapidly. This approach is more simple and eliminates the main disadvantages of the classical method. Conclusions. The procedure of scratch wound width measurement calculated on the base of detection of cell free area and the length of the field of observation is more effective than the classical wound healing assay. It will be useful for the estimation of cell migration dynamics in monolayer culture for a wide range of live cell based experiments.

  1. Comparison of a modified shell vial culture procedure with conventional mouse inoculation for rabies virus isolation.

    Science.gov (United States)

    Ribas Antúnez, María de los Angeles; Girón, Blanca; Monsalvez, Iraima; Morier, Luis; Acosta, Gretel; Tejero, Yahisel; Cordero, Yanislet; Piedra, Dainelyd

    2013-04-01

    Rabies is a neurotropic disease that is often lethal. The early diagnosis of rabies infection is important and requires methods that allow for the isolation of the virus from animals and humans. The present study compared a modified shell vial (MSV) procedure using 24-well tissue culture plates with the mouse inoculation test (MIT), which is considered the gold standard for rabies virus isolation. Thirty brain samples (25 positive and 5 negative by the fluorescent antibody test) obtained from different animal species at the National Institute of Hygiene Rafael Rangel in Caracas, Venezuela, were studied by the MIT and MSV assays. Nine samples (36%) were positive at 24 h, 10 (40%) were positive at 48 h and six (24%) were positive at 72 h by the MSV assay. With the MIT assay, 76% were positive at six days post inoculation and 12% were positive at 12 and 18 days post inoculation. One sample that was negative according to the MSV assay was positive with MIT on the 12th day. The MSV procedure exhibited a sensitivity of 96.2%, a specificity of 100%, a positive predictive value of 100% and a negative predictive value 80%. This procedure allowed for rapid rabies virus detection. MIT can be employed as an alternative method in laboratories without tissue culture facilities.

  2. Radiochemical procedures

    International Nuclear Information System (INIS)

    Lyon, W.S.

    1982-01-01

    The modern counting instrumentation has largely obviated the need for separation processes in the radiochemical analysis but problems in low-level radioactivity measurement, environmental-type analyses, and special situations caused in the last years a renaissance of the need for separation techniques. Most of the radiochemical procedures, based on the classic works of the Manhattan Project chemists of the 1940's, were published in the National Nuclear Energy Series (NNES). Improvements such as new solvent extraction and ion exchange separations have been added to these methods throughout the years. Recently the Los Alamos Group have reissued their collected Radiochemical Procedures containing a short summary and review of basic inorganic chemistry - 'Chemistry of the Elements on the Basis of Electronic Configuration'. (A.L.)

  3. Microculture virus titration--a simple colourimetric assay for influenza virus titration.

    Science.gov (United States)

    Levi, R; Beeor-Tzahar, T; Arnon, R

    1995-03-01

    Influenza antigens can be detected by several well established methods. However, when it is important to determine the titre of infective virions, a bioassay should be employed. The standard and the most widely used tests for influenza infectivity are titration carried out in embryonated hen eggs, or the plaque assay employing tissue culture techniques. A simple colourimetric assay for influenza virus detection and titration is described. Samples of allantoic fluid or mice lung homogenates were used to infect MDCK cultures in microplate wells. After an incubation period, the tetrazolium (MTT) colourimetric assay was used to determine cell viability, and when compared to untreated culture control enabled the detection and titration of several influenza strains. When samples were assayed simultaneously in embryonated eggs and by the MCVT method, good correlation in determined titres was obtained. The availability of an additional method for influenza titration allows more flexibility in the choice of titration method according to the specific needs of the study. Furthermore, this method lends itself to full automatization. Similar procedures should also be applicable to titration of other cytopathic viruses.

  4. Toxoplasma gondii plaque assays revisited: Improvements for ultrastructural and quantitative evaluation of lytic parasite growth.

    Science.gov (United States)

    Ufermann, Christoph-Martin; Müller, Florian; Frohnecke, Nora; Laue, Michael; Seeber, Frank

    2017-09-01

    Lytic growth of intracellular Toxoplasma gondii tachyzoite stages over a period of days results in plaques within mononolayers of host cells. Plaque assays are in frequent use to isolate single clones and to investigate invasion, replication and egress over a longer time frame. To allow correlating plaque morphology and/or size with ultrastructural examination of individual parasites we introduce a simple protocol for correlative light and electron microscopy (CLEM) of entire plaques. We also illustrate the advantages of visualizing only the boundaries of plaques by staining for infected cells ('positive staining') rather than the traditional staining of the intact cell monolayer, thus outlining the area of lysed cells ('negative staining'). Tachyzoites expressing β-galactosidase of Escherichia coli are an easy to visualize histochemical marker for this purpose. Quantitative measurements of plaque area with our compiled user-friendly ImageJ macros are compared to commercial software for ease and shown to be more accurate for some applications. Finally, a chemically defined medium is shown to be superior to the fetal bovine serum-containing medium for plaque assays, resulting in larger plaques. The reported additions and changes of the plaque assay procedure offer improved ways to analyze subtle differences in invasion, pathogen growth and egress. Our chemically defined medium will improve standardization of e.g. drug screening assays. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Radon assay for SNO+

    Energy Technology Data Exchange (ETDEWEB)

    Rumleskie, Janet [Laurentian University, Greater Sudbury, Ontario (Canada)

    2015-12-31

    The SNO+ experiment will study neutrinos while located 6,800 feet below the surface of the earth at SNOLAB. Though shielded from surface backgrounds, emanation of radon radioisotopes from the surrounding rock leads to back-grounds. The characteristic decay of radon and its daughters allows for an alpha detection technique to count the amount of Rn-222 atoms collected. Traps can collect Rn-222 from various positions and materials, including an assay skid that will collect Rn-222 from the organic liquid scintillator used to detect interactions within SNO+.

  6. Radiorespirometic assay device

    International Nuclear Information System (INIS)

    Levin, G.V.; Straat, P.A.

    1981-01-01

    A radiorespirometic assay device is described in which the presence of microorganisms in a sample is determined by placing the sample in contact with a metabolisable radioactive labelled substrate, collecting any gas evolved, exposing a photosensitive material to the gas and determining if a spot is produced on the material. A spot indicates the presence of radioactivity showing that the substrate has been metabolized by a microorganism. Bacteria may be detected in body fluids, hospital operating rooms, water, food, cosmetics and drugs. (U.K.)

  7. A robust assay to measure DNA topology-dependent protein binding affinity.

    Science.gov (United States)

    Litwin, Tamara R; Solà, Maria; Holt, Ian J; Neuman, Keir C

    2015-04-20

    DNA structure and topology pervasively influence aspects of DNA metabolism including replication, transcription and segregation. However, the effects of DNA topology on DNA-protein interactions have not been systematically explored due to limitations of standard affinity assays. We developed a method to measure protein binding affinity dependence on the topology (topological linking number) of supercoiled DNA. A defined range of DNA topoisomers at equilibrium with a DNA binding protein is separated into free and protein-bound DNA populations using standard nitrocellulose filter binding techniques. Electrophoretic separation and quantification of bound and free topoisomers combined with a simple normalization procedure provide the relative affinity of the protein for the DNA as a function of linking number. Employing this assay we measured topology-dependent DNA binding of a helicase, a type IB topoisomerase, a type IIA topoisomerase, a non-specific mitochondrial DNA binding protein and a type II restriction endonuclease. Most of the proteins preferentially bind negatively supercoiled DNA but the details of the topology-dependent affinity differ among proteins in ways that expose differences in their interactions with DNA. The topology-dependent binding assay provides a robust and easily implemented method to probe topological influences on DNA-protein interactions for a wide range of DNA binding proteins. Published by Oxford University Press on behalf of Nucleic Acids Research 2014. This work is written by US Government employees and is in the public domain in the US.

  8. Endoproteolytic activity assay in malting barley

    Directory of Open Access Journals (Sweden)

    Blanca Gómez Guerrero

    2013-12-01

    Full Text Available Hydrolysis of barley proteins into peptides and amino acids is one of the most important processes during barley germination.The degradation of the endosperm stored proteins facilitates water and enzyme movements, enhances modification, liberates starch granules and increases soluble amino nitrogen. Protease activity is the result of the activities of a mixture of exo- and endo-proteases. The barley proteins are initially solubilized by endo-proteases and the further by exo-proteases. Four classes of endo-proteases have been described: serine-proteases, cysteine-proteases, aspartic-proteases and metallo-proteases. The objective of this work was to develop a rapid and colorimetric enzymatic assay to determine the endo-proteolytic activity of the four endo-protease classes using two different substrates: azo-gelatin and azo-casein. Optimum conditions for the assays such as: pH,reaction time and temperature and absorbance scale were determined. Azo-gelatin presented several difficulties in standardizing an “in solution” assay. On the other hand, azo-casein allowed standardization of the assay for the four enzyme classes to produce consistent results. The endo-proteoteolytic method developed was applied to determine the endo-protease activity in barley, malt and wort.

  9. Disagreement between Human Papillomavirus Assays

    DEFF Research Database (Denmark)

    Rebolj, Matejka; Preisler, Sarah; Ejegod, Ditte Møller

    2014-01-01

    -65 years (n = 2,881), 23% tested positive on at least one assay, and 42 to 58% of these showed positive agreement on any compared pair of the assays. While 4% of primary screening samples showed abnormal cytology, 6 to 10% were discordant on any pair of assays. A literature review corroborated our findings...

  10. Evaluation of lot-to-lot repeatability and effect of assay media choice in the recombinant Factor C assay.

    Science.gov (United States)

    McKenzie, Jennifer Helen; Alwis, K Udeni; Sordillo, Joanne E; Kalluri, Kesava Srinivas; Milton, Donald Kirby

    2011-06-01

    Measurement of environmental endotoxin exposures is complicated by variability encountered using current biological assay methods arising in part from lot-to-lot variability of the Limulus-amebocyte lysate (LAL) reagents. Therefore, we investigated the lot-to-lot repeatability of commercially available recombinant Factor C (rFC) kits as an alternative to LAL. Specifically, we compared endotoxin estimates obtained from rFC assay of twenty indoor dust samples, using four different extraction and assay media, to endotoxin estimates previously obtained by Limulus amebocyte lysate (LAL) assay and amounts of 3-hydroxy fatty acids (3-OHFA) in lipopolysaccharide (LPS) using gas-chromatography mass spectroscopy (GC-MS). We found that lot-to-lot variability of the rFC assay kits does not significantly alter endotoxin estimates in house dust samples when performed using three of the four assay media tested and that choice of assay media significantly altered endotoxin estimates obtained by rFC assay of house dust samples. Our findings demonstrate lot-to-lot reproducibility of rFC assay of environmental samples and suggest that use of rFC assay performed with Tris buffer or water as the extraction and assay medium for measurement of endotoxin in dust samples may be a suitable choice for developing a standardized methodology.

  11. Whole blood microculture assay of human lymphocyte function.

    Science.gov (United States)

    Pauly, J L; Han, T

    1976-11-01

    A whole blood microculture assay is described for measuring lymphocyte reactivity to mitogenic and antigenic stimulants. This assay employs heparinized whole blood, serum-free culture medium, microtiter plates, and a Multiple Automated Sample Harvester (MASH). When this assay is compared to other leukocyte assays, its major advantages include (1) the utilization of fewer lymphocytes per microculture, thuus reducing the amount of blood required per test while increasing the number of test agents and replicate cultures which can be employed in any given experiment; (2) the conservation of mitogens, antigens, drugs, enzymes, hormones, lymphokines, and other test agents, some of which are either expensive of difficult to prepare in large quantities; (3) the elimination of lymphocyte isolation and purification procedures which may disrupt the relative proportion of T cells, B cells and antigen-processing cells; and (4) the application of an automated harvester which simplifies and expedites procedures required for processing cells for liquid scintillation counting.

  12. Procedimiento experimental, innovador y establecido: Ética y ciencia en la introducción de la tecnología médica Experimental, innovative and standard procedures: Ethics and sciencie in the introduction of medical technology

    Directory of Open Access Journals (Sweden)

    J.M.V. Pons

    2003-10-01

    Full Text Available La frontera que delimita un procedimiento como experimental, innovador o establecido, dentro del proceso médico asistencial, suele ser imprecisa en gran parte de los casos. Aún lo es más en el campo quirúrgico y de los productos implantables que difieren sustancialmente de las intervenciones terapéuticas farmacológicas, que están mucho más reguladas. Sin embargo, tanto ética como científicamente, conviene delimitar al máximo el carácter de las distintas intervenciones médicas que se aplican en sujetos humanos, sin dejar a criterio individual el margen de discreción existente hoy en día, especialmente en la innovación quirúrgica. El examen de forma externa e independiente del cociente beneficio/riesgo de la innovación propuesta ha de permitir transparentar, en la relación médico-paciente, el carácter particular de la técnica, así como los requerimientos éticos y científicos para su evaluación más apropiada.The dividing lines between experimental, innovative and standard medical procedures are frequently blurred in current clinical practice. This is even more true in the fields of surgery and implantable devices. These differ substantially from pharmacological interventions, which are better regulated. However, the character of the various medical interventions applied in human subjects should be ethically and scientifically delimited as clearly as possible. This task cannot be abandoned to personal discretion and criteria, which are currently used, especially in the field of surgical innovation. External and independent review of the risk-benefit ratio of proposed innovations should enable specification of the particular features of a technique in the patient-doctor relationship, as well as the ethical and scientific requirements for more appropriate evaluation.

  13. Standardization of RAPD assay for genetic analysis of olive

    African Journals Online (AJOL)

    PRECIOUS

    2009-12-15

    Dec 15, 2009 ... europaea L. Genetic variability and molecular cultivar identification. Genet. Res. Crop Evol. 54(1): 117-128. Mir Ali N, Nabulsi I (2003). Genetic diversity of almond (Prunus dulcis) using RAPD technique, Sci. Hort. 98: 461-471. Nei M (1972). Nei's Original Measures of Genetic Identity and Genetic. Distance.

  14. Standardization of RAPD assay for genetic analysis of olive | Sesli ...

    African Journals Online (AJOL)

    ... also PCR cycles I and II; however, favorable results were attained by PCR Mix III and. PCR cycle III. Evaluable bands were obtained for defining the olive samples by using primers from OP-I. Thus, it was concluded that RAPD profiles are effective in the study of genetic similarities and distances of wild and cultivated olives ...

  15. 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

  16. The use of calorimetry for plutonium assay

    International Nuclear Information System (INIS)

    Mason, J.A.

    1982-12-01

    Calorimetry is a technique for measuring the thermal power of heat-producing substances. The technique may be applied to the measurement of plutonium-bearing materials which evolve heat as a result of alpha and beta decay. A calorimetric measurement of the thermal power of a plutonium sample, combined with a knowledge or measurement of the plutonium isotopic mass ratios of the sample provides a convenient and accurate, non-destructive measure of the total plutonium mass of the sample. The present report provides a description, and an assessment of the calorimetry technique applied to the assay of plutonium-bearing materials. Types and characteristics of plutonium calorimeters are considered, as well as calibration and operating procedures. The instrumentation used with plutonium calorimeters is described and the use of computer control for calorimeter automation is discussed. A critical review and assessment of plutonium calorimetry literature since 1970 is presented. Both fuel element and plutonium-bearing material calorimeters are considered. The different types of plutonium calorimeters are evaluated and their relative merits are discussed. A combined calorimeter and gamma-ray measurement assay system is considered. The design principles of plutonium assay calorimeters are considered. An automatic, computer-based calorimeter control system is proposed in conjunction with a general plutonium assay calorimeter design. (author)

  17. Extracellular Enzyme Activity assay as indicator of soil microbial functional diversity and activity

    DEFF Research Database (Denmark)

    Hendriksen, Niels Bohse; Winding, Anne

    2012-01-01

    and soil ecosystem services. The soil enzyme activity has been measured by the use of fluorogenic model substrates e.g. methylumbelliferyl (MUF) substrates for a number of enzymes involved in the degradation of polysaccharides as cellulose, hemicellulose and chitin, while degradation of proteins has been......Extracellular Enzyme Activity assay as indicator of soil microbial functional diversity and activity Niels Bohse Hendriksen, Anne Winding. Department of Environmental Science, Aarhus University, 4000 Roskilde, Denmark Soil enzymes originate from a variety of organisms, notably fungi and bacteria......, experimental conditions of extraction of enzymes from soils, buffer and pH, substrate concentration, temperature and the necessary controls were optimized and standardized. This has resulted in an optimized standard operating procedure of EEA, which are being tested as an indicator of soil functional diversity...

  18. Robust ridge regression estimators for nonlinear models with applications to high throughput screening assay data.

    Science.gov (United States)

    Lim, Changwon

    2015-03-30

    Nonlinear regression is often used to evaluate the toxicity of a chemical or a drug by fitting data from a dose-response study. Toxicologists and pharmacologists may draw a conclusion about whether a chemical is toxic by testing the significance of the estimated parameters. However, sometimes the null hypothesis cannot be rejected even though the fit is quite good. One possible reason for such cases is that the estimated standard errors of the parameter estimates are extremely large. In this paper, we propose robust ridge regression estimation procedures for nonlinear models to solve this problem. The asymptotic properties of the proposed estimators are investigated; in particular, their mean squared errors are derived. The performances of the proposed estimators are compared with several standard estimators using simulation studies. The proposed methodology is also illustrated using high throughput screening assay data obtained from the National Toxicology Program. Copyright © 2014 John Wiley & Sons, Ltd.

  19. Juveniles in criminal procedure

    Directory of Open Access Journals (Sweden)

    Lukić Tatjana

    2012-01-01

    Full Text Available Taking into consideration the importance and role of children in modern society, as well as their position, this article has as its focus juveniles in criminal procedure. The existence of a separate juvenile justice system independent of the criminal law applicable to the adult offenders and general criminal procedure, as well as the periodic changes of the dominant approach in theory and practice reflects the ascendancy of different theoretical perspectives in the juvenile justice. In this paper, the authors scrutinize the models of responding to juvenile crime - justice and welfare model - as two models of the greatest importance in the present reaction of the society to the crimes conducted by the youngest delinquents at the beginning of the new century and millennium. Furthermore, the paper deals with a matter of international legal standards which, to a large extent, give shape to the legal framework for juvenile offenders and provide their rights and position in the criminal procedure. The authors refer to the internationally accepted documents on several levels. From the (almost universally accepted multilateral conventions on human rights, through the field of recommendations, rules and guidelines which are obeyed and enforced in practice of the juvenile justice although they are of non-binding nature, via the regional European legislative to the national provisions in a particular number of countries. On all the levels mentioned above the rights of the juveniles are regulated having in mind their possible role in the criminal procedure as a perpetrator of a criminal act, as a victim or as a witness. This paper also analyzes the criminal procedure with respect to juvenile perpetrators of the criminal acts in the Republic of Serbia and compliance of the provisions currently in vigor with the international legal standards contained in the international conventions and other internationally accepted and recognized instruments.

  20. Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation.

    Science.gov (United States)

    Noble, James E; Bunk, David M; Christenson, Robert H; Cole, Kenneth D; He, Hua-Jun; Katrukha, Alexei G; Panteghini, Mauro; Porter, Robert A; Schimmel, Heinz; Tate, Jillian R; Wang, Lili

    2010-11-01

    In this study, the first steps in the development of a secondary reference measurement procedure (RMP) 'higher metrological order measurement procedure' to support the cardiac troponin I (cTnI) standardization initiative is described. The RMP should be used to assign values to serum-based secondary reference materials (RMs) without analytical artifacts causing bias. A multiplexed bead-based assay and sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) were used to identify the optimum monoclonal antibody pair (clones 560 and 19C7) for the RMP. Using these antibodies, an ELISA-based procedure was developed to accurately measure the main cTnI forms present in blood. The proposed RMP appears to show no bias when tested on samples containing various troponin complexes, phosphorylated and dephosphorylated forms, and heparin. The candidate assay displayed suitable linearity and sensitivity (limit of detection, 0.052 μg/L) for the measurement of the proposed cTnI secondary RMs. Preliminary comparison data on patient samples with a commercial cTnI assay are also provided to support the suitability of RMP for value assignment to RMs. Full validation and final assessment of the RMP will be performed through transferability and inter-comparison studies.