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Sample records for clinical enzyme tests

  1. Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever.

    Science.gov (United States)

    Pal, Subhamoy; Dauner, Allison L; Valks, Andrea; Forshey, Brett M; Long, Kanya C; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C; Halsey, Eric S; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J; Jasper, Louis E; Wu, Shuenn-Jue L

    2015-04-01

    We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

  2. Diagnosis and Clinical Virology of Lassa Fever as Evaluated by Enzyme-Linked Immunosorbent Assay, Indirect Fluorescent-Antibody Test, and Virus Isolation

    OpenAIRE

    Bausch, D. G.; Rollin, P E; Demby, A H; Coulibaly, M.; Kanu, J.; Conteh, A. S.; Wagoner, K. D.; McMullan, L. K.; Bowen, M. D.; Peters, C. J.; Ksiazek, T. G.

    2000-01-01

    The Lassa virus (an arenavirus) is found in West Africa, where it sometimes causes a severe hemorrhagic illness called Lassa fever. Laboratory diagnosis has traditionally been by the indirect fluorescent-antibody (IFA) test. However, enzyme-linked immunosorbent assays (ELISAs) for Lassa virus antigen and immunoglobulin M (IgM) and G (IgG) antibodies have been developed that are thought to be more sensitive and specific. We compared ELISA and IFA testing on sera from 305 suspected cases of Las...

  3. 21 CFR 862.2500 - Enzyme analyzer for clinical use.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Enzyme analyzer for clinical use. 862.2500 Section... Instruments § 862.2500 Enzyme analyzer for clinical use. (a) Identification. An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement...

  4. Clinical Comparison of the Treponema pallidum CAPTIA Syphilis-G Enzyme Immunoassay with the Fluorescent Treponemal Antibody Absorption Immunoglobulin G Assay for Syphilis Testing

    OpenAIRE

    Halling, V. W.; Jones, M. F.; Bestrom, J. E.; Wold, A D; Rosenblatt, J E; Smith, T. F.; Cockerill, F R

    1999-01-01

    Recently, a treponema-specific immunoglobulin G (IgG) enzyme immunoassay (EIA), the CAPTIA Syphilis-G (Trinity Biotech, Jamestown, N.Y.), has become available as a diagnostic test for syphilis. A total of 89 stored sera previously tested by the fluorescent treponemal antibody absorption (FTA-ABS) IgG assay were evaluated by the CAPTIA EIA. The FTA-ABS IgG procedure was performed by technologists unblinded to results of rapid plasmid reagin (RPR) testing of the same specimens. Borderline CAPTI...

  5. Towards a clinical practice guide in pharmacogenomics testing for functional polymorphisms of drug-metabolising enzymes. Gene/drug pairs and barriers perceived in Spain.

    Directory of Open Access Journals (Sweden)

    José A G Agúndez

    2012-11-01

    Full Text Available The development of clinical practice recommendations or guidelines for the clinical use of biomarkers is an issue of great importance with regard to adverse drug reactions. The potential of pharmacogenomic biomarkers has been extensively investigated in recent years. However, several barriers to implementing the use of pharmacogenomics testing exist. We conducted a survey among members of the Spanish Societies of Pharmacology and Clinical Pharmacology to obtain information about the perception of such barriers and to compare the perceptions of participants about the relative importance of major gene/drug pairs.Of 11 potential barriers, the highest importance was attributed to lack of institutional support for pharmacogenomics testing, and to the issues related to the lack of guidelines. Of the proposed gene/drug pairs the highest importance was assigned to HLA-B/abacavir, UGT1A1/irinotecan and CYP2D6/tamoxifen. In this perspective article we compare the relative importance of 29 gene/drug pairs in the Spanish study with that of the same pairs in the American Society for Clinical Pharmacology & Therapeutics study, and we provide suggestions and areas of focus to develop a guide for clinical practice in pharmacogenomics testing.

  6. Clinical uses of an enzyme-containing dentifrice.

    Science.gov (United States)

    Midda, M; Cooksey, M W

    1986-11-01

    Previous studies have shown that the inclusion of certain enzymes in mouthrinses and dentifrices will reduce plaque and gingivitis scores. The enzymes that are most effective clinically have, as their active ingredients, amyloglucosidase and glucose oxidase. These produce hydrogen peroxide from dietary fermentable carbohydrates which in turn converts thiocyanate to hypothiocyanite in the presence of salivary lactoperoxidase. The resultant hypothiocyanite acts as a bacterial inhibitor by interfering with cell metabolism; thus, there is a reduction in plaque accumulation and therefore in gingival inflammation. Pilot studies have compared over a short period the action of the trial dentifrice with enzymes and fluoride at 1100 ppm, using as controls the paste without enzymes but with fluoride and a commercial fluoride paste. There was an expected reduction in all scores with all products due to the mechanical removal of plaque, but a significantly greater reduction in gingivitis was noted in the paste with enzymes. This study is of longer duration with many more subjects. Baseline data include plaque and gingival indices and Periotron readings for crevicular fluid. The trial is of a double-blind non-crossover study design using a split-mouth technique. One side of the mouth is given a prophylaxis and the subject given one of the 3 test pastes to use. Readings were repeated every 2 weeks for 3 months. The results show a significant reduction in gingivitis scores in the enzyme-containing dentifrice group.

  7. Diagnosis and Clinical Virology of Lassa Fever as Evaluated by Enzyme-Linked Immunosorbent Assay, Indirect Fluorescent-Antibody Test, and Virus Isolation

    Science.gov (United States)

    Bausch, D. G.; Rollin, P. E.; Demby, A. H.; Coulibaly, M.; Kanu, J.; Conteh, A. S.; Wagoner, K. D.; McMullan, L. K.; Bowen, M. D.; Peters, C. J.; Ksiazek, T. G.

    2000-01-01

    The Lassa virus (an arenavirus) is found in West Africa, where it sometimes causes a severe hemorrhagic illness called Lassa fever. Laboratory diagnosis has traditionally been by the indirect fluorescent-antibody (IFA) test. However, enzyme-linked immunosorbent assays (ELISAs) for Lassa virus antigen and immunoglobulin M (IgM) and G (IgG) antibodies have been developed that are thought to be more sensitive and specific. We compared ELISA and IFA testing on sera from 305 suspected cases of Lassa fever by using virus isolation with a positive reverse transcription-PCR (RT-PCR) test as the “gold standard.” Virus isolation and RT-PCR were positive on 50 (16%) of the 305 suspected cases. Taken together, Lassa virus antigen and IgM ELISAs were 88% (95% confidence interval [CI], 77 to 95%) sensitive and 90% (95% CI, 88 to 91%) specific for acute infection. Due to the stringent gold standard used, these likely represent underestimates. Diagnosis could often be made on a single serum specimen. Antigen detection was particularly useful in providing early diagnosis as well as prognostic information. Level of antigenemia varied inversely with survival. Detection by ELISA of IgG antibody early in the course of illness helped rule out acute Lassa virus infection. The presence of IFA during both acute and convalescent stages of infection, as well as significant interobserver variation in reading the slides, made interpretation difficult. However, the assay provided useful prognostic information, the presence of IFA early in the course of illness correlating with death. The high sensitivity and specificity, capability for early diagnosis, and prognostic value of the ELISAs make them the diagnostic tests of choice for the detection of Lassa fever. PMID:10878062

  8. Clinical Genetic Testing in Gastroenterology

    Science.gov (United States)

    Goodman, Russell P; Chung, Daniel C

    2016-01-01

    Rapid advances in genetics have led to an increased understanding of the genetic determinants of human disease, including many gastrointestinal (GI) disorders. Coupled with a proliferation of genetic testing services, this has resulted in a clinical landscape where commercially available genetic tests for GI disorders are now widely available. In this review, we discuss the current status of clinical genetic testing for GI illnesses, review the available testing options, and briefly discuss indications for and practical aspects of such testing. Our goal is to familiarize the practicing gastroenterologist with this rapidly changing and important aspect of clinical care. PMID:27124700

  9. Evaluation of a Treponema pallidum enzyme immunoassay as a screening test for syphilis.

    OpenAIRE

    Hooper, N E; Malloy, D C; Passen, S

    1994-01-01

    The CAPTIA Syphilis-G enzyme immunoassay for the detection of antibodies to Treponema pallidum was evaluated as a screening test for syphilis in comparison with the standard rapid plasma reagin (RPR) test. One thousand samples were tested, and the standard fluorescent treponemal antibody absorption test and the standard microhemmaglutination test were used to confirm the presence of treponemal antibodies. Diagnosis of syphilis was based on traditional standard serology results. Clinical data ...

  10. The use of enzyme test kits for teaching lipid chemistry

    Science.gov (United States)

    Many methods are available for the analysis of lipids and other natural products. Although they are rarely used in research laboratories, enzyme-based assays are used extensively for routine analyses in the clinical chemistry and in food analysis laboratories. Many of these enzymatic methods can b...

  11. Clinical Genetic Testing in Epilepsy

    OpenAIRE

    Mefford, Heather C.

    2015-01-01

    New technologies for mutation detection in the human genome have greatly increased our understanding of epilepsy genetics. Application of genomic technologies in the clinical setting allows for more efficient genetic diagnosis in some patients; therefore, it is important to understand the types of tests available and the types of mutations that can be detected. Making a genetic diagnosis improves overall patient care by enhancing prognosis and recurrence risk counseling and informing treatmen...

  12. Enzyme immunoassay for direct detection of influenza type A and adenovirus antigens in clinical specimens.

    OpenAIRE

    Harmon, M W; Pawlik, K M

    1982-01-01

    Detection of viral antigens in specimens without prior cultivation in cell culture provides the most rapid method for specific viral diagnosis. A solid-phase, double-antibody enzyme immunoassay was developed for this purpose and tested with clinical specimens containing influenza type A and adenovirus. Polystyrene microtiter wells were the solid phase and were coated with virus-specific guinea pig immunoglobulins. Specimens were added, and bound viral antigens were detected by addition of vir...

  13. Enzyme

    Science.gov (United States)

    Enzymes are complex proteins that cause a specific chemical change in all parts of the body. For ... use them. Blood clotting is another example of enzymes at work. Enzymes are needed for all body ...

  14. Monitoring of pulmonary endothelial enzyme function: an animal model for a simplified clinically applicable procedure

    International Nuclear Information System (INIS)

    The authors present a simple and clinically applicable method for the serial monitoring of pulmonary microvascular enzyme function in vivo. This method requires the intravenous injection of trace amounts of a radiolabelled substrate and the collection of a single arterial blood sample. Simultaneous measurement of pulmonary blood flow, (e.g., by dye- or thermo-dilution) and the determination of blood hematocrit are also needed for the calculations. This method was compared to the multiple blood sample indicator dilution method in normal anesthesized rabbits. Both methods gave identical results for the metabolism of the synthetic, hemodynamically inactive tripeptide, 3H-benzoyl-Phe-Ala-Pro (3H-BPAP), by pulmonary microvascular endothelial angiotensin converting enzyme. The parameters measured were: 1) substrate utilization, expressed linearly and logarithmically, and 2) the apparent first order reaction constant. The new method was also used for the simultaneous measurement of single pass, transpulmonary metabolism of 3H-BPAP by angiotensin converting enzyme and of 5'-adenosine monophosphate by 5'-nucleotidase in rabbits in vivo. The authors propose that similar enzyme kinetic measurements could be used in clinical studies to test their usefulness as an aid in the early diagnosis of incipient pulmonary endothelial dysfunction, e.g., adult respiratory distress syndrome

  15. Evaluation of extended spectrum beta lactamase enzymes prevalence in clinical isolates of Escherichia coli

    Directory of Open Access Journals (Sweden)

    Ronak Bakhtiari

    2011-10-01

    Full Text Available Resistance to b-lactam antibiotics by gramnegative bacteria, especially Escherichia coli (E. coli, is a major public health issue worldwide. The predominant resistance mechanism in gram negative bacteria particularly E. coli is via the production of extended spectrum beta lactamase (ESBLs enzymes. In recent years, the prevalence of b-lactamase producing organisms is increased and identification of these isolates by using disk diffusion method and no-one else is not satisfactory. So, this investigation focused on evaluating the prevalence of ESBL enzymes by disk diffusion method and confirmatory test (Combined Disk. Five hundred clinical samples were collected and 200 E. coli isolates were detected by standard biochemical tests. To performing initial screening of ESBLs was used from Disk diffusion method on E. coli isolates. A confirmation test (Combined Disk method was performed on isolates of resistant to cephalosporin's indicators. Up to 70% isolates exhibited the Multi Drug Resistance phenotype. In Disk diffusion method, 128(64% E. coli isolates which resistant to ceftazidime and cefotaxime while in Combined Disk, among 128 screened isolates, 115 (89.8% isolates were detected as ESBLs producers. This survey indicate beta lactamase enzymes are playing a significant role in antibiotic resistance and correct detection of them in phenotypic test by using disk diffusion and combined Disk is essential for accurate recognition of ESBLs.

  16. 21 CFR 862.1090 - Angiotensin converting enzyme (A.C.E.) test system.

    Science.gov (United States)

    2010-04-01

    ... Test Systems § 862.1090 Angiotensin converting enzyme (A.C.E.) test system. (a) Identification. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Angiotensin converting enzyme (A.C.E.) test...

  17. The management of isolated positive syphilis enzyme immunoassay results in HIV-negative patients attending a sexual health clinic.

    Science.gov (United States)

    Thorley, Nicola; Adebayo, Michael; Smit, Erasmus; Radcliffe, Keith

    2016-08-01

    An unconfirmed positive treponemal enzyme immunoassay (enzyme immunoassay positive, Treponema pallidum particle agglutination negative and rapid plasma reagin negative) presents a clinical challenge to distinguish early syphilis infection from false-positive results. These cases are referred for syphilis line assay (INNO-LIA) and recalled for repeat syphilis serology. We performed a retrospective audit to establish the proportion of HIV-negative cases with unconfirmed positive enzyme immunoassay results, the proportion of these cases that received an INNO-LIA test and repeat syphilis serology testing and reviewed the clinical outcomes; 0.35% (80/22687) cases had an unconfirmed positive treponemal enzyme immunoassay result. Repeat syphilis serology was performed in 80% (64/80) cases, but no additional cases of syphilis were identified. Eighty-eight per cent (70/80) received an INNO-LIA test; 14% (5/37) unconfirmed enzyme immunoassay-positive cases with no prior history of syphilis were confirmed on INNO-LIA assay, supporting a diagnosis of latent syphilis. As a confirmatory treponemal test, the INNO-LIA assay may be more useful than repeat syphilis serological testing. PMID:26637236

  18. Enzymes in the dissolution testing of gelatin capsules.

    Science.gov (United States)

    Marques, Margareth R C

    2014-12-01

    Gelatin capsules are a widely used dosage form both for pharmaceutical drug products as well as dietary supplements. Gelatin in the presence of certain compounds, mainly aldehydes, or in high humidity and high temperature conditions can cross-link. Cross-linking involves covalent bonding of the amine group of a lysine side chain of one gelatin molecule to a similar amine group on another molecule. The covalent bonding is, for practical purposes, irreversible. Cross-linking results in the formation of a pellicle on the internal or external surface of the gelatin capsule shell that prevents the capsule fill from being released. In vitro dissolution testing of cross-linked gelatin capsules can result in slower release of the drug or no release at all. The data obtained by the Gelatin Capsule Working Group, created in the early 90s to investigate noncompliance of gelatin capsules, was used to establish the type and amounts of enzymes that can be added to the dissolution medium in the case of test failure to the presence of cross-linking in the gelatin. The two-tier dissolution testing was included in the US Pharmacopeia and it recommends the addition of pepsin (pH below 6.8) or pancreatin (pH above 6.8) to the medium depending on its pH. Pepsin shows good protease activity up to pH 4 and pancreatin above pH 6 leaving a gap where neither one has good activity. Possible proteolytic enzymes that could be used for the pH range 4-6.8 could be papain or bromelain. PMID:24942315

  19. Clinical utility of chitotriosidase enzyme activity in nephropathic cystinosis

    OpenAIRE

    Elmonem, M.A.; Makar, S.H.; Heuvel, L.P.W.J. van den; Abdelaziz, H.; Abdelrahman, S.M.; Bossuyt, X; Janssen, M.C.; Cornelissen, E.; Lefeber, D.J.; Joosten, L.; Nabhan, M.M.; Arcolino, F.O.; Hassan, F. A. [فكري حسن; Chevronnay, H.P. Gaide; Soliman, N.A.

    2014-01-01

    BackgroundNephropathic cystinosis is an inherited autosomal recessive lysosomal storage disorder characterized by the pathological accumulation and crystallization of cystine inside different cell types. WBC cystine determination forms the basis for the diagnosis and therapeutic monitoring with the cystine depleting drug (cysteamine). The chitotriosidase enzyme is a human chitinase, produced by activated macrophages. Its elevation is documented in several lysosomal storage disorders. Although...

  20. Clinical Use of Pharmacogenomic Tests in 2009

    OpenAIRE

    Sheffield, Leslie J; Phillimore, Hazel E

    2009-01-01

    Pharmacogenomics is a new field where testing an individual can define either a risk status for an adverse event, or the rate of metabolism of a drug. This is achieved by the categorisation of the enzyme activity or documenting genetic polymorphisms of a metabolising enzyme. The best example of risk status assessment is the recent finding that HLA-B typing a person can predict whether they are at risk of a severe skin reaction from the drug abacavir. Those patients showing HLA-B*5701, who are...

  1. Enzyme therapy of xeroderma pigmentosum: safety and efficacy testing of T4N5 liposome lotion containing a prokaryotic DNA repair enzyme.

    Science.gov (United States)

    Yarosh, D; Klein, J; Kibitel, J; Alas, L; O'Connor, A; Cummings, B; Grob, D; Gerstein, D; Gilchrest, B A; Ichihashi, M; Ogoshi, M; Ueda, M; Fernandez, V; Chadwick, C; Potten, C S; Proby, C M; Young, A R; Hawk, J L

    1996-06-01

    Xeroderma pigmentosum (XP) is a rare genetic disease in which patients are defective in DNA repair and are extremely sensitive to solar UV radiation exposure. A new treatment approach was tested in these patients, in which a prokaryotic DNA repair enzyme specific for UV-induced DNA damage was delivered into the skin by means of topically applied liposomes to supplement the deficient activity. Acute and chronic safety testing in both mice and humans showed neither adverse reactions nor significant changes in serum chemistry or in skin histology. The skin of XP patients treated with the DNA repair liposomes had fewer cyclobutylpyrimidine dimers in DNA and showed less erythema than did control sites. The results encourage further clinical testing of this new enzyme therapy approach.

  2. Comparison of a new rapid test (TestPack Rotavirus) with standard enzyme immunoassay and electron microscopy for the detection of rotavirus in symptomatic hospitalized children.

    OpenAIRE

    Brooks, R G; Brown, L.; Franklin, R. B.

    1989-01-01

    We compared a new, rapid, qualitative test for rotavirus (TestPack Rotavirus; Abbott Laboratories, North Chicago, Ill.) with another enzyme immunoassay (Pathfinder Rotavirus; Kallestad Laboratories, Inc., Austin, Tex.) and electron microscopy to determine its clinical utility in a population of symptomatic hospitalized children. In the first part of the study, 100 frozen stool samples were tested. The results after resolution with a blocking reagent showed a sensitivity of only 50% and a spec...

  3. A clinical evaluation of the Cobas Fara clinical chemistry analyzer for some routine serum enzymes and glucose.

    Science.gov (United States)

    Moses, G C; Lightle, G O; Tuckerman, J F; Henderson, A R

    1987-11-01

    The authors evaluated the Cobas FARA centrifugal analyzer with respect to pipetting precision and accuracy, instrument temperature, spectrophotometric response, and analytic performance for the assay of five serum enzymes and glucose. Spectrophotometric response, temperature response, pipetting precision, and accuracy were satisfactory. However, sufficient time must be allowed for cuvet contents to reach a stable temperature before measurements are made. Total day-to-day imprecision (within plus between run) was less than 5% (coefficient of variation) for aspartate and alanine aminotransferases (AST; Enzyme Commission classification number [EC] EC 2.6.1.1; and ALT; EC 2.6.1.2); alkaline phosphatase (AP; EC 3.1.3.1); gamma-glutamyltransferase (GGT; EC 2.3.1.2); lactate dehydrogenase (LD; EC 1.1.1.17); creatine kinase (CK; EC 2.7.3.1); and glucose assays. Results compare well with those obtained with other current clinical chemistry analyzers; correlation coefficients were greater than 0.993. Sample-to-sample carryover was negligible, and method linearity was satisfactory for all tests.

  4. Clinical use of pharmacogenomic tests in 2009.

    Science.gov (United States)

    Sheffield, Leslie J; Phillimore, Hazel E

    2009-05-01

    Pharmacogenomics is a new field where testing an individual can define either a risk status for an adverse event, or the rate of metabolism of a drug. This is achieved by the categorisation of the enzyme activity or documenting genetic polymorphisms of a metabolising enzyme. The best example of risk status assessment is the recent finding that HLA-B typing a person can predict whether they are at risk of a severe skin reaction from the drug abacavir. Those patients showing HLA-B*5701, who are being considered for abacavir therapy, can be prevented from developing potentially toxic epidermal necrosis (TEN) or Stevens-Johnson Syndrome by avoiding abacavir. The evidence for HLA-B typing for allopurinol and carbamazepine has also been described. Most other pharmacogenomic tests are of drug metabolising enzymes, which can either be assessed using "probe" drugs and measuring a ratio of parent drug to metabolite, or, by genetic testing for polymorphisms of the genes. In practice, testing is usually done by molecular testing, but this typically does not detect all polymorphisms. This article briefly reviews the evidence for the utilisation of pharmacogenomics for antidepressant drugs, tamoxifen, codeine, warfarin, azathioprine, clopidogrel, omeprazole, tacrolimus and irinotecan. There are few pharmacogenomics tests being carried out in practice, as there has not been a wide appreciation of their use, and only limited evidence exists for many individual drugs. It is expected that utilisation will increase as more evidence becomes available and there is a wider understanding of the existing evidence by the medical profession. PMID:19565025

  5. Diagnosis of brain death: confirmatory tests after clinical test

    Institute of Scientific and Technical Information of China (English)

    Su Yingying; Yang Qinglin; Liu Gang; Zhang Yan; Ye Hong; Gao Daiquan; Zhang Yunzhou

    2014-01-01

    Background The brain death confirmation tests occupy a different position in each country's diagnostic criteria (or guideline); the choices of tests are also different.China brain death criteria include clinical judgment and confirmation tests.This study aimed to confirm the preferred confirmatory test and complementary confirmatory tests.Methods We did a clinical brain death determination on deep coma patients,and then divided them into brain death group and non-brain death group.According to the Chinese standards for determining brain death,both the groups accepted confirmatory tests including electroencephalograph (EEG),somatosensory evoked potentials (SEP),and transcranial Doppler (TCD).The sensitivity,specificity,false positive rate,and false negative rate were calculated to evaluate the accuracy of the confirmatory tests.Results Among the 131 cases of patients,103 patients met the clinical criteria of brain death.Respiratory arrest provocation test was performed on 44 cases and 32 cases (73%) successfully completed and confirmed that they have no spontaneous breathing.Of the three confirmation tests,EEG had the highest completion rate (98%) and good sensitivity (83%) and specificity (97%); TCD had followed completion rate (54%) and not good sensitivity (73%) and specificity (75%); SEP had the lowest completion rate (49%),good sensitivity (100%),and not good specificity (78%).After the combination of SEP or TCD with EEG,the specificity can increase to 100%.Conclusions The completion rate of respiratory arrest provocation test remains a problem in the clinical diagnosis of brain death.If the test cannot be completed,whether to increase a confirmatory test is debatable.SEP had an ideal sensitivity,and the specificity will reach 100% after combining with TCD or EEG.When a confirmed test was uncertain,we suggest increasing another confirmatory test.

  6. Hypothesis Formation and Testing in Clinical Judgment.

    Science.gov (United States)

    Strohmer, Douglas C.; And Others

    1983-01-01

    Examined the influence of cognitive complexity and client observation on the quality of clinical hypotheses counselors develop and the number of questions generated to test them. Results showed no effect of these variables on hypothesis quality; but a significant interaction between client observations on the number of questions developed. (LLL)

  7. Satiety testing: Ready for the clinic?

    Institute of Scientific and Technical Information of China (English)

    Michael P Jones

    2008-01-01

    Drink tests are advocated as an inexpensive,nonivesive technique to assess gastric function in patients with a variety of upper digestive symptoms.Many patients with dyspeptic complaints will achieve satiation or develop symptoms at ingested volumes below those typically required to achieve these endpoints in controls.Substantial variation in test performance exists and a greater degree of standardization is required.Additionally,it remains unclear exactly what drink tests measure as correlations with measures of gastric sensation,accomodation and emptying are modest at best.Finally,results of drink tests do not guide therpay.At present,these tests are best reserved for research studies and are not advocated for use in clinical practice.(C)2008 The W.1G Press.All rights reserved.

  8. Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

    Science.gov (United States)

    Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

    2015-01-01

    Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. PMID:25112173

  9. Probability, clinical decision making and hypothesis testing

    Directory of Open Access Journals (Sweden)

    A Banerjee

    2009-01-01

    Full Text Available Few clinicians grasp the true concept of probability expressed in the ′P value.′ For most, a statistically significant P value is the end of the search for truth. In fact, the opposite is the case. The present paper attempts to put the P value in proper perspective by explaining different types of probabilities, their role in clinical decision making, medical research and hypothesis testing.

  10. Feline genetics: clinical applications and genetic testing.

    Science.gov (United States)

    Lyons, Leslie A

    2010-11-01

    DNA testing for domestic cat diseases and appearance traits is a rapidly growing asset for veterinary medicine. Approximately 33 genes contain 50 mutations that cause feline health problems or alterations in the cat's appearance. A variety of commercial laboratories can now perform cat genetic diagnostics, allowing both the veterinary clinician and the private owner to obtain DNA test results. DNA is easily obtained from a cat via a buccal swab with a standard cotton bud or cytological brush, allowing DNA samples to be easily sent to any laboratory in the world. The DNA test results identify carriers of the traits, predict the incidence of traits from breeding programs, and influence medical prognoses and treatments. An overall goal of identifying these genetic mutations is the correction of the defect via gene therapies and designer drug therapies. Thus, genetic testing is an effective preventative medicine and a potential ultimate cure. However, genetic diagnostic tests may still be novel for many veterinary practitioners and their application in the clinical setting needs to have the same scrutiny as any other diagnostic procedure. This article will review the genetic tests for the domestic cat, potential sources of error for genetic testing, and the pros and cons of DNA results in veterinary medicine. Highlighted are genetic tests specific to the individual cat, which are a part of the cat's internal genome. PMID:21147473

  11. Feline genetics: clinical applications and genetic testing.

    Science.gov (United States)

    Lyons, Leslie A

    2010-11-01

    DNA testing for domestic cat diseases and appearance traits is a rapidly growing asset for veterinary medicine. Approximately 33 genes contain 50 mutations that cause feline health problems or alterations in the cat's appearance. A variety of commercial laboratories can now perform cat genetic diagnostics, allowing both the veterinary clinician and the private owner to obtain DNA test results. DNA is easily obtained from a cat via a buccal swab with a standard cotton bud or cytological brush, allowing DNA samples to be easily sent to any laboratory in the world. The DNA test results identify carriers of the traits, predict the incidence of traits from breeding programs, and influence medical prognoses and treatments. An overall goal of identifying these genetic mutations is the correction of the defect via gene therapies and designer drug therapies. Thus, genetic testing is an effective preventative medicine and a potential ultimate cure. However, genetic diagnostic tests may still be novel for many veterinary practitioners and their application in the clinical setting needs to have the same scrutiny as any other diagnostic procedure. This article will review the genetic tests for the domestic cat, potential sources of error for genetic testing, and the pros and cons of DNA results in veterinary medicine. Highlighted are genetic tests specific to the individual cat, which are a part of the cat's internal genome.

  12. The enzymes of the hepatobiliary tract: a biochemical and clinical comparison.

    Science.gov (United States)

    Batsakis, J G

    1974-01-01

    The "biliary tract" enzymes (leucine aminopeptidase, gamma-glutamyltranspeptidase and 5'-nucleotidase) in serum reflect to varying degrees, obstruction, proliferation, inflammation and neoplasia involving the hepatobiliary duct system. Their use is directed towards two purposes: (1) as non-electrophoretic assays to evaluate the source of an elevated non-specific alkaline phosphatase and (2) to offer greater sensitivity and specificity for space-occuping lesions in the liver. In appropriate clinical states, any of the three enzymes offer these advantages and there is little to chose among them. Selection of the assay to use in the clinical laboratory then becomes based on non-clinical factors, i.e., technical ease, apparent substrate specifities, etc. With these additional factors and despite some shortcomings, our selection is leucine aminopeptidase.

  13. Distribution of genes encoding aminoglycoside-modifying enzymes among clinical isolates of methicillin-resistant staphylococci

    Directory of Open Access Journals (Sweden)

    N Perumal

    2016-01-01

    Full Text Available The objective of this study was to determine the distribution of genes encoding aminoglycoside-modifying enzymes (AMEs and staphylococcal cassette chromosome mec (SCCmec elements among clinical isolates of methicillin-resistant staphylococci (MRS. Antibiotic susceptibility test was done using Kirby-Bauer disk diffusion method. The presence of SCCmec types and AME genes, namely, aac (6′-Ie-aph (2′′, aph (3′-IIIa and ant (4′-Ia was determined using two different multiplex polymerase chain reaction. The most encountered AME genes were aac (6′-Ie-aph (2′′ (55.4% followed by aph (3′-IIIa (32.3% and ant (4′-Ia gene (9%. SCCmec type I (34% was predominant in this study. In conclusion, the aac (6′-Ie-aph (2′′ was the most common AME gene and SCCmec type I was most predominant among the MRS isolates.

  14. A micro-enzyme-linked immunosorbent assay (ELISA) and radioimmunosorbent technique (RIST) for the detection of immunity to clinical tetanus

    International Nuclear Information System (INIS)

    Enzyme-linked immunosorbent assay (ELISA), and radioimmunosorbent assay (RIST) techniques for the detection of tetanus toxin antibodies are described. Both methods proved to be highly sensitive, and allowed the measurement of 5 x 10-3 units/ml tetanus antitoxin in human serum or plasma, sensitivity and reproducibility comparing well with other techniques previously described, and being superior to haemagglutination and latex agglutination tests. Results of the two methods correlated well, and reflected the immunization histories obtained. Micro ELISA and micro RIST would seem to be suitable for the detection of immunity, or non-immunity to clinical tetanus. (author)

  15. Photoprotection by topical DNA repair enzymes: molecular correlates of clinical studies.

    Science.gov (United States)

    Yarosh, D B; O'Connor, A; Alas, L; Potten, C; Wolf, P

    1999-02-01

    A new approach to photoprotection is to repair DNA damage after UV exposure. This can be accomplished by delivery of a DNA repair enzyme with specificity to UV-induced cyclobutane pyrimidine dimers into skin by means of specially engineered liposomes. Treatment of DNA-repair-deficient xeroderma pigmentosum patients or skin cancer patients with T4N5 liposome lotion containing such DNA repair liposomes increases the removal of DNA damage in the first few hours after treatment. In these studies, a DNA repair effect was observed in some patients treated with heat-inactivated enzyme. Unexpectedly, it was discovered that the heat-inactivated T4 endonuclease V enzyme refolds and recovers enzymatic activity. These studies demonstrate that measurements of molecular changes induced by biological drugs are useful adjuvants to clinical studies.

  16. [The clinical application of 13C-breath tests in pancreatic diseases].

    Science.gov (United States)

    Cherniavskiĭ, V V

    2014-11-01

    Maldigestion persists in most patients with chronic pancreatitis (GP). The objective lipase and amylase insufficiency diagnosis is needed to achieve an adequate clinical response to oral pancreatic enzyme substitution therapy. The novel data is presented in the article about the role of 13C-mixed triglyceride and 13C-corn starch breath tests as a tools for exocrine pancreatic insufficiency diagnosis, for evaluating fat and starch malabsorbtion in CP patients. 135 patients were included in the investigation. It has been shown, that 13C-breath tests could be useful tools in clinical practice for CP diagnosis. They are well correlate with fecal elastase-1 level, has high sensitivity and specificity for diagnosis of lipase and amylase deficiency. Tests make it possible to choose the initial pancreatic enzyme dosage and are beneficial during the treatment for pancreatic enzyme dose correction.

  17. Diagnostic tests for amoebic liver abscess: comparison of enzyme - linked immunosorbent assay (Elisa and counterimmunoelectrophoresis (CIE

    Directory of Open Access Journals (Sweden)

    Marcos I. Restrepo

    1996-02-01

    Full Text Available The liver abscess is the most frequent extraintestinal complication of intestinal amoebiasis: its diagnosis is suggested by the clinical picture but it must be confirmed by paraclinic tests. Themost stringent diagnosis requires identification of E. histolytica. But this is possible only in a few cases. Serological tests greatly improve the diagnosis of this severe complication of amoebiasis. We compared the Enzyme Linfed Immunosorbent Assay and the Counterimmunoeletrophoresis techniques. Both techniques were used to detect amoebic antibodies in 50 control patients, 30 patients with liver abscess and 30 patients with intestinal amoebiasis. All the sera from control patients gave negative results iin both techniques. When analysing the sera from patients with intestinal amoebiasis, 10% of them were positive by ELISA but non by CIE. The sera of patients with liver abscess, we found that 90% were positive by the ELISA method and 66.6% by the CIE technique. In patients with amoebic liver abscess, the results showed that the ELISA was more sensitive than the CIE, as it presented a higher sensitivity (100% than that of the CIE technique (66%.

  18. THE CAPABILITIES OF ANGIOTENSIN CONVERTING ENZYME INHIBITORS IN CLINICAL PRACTICE: FOCUS ON VASOPROTECTION

    Directory of Open Access Journals (Sweden)

    D. B. Nebieridze

    2015-12-01

    Full Text Available Data of large-scale research that shows comprehensive abilities of an angiotensin converting enzyme (ACE inhibitors in clinical practice were represented. The traditional usage of ACE inhibitors in patients with arterial hypertension and chronic heart failure has extended recently. The study results demonstrate the efficacy of ACE inhibitors in slowing down of disease progression related to atherosclerosis and prove the possibility of a new clinical approach. Evidences support new strategic abilities of a number of ACE inhibitors (ramipril, perindopril, which are associated with vasoprotection.

  19. THE CAPABILITIES OF ANGIOTENSIN CONVERTING ENZYME INHIBITORS IN CLINICAL PRACTICE: FOCUS ON VASOPROTECTION

    Directory of Open Access Journals (Sweden)

    D. B. Nebieridze

    2007-01-01

    Full Text Available Data of large-scale research that shows comprehensive abilities of an angiotensin converting enzyme (ACE inhibitors in clinical practice were represented. The traditional usage of ACE inhibitors in patients with arterial hypertension and chronic heart failure has extended recently. The study results demonstrate the efficacy of ACE inhibitors in slowing down of disease progression related to atherosclerosis and prove the possibility of a new clinical approach. Evidences support new strategic abilities of a number of ACE inhibitors (ramipril, perindopril, which are associated with vasoprotection.

  20. Evaluation of an enzyme immunoassay for clinical diagnosis of neurocysticercosis in symptomatic patients Avaliação de um teste imunoenzimático para o diagnóstico clínico de neurocisticercose em pacientes sintomáticos

    Directory of Open Access Journals (Sweden)

    Reynaldo Mendes de Carvalho Junior

    2010-12-01

    Full Text Available INTRODUCTION: Neurocysticercosis is an infection of the human central nervous system caused by the metacestode larvae of Taenia solium. Neurocysticercosis is the most common parasitic disease in developing countries. Epilepsy is the most common clinical manifestation. Difficulties in confirming the diagnosis motivated the evaluation of the enzyme-linked immunosorbent assay on cerebral spinal fluid (CSF. METHODS: Twenty-two patients with NCC and 44 control patients were studied. CSF was analyzed using a commercial ELISA kit developed for NCC. Sensitivity and specificity were measured and a multivariate logistic regression was performed. RESULTS: Sensitivity and specificity of ELISA were 31.8% and 100%, respectively, with accuracy of 77.3%. Only the size of the lesions proved to be important for performance of the test. CONCLUSIONS: The results showed that ELISA contributes to the diagnosis of neurocysticercosis if the result is negative or if the patient has a lesion of 2 cm or more.INTRODUÇÃO: Neurocisticercose é a infecção do sistema nervoso central causada pela larva metacestódea da Taenia solium. Neurocisticercose é a parasitose mais comum nos países em desenvolvimento. Epilepsia é a sua manifestação clínica mais comum. A dificuldade para confirmar o diagnóstico motivou a avaliação do ensaio imunoenzimático ligado à enzima no líquido cérebro-espinhal. MÉTODOS: Vinte e dois pacientes com NCC e 44 pacientes controles foram estudados. Líquido cérebro-espinhal foi analisado por um kit ELISA comercial desenvolvido para NCC. A sensibilidade e especificidade foram medidas e uma análise multivariada de regressão logística foi realizada. RESULTADOS: A sensibilidade e a especificidade de ELISA foram, respectivamente, 31,8% e 100%, com acurácia de 77,3%. Apenas o tamanho das lesões mostrou-se importante para o desempenho do teste. CONCLUSÕES: Este estudo concluiu que ELISA contribui para o diagnóstico de NCC, caso o teste

  1. Conglutinating complex fixation test (CCFR) as a method alternate to enzyme linked immunosorbent assay (ELISA)

    International Nuclear Information System (INIS)

    An enzyme linked immunosorbent assay (ELISA) has proved to be the most versatile and sensitive method for the serological diagnosis of infectious animal diseases. However, other assays offer similar advantages. This has been shown by our research through the development of a conglutinating complex fixation test (CCFT). This is analogous to the complement fixation test (CFT) and is based on the phenomenon of conglutination. The limiting factor in this test is the source in cattle blood

  2. Paragangliomas/Pheochromocytomas: Clinically Oriented Genetic Testing

    Directory of Open Access Journals (Sweden)

    Rute Martins

    2014-01-01

    Full Text Available Paragangliomas are rare neuroendocrine tumors that arise in the sympathetic or parasympathetic nervous system. Sympathetic paragangliomas are mainly found in the adrenal medulla (designated pheochromocytomas but may also have a thoracic, abdominal, or pelvic localization. Parasympathetic paragangliomas are generally located at the head or neck. Knowledge concerning the familial forms of paragangliomas has greatly improved in recent years. Additionally to the genes involved in the classical syndromic forms: VHL gene (von Hippel-Lindau, RET gene (Multiple Endocrine Neoplasia type 2, and NF1 gene (Neurofibromatosis type 1, 10 novel genes have so far been implicated in the occurrence of paragangliomas/pheochromocytomas: SDHA, SDHB, SDHC, SDHD, SDHAF2, TMEM127, MAX, EGLN1, HIF2A, and KIF1B. It is currently accepted that about 35% of the paragangliomas cases are due to germline mutations in one of these genes. Furthermore, somatic mutations of RET, VHL, NF1, MAX, HIF2A, and H-RAS can also be detected. The identification of the mutation responsible for the paraganglioma/pheochromocytoma phenotype in a patient may be crucial in determining the treatment and allowing specific follow-up guidelines, ultimately leading to a better prognosis. Herein, we summarize the most relevant aspects regarding the genetics and clinical aspects of the syndromic and nonsyndromic forms of pheochromocytoma/paraganglioma aiming to provide an algorithm for genetic testing.

  3. Cost-effectiveness of pharmacogenetic testing to predict treatment response to angiotensin-converting enzyme inhibitor

    NARCIS (Netherlands)

    Costa-Scharplatz, Madlaina; van Asselt, Antoinette D I; Bachmann, Lucas M; Kessels, Alfons G H; Severens, Johan L

    2007-01-01

    OBJECTIVE: This study aimed to assess the potential cost-effectiveness of testing patients with nephropathies for the I/D polymorphism before starting angiotensin-converting enzyme (ACE) inhibitor therapy, using a 3-year time horizon and a healthcare perspective. METHODS: We used a combination of a

  4. Clinical Applications of CO2 and H2 Breath Test

    OpenAIRE

    ZHAO Si-qian; Chen, Bao-Jun; LUO Zhi-fu

    2016-01-01

    Breath test is non-invasive, high sensitivity and high specificity. In this article, CO2 breath test, H2 breath test and their clinical applications were elaborated. The main applications of CO2 breath test include helicobacter pylori test, liver function detection, gastric emptying test, insulin resistance test, pancreatic exocrine secretion test, etc. H2 breath test can be applied in the diagnosis of lactose malabsorption and detecting small intestinal bacterial overgrowth. With further res...

  5. Rapid enzyme analysis as a diagnostic tool for wound infection: Comparison between clinical judgment, microbiological analysis, and enzyme analysis

    NARCIS (Netherlands)

    Blokhuis-Arkes, Miriam H.E.; Haalboom, Marieke; Palen, van der Job; Heinzle, Andrea; Sigi, Eva; Guebitz, Georg; Beuk, Roland

    2015-01-01

    In clinical practice, diagnosis of wound infection is based on the classical clinical signs of infection. When infection is suspected, wounds are often swabbed for microbiological culturing. These methods are not accurate (clinical judgment in chronic wounds) or provide results after several days (w

  6. Inter-rater-agreement in clinical tests of subacromial impingement

    OpenAIRE

    2003-01-01

    Introduction: Shoulder pain is a common complain in the population. Subacromial impingement syndrome(SIS) is cause of many of these. SIS is a clinical diagnosis, mainly based on impingement signs. Clinical tests used for diagnosing specific disease, must be valid and reliable and have as high sensitivity and specificity as possible. They should be easy to learn and to reproduce. Material and method: Tests included were Neers test, Hawkins test, painful arch and isometric test of the sup...

  7. Frequencies and Specificities of “Enzyme-Only” Detected Erythrocyte Alloantibodies in Patients Hospitalized in Austria: Is an Enzyme Test Required for Routine Red Blood Cell Antibody Screening?

    OpenAIRE

    Dietmar Enko; Claudia Habres; Franz Wallner; Barbara Mayr; Gabriele Halwachs-Baumann

    2014-01-01

    The aim of this study was to determine the frequencies and specificities of “enzyme-only” detected red blood cell (RBC) alloantibodies in the routine antibody screening and antibody identification in patients hospitalized in Austria. Routine blood samples of 2420 patients were investigated. The antibody screening was performed with a 3-cell panel in the low-ionic strength saline- (LISS-) indirect antiglobulin test (IAT) and with an enzyme-pretreated (papain) 3-cell panel fully automated on th...

  8. Tests of pancreatic exocrine function - clinical significance in pancreatic and non-pancreatic disorders.

    Science.gov (United States)

    Keller, Jutta; Aghdassi, Ali Alexander; Lerch, Markus M; Mayerle, Julia V; Layer, Peter

    2009-01-01

    The pancreas functions as the main factory for digestive enzymes and therefore enables food utilisation. Pancreatic exocrine insufficiency, partial or complete loss of digestive enzyme synthesis, occurs primarily in disorders directly affecting pancreatic tissue integrity. However, other disorders of the gastrointestinal tract, such as coeliac disease, inflammatory bowel disease, Zollinger-Ellison syndrome or gastric resection can either mimic or cause pancreatic exocrine insufficiency. The overt clinical symptoms of pancreatic exocrine insufficiency are steatorrhoea and maldigestion, which frequently become apparent in advanced stages. Several direct and indirect function tests are available for assessment of pancreatic function but until today diagnosis of excretory insufficiency is difficult as in mild impairment clinically available function tests show limitations of diagnostic accuracy. This review focuses on diagnosis of pancreatic exocrine insufficiency in pancreatic and non-pancreatic disorders. PMID:19505669

  9. The utility of repeat enzyme immunoassay testing for the diagnosis of Clostridium difficile infection: A systematic review of the literature

    Directory of Open Access Journals (Sweden)

    P S Garimella

    2012-01-01

    Full Text Available Over the last 20 years, the prevalence of healthcare-associated Clostridium difficile (C. diff disease has increased. While multiple tests are available for the diagnosis of C. diff infection, enzyme immunoassay (EIA testing for toxin is the most used. Repeat EIA testing, although of limited utility, is common in medical practice. To assess the utility of repeat EIA testing to diagnose C. diff infections. Systematic literature review. Eligible studies performed >1 EIA test for C. diff toxin and were published in English. Electronic searches of MEDLINE and EMBASE were performed and bibliographies of review articles and conference abstracts were hand searched. Of 805 citations identified, 32 were reviewed in detail and nine were included in the final review. All studies except one were retrospective chart reviews. Seven studies had data on number of participants (32,526, and the overall reporting of test setting and patient characteristics was poor. The prevalence of C. diff infection ranged from 9.1% to 18.5%. The yield of the first EIA test ranged from 8.4% to 16.6%, dropping to 1.5-4.7% with a second test. The utility of repeat testing was evident in outbreak settings, where the yield of repeat testing was 5%. Repeat C. diff testing for hospitalized patients has low clinical utility and may be considered in outbreak settings or when the pre-test probability of disease is high. Future studies should aim to identify patients with a likelihood of disease and determine the utility of repeat testing compared with empiric treatment.

  10. Odontogenic keratocysts: a clinical and histological study with special reference to enzyme histochemistry.

    Science.gov (United States)

    Magnusson, B C

    1978-02-01

    Of a total of 1,420 odontogenic cysts, 52 (3.3%) were diagnosed as odontogenic keratocysts. Clinical and histological findings in these 52 cysts are reported. Frozen sections of 26 of the keratocysts were incubated to show the following enzyme activities: NADH2- and NADPH2-diaphorase, glucose-6-phosphate dehydrogenase, glutamate dehydrogenase, acid phosphatase, leucine aminopeptidase and ATPase. Furthermore, keratinization was studied with the rhodamine B method and lipids with the oil red O, the OTAN and the acid hematein methods. Sections from epidermis, oral mucosa, radicular cysts, residual cysts and follicular cysts served as reference material. The oxidative enzymes showed strong activity in the keratocyst epithelium which contrasted with weak activity in the reference cysts. Acid phosphatase activity was weak in all epithelia except that in keratocysts, which displayed a marked activity. In the fibrous capsule of the keratocyst a high activity of leucine aminopeptidase was recorded. This high activity contrasted with a weak activity in the reference material. The significance of the histochemical results in relation to the aggressive behavior of the keratocyst is discussed. PMID:148497

  11. Polymorphisms in drug-metabolizing enzymes: What is their clinical relevance and why do they exist?

    Energy Technology Data Exchange (ETDEWEB)

    Nebert, D.W. [Univ. of Cincinnati Medical Center, OH (United States)

    1997-02-01

    The beautiful report by Sachse in this issue of the journal represents the culmination of 2 decades of increasingly exciting work on the {open_quotes}debrisoquine oxidation polymorphism,{close_quotes} one of dozens of pharmacogenetic or ecogenetic polymorphisms that have been shown to have an important impact on innumerable clinical diseases. Pharmacogenetics is the study of the hereditary basis of the differences in responses to drugs. Ecogenetics is the broader field of interindividual differences in response to all environmental chemical and physical agents (e.g., heavy metals, insecticides, compounds formed during combustion, and UV radiation). It is now clear that each of us has his or her own {open_quotes}individual fingerprint{close_quotes} of unique alleles encoding the so-called drug-metabolizing enzymes (DMEs) and the receptors that regulate these enzymes. In this invited editorial, I first introduce the current thinking in the field of DME (and DME-receptor) research and how DMEs have evolved from animal-plant interactions. I then describe the debrisoquine oxidation polymorphism, as well as two other relevant DME polymorphisms; show the relationship between these polymorphisms and human disease; provide examples of synergistic effects caused by the combination of two DME polymorphisms; and discuss the ethical considerations of such research. Last, I speculate on why these allelic frequencies of the DME genes might exist in human populations in the first place. 35 refs.

  12. Elevation of antioxidant enzymes in the clinical effects of radon and thermal therapy for bronchial asthma

    International Nuclear Information System (INIS)

    An increased systemic production of oxygen-free radicals by activated inflammatory cells is thought to be involved in the pathophysiology of asthma. The aim of this study is to evaluate the clinical effects of radon and thermal therapy on asthma in relation to antioxidant enzymes and lipid peroxide. Radon and thermal therapy were performed once a week. All subjects went to a hot bathroom with a high concentration of radon, and nasal inhalation of vapor from a hot spring was performed for 40 min once a day under conditions of high humidity. The room temperature was 48 deg C; the room radon concentration was 2,080 Bq/m3. Blood samples were collected at 2 h, 14, and 28 days after the first therapy. A blood sample also was collected before the first therapy (at body temperature and background radon level) to be used as the control. The forced expiratory volume in one second (%FEV1) was significantly increased 28 days after the first therapy. On day 28, the catalase (CAT) activity was significantly increased in comparison with the control. The superoxide dismutase (SOD) activity was significantly increased compared to the control after first inhalation. On days 14 and 28, the lipid peroxide level was significantly decreased in comparison with the control. In conclusion, the present pilot study has shown that radon and thermal therapy improved the pulmonary function of asthmatics by increasing the reduced activities of antioxidant enzymes. (author)

  13. Detection of respiratory syncytial virus antigen in nasal washings by Abbott TestPack enzyme immunoassay.

    OpenAIRE

    Wren, C G; Bate, B J; Masters, H B; Lauer, B A

    1990-01-01

    We compared the new Abbott TestPack (TP) respiratory syncytial virus (RSV) enzyme immunoassay (EIA) with cell culture and two commercial RSV EIAs (from Abbott Diagnostics and Kallestad Laboratories) by using split samples of fresh nasal washings from children with suspected RSV disease. Two tubes of HEp-2 cells were inoculated and observed for cytopathic effect for 14 days, and isolates were confirmed by immunofluorescence. The TP EIA was performed by following the manufacturer's instructions...

  14. Soluble Angiotensin Converting Enzyme 2 in Human Heart Failure: Relation with Myocardial Function and Clinical Outcomes

    Science.gov (United States)

    Epelman, Slava; Shrestha, Kevin; Troughton, Richard W.; Francis, Gary S.; Sen, Subha; Klein, Allan L.; Tang, W .H. Wilson

    2011-01-01

    Objective Angiotensin converting enzyme 2 (ACE2) is an endogenous counter-regulator of the renin-angiotensin system. The relationship between soluble ACE2 (sACE2), myocardial function, and clinical outcomes in patients with chronic systolic heart failure is not well established. Methods We measured sACE2 activity in 113 patients with chronic systolic heart failure (left ventricular ejection fraction [LVEF] ≤ 35%, NYHA class II-IV). Comprehensive echocardiography was performed at the time of blood sampling. We prospectively examined adverse clinical events (death, cardiac transplant, and heart failure hospitalizations) over 34 ± 17 months. Results Patients who had higher sACE2 plasma activity were more likely to have a lower LVEF (Spearman’s r= −0.36, p <0.001), greater RV systolic dysfunction (r=0.33, p<0.001), higher estimated pulmonary artery systolic pressure (r=0.35, p=0.002), larger LV end diastolic diameter (r=0.23, p=0.02), and higher plasma NT-proBNP levels (r=0.35, p<0.001). sACE2 was less associated with diastolic dysfunction (r=0.19, p=0.05), and was similar between patients with ischemic and non-ischemic cardiomyopathies. There was no relationship between sACE2 activity and markers of systemic inflammation. After adjusting for NT-proBNP and LVEF, sACE2 activity remained an independent predictor of adverse clinical events (HR=1.7 [95% CI: 1.1 – 2.6], p=0.018). Conclusions Elevated plasma sACE2 activity was associated with greater severity of myocardial dysfunction and was an independent predictor of adverse clinical events. PMID:19700132

  15. [THE DEVELOPMENT OF IMMUNE ENZYME AND IMMUNE CHROMATOGRAPHIC MONOCLONAL TEST-SYSTEM FOR DETECTING TULAREMIA AGENT].

    Science.gov (United States)

    Eremkin, A V; Elagin, G D; Petchenkin, D V; Fomenkov, O O; Bogatcheva, N V; Kitmanov, A A; Kuklina, G V; Tikhvinskaya, O V

    2016-03-01

    The immune enzyme and immunochromatographic test-systems for detecting tularemia agent were developed on the basis of selected set of monoclonal antibodies having immunochemical activity to antigens Francisella tularensis. The evaluation of sensitivity and specificity of developed test-systems demonstrated that samples provided detection of strains of F. tularensis in concentration from 5.0 x 105 mkxcm-3 to 1.0 x 106 mkxcm-3 and gave no false positive results in analysis of heterologous microorganisms in concentration of 1.0 x 108 mkxcm-3.

  16. Autonomic testing: common techniques and clinical applications.

    Science.gov (United States)

    Weimer, Louis H

    2010-07-01

    Laboratories able to test autonomic function are increasingly available and rely on batteries of well-accepted, noninvasive tests. Tests of parasympathetic cardiovagal, sympathetic vasoconstriction, and sudomotor (sweating) function are most commonly employed. Common examples include heart rate variability to various challenges, Valsalva maneuver, standing and tilt-table studies, and various sudomotor methods. New techniques and technical refinements continue to be described. Most studies rely on perturbations of complex systems and not direct assessment. Testing has helped to improve disease recognition and prompted advances in classification, pathophysiology, and treatment. Major areas impacted include hereditary and immune-mediated autonomic neuropathy, diabetic autonomic neuropathy, distal symmetric polyneuropathy, Parkinson disease and other autonomic failure syndromes, orthostatic intolerance, and unexplained syncope. PMID:20592565

  17. Frequencies and Specificities of “Enzyme-Only” Detected Erythrocyte Alloantibodies in Patients Hospitalized in Austria: Is an Enzyme Test Required for Routine Red Blood Cell Antibody Screening?

    Directory of Open Access Journals (Sweden)

    Dietmar Enko

    2014-01-01

    Full Text Available The aim of this study was to determine the frequencies and specificities of “enzyme-only” detected red blood cell (RBC alloantibodies in the routine antibody screening and antibody identification in patients hospitalized in Austria. Routine blood samples of 2420 patients were investigated. The antibody screening was performed with a 3-cell panel in the low-ionic strength saline- (LISS- indirect antiglobulin test (IAT and with an enzyme-pretreated (papain 3-cell panel fully automated on the ORTHO AutoVue Innova System. The antibody identification was carried out manually with an 11-cell panel in the LISS-IAT and with an enzyme-pretreated (papain 11-cell panel. In total 4.05% (n=98 of all patients (n=2420 had a positive RBC antibody screening result. Of them 25.51% (25/98 showed “enzyme-only” detected specific or nonspecific RBC alloantibodies. Rhesus and Lewis system antibodies were found the only specificities of “enzyme-only” RBC alloantibodies: all in all 4.8% (4/98 were detected with anti-E, 3.06% (3/98 with anti-Lea, 3.06% (3/98 with anti-D after anti-D prophylaxis and 1.02% (1/98 with anti-e. In total, 14.29% (14/98 showed a nonspecific RBC alloantibody result with the enzyme test. The results of the present study demonstrate that a high number of unwanted positive reactions with the enzyme technique overshadows the detection of “enzyme-only” RBC alloantibodies. (Trial Registration: K-37-13.

  18. The clinical application of UGT1A1 pharmacogenetic testing: Gene-environment interactions

    Directory of Open Access Journals (Sweden)

    Marques Sara

    2010-04-01

    Full Text Available Abstract Over the past decade, the number of pharmacogenetic tests has increased considerably, allowing for the development of our knowledge of their clinical application. The uridine diphosphate glucuronosyltransferase 1A1 gene (UGT1A1 assay is an example of a pharmacogenetic test. Numerous variants have been found in UGT1A1, the main conjugating enzyme of bilirubin and drugs such as the anticancer drug irinotecan. Recently, the US Food and Drug Administration (FDA recommended testing for the presence of UGT1A1*28, an allele correlated with decreased transcriptional activity, to predict patients at risk of irinotecan toxicity. The administration of other drugs -- such as inhibitors of the UGT1A1 enzyme -- can clinically mimic the *28 phenotype, whereas inducers of UGT1A1 can increase the glucuronidation rate of the enzyme. The *28 polymorphism is not present in all ethnicities at a similar frequency, which suggests that it is important to study different populations to determine the clinical relevance of testing for UGT1A1*28 and to identify other clinically relevant UGT1A1 variants. Environmental factors such as lifestyle can also affect UGT1A1 activity. This review is a critical analysis of studies on drugs that can be affected by the presence of UGT1A1*28, the distribution of this polymorphism around the globe, distinct variants that may be clinically significant in African and Asian populations and how lifestyle can affect treatment outcomes that depend on UGT1A1 activity.

  19. Clinical Genetic Testing of Periodic Fever Syndromes

    Directory of Open Access Journals (Sweden)

    Annalisa Marcuzzi

    2013-01-01

    Full Text Available Periodic fever syndromes (PFSs are a wide group of autoinflammatory diseases. Due to some clinical overlap between different PFSs, differential diagnosis can be a difficult challenge. Nowadays, there are no universally agreed recommendations for most PFSs, and near half of patients may remain without a genetic diagnosis even after performing multiple-gene analyses. Molecular analysis of periodic fevers’ causative genes can improve patient quality of life by providing early and accurate diagnosis and allowing the administration of appropriate treatment. In this paper we focus our discussion on effective usefulness of genetic diagnosis of PFSs. The aim of this paper is to establish how much can the diagnostic system improve, in order to increase the success of PFS diagnosis. The mayor expectation in the near future will be addressed to the so-called next generation sequencing approach. Although the application of bioinformatics to high-throughput genetic analysis could allow the identification of complex genotypes, the complexity of this definition will hardly result in a clear contribution for the physician. In our opinion, however, to obtain the best from this new development a rule should always be kept well in mind: use genetics only to answer specific clinical questions.

  20. Detection of Chlamydia trachomatis in urine samples by nucleic acid tests: comparison with culture and enzyme immunoassay of genital swab specimens.

    OpenAIRE

    Schepetiuk, S.; Kok, T.; Martin, L; Waddell, R; Higgins, G

    1997-01-01

    Two commercially available nucleic acid-based tests, ligase chain reaction (LCR; Abbott Laboratories) and PCR (Roche Diagnostics), for the detection of Chlamydia trachomatis in male and female urine samples were compared with culture and enzyme immunoassay (EIA) (Microtrak; Syva) for C. trachomatis detection in genital samples. The samples were collected from 1,005 patients who attended a sexually transmitted disease clinic. In this study population, the prevalence of the infection was 4%. Sp...

  1. Toxicological assessment of enzyme-treated asparagus extract in rat acute and subchronic oral toxicity studies and genotoxicity tests.

    Science.gov (United States)

    Ito, Tomohiro; Ono, Tomoko; Sato, Atsuya; Goto, Kazunori; Miura, Takehito; Wakame, Koji; Nishioka, Hiroshi; Maeda, Takahiro

    2014-03-01

    The safety of enzyme-treated asparagus extract (ETAS) developed as a novel anti-stress functional material was assessed in acute and subchronic studies and genotoxicity assays. In the acute oral dose toxicity study, all rats survived during the test period and ETAS did not influence clinical appearance, body weight gain and necropsy findings at a dosage of 2000mg/kg body weight. Thus, the 50% lethal dose (LD50) of ETAS was determined to be greater than 2000mg/kg. The 90-day subchronic study (500, 1000 and 2000mg/kg body weight, delivered by gavage) in rats reported no significant adverse effects in food consumption, body weight, mortality, urinalysis, hematology, biochemistry, necropsy, organ weight and histopathology. In the micronucleus test of mice, the incidence of micronuclei in ETAS-administered groups (500, 1000 and 2000mg/kg/day, injected twice) was equivalent to that of the negative control group, while the positive control group receiving mitomycin C showed a high incidence. The potential of ETAS to induce gene mutation was tested using four Salmonella typhimurium strains and Escherichia coli WP2uvrA. The test sample was not mutagenic to the test strains. These results support the safety of ETAS as food and dietary supplement.

  2. The clinical value of enzyme-multiplied immunoassay technique monitoring the plasma concentrations of cyclosporine A a%The clinical value of enzyme-multiplied immunoassay technique monitoring the plasma concentrations of cyclosporine A aft

    Institute of Scientific and Technical Information of China (English)

    Xiao-Hui Luo; wu-Jun Xue; Pu-Xun Tian; Xiao-Ming Ding; Hang Yan; He-Li Xiang; Yang Li

    2011-01-01

    The feasibility and the clinical value of the enzyme-multiplied immunoassay technique (EMIT) monitoring of blood concentrations of cyclosporine A (CsA) in patients treated with CsA were investigated after kidney transplantation. The validation method was

  3. Expanding role of microsomal enzyme induction, and its implications for clinical chemistry

    Energy Technology Data Exchange (ETDEWEB)

    Goldberg, D.M.

    1980-05-01

    Microsomal enzyme induction, a term denoting the ability of the substrate for a microsomal enzyme to enhance the activity of that enzyme and frequently of related enzymes, has been demonstrated in a wide range of tissues, notably the liver, placenta, small intestinal muccosa, and peripheral lymphocytes. The major agents that cause microsomal enzyme induction are drugs and xenobiotics. Factors modulating the extent of enzyme induction by a given agent include age and nutrition, and wide species variations are encountered with different inducing agents. Markers for microsomal enzyme induction include determination of the plasma half-life for conveniently measured drugs, and the measurement of endogenous metabolites such as 6;-hydroxycortisol and D-glucaric acid in 24-h urine collections. While these are valuable for monitoring enzyme induction in healthy patients, they are altered in certain forms of liver disease, and results must then be interpreted with caution. Microsomal enzyme induction may interfere with reference values, particularly for membrane-bound enzymes, in otherwise healthy populations, and may play a role in metabolic bone disease, drug interactions, carcinogenesis, and hypertriglyceridemia. Drug therapy of the neonatal and congenital hyperbilirubinemias has been inspired by the mechanism of hepatic microsomal enzyme induction, and ''markers'' for enzyme induction can be used to monitor drug compliance. The activity of serum <-glutamyltransferase seems to be especially valuable for this purpose.

  4. [Clinical trial data validation and user acceptance testing].

    Science.gov (United States)

    Sun, Hua-long; Dai, Nan

    2015-11-01

    For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database. PMID:26911047

  5. Best practices for clinical pathology testing in carcinogenicity studies.

    Science.gov (United States)

    Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

    2011-02-01

    The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

  6. Genes implicated in thiopurine-induced toxicity: Comparing TPMT enzyme activity with clinical phenotype and exome data in a paediatric IBD cohort

    Science.gov (United States)

    Coelho, Tracy; Andreoletti, Gaia; Ashton, James J.; Batra, Akshay; Afzal, Nadeem Ahmad; Gao, Yifang; Williams, Anthony P.; Beattie, Robert M.; Ennis, Sarah

    2016-01-01

    The aim of our study was to assess the utility of next generation sequencing (NGS) for predicting toxicity and clinical response to thiopurine drugs in paediatric patients with inflammatory bowel disease. Exome data for 100 patients were assessed against biochemically measured TPMT enzyme activity, clinical response and adverse effects. The TPMT gene and a panel of 15 other genes implicated in thiopurine toxicity were analysed using a gene based statistical test (SKAT-O test). Nine patients out of 100 (Crohn’s disease- 67, ulcerative colitis- 23 and IBDU-10) had known TPMT mutations associated with deficient enzyme activity. A novel and a highly pathogenic TPMT variant not detectable through standard genotyping, was identified through NGS in an individual intolerant to thiopurines. Of the 14 patients intolerant to thiopurines, NGS identified deleterious TPMT variants in 5 individuals whereas the biochemical test identified 8 individuals as intolerant (sensitivity 35.7% and 57.14%; specificity 93.75% and 50% respectively). SKAT-O test identified a significant association between MOCOS gene and TPMT activity (p = 0.0015), not previously reported. Although NGS has the ability to detect rare or novel variants not otherwise identified through standard genotyping, it demonstrates no clear advantage over the biochemical test in predicting toxicity in our modest cohort. PMID:27703193

  7. Clinical significance of quantitative analysis of thyroid peroxidase antibody (TPOAb) with chemiluminescence enzyme immunoassay

    International Nuclear Information System (INIS)

    Objective: The only method of laboratory diagnosis for autoimmune thyroid diseases used to be serum TGA and TMA detections. Morerecently, quantitative analysis of TPOAb has been introduced. To assess the relative sensitivity of these tests , positive rates detected with the respective tests were compared. Methods: Serum TGA, TMA (with RIA) and TPOAb (with chemiluminescence enzyme immunoassay) were simultaneously detected in 998 cases of thyroid diseases (hyperthyroidism 307, Hashimoto's disease 193, simple goiter 498). For complementary sake, fine needle aspiration cytology was obtained in a number of cases including all the patients with Hashimoto's disease. Results: Positive detection rate of TPOAb in three groups of patients (hyperthyroidism, Hashimoto's, simple goiter) was 81.76%, 96.89 % and 42.97% respectively. With TMA, the positive rate was only 54.72%, 65.80%, 22.09% respectively. About one third more cases would be detected with the newer method. Conclusion: For the laboratory detection of auto immune thyroid diseases, quantitative analysis of TPOAb is much wore sensitive than the conventional TMA detection. (authors)

  8. Lifestyle and Clinical Health Behaviors and PSA Tests

    Science.gov (United States)

    Norris, Cynthia; McFall, Stephanie

    2006-01-01

    This study assessed the association of lifestyle and clinical health behaviors with prostate specific antigen (PSA) tests. The study used cross-sectional data from the 2002 Behavioral Risk Factor Surveillance System (BRFSS). We used Stata 8.0 to take into account the complex sample design in analyses. Both lifestyle and clinical health behaviors…

  9. Current Clinical Trials Testing Combinations of Immunotherapy and Radiation

    OpenAIRE

    Crittenden, M.; Kohrt, H.; Levy, R.; Jones, J.; Camphausen, K.; Dicker, A.; Demaria, S.; Formenti, S.

    2015-01-01

    Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an absco...

  10. Usefulness of factor V Leiden mutation testing in clinical practice

    Science.gov (United States)

    Blinkenberg, Ellen Ø; Kristoffersen, Ann-Helen; Sandberg, Sverre; Steen, Vidar M; Houge, Gunnar

    2010-01-01

    We have investigated the clinical usefulness of the activated protein C resistance (APCR)/factor V Leiden mutation (FVL) test by sending out questionnaires to all Norwegian physicians who ordered these tests from our publicly funded service laboratory during a 3-month period, and of whom 70% (267/383) responded. Indications for testing, patient follow-up, the use of APCR versus FVL tests and differences in practice between hospital doctors and GPs were examined. We found that 46% of the tests were predictive, ordered for risk assessment in healthy individuals with no previous history of venous thromboembolism (VTE). Among these, 42% of the tests were taken on the initiative of the patient and 24% were screening tests before prescription of oral contraceptives. In total, 54% of the tests were classified as diagnostic, among which 42% were ordered owing to a previous history of VTE and 22% to a history of brain stroke or myocardial infarction. The prevalence of FVL heterozygotes was not significantly different between the predictive and diagnostic test groups, that is, 26 and 20%, respectively. Only the predictive tests influenced patient follow-up. Here, the physician's advice to patients depended on the test result. In general, the clinical usefulness of APCR/FVL testing was low. Many tests were performed on unsubstantiated or vague indications. Furthermore, normal test results led to unwarranted refrain from giving advice about antithrombotic measures, leading to potential harm to the patient. PMID:20332812

  11. Core Stability: Inter- and Intraobserver Reliability of 6 Clinical Tests

    NARCIS (Netherlands)

    A. Weir; J. Darby; H. Inklaar; B. Koes; E. Bakker; J.L. Tol

    2010-01-01

    Objective: Core stability is a complex concept within sports medicine and is thought to play a role in sports injuries. There is a lack of reliable and valid clinical tests for core stability. The inter- and intraobserver reliability of 6 tests commonly used to assess core stability was determined.

  12. [Evaluation of an immunochromatography test using enzyme immunoassay for rapid detection of influenza A and B viruses].

    Science.gov (United States)

    Mitamura, Keiko; Yamazaki, Masahiko; Ichikawa, Masataka; Kimura, Kazuhiro; Kawakami, Chiharu; Shimizu, Hideaki; Watanabe, Sumi; Imai, Mitsunobu; Shinjo, Masayoshi; Takeuchi, Yoshinao; Sugaya, Norio

    2004-07-01

    We evaluated the performance of an improved version of Espline Influenza A & B-N (Fujirebio Inc., Japan), an immunochromatography test using enzyme immunoassay for rapid diagnosis of influenza A and B. The test produced positive results for four strains of influenza viruses and thirty-one influenza viral antigens and negative results for all of thirty strains of other respiratory viruses that were tested. The detection limit of this test was 5.8 x 10(2) to 5.8 x 10(3) pfu/assay, which is more sensitive than the old version of Espline. Furthermore, 715 respiratory specimens collected from the patients (children, 79.4%; adults, 18.5%; unknown, 2.1%) with influenza-like illnesses during the 2002/2003 influenza season in Japan were tested as part of a clinical evaluation of this test. The relative performance of this test compared to cell culture and nested RT-PCR results were examined. In the cell cultures, influenza viruses were detected in 488 of the 715 specimens (overall, 68.3%; AH3, 41.7%; B, 26.4%; AH3 and B, 0.1%). For influenza A, the sensitivity of this test was 95.4% (125/131) for nasal aspirates, 96.8% (92/95) for nasal swabs, and 85.1% (63/74) for throat swabs. For influenza B, the sensitivity of this test was 91.2% (52/57) for nasal aspirates, 88.1% (59/67) for nasal swabs, and 71.6% (48/67) for throat swabs. The new test exhibited a remarkably higher sensitivity to influenza A in throat swabs than the old version of Espline. Only two false positive results were obtained out of a total of 223 virus negative specimens; the specificity of the test was 100% (88/88) for nasal aspirates, 97.6% (81/83) for nasal swabs, and 100% (52/52) for throat swabs. We conclude that the new Espline Influenza A&B-N rapid diagnostic test is easy to use and has a high sensitivity and specificity, especially for influenza A.

  13. Mining the Swedish clinical archives to develop pharmacogenomic tests.

    Science.gov (United States)

    Sanders, R

    1999-12-01

    Eurona Medical is a Swedish company that develops diagnostic tests to predict response to drugs or treatment. Sweden offers unparalleled retrospective clinical data resources, with epidemiological registers and collections of tissue samples built up over decades. Efficient pharmacogenomic research can be performed using these registers and sample collections in collaboration with experienced medical researchers. Eurona's tests are based on Genetic Signatures, groups of polymorphic, polygenic genomic positions linked to and therefore predictive of drug response. These are elucidated from complex data sets using unique applications of multivariate and combinatorial statistics and a multigenic approach. The company develops tests applicable to current medical practice and is preparing to launch its first within the hypertension field. Quality control (including ISO9001 certification) and clinical regulatory compliance are applied throughout all programs to produce data that can be directly translated into clinical tests. PMID:10671642

  14. Skin signs in Ehlers-Danlos syndrome: clinical tests and para-clinical methods

    DEFF Research Database (Denmark)

    Remvig, Lars; Duhn, Ph; Ullman, S;

    2010-01-01

    extensibility. The present study aimed to assess skin signs by means of clinical and para-clinical methods. Methods: A total of 31 EDS patients and 28 healthy controls were examined blinded and in random order. Inter-examiner analysis of clinical tests for skin extensibility, consistency, scarring, and bruising...... was performed, followed by analyses of extensibility with the suction cup (SC), consistency with a soft tissue stiffness meter (STSM), and thickness with ultrasonography (US). Semi-quantitative assessment of skin extensibility in healthy controls was incorporated in the tests. Results: The clinical analyses...... with classical-type EDS and controls with respect to skin extensibility by SC (4.91 vs. 12.52 kPa/mm) and skin consistency by STSM (0.59 vs. 0.76 N). We found no difference in skin thickness. Conclusion: The reproducibility of the clinical skin tests was substantial to good, apart from the consistency...

  15. Platelet function testing: methods of assessment and clinical utility.

    LENUS (Irish Health Repository)

    Mylotte, Darren

    2012-02-01

    Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  16. Platelet function testing: methods of assessment and clinical utility.

    LENUS (Irish Health Repository)

    Mylotte, Darren

    2011-01-01

    Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  17. Clinical and para-clinical tests in the routine examination of headache patients

    DEFF Research Database (Denmark)

    Friberg, L; Sandrini, G; Jänig, W;

    2000-01-01

    Para-clinical examinations in the diagnosis and treatment control of headache patients vary considerably between clinics and headache centers. Among the neurological societies in Europe there has been a consensus that some common procedures and recommendations should be created. In the Fall of 1998......) autonomic nervous system and clinical tests and 3) imaging and cerebrovascular tests (X-ray, CT, MR, fMRI, PET, SPECT and transcranial Doppler). The literature was carefully evaluated with respect to validity and strength of the data. The task was to reach conclusions about each technique in the form...

  18. The Effect of Follow up (Telenursing on Liver Enzymes in Patients with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Sorur Javanmardi Fard

    2016-07-01

    Full Text Available Background: Non-alcoholic fatty liver disease (NAFLD is characterized by macro vesicular steatosis in the absence of alcohol. Patients with (NAFLD need extensive education and support in their treatment. Our aim was to investigate the effect of telenursing on liver enzymes (ALT and AST in patients with NAFLD. Methods: Our study is a randomized controlled clinical trial. In this study, 60 patients were enrolled from patients who referred to subspecialty gastrointestinal clinics affiliated to Shiraz University of Medical Sciences. Specialists confirmed their diseases by ultrasound and laboratory test. Simple randomization, based on random number table, was used to randomize the participants into intervention (N=30 and control (N=30 groups. Patients in both groups received dietary advice from a nutritionist and were trained to perform physical activities. Telephone intervention in the intervention group lasted for 12 weeks, in order to see the effect of follow up on the recommended diet and physical activities given by the specialist, while; the control group subjects were only followed up as usual by their physician. Results: The result of an independent t-test showed that the mean difference of liverEnzymesbetween the two groups was statistically significant (P<0.001. The difference of AST and ALT in the intervention and control groups was 18.03 , -1.27 and 40.70, 1.52, respectively. Conclusion: We found out that; telenursing could have a positive effect on reduction of liver enzymes (ALT, AST in patients with NAFLD.

  19. Enzyme inhibition assay for pyruvate dehydrogenase complex: Clinical utility for the diagnosis of primary biliary cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Katsuhisa Omagri; Hiroaki Hazama; Shigeru Kohno

    2005-01-01

    Primary biliary cirrhosis (PBC) is usually diagnosed by the presence of characteristic histopathological features of the liver and/or antimitochondrial antibodies (AMA) in the serum traditionally detected by immunofluorescence.Recently, new and more accurate serological assays for the detection of AMA, such as enzyme-linked immunosorbent assay (ELISA), immunoblotting, and enzyme inhibition assay, have been developed. Of these,the enzyme inhibition assay for the detection of antipyruvate dehydrogenase complex (PDC) antibodies offers certain advantages such as objectivity, rapidity,simplicity, and low cost. Since this assay has almost 100% specificity, it may have particular applicability in screening the at-risk segment of the population in developing countries. Moreover, this assay could be also used for monitoring the disease course in PBC. Almost all sera of PBC-suspected patients can be confirmed for PBC or non-PBC by the combination results of immunoblotting and enzyme inhibition assay without histopathological examination. For the development of a "complete" or "gold standard" diagnostic assay for PBC, similar assays of the enzyme inhibition for anti2-oxoglutarate dehydrogenase complex (OGDC) and anti-branched chain oxo-acid dehydrogenase complex (BCOADC) antibodies will be needed in future.

  20. The Stice model of overeating: Tests in clinical and non-clinical samples

    NARCIS (Netherlands)

    Strien, T. van; Engels, R.C.M.E.; Leeuwe, J.F.J. van; Snoek, H.M.

    2005-01-01

    The present study tested the dual pathway model of Stice [Stice, E (1994). A review of the evidence for a sociocultural model of bulimia nervosa and an exploration of the mechanisms of action. Clinical Psychology Review, 14, 633-661 and Stice, E. (2001). A prospective test of the dual-pathway model

  1. Role of pyruvate dehydrogenase complex in traumatic brain injury and Measurement of pyruvate dehydrogenase enzyme by dipstick test

    Directory of Open Access Journals (Sweden)

    Sharma Pushpa

    2009-01-01

    Full Text Available Objectives: The present study was designed to investigate the role of a mitochondrial enzyme pyruvate dehydrogenase (PDH on the severity of brain injury, and the effects of pyruvate treatment in rats with traumatic brain injury (TBI. Materials and Methods: We examined rats subjected to closed head injury using a fluid percussion device, and treated with sodium pyruvate (antioxidant and substrate for PDH enzyme. At 72 h post injury, blood was analyzed for blood gases, acid-base status, total PDH enzyme using a dipstick test and malondialdehyde (MDA levels as a marker of oxidative stress. Brain homogenates from right hippocampus (injured area were analyzed for PDH content, and immunostained hippocampus sections were used to determine the severity of gliosis and PDH E1-∞ subunit. Results: Our data demonstrate that TBI causes a significant reduction in PDH enzyme, disrupt-acid-base balance and increase oxidative stress in blood. Also, lower PDH enzyme in blood is related to the increased gliosis and loss of its PDH E1-∞ subunit PDH in brain tissue, and these effects of TBI were prevented by pyruvate treatment. Conclusion: Lower PDH enzyme levels in blood are related to the global oxidative stress, increased gliosis in brain, and severity of brain injury following TBI. These effects can be prevented by pyruvate through the protection of PDH enzyme and its subunit E-1.

  2. Biological variation in 32 clinical laboratory routine tests

    Institute of Scientific and Technical Information of China (English)

    陈政君

    2012-01-01

    Objective To set quality goals of conventional biochemical tests through the research of biological variation of the 32 routine items in Chinese population to provide the basis for Chinese clinical and laboratory standards. Methods According to the experimental designs and computing methods

  3. The Effect of Follow up (Telenursing) on Liver Enzymes in Patients with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Fard, Sorur Javanmardi; Ghodsbin, Fariba; Kaviani, Mohammad Javad; Jahanbin, Iran; Bagheri, Zahra

    2016-01-01

    Background: Non-alcoholic fatty liver disease (NAFLD) is characterized by macro vesicular steatosis in the absence of alcohol. Patients with (NAFLD)need extensive education and support in their treatment. Our aim was to investigate the effect of telenursing on liver enzymes (ALT and AST) in patients with NAFLD. Methods: Our study is a randomized controlled clinical trial. In this study, 60 patients were enrolled from patients who referred to subspecialty gastrointestinal clinics affiliated to Shiraz University of Medical Sciences. Specialists confirmed their diseases by ultrasound and laboratory test. Simple randomization, based on random number table, was used to randomize the participants into intervention (N=30) and control (N=30) groups. Patients in both groups received dietary advice from a nutritionist and were trained to perform physical activities. Telephone intervention in the intervention group lasted for 12 weeks, in order to see the effect of follow up on the recommended diet and physical activities given by the specialist, while; the control group subjects were only followed up as usual by their physician. Results: The result of an independent t-test showed that the mean difference of liver Enzymes between the two groups was statistically significant (P<0.001). The difference of AST and ALT in the intervention and control groups was 18.03, -1.27 and 40.70, 1.52, respectively. Conclusion: We found out that; telenursing could have a positive effect on reduction of liver enzymes (ALT, AST) in patients with NAFLD. Trial Registration Number: IRCT2015040411691N5 PMID:27382590

  4. The Effect of Follow up (Telenursing) on Liver Enzymes in Patients with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Fard, Sorur Javanmardi; Ghodsbin, Fariba; Kaviani, Mohammad Javad; Jahanbin, Iran; Bagheri, Zahra

    2016-01-01

    Background: Non-alcoholic fatty liver disease (NAFLD) is characterized by macro vesicular steatosis in the absence of alcohol. Patients with (NAFLD)need extensive education and support in their treatment. Our aim was to investigate the effect of telenursing on liver enzymes (ALT and AST) in patients with NAFLD. Methods: Our study is a randomized controlled clinical trial. In this study, 60 patients were enrolled from patients who referred to subspecialty gastrointestinal clinics affiliated to Shiraz University of Medical Sciences. Specialists confirmed their diseases by ultrasound and laboratory test. Simple randomization, based on random number table, was used to randomize the participants into intervention (N=30) and control (N=30) groups. Patients in both groups received dietary advice from a nutritionist and were trained to perform physical activities. Telephone intervention in the intervention group lasted for 12 weeks, in order to see the effect of follow up on the recommended diet and physical activities given by the specialist, while; the control group subjects were only followed up as usual by their physician. Results: The result of an independent t-test showed that the mean difference of liver Enzymes between the two groups was statistically significant (P<0.001). The difference of AST and ALT in the intervention and control groups was 18.03, -1.27 and 40.70, 1.52, respectively. Conclusion: We found out that; telenursing could have a positive effect on reduction of liver enzymes (ALT, AST) in patients with NAFLD. Trial Registration Number: IRCT2015040411691N5

  5. Useful tests for hepatic encephalopathy in clinical practice.

    Science.gov (United States)

    Nabi, Eiman; Bajaj, Jasmohan S

    2014-01-01

    Hepatic encephalopathy (HE) is a serious complication of liver disease and portosystemic shunting that represents a continuum of neuropsychiatric changes and altered consciousness. It is classified as overt HE (OHE) when clinically apparent or as covert HE (CHE) in its mildest form. Progression of CHE to OHE and its impact of quality of life make its early diagnosis imperative. Several diagnostic techniques ranging from simple clinical scales to sophisticated computerized tests exist, yet diagnosis remains a challenge, due to the time, cost, and personnel involved. Psychometric tests appear promising due to their high sensitivity and low cost, but results are variable depending on age and education. The pros and cons of current diagnostic methods for OHE and CHE are reviewed, along with strategy for CHE testing. PMID:24357348

  6. Basophil activation test compared to skin prick test and fluorescence enzyme immunoassay for aeroallergen-specific Immunoglobulin-E

    Directory of Open Access Journals (Sweden)

    Khan Faisal M

    2012-01-01

    Full Text Available Abstract Background Skin prick test (SPT and fluorescence enzyme immunoassay (FEIA are widely used for the diagnosis of Immunoglobulin-E (IgE-mediated allergic disease. Basophil activation test (BAT could obviate disadvantages of SPT and FEIA. However, it is not known whether BAT gives similar results as SPT or FEIA for aeroallergens. Objectives In this study, we compared the results of SPT, BAT and FEIA for different aeroallergens. Methods We performed BAT, SPT and FEIA in 41 atopic subjects (symptomatic and with positive SPT for at least 1 of 9 common aeroallergens and 31 non-atopic subjects (asymptomatic and with negative SPT. Results Correlations between SPT and BAT, SPT and FEIA, and BAT and FEIA results were statistically significant but imperfect. Using SPT as the "gold standard", BAT and FEIA were similar in sensitivity. However, BAT had lower specificity than FEIA. False positive (BATposSPTneg results were frequent in those atopic subjects who were allergic by SPT to a different allergen and rare in non-atopic subjects. The false positivity in atopic subjects was due in part to high levels of serum Total-IgE (T-IgE levels in atopic individuals that lead to basophil activation upon staining with fluorochrome-labeled anti-IgE. Conclusion As an alternative to SPT in persons allergic to aeroallergens, BAT in its present form is useful for distinguishing atopic from non-atopic persons. However, BAT in its present form is less specific than FEIA when determining the allergen which a patient is allergic to. This is due to IgE staining-induced activation of atopic person's basophils and/or nonspecific hyperreactivity of atopic person's basophils.

  7. Red cell antibodies and low ionic strength: a study with enzyme-linked antiglobulin test.

    Science.gov (United States)

    Leikola, J; Perkins, H A

    1980-01-01

    Alloantibody uptake on red blood cells was quantified with an accurate and reproducible enzyme-linked antiglobulin test. The uptake of anti-D, anti-Fy2 and anti-JK3 was markedly accelerated by low ionic strength salt solution (LISS) with a final ionic strength of 0.05 M. Near maximum uptake occurred within ten minutes at room temperature which corresponded to 60 minutes in saline at 37 C. Papain treatment of red blood cells increased the amount of anti-D bound, and there was no difference whether or not the papain-treated cells were suspended in LISS. In contrast, the uptake of IgG anti-A and anti-Leb was not accelerated by LISS, nor did LISS increase the rate of binding of antiblogulin to IgG antibody-coated red blood cells. We suggest this may be explained by the fact that the ABH and Lewis antigens (as well as bound IgG antibodies) extend beyond the "ionic cloud" surrounding the red blood cell. Antibody binding in the presence of albumin was approximately the same as in saline; but if the albumin was first dialyzed against LISS, the reaction was markedly accelerated and the final antibody uptake somewhat higher than in LISS alone.

  8. Development and evaluation of an enzyme-labeled antibody test for the rapid detection of hog cholera antibodies

    Energy Technology Data Exchange (ETDEWEB)

    Saunders, G.C.

    1977-01-01

    A rapid enzyme-labeled antibody (ELA) microtechnique for the screening of swine for hog cholera antibodies was developed and evaluated with a blind study, using a 640-sample hog cholera serum bank. The total time to run a group of 22 samples was approximately 1 hour. The ELA test results correlated >99% with hog cholera serum-neutralization test results on the same serums. Test results also indicated that the ELA test shares with the hog cholera serum-neutralization test the problem of cross reactions between the antibodies of hog cholera and bovine viral diarrhea.

  9. Identification of Hantavirus serotypes by testing of post-infection sera in immunofluorescence and enzyme-linked immunosorbent assays.

    NARCIS (Netherlands)

    J. Groen (Jan); H.G.M. Jordans; J.P.G. Clement; E.J.M. Rooijakkers; F.G.C.M. Uytdehaag (Fons); J.M. Dalrymple; G. van der Groen (Guido); A.D.M.E. Osterhaus (Ab)

    1991-01-01

    textabstractSerum samples were collected from 27 individuals who had been infected with a member of the genus Hantavirus in the Netherlands or Belgium during the last 15 years. These samples were tested in an immunofluorescence assay (IFA) and two enzyme-linked immunosorbent assay (ELISA) systems, u

  10. Evaluation of dengue NS1 antigen rapid tests and ELISA kits using clinical samples.

    Directory of Open Access Journals (Sweden)

    Subhamoy Pal

    Full Text Available Early diagnosis of dengue virus (DENV infection can improve clinical outcomes by ensuring close follow-up, initiating appropriate supportive therapies and raising awareness to the potential of hemorrhage or shock. Non-structural glycoprotein-1 (NS1 has proven to be a useful biomarker for early diagnosis of dengue. A number of rapid diagnostic tests (RDTs and enzyme-linked immunosorbent assays (ELISAs targeting NS1 antigen (Ag are now commercially available. Here we evaluated these tests using a well-characterized panel of clinical samples to determine their effectiveness for early diagnosis.Retrospective samples from South America were used to evaluate the following tests: (i "Dengue NS1 Ag STRIP" and (ii "Platelia Dengue NS1 Ag ELISA" (Bio-Rad, France, (iii "Dengue NS1 Detect Rapid Test (1st Generation" and (iv "DENV Detect NS1 ELISA" (InBios International, United States, (v "Panbio Dengue Early Rapid (1st generation" (vi "Panbio Dengue Early ELISA (2nd generation" and (vii "SD Bioline Dengue NS1 Ag Rapid Test" (Alere, United States. Overall, the sensitivity of the RDTs ranged from 71.9%-79.1% while the sensitivity of the ELISAs varied between 85.6-95.9%, using virus isolation as the reference method. Most tests had lower sensitivity for DENV-4 relative to the other three serotypes, were less sensitive in detecting secondary infections, and appeared to be most sensitive on Day 3-4 post symptom onset. The specificity of all evaluated tests ranged from 95%-100%.ELISAs had greater overall sensitivity than RDTs. In conjunction with other parameters, the performance data can help determine which dengue diagnostics should be used during the first few days of illness, when the patients are most likely to present to a clinic seeking care.

  11. Platelet Function Tests: A Review of Progresses in Clinical Application

    Directory of Open Access Journals (Sweden)

    Jae-Lim Choi

    2014-01-01

    Full Text Available The major goal of traditional platelet function tests has been to screen and diagnose patients who present with bleeding problems. However, as the central role of platelets implicated in the etiology of arterial thrombotic diseases such as myocardial infarction and stroke became widely known, platelet function tests are now being promoted to monitor the efficacy of antiplatelet drugs and also to potentially identify patients at increased risk of thrombosis. Beyond hemostasis and thrombosis, an increasing number of studies indicate that platelets play an integral role in intercellular communication, are mediators of inflammation, and have immunomodulatory activity. As new potential biomarkers and technologies arrive at the horizon, platelet functions testing appears to take on a new aspect. This review article discusses currently available clinical application of platelet function tests, placing emphasis on essential characteristics.

  12. Translating biological parameters into clinically useful diagnostic tests.

    Science.gov (United States)

    Arfken, Cynthia L; Carney, Stuart; Boutros, Nash N

    2009-08-01

    Psychiatry has lagged behind other specialties in developing diagnostic laboratory tests for the purpose of confirming or ruling out a diagnosis. Biological research into the pathophysiology of psychiatric disorders has, however, yielded some highly replicable abnormalities that have the potential for development into clinically useful diagnostic tests. To achieve this goal, a process for systematic translation must be developed and implemented. Building on our previous work, we review a proposed process using four clearly defined steps. We conclude that biological parameters currently face challenges in their pathways to becoming diagnostic tests because of both the premature release and premature abandonment of tests. Attention to a systematic translation process aided by these principles may help to avoid these problems.

  13. Combined clinical and genetic testing algorithm for cervical cancer diagnosis

    OpenAIRE

    Liou, Yu-Ligh; Zhang, Tao-Lan; Yan, Tian; Yeh, Ching-Tung; Kang, Ya-Nan; Cao, Lanqin; Wu, Nayiyuan; Chang, Chi-Feng; Wang, Huei-Jen; Yen, Carolyn; Chu, Tang-Yuan; Zhang, Yi; Zhang, Yu; Zhou, Honghao

    2016-01-01

    Background Opportunistic screening in hospitals is widely used to effectively reduce the incidence rate of cervical cancer in China and other developing countries. This study aimed to identify clinical risk factor algorithms that combine gynecologic examination and molecular testing (paired box gene 1 (PAX1) or zinc finger protein 582 (ZNF582) methylation or HPV16/18) results to improve diagnostic accuracy. Methods The delta Cp of methylated PAX1 and ZNF582 was obtained via quantitative methy...

  14. The UK clinical aptitude test and clinical course performance at Nottingham: a prospective cohort study

    OpenAIRE

    Yates, Janet; James, David

    2013-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham un...

  15. Environmental Technology Verification Report for Abraxis Ecologenia® 17β-Estradiol (E2) Microplate Enzyme-Linked Immunosorbent Assay (ELISA) Test Kits

    Science.gov (United States)

    This verification test was conducted according to procedures specifiedin the Test/QA Planfor Verification of Enzyme-Linked Immunosorbent Assay (ELISA) Test Kis for the Quantitative Determination of Endocrine Disrupting Compounds (EDCs) in Aqueous Phase Samples. Deviations to the...

  16. A critique of statistical hypothesis testing in clinical research

    Directory of Open Access Journals (Sweden)

    Somik Raha

    2011-01-01

    Full Text Available Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined.

  17. A critique of statistical hypothesis testing in clinical research.

    Science.gov (United States)

    Raha, Somik

    2011-07-01

    Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs) to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined.

  18. Clinical Testing for Extra-Articular Lateral Knee Pain. A Modification and Combination of Traditional Tests

    Science.gov (United States)

    2008-01-01

    Knee pain is one of the most common problems encountered by recreational and competitive athletes. Pain over the lateral aspect of the knee can be the result of intra or extra articular conditions. The purpose of this clinical suggestion is to present the modification of a traditional clinical test to aide in the differential diagnosis of lateral knee pain. This method has not been described elsewhere and anecdotally has been helpful in the evaluation of patients with lateral knee pain. PMID:21509133

  19. BOVINE LEUKEMIA VIRUS INFECTION IN TAIWAN : EVALUATION OF THE ENZYME-LINKED IMMUNOSORBENT ASSAY AND AGAR GEL IMMUNODIFFUSION TEST

    OpenAIRE

    WANG, Chun-Tshen

    1991-01-01

    I evaluated an enzyme-linked immunosorbent assay (ELISA) and agar gel immunodiffusion (AGID) test simultaneously for the detection of bovine leukemia virus (BLV) antibodies. Total 1,293 serum samples were tested for ELISA and AGID test and the results were compared. The results of ELISA and AGID agreed by 1,156 out of 1,293 (89.4%). All of AGID-positive 356 sera were positive by ELISA. However, of 451 ELISA-positive sera, 95 sera were either negative or equivocal by AGID test. Eleven animals ...

  20. Comparative assessment of a double antibody enzyme immunoassay test kit and a triple antibody enzyme immunoassay for the diagnosis of Trichinella spiralis spiralis and Trichinella spiralis nativa infections in swine.

    OpenAIRE

    Smith, H. J.; Snowdon, K E

    1989-01-01

    Enzyme immunoassays using the triple antibody enzyme linked immunosorbent assay (ELISA) with both Trichinella spiralis spiralis and T. spiralis nativa excretory-secretory (ES) antigens and a commercial Trichinella spiralis enzyme immunoassay test kit were carried out on sera from pigs that were infected with light, moderate and high doses of infective T. spiralis spiralis and T. spiralis nativa respectively. Seroconversion occurred in all pigs given infective Trichinella larvae although no tr...

  1. Clinical utility of antinuclear antibody tests in children

    Directory of Open Access Journals (Sweden)

    Kickingbird Lauren M

    2004-07-01

    Full Text Available Abstract Background Antinuclear antibody (ANA tests are frequently used to screen children for chronic inflammatory diseases such as systemic lupus erythematosus (SLE. However, the diagnostic utility of this test is limited because of the large number of healthy children who have low-titer positive tests. We sought to determine the clinical utility of ANA tests in screening children for rheumatic disease and to determine whether there are specific signs or symptoms that enhance the clinical utility of ANA tests in children. Methods We undertook a retrospective analysis of 509 new patient referrals. Charts of patients referred because of results of ANA testing were selected for further analysis. Children with JRA, SLE, and other conditions were compared using demographic data, chief complaints at the time of presentation, and ANA titers. Results One hundred ten patients were referred because of an ANA test interpreted as positive. Ten patients were subsequently diagnosed with SLE. In addition, we identified one patient with mixed connective tissue disease, and an additional child with idiopathic Raynaud's phenomenon. Eighteen children of the children referred for a positive ANA test had juvenile rheumatoid arthritis (JRA. Another 80 children with positive ANA tests were identified, the majority of whom (n = 39, 49% had musculoskeletal pain syndromes. Neither the presence nor the titer of ANA served to distinguish children with JRA from children with other musculoskeletal conditions. Children with JRA were readily identified on the basis of the history and physical examination. Children with SLE were therefore compared with children with positive ANA tests who did not have JRA, designated the "comparison group." Non-urticarial rash was more common in children with SLE than in children without chronic inflammatory disease (p = 0.007. Children with SLE were also older (mean ± sd = 14.2 ± 2.5 years than the comparison group (11.0 ± 3.6 years; p

  2. Clinical evaluation of chitotriosidase enzyme activity in Gaucher and Niemann Pick A/B diseases: A retrospective study from India.

    Science.gov (United States)

    Kadali, Srilatha; Kolusu, Anusha; Sunkara, Satish; Gummadi, Maheshwar Reddy; Undamatla, Jayanthi

    2016-06-01

    Plasma chitotriosidase originates from activated macrophages and is reported to be elevated in many Lysosomal Storage Disorders. Measurement of this enzyme activity has been an available tool for monitoring therapy of Gaucher disease. The degree of elevation of chitotriosidase is useful for differential diagnosis of Gaucher disease and Niemann Pick A/B. However the potential utility of this chitotriosidase assay depends on the frequency of deficient chitotriosidase activity in a particular population. We therefore aim to study the clinical utility of this assay Gaucher and Niemann Pick A/B diseases in the backdrop of chitotriosidase deficiency in our population. The study comprises 173 patients with clinical suspicion of either Gaucher disease (n=108) or Niemann Pick A/B (n=65) and 92 healthy controls. The plasma samples of controls, Gaucher disease, and Niemann Pick A/B showed chitotriosidase deficiency of 12%, 25% and 27% respectively. The degree of elevation of chitotriosidase in Gaucher disease and Niemann Pick A/B patients is 40-326 (11,325.7±6395.4nmol/h/ml) and 7-22 folds (1192.5±463.0nmol/h/ml) respectively. In view of these findings of distinguishable fold elevation of chitotriosidase in Gaucher disease or Niemann Pick A/B, it can be a potential surrogate differential diagnostic marker for these groups of diseases, except in the patients in whom this enzyme is deficient. PMID:26975750

  3. Can clinical tests help monitor human papillomavirus vaccine impact?

    Science.gov (United States)

    Meites, Elissa; Lin, Carol; Unger, Elizabeth R; Steinau, Martin; Patel, Sonya; Markowitz, Lauri E; Hariri, Susan

    2013-09-01

    As immunization programs for human papillomavirus (HPV) are implemented more widely around the world, interest is increasing in measuring their impact. One early measurable impact of HPV vaccine is on the prevalence of specific HPV types in a population. In low-resource settings, a potentially attractive strategy would be to monitor HPV prevalence using clinical cervical cancer screening test results to triage specimens for HPV typing. We assessed this approach in a nationally representative population of U.S. females aged 14-59 years. Using self-collected cervico-vaginal swab specimens from 4,150 women participating in the National Health and Nutrition Examination Survey during 2003-2006, we evaluated type-specific HPV prevalence detected by the Roche linear array (LA) research test on all specimens, compared with type-specific HPV prevalence detected by LA conducted only on specimens positive by the digene hybrid capture 2 (HC-2) clinical test. We calculated weighted prevalence estimates and their 95% confidence intervals (CIs), and examined relative type-specific HPV prevalence according to the two testing approaches. The population prevalence of oncogenic HPV vaccine types 16/18 was 6.2% (CI:5.4-7.1) by LA if all specimens were tested, and 2.4% (CI:1.9-3.0) if restricted to positive HC-2. Relative prevalence of individual HPV types was similar for both approaches. Compared with typing all specimens, a triage approach would require testing fewer specimens, but a greater reduction in HPV prevalence or a larger group of specimens would be needed to detect vaccine impact. Further investigation is warranted to inform type-specific HPV monitoring approaches around the world.

  4. [Enzymes of the Xenobiotic Metabolism of Continuous Cell Lines in invitro Toxicity Testing

    Science.gov (United States)

    Wiebel, Friedrich J.; Roscher, Eike

    1988-01-01

    Cells in continuous culture contain a large number of enzymes which are involved in the metabolism of potentially toxic chemicals. As a rule, the activities of these enzymes represent functions of low tussle specificity. In contrast, those functions which are specialized "differentiated" functions in vivo are no longer expressed in continuous cell lines. However, an increasing number of observations indicates that cell lines may also contain these functions. Cell lines which lack or possess specific xenobiotic metabolizing enzymes are already applicable for analyzing the complex mechanisms of activation and inactivation of chemicals. With a better understanding how differentiated cell functions are regulated, prospects are promising for establishing metabolically competent cell lines, which can also be used in the screening of toxic chemicals. PMID:11227057

  5. Genomic Testing and Therapies for Breast Cancer in Clinical Practice

    Science.gov (United States)

    Haas, Jennifer S.; Phillips, Kathryn A.; Liang, Su-Ying; Hassett, Michael J.; Keohane, Carol; Elkin, Elena B.; Armstrong, Joanne; Toscano, Michele

    2011-01-01

    Purpose: Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important. Study Design: Cross-sectional. Methods: We performed a medical record review of women age 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775). Results: Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category (< $40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% CI, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence. Conclusion: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs. PMID:21886507

  6. Clinical Evaluation of Heart Failure: Agreement among Tests.

    Science.gov (United States)

    Pandey, Amit K; Penny, William F; Bhargava, Valmik; Lai, N Chin; Xu, Ronghui; Hammond, H Kirk

    2016-01-01

    Methods commonly used clinically to assess cardiac function in patients with heart failure include ejection fraction (EF), exercise treadmill testing (ETT), and symptom evaluation. Although these approaches are useful in evaluating patients with heart failure, there are at times substantial mismatches between individual assessments. For example, ETT results are often discordant with EF, and patients with minimal symptoms sometimes have surprisingly low EFs. To better define the relationship of these methods of assessment, we studied 56 patients with heart failure with reduced EF (HFrEF) who underwent measurement of ETT duration, EF by echocardiography, quantitative symptom evaluation, and LV peak dP/dt (rate of left ventricular pressure development and decline, measured invasively). Correlations were determined among these four tests in order to assess the relationship of EF, ETT, and symptoms against LV peak dP/dt. In addition, we sought to determine whether EF, ETT, and symptoms correlated with each other. Overall, correlations were poor. Only 15 of 63 total correlations (24%) were significant (p < 0.05). EF correlated most closely with LV peak -dP/dt. Linear regression analysis indicated that EF, ETT, and symptoms taken together predicted LV peak dP/dt better than any one measure alone. We conclude that clinical tests used to assess LV function in patients with HFrEF may not be as accurate or correlate as well as expected. All three clinical measures considered together may be the best representation of cardiac function in HFrEF patients currently available. PMID:27537778

  7. Genetic relationships between clinical and non-clinical strains of Yersinia enterocolitica biovar 1A as revealed by multilocus enzyme electrophoresis and multilocus restriction typing

    Directory of Open Access Journals (Sweden)

    Virdi Jugsharan S

    2010-05-01

    Full Text Available Abstract Background Genetic relationships among 81 strains of Y. enterocolitica biovar 1A isolated from clinical and non-clinical sources were discerned by multilocus enzyme electrophoresis (MLEE and multilocus restriction typing (MLRT using six loci each. Such studies may reveal associations between the genotypes of the strains and their sources of isolation. Results All loci were polymorphic and generated 62 electrophoretic types (ETs and 12 restriction types (RTs. The mean genetic diversity (H of the strains by MLEE and MLRT was 0.566 and 0.441 respectively. MLEE (DI = 0.98 was more discriminatory and clustered Y. enterocolitica biovar 1A strains into four groups, while MLRT (DI = 0.77 identified two distinct groups. BURST (Based Upon Related Sequence Types analysis of the MLRT data suggested aquatic serotype O:6,30-6,31 isolates to be the ancestral strains from which, clinical O:6,30-6,31 strains might have originated by host adaptation and genetic change. Conclusion MLEE revealed greater genetic diversity among strains of Y. enterocolitica biovar 1A and clustered strains in four groups, while MLRT grouped the strains into two groups. BURST analysis of MLRT data nevertheless provided newer insights into the probable evolution of clinical strains from aquatic strains.

  8. Diagnostic values of clinical diagnostic tests in subacromial impingement syndrome

    OpenAIRE

    Calis, M.; Akgun, K; Birtane, M; Karacan, I; Calis, H.; Tuzun, F.

    2000-01-01

    OBJECTIVE—Subacromial impingement syndrome (SIS) is a frequent cause of shoulder pain. The aim of this study was to investigate the diagnostic values of clinical diagnostic tests, in patients with SIS.
METHODS—72 female, 48 male patients with shoulder pain were included in the study. Five had bilateral shoulder pain, so 125 painful shoulders were evaluated. Details were recorded about the patients' ages and sexes, as well as characteristics of pain and related problems. Detailed physical exam...

  9. Non-invasive prenatal chromosomal aneuploidy testing--clinical experience: 100,000 clinical samples.

    Directory of Open Access Journals (Sweden)

    Ron M McCullough

    Full Text Available OBJECTIVE: As the first laboratory to offer massively parallel sequencing-based noninvasive prenatal testing (NIPT for fetal aneuploidies, Sequenom Laboratories has been able to collect the largest clinical population experience data to date, including >100,000 clinical samples from all 50 U.S. states and 13 other countries. The objective of this study is to give a robust clinical picture of the current laboratory performance of the MaterniT21 PLUS LDT. STUDY DESIGN: The study includes plasma samples collected from patients with high-risk pregnancies in our CLIA-licensed, CAP-accredited laboratory between August 2012 to June 2013. Samples were assessed for trisomies 13, 18, 21 and for the presence of chromosome Y-specific DNA. Sample data and ad hoc outcome information provided by the clinician was compiled and reviewed to determine the characteristics of this patient population, as well as estimate the assay performance in a clinical setting. RESULTS: NIPT patients most commonly undergo testing at an average of 15 weeks, 3 days gestation; and average 35.1 years of age. The average turnaround time is 4.54 business days and an overall 1.3% not reportable rate. The positivity rate for Trisomy 21 was 1.51%, followed by 0.45% and 0.21% rate for Trisomies 18 and 13, respectively. NIPT positivity rates are similar to previous large clinical studies of aneuploidy in women of maternal age ≥ 35 undergoing amniocentesis. In this population 3519 patients had multifetal gestations (3.5% with 2.61% yielding a positive NIPT result. CONCLUSION: NIPT has been commercially offered for just over 2 years and the clinical use by patients and clinicians has increased significantly. The risks associated with invasive testing have been substantially reduced by providing another assessment of aneuploidy status in high-risk patients. The accuracy and NIPT assay positivity rate are as predicted by clinical validations and the test demonstrates improvement in the

  10. 42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new...

  11. Interference of cationic polymeric nanoparticles with clinical chemistry tests--clinical relevance.

    Science.gov (United States)

    Shcharbin, Dzmitry; Shcharbina, Natallia; Milowska, Katarzyna; de la Mata, Francisco Javier; Muñoz-Fernandez, Maria Angeles; Mignani, Serge; Gomez-Ramirez, Rafael; Majoral, Jean-Pierre; Bryszewska, Maria

    2014-10-01

    The development of medical nanosystems requires knowledge of their behavior in vivo. Clinical chemistry tests are widely used to estimate the systemic toxicity of nanoparticles. In this paper we have explored the impact of small positively charged nanoparticles-poly(amidoamine), phosphorous and carbosilane dendrimers - on biochemical parameters of standardized serum in vitro. All the dendrimers could shift the main biochemical parameters. Thus, in the case of patients having the normal, but 'boundary', values of biochemical parameters, nanoparticle-induced changes can be wrongly interpreted as evidence of some dysfunctions (hepatic, renal, etc.). Moreover, the effects of nanoparticles of metals, carbon nanotubes, quantum dots, fullerenes, dendrimers having been sized up to 4000 nm and the hundreds of reactive groups, can be significantly higher. Thus, preliminary evaluation of any nanomaterial in vitro is required in clinical chemistry tests before its application in vivo to draw the correct conclusions and benefit animals.

  12. Testing Biochemistry Revisited : How In Vivo Metabolism Can Be Understood from In Vitro Enzyme Kinetics

    NARCIS (Netherlands)

    van Eunen, Karen; Kiewiet, Jose A. L.; Westerhoff, Hans V.; Bakker, Barbara M.

    2012-01-01

    A decade ago, a team of biochemists including two of us, modeled yeast glycolysis and showed that one of the most studied biochemical pathways could not be quite understood in terms of the kinetic properties of the constituent enzymes as measured in cell extract. Moreover, when the same model was la

  13. Filtering Medline for a clinical discipline: diagnostic test assessment framework

    Science.gov (United States)

    Iansavichus, Arthur V; Wilczynski, Nancy L; Kastner, Monika; Baier, Leslie A; Shariff, Salimah Z; Rehman, Faisal; Weir, Matthew; McKibbon, K Ann; Haynes, R Brian

    2009-01-01

    Objective To develop and test a Medline filter that allows clinicians to search for articles within a clinical discipline, rather than searching the entire Medline database. Design Diagnostic test assessment framework with development and validation phases. Setting Sample of 4657 articles published in 2006 from 40 journals. Reviews Each article was manually reviewed, and 19.8% contained information relevant to the discipline of nephrology. The performance of 1 155 087 unique renal filters was compared with the manual review. Main outcome measures Sensitivity, specificity, precision, and accuracy of each filter. Results The best renal filters combined two to 14 terms or phrases and included the terms “kidney” with multiple endings (that is, truncation), “renal replacement therapy”, “renal dialysis”, “kidney function tests”, “renal”, “nephr” truncated, “glomerul” truncated, and “proteinuria”. These filters achieved peak sensitivities of 97.8% and specificities of 98.5%. Performance of filters remained excellent in the validation phase. Conclusions Medline can be filtered for the discipline of nephrology in a reliable manner. Storing these high performance renal filters in PubMed could help clinicians with their everyday searching. Filters can also be developed for other clinical disciplines by using similar methods. PMID:19767336

  14. Validation of a clinical critical thinking skills test in nursing

    Directory of Open Access Journals (Sweden)

    Sujin Shin

    2015-01-01

    Full Text Available Purpose: The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS and to subsequently validate its performance. Methods: This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school students in July 2013. The content validity of the revised items was analyzed by calculating the degree of agreement between instrument developer intention in item development and the judgments of six experts. To analyze response process validity, qualitative data related to the response processes of nine nursing college students obtained through cognitive interviews were analyzed. Results: Out of initial 30 items, 11 items were excluded after the analysis of difficulty and discrimination parameter. When the 19 items of the revised version of the CCTS were analyzed, levels of item difficulty were found to be relatively low and levels of discrimination were found to be appropriate or high. The degree of agreement between item developer intention and expert judgments equaled or exceeded 50%. Conclusion: From above results, evidence of the response process validity was demonstrated, indicating that subjects respondeds as intended by the test developer. The revised 19-item CCTS was found to have sufficient reliability and validity and will therefore represents a more convenient measurement of critical thinking ability.

  15. Clinical effects of early angiotensin-converting enzyme inhibitor treatment for acute myocardial infarction are similar in the presence and absence of aspirin: systematic overview of individual data from 96,712 randomized patients. Angiotensin-converting Enzyme Inhibitor Myocardial Infarction

    DEFF Research Database (Denmark)

    Latini, R; Tognoni, G; Maggioni, A P;

    2000-01-01

    OBJECTIVES: We sought to determine whether the clinical effects of early angiotensin-converting enzyme (ACE) inhibitor (ACEi) treatment for acute myocardial infarction (MI) are influenced by the concomitant use of aspirin (ASA). BACKGROUND: Aspirin and ACEi both reduce mortality when given early.......004). Angiotensin-converting enzyme inhibitor was associated with similar proportional reductions in 30-day mortality among the 86,484 patients who were taking ASA (6% [SD, 3%] reduction) and among the 10,228 patients who were not (10% [SD, 5%] reduction: chi-squared test of heterogeneity between these reductions...... = 0.4; p = 0.5). Angiotensin-converting enzyme inhibitor produced definite increases in the incidence of persistent hypotension (17.9% ACEi vs. 9.4% control) and of renal dysfunction (1.3% ACEi vs. 0.6% control), but there was no good evidence that these effects were different in the presence...

  16. Reliability, construct and discriminative validity of clinical testing in subjects with and without chronic neck pain

    DEFF Research Database (Denmark)

    Jørgensen, René; Ris Hansen, Inge; Juul-Kristensen, Birgit;

    2014-01-01

    Abstract BACKGROUND: The reliability of clinical tests for the cervical spine has not been adequately evaluated. Six cervical clinical tests, which are low cost and easy to perform in clinical settings, were tested for intra- and inter-examiner reliability, and two performance tests were assessed...

  17. The use of cytosolic enzyme increase in cerebrospinal fluid of patients resuscitated after cardiac arrest. Brain Resuscitation Clinical Trial I Study Group.

    Science.gov (United States)

    Vaagenes, P; Mullie, A; Fodstad, D T; Abramson, N; Safar, P

    1994-11-01

    Levels of brain creatine phosphokinase (CPK), glutamic oxalic transaminase, lactate dehydrogenase, and lactate in lumbar cerebrospinal fluid (CSF) were analyzed as an adjunctive study in a randomized clinical trial evaluating the effects of thiopental loading intravenously in comatose survivors of cardiac arrest. Three hospitals participated and a total of 62 cases of enzyme changes were studied. Enzyme levels but not lactate were higher at 48 hours than at 24 hours after restoration of spontaneous circulation. All enzymes were highly correlated with one another at 24 and 48 hours (P < .001). There was a significant negative correlation between cerebral recovery and increased CPK levels at 24 hours (P < .05), and a highly significant correlation with all three enzyme levels at 48 hours (P < .0001). The increase of cytosolic enzyme activity in lumbar CSF reflects permanent brain damage, and there is a relationship between activity levels and cerebral outcome. PMID:7945601

  18. Can clinical colour vision tests be used to predict the results of the Farnsworth lantern test?

    Science.gov (United States)

    Cole, B L; Maddocks, J D

    1998-11-01

    Clinicians usually do not have access to a lantern test when making an occupational assessment of the ability of a person with defective colour vision to recognise signal light colours: they must rely on the results of ordinary clinical tests. While all colour vision defectives fail the Holmes Wright Type B lantern test and most fail the Holmes Wright Type A lantern, 35% of colour vision defectives pass the Farnsworth lantern. Can clinical tests predict who will pass and fail the Farnsworth lantern? We find that a pass (less than two or more diametrical crossings) at the Farnsworth Panel D 15 Dichotomous test has a sensitivity of 0.67 and specificity of 0.94 in predicting a pass or fail at the Farnsworth lantern test: a Nagel range of > 10 has a sensitivity of 0.87 and a specificity of 0.57. We conclude that neither the D 15 nor the Nagel Anomaloscope matching range are satisfactory predictors of performance on the Farnsworth Lantern.

  19. Different angiotensin-converting enzyme inhibitors have similar clinical efficacy after myocardial infarction

    DEFF Research Database (Denmark)

    Hansen, Morten L; Gislason, Gunnar H; Køber, Lars;

    2008-01-01

    efficacy. Risk of all-cause mortality: trandolapril (reference) 1.00, ramipril 0.97 (0.89, 1.05), enalapril 1.04 (0.95, 1.150), captopril 0.95 (0.83, 1.08), perindopril 0.98 (0.84, 1.15) and other ACE inhibitors or angiotensin II receptor blockers (ARB) 1.06 (0.94, 1.19). Reinfarction: trandolapril...... (reference) 1.00, ramipril 0.98 (0.89, 1.08), enalapril 1.04 (0.92, 1.17), captopril 1.05 (0.89, 1.25), perindopril 0.96 (0.81, 1.14) and other ACE inhibitors or ARB 0.99 (0.86, 1.14). Furthermore, the association between ARBs and clinical events was similar to ACE inhibitors (trandolapril reference): all...

  20. 42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... Condition: Laboratories performing high complexity testing; clinical consultant. The laboratory must have a... testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  1. Clinical significance of activity of ALT enzyme in patients with hepatitis C virus

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    AIM: To investigate serum alanine aminotransferase (ALT) levels in relation to the clinical, biochemical,ultrasonographic and histological characteristics of patients with hepatitis C virus.METHODS: Duration of disease, HCV-RNA, liver steatosis, and the hepatitis activity index (HAI) were correlated with serum ALT in 36 patients with HCV. ALT values were also investigated in 16 control subjects without any liver diseases.RESULTS: In bivariate analyses, ALT levels correlated with duration of HCV infection (P< 0.01), HCV-RNA (P<0.05), and the HAI(P<0.01). Among the components of the HAI, ALT concentrations were significantly associated with pedportal bridging/necrosis (P<0.01) and fibrosis (P<0.05). In multivariate analysis, periportal bridging/necrosis (β = 0.508; P < 0.01), duration of HCV infection (β = 0.413; P < 0.01), and HCV-RNA (β= 0.253; P < 0.05)were independently associated with ALT activity. The normal ALT activity for men and women was < 23 IU/L and < 22 IU/L, respectively.CONCLUSION: In patients with HCV, alterations in the liver tissue as reflected by ALT elevation are mainly associated with periportal bridging/necrosis, viral load and duration of disease. A cut-off value < 23 IU/L distinguished with high diagnostic accuracy healthy controls from patients with HCV.

  2. Enzyme immunoassay

    DEFF Research Database (Denmark)

    Feldt-Rasmussen, B; Dinesen, B; Deckert, M

    1985-01-01

    An enzyme linked immunoadsorbent assay for urinary albumin using commercially available reagents is described. The assay range is 2.5-120 micrograms/l. When samples are analysed in two standard dilutions, the assayable albumin concentration range is 2.5-240 mg/l, covering the clinical range from...

  3. Comparison of enzyme-linked immunosorbent assays and virus neutralization test for detection of antibodies to avian pneumovirus.

    Science.gov (United States)

    Alkahalaf, A N; Halvorson, D A; Saif, Y M

    2002-01-01

    Two different whole-virus enzyme-linked immunosorbent assays (ELISAs), developed in Ohio (OH) with APV/Minnesota/turkey/2a/97 and in Minnesota (MN) with APV/Colorado/turkey/97, and the virus neutralization (VN) test were used to test 270 turkey serum samples from 27 Minnesota turkey flocks for avian pneumovirus (APV) antibodies. In addition, 77 turkey serum samples and 128 ostrich serum samples from Ohio were tested. None of the turkey samples from Ohio had antibodies to APV by the VN test and OH ELISA. The ostrich samples were only tested with the VN test and were all negative for antibodies to APV. For the Minnesota serum samples, 107, 115, and 120 were positive by the VN test, the OH ELISA, and the MN ELISA, respectively. The Kappa values of 0.938 and 0.825 showed excellent agreement between the VN test and the OH ELISA and the MN ELISA, respectively, for detection of antibodies to the APV. The OH ELISA and MN ELISA had sensitivities of 1.0 and 0.953, specificities of 0.950 and 0.889, and accuracies of 0.970 and 0.914, respectively. Our results indicate that the 3 methods are sensitive and specific for diagnosis of the APV infection.

  4. IMMUNOLOCALIZATION OF INHIBIN/ACTIVIN SUBUNITS AND STEROIDOGENIC ENZYMES IN THE TESTES OF AN ADULT AFRICAN ELEPHANT (LOXODONTA AFRICANA).

    Science.gov (United States)

    Li, Qinglin; Lu, Lu; Weng, Qiang; Kawakami, Shigehisa; Saito, Eriko; Yamamoto, Tatsuya; Yamamoto, Yuki; Kaewmanee, Saroch; Nagaoka, Kentaro; Watanabe, Gen; Taya, Kazuyoshi

    2016-06-01

    In this case report, the authors investigated immunolocalization of inhibin α and inhibin/activin βA and βB subunits, as well as steroidogenic enzymes, in the testes of an African elephant. Testes were collected from a reproductively active male African elephant (24 yr old) at autopsy. Histologically, all types of spermatogenic cells including mature-phase spermatozoa were found in the seminiferous tubules. Positive immunostaining for inhibin α and inhibin/activin βA and βB subunits was observed in Sertoli and Leydig cells. In addition, P450scc, 3βHSD, P450c17, and P450arom were also detected in the cytoplasm of Leydig cells. These results suggested that Leydig cells of adult African elephant testes have the ability to synthesize progestin, androgen, and estrogen, whereas both Sertoli and Leydig cells appear as a major source of inhibin secretion in the male African elephant. PMID:27468011

  5. An innovative method to assess clinical reasoning skills: Clinical reasoning tests in the second national medical science Olympiad in Iran

    Directory of Open Access Journals (Sweden)

    Shafaghi Afshin

    2011-10-01

    Full Text Available Abstract Background Clinical reasoning plays a major role in the ability of doctors to make a diagnosis and reach treatment decisions. This paper describes the use of four clinical reasoning tests in the second National Medical Science Olympiad in Iran: key features (KF, script concordance (SCT, clinical reasoning problems (CRP and comprehensive integrative puzzles (CIP. The purpose of the study was to design a multi instrument for multiple roles approach in clinical reasoning field based on the theoretical framework, KF was used to measure data gathering, CRP was used to measure hypothesis formation, SCT and CIP were used to measure hypothesis evaluation and investigating the combined use of these tests in the Olympiad. A bank of clinical reasoning test items was developed for emergency medicine by a scientific expert committee representing all the medical schools in the country. These items were pretested by a reference group and the results were analyzed to select items that could be omitted. Then 135 top-ranked medical students from 45 medical universities in Iran participated in the clinical domain of the Olympiad. The reliability of each test was calculated by Cronbach's alpha. Item difficulty and the correlation between each item and the total score were measured. The correlation between the students' final grade and each of the clinical reasoning tests was calculated, as was the correlation between final grades and another measure of knowledge, i.e., the students' grade point average. Results The combined reliability for all four clinical reasoning tests was 0.91. Of the four clinical reasoning tests we compared, reliability was highest for CIP (0.91. The reliability was 0.83 for KF, 0.78 for SCT and 0.71 for CRP. Most of the tests had an acceptable item difficulty level between 0.2 and 0.8. The correlation between the score for each item and the total test score for each of the four tests was positive. The correlations between scores

  6. Multisite clinical evaluation of a rapid test for Entamoeba histolytica in stool.

    Science.gov (United States)

    Verkerke, Hans P; Hanbury, Blake; Siddique, Abdullah; Samie, Amidou; Haque, Rashidul; Herbein, Joel; Petri, William A

    2015-02-01

    Rapid point-of-care detection of enteric protozoa in diarrheal stool is desirable in clinical and research settings to efficiently determine the etiology of diarrhea. We analyzed the ability of the third-generation E. histolytica Quik Chek assay developed by Techlab to detect amebic antigens in fecal samples collected from independent study populations in South Africa and Bangladesh. We compared the performance of this recently released rapid test to that of the commercially available ProSpecT Entamoeba histolytica microplate assay from Remel and the E. histolytica II enzyme-linked immunosorbent assay (ELISA) from Techlab, using real-time and nested-PCR for Entamoeba species to resolve any discrepant results. After discrepant resolution, The E. histolytica Quik Chek assay exhibited sensitivity and specificity compared to the E. histolytica II ELISA of 98.0% (95% confidence interval [CI], 92.9% to 99.8%) and 100% (95% CI, 99.0% to 100%), respectively. Compared to the ProSpecT microplate assay, the E. histolytica Quik Chek (Quik Chek) assay exhibited 97.0% sensitivity (95% CI, 91.5% to 99.4%) and 100% specificity (95% CI, 99.0% to 100%). Our results indicate that the Quik Chek is a robust assay for the specific detection of E. histolytica trophozoites in unfixed frozen clinical stool samples.

  7. [Vasculitic Peripheral Neuropathies: Clinical Features and Diagnostic Laboratory Tests].

    Science.gov (United States)

    Ogata, Katsuhisa

    2016-03-01

    Vasculitic peripheral neuropathy (VPN) occurs due to ischemic changes of peripheral nerves, resulting from a deficit of vascular blood supply due to damaged vasa nervorum leading to vasculitis. VPN usually manifests as sensorimotor or sensory disturbances accompanied by pain, presenting as a type of multiple mononeuropathy, with a scattered distribution in distal limbs. VPN may also present as a mononeuropathy, distal symmetric polyneuropathy, plexopathy, or radiculopathy. The rapidity of VPN is variable, ranging from days to months, with symptoms occasionally changing with the appearance of new lesions. Careful history taking and neurological examination provides an exact diagnosis. The most common cause of VPN is primary vasculitis predominantly affecting small vessels, including vasa nervorum, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and polyarteritis nodosa. Similar vasculitic processes can also result from a systemic collagen disorder or secondary vasculitis. Electrophysiological studies and pathological investigation of biopsied peripheral nerves and muscles are important for diagnosis of vasculitis. Serological tests, including ANCA, are useful for diagnosis of vasculitis. Accurate neurological examinations are essential for diagnosis and evaluation of clinical course.

  8. Seroprevalence Study of Human Brucellosis by Conventional Tests and Indigenous Indirect Enzyme-Linked Immunosorbent Assay

    OpenAIRE

    Agasthya, Annapurna S.; Srikrishna Isloor; Prabhudas Krishnamsetty

    2012-01-01

    Brucellosis is one of the most important reemerging zoonoses in many countries. Brucellosis is caused by Gram-negative coccobacillus belonging to genus Brucella. Human brucellosis often makes the diagnosis difficult. The symptoms and clinical signs most commonly reported are fever, fatigue, malaise, chills, sweats headaches, myalgia, arthralgia, and weight loss. Some cases have been presented with only joint pain, lower backache, and involuntary limb movement, burning feet, or ischemic heart ...

  9. Preoperative angiotensin converting enzyme inhibitor usage in patients with chronic subdural hematoma: Associations with initial presentation and clinical outcome.

    Science.gov (United States)

    Neidert, Marian C; Schmidt, Tobias; Mitova, Tatyana; Fierstra, Jorn; Bellut, David; Regli, Luca; Burkhardt, Jan-Karl; Bozinov, Oliver

    2016-06-01

    The aim of this study is to analyze the association of preoperative usage of angiotensin converting enzyme (ACE) inhibitors with the initial presentation and clinical outcome of patients with chronic subdural hematoma (cSDH). Patients treated for cSDH between 2009 and 2013 at our institution were included in this retrospective case-control study. Medical charts were reviewed retrospectively and data were analyzed using descriptive and inferential statistics. Out of 203 patients (58 females, mean age 73.2years), 53 (26%) patients were on ACE inhibitors before their presentation with cSDH. Median initial hematoma volume in individuals with ACE inhibitors (179.2±standard error of the mean [SEM] 13.0ml) was significantly higher compared to patients without ACE inhibitors (140.4±SEM 6.2ml; p=0.007). There was an increased probability of surgical reintervention in the ACE inhibitor group (12/53, 23% versus 19/153, 12%; p=0.079), especially in patients older than 80years (6/23, 26% versus 3/45, 7%; p=0.026). ACE inhibitors are associated with higher hematoma volume in patients with cSDH and with a higher frequency of recurrences requiring surgery (especially in the very old). We hypothesize that these effects are due to ACE inhibitor induced bradykinin elevation causing increased vascular permeability of the highly vascularized neomembranes in cSDH. PMID:26898577

  10. A comparison of intradermal testing and detection of allergen-specific immunoglobulin E in serum by enzyme-linked immunosorbent assay in horses affected with skin hypersensitivity.

    Science.gov (United States)

    Morgan, Erin E; Miller, William H; Wagner, Bettina

    2007-12-15

    Skin hypersensitivities (allergies) in horses are often diagnosed using clinical signs only. Intradermal testing or serological assays are diagnostic options to confirm the allergic nature of the disease and to identify the allergen(s). Our objective was to develop an allergen-specific enzyme-linked immunosorbent assay (ELISA) using a monoclonal antibody specific for horse IgE and to examine its potential for allergen detection in serum in comparison to intradermal testing. Intradermal testing with 61 allergen extracts was performed on 10 horses affected with skin hypersensitivity. Their sera were analyzed by ELISA for IgE antibodies to the same allergens. The kappa test of concordance was used for comparison of the results of both tests. Out of 61 allergen extracts, only two (Timothy and Quack) had kappa values greater than 0.60, suggesting a substantial agreement between skin testing and IgE ELISA. The statistical comparison of the remaining 59 allergens showed little or no concordance between the tests beyond chance. To identify parameters that may influence the sensitivity of the ELISA, the assay was modified to detect allergen-specific IgGb and IgG(T) in serum, and the protein content in all allergen extracts was determined by SDS-PAGE. The commercial allergen extracts revealed a high variation in detectable protein. High concentrations of allergen-specific IgG in horse serum were found to compete with IgE for binding to the plates. In conclusion, an ELISA using whole serum and crude allergen preparations provides limited diagnostic information in horses. The reliable diagnosis of allergens in equine skin hypersensitivity is essential to improve allergen-specific treatments, such as hyposensitization, or the development of allergy vaccines.

  11. Development and testing of radio and enzyme immunoassays for acidic fibroblast growth factor (aFGF)

    International Nuclear Information System (INIS)

    Acidic fibroblast growth factor (aFGF) and basic fibroblast growth factor from bovine brain stimulate growth in a variety of tissues in several species. Despite the 55% amino acid sequence homology of the two forms of FGF, a specific immunoassay of aFGF has been developed using a polyclonal antibody raised in a rabbit. Two immunoassays were compared: a radioimmunoassay (RIA) using 125I aFGF and an enzyme immunoassay (EIA) using aFGF coupled to the tetrameric form of acetylcholinesterase (aFGF-AchE) as tracer. With EIA, the detection limit was 1.5 ng/ml, versus 2.2 ng/ml with RIA, while the dose at 50% was 5.9 ng/ml for EIA and 9.6 ng/ml for RIA. Using a modified EIA procedure where aFGF-AchE was added 2 h after the other reagents, the dose at 50% binding was 1.5 ng/ml. Examples of the performance of both immunoassays are presented for various brain extracts of different species including human. The aFGF content obtained by these methods correlates (CR = 0.987) with the values obtained by biological assay

  12. Assessment of two enzyme-linked immunosorbent assay tests marketed for detection of ruminant proteins in finished feed.

    Science.gov (United States)

    Myers, Michael J; Yancy, Haile F; Farrell, Dorothy E; Washington, Jewell D; Deaver, Christine M; Frobish, Russell A

    2007-03-01

    The performance characteristics of two enzyme-linked immunosorbent assay (ELISA) test kits, ELISA Technologies' MELISA-Tek test and Tepnel BioSystems' BioKit for (Cooked) Species Identification test, designed to detect ruminant proteins in animal feed, were evaluated. The test kits were evaluated by using acceptance criteria developed by the U.S. Food and Drug Administration's Center for Veterinary Medicine Office of Research for evaluating selectivity, sensitivity, ruggedness, and specificity. The acceptance criteria for determining success used a statistical approach requiring a 90% probability of achieving the correct response within a 95% confidence interval. In practice, this measure requires the test to achieve the correct response 58 times for every 60 samples evaluated, or a 96.7% accuracy rate. A minimum detection level of 0.1% bovine meat and bone meal (BMBM) was required, consistent with the sensitivity of the analytical methods presently used by the U.S. Food and Drug Administration. Selectivity was assessed by testing 60 dairy feed samples that contained no added animal proteins; sensitivity was determined by evaluating 60 samples (per level of fortification) of this same feed that contained 0.025, 0.05, 0.1, 0.25, 0.5, 1, or 2% BMBM. The MELISA-Tek test passed the acceptance set-point criteria for selectivity assessment but failed the sensitivity assessment at all levels except at the 2% level. The MELISA-Tek test came close to passing at the 1% level, detecting true-positive findings at a rate of 93%, but failed at lower levels, in spite of the label claim of 0.5% sensitivity. The BioKit for (Cooked) Species Identification test detected only 2 of 17 samples fortified at the 2% BMBM level and failed to detect any other BMBM-fortified samples. The results of this evaluation indicate that neither test is adequate for regulatory use. PMID:17388061

  13. Comparison of agar gel immunodiffusion test, enzyme-linked immunosorbent assay and PCR in diagnostics of enzootic bovine leukosis

    Directory of Open Access Journals (Sweden)

    Malovrh Tadej

    2005-01-01

    Full Text Available Bovine leukaemia virus (BLV is a retrovirus that induces a chronic infection in cattle. Once infected, cattle remain virus carriers for life and start to show an antibody response within a few weeks after infection. Eradication and control of the disease are based on early diagnostics and segregation of the carriers. The choice of a diagnostic method depends on the eradication programme, money resources and characteristics of the herd to be analysed. The agar gel immunodiffusion (AGID test has been the serological test of choice for routine diagnosis of serum samples. Nevertheless, in more recent years, the enzyme-linked immunosorbent assay (ELISA has replaced the AGID for large scale testing. For this purpose, commercially available BLV-ELISA kits were compared to the AGID and to the polymerase chain reaction (PCR method performed with two sets of primers, amplifying env region. The ELISA kit based on the p24 core protein was found to be less specific and served as a screening test. The ELISA kit based on the envelope glycoprotein (gpSI served as a verification test and gave a good correlation with the AGID test and PCR method. However, ELISA showed a higher sensitivity than AGID. The p24 based ELiSA was useful for screening a large number of samples, whereas gp51 based ELISA, AGID and PCR were more important for detecting the antibody response against the individual BLV-proteins and therefore for verification of the infection with BLV.

  14. Enzyme activity assay of glycoprotein enzymes based on a boronate affinity molecularly imprinted 96-well microplate.

    Science.gov (United States)

    Bi, Xiaodong; Liu, Zhen

    2014-12-16

    Enzyme activity assay is an important method in clinical diagnostics. However, conventional enzyme activity assay suffers from apparent interference from the sample matrix. Herein, we present a new format of enzyme activity assay that can effectively eliminate the effects of the sample matrix. The key is a 96-well microplate modified with molecularly imprinted polymer (MIP) prepared according to a newly proposed method called boronate affinity-based oriented surface imprinting. Alkaline phosphatase (ALP), a glycoprotein enzyme that has been routinely used as an indicator for several diseases in clinical tests, was taken as a representative target enzyme. The prepared MIP exhibited strong affinity toward the template enzyme (with a dissociation constant of 10(-10) M) as well as superb tolerance for interference. Thus, the enzyme molecules in a complicated sample matrix could be specifically captured and cleaned up for enzyme activity assay, which eliminated the interference from the sample matrix. On the other hand, because the boronate affinity MIP could well retain the enzymatic activity of glycoprotein enzymes, the enzyme captured by the MIP was directly used for activity assay. Thus, additional assay time and possible enzyme or activity loss due to an enzyme release step required by other methods were avoided. Assay of ALP in human serum was successfully demonstrated, suggesting a promising prospect of the proposed method in real-world applications.

  15. Use of clinical movement screening tests to predict injury in sport.

    Science.gov (United States)

    Chimera, Nicole J; Warren, Meghan

    2016-04-18

    Clinical movement screening tests are gaining popularity as a means to determine injury risk and to implement training programs to prevent sport injury. While these screens are being used readily in the clinical field, it is only recently that some of these have started to gain attention from a research perspective. This limits applicability and poses questions to the validity, and in some cases the reliability, of the clinical movement tests as they relate to injury prediction, intervention, and prevention. This editorial will review the following clinical movement screening tests: Functional Movement Screen™, Star Excursion Balance Test, Y Balance Test, Drop Jump Screening Test, Landing Error Scoring System, and the Tuck Jump Analysis in regards to test administration, reliability, validity, factors that affect test performance, intervention programs, and usefulness for injury prediction. It is important to review the aforementioned factors for each of these clinical screening tests as this may help clinicians interpret the current body of literature. While each of these screening tests were developed by clinicians based on what appears to be clinical practice, this paper brings to light that this is a need for collaboration between clinicians and researchers to ensure validity of clinically meaningful tests so that they are used appropriately in future clinical practice. Further, this editorial may help to identify where the research is lacking and, thus, drive future research questions in regards to applicability and appropriateness of clinical movement screening tools. PMID:27114928

  16. Differential Reinforcement of Alternative Behavior Increases Resistance to Extinction: Clinical Demonstration, Animal Modeling, and Clinical Test of One Solution

    OpenAIRE

    Mace, F. Charles; McComas, Jennifer J; Mauro, Benjamin C.; Progar, Patrick R; Taylor, Bridget; Ervin, Ruth; Zangrillo, Amanda N

    2010-01-01

    Basic research with pigeons on behavioral momentum suggests that differential reinforcement of alternative behavior (DRA) can increase the resistance of target behavior to change. This finding suggests that clinical applications of DRA may inadvertently increase the persistence of target behavior even as it decreases its frequency. We conducted three coordinated experiments to test whether DRA has persistence-strengthening effects on clinically significant target behavior and then tested the ...

  17. Useful Tests for Hepatic Encephalopathy in Clinical Practice

    OpenAIRE

    Nabi, Eiman; Bajaj, Jasmohan S

    2014-01-01

    Hepatic encephalopathy (HE) is a serious complication of liver disease and portosystemic shunting that represents a continuum of neuropsychiatric changes and altered consciousness. It is classified as overt hepatic encephalopathy (OHE) when clinically apparent or as covert hepatic encephalopathy (CHE) in its mildest form. Progression of CHE to OHE and its impact of quality of life make its early diagnosis imperative. Several diagnostic techniques ranging from simple clinical scales to sophist...

  18. Clinical Evaluation of Rapid Diagnostic Test Kit for Scrub Typhus with Improved Performance

    Science.gov (United States)

    2016-01-01

    Diagnosis of scrub typhus is challenging due to its more than twenty serotypes and the similar clinical symptoms with other acute febrile illnesses including leptospirosis, murine typhus and hemorrhagic fever with renal syndrome. Accuracy and rapidity of a diagnostic test to Orientia tsutsugamushi is an important step to diagnose this disease. To discriminate scrub typhus from other diseases, the improved ImmuneMed Scrub Typhus Rapid Diagnostic Test (RDT) was evaluated in Korea and Sri Lanka. The sensitivity at the base of each IgM and IgG indirect immunofluorescent assay (IFA) in Korean patients was 98.6% and 97.1%, and the specificity was 98.2% and 97.7% respectively. The sensitivity and specificity for retrospective diagnosis at the base of IFA in Sri Lanka was 92.1% and 96.1%. ImmuneMed RDT was not reactive to any serum from seventeen diseases including hemorrhagic fever with renal syndrome (n = 48), leptospirosis (n = 23), and murine typhus (n = 48). ImmuneMed RDT shows superior sensitivity (98.6% and 97.1%) compared with SD Bioline RDT (84.4% at IgM and 83.3% at IgG) in Korea. The retrospective diagnosis of ImmuneMed RDT exhibits 94.0% identity with enzyme-linked Immunosorbent assay (ELISA) using South India patient serum samples. These results suggest that this RDT can replace other diagnostic tests and is applicable for global diagnosis of scrub typhus. This rapid and accurate diagnosis will be beneficial for diagnosing and managing scrub typhus. PMID:27478327

  19. Six-minute stepper test: a valid clinical exercise tolerance test for COPD patients

    Directory of Open Access Journals (Sweden)

    Grosbois JM

    2016-03-01

    .005. Performances on the 6MST and 6MWT were significantly improved after PR (570 vs 488 steps, P=0.001 and 448 vs 406 m, respectively; P<0.0001. Improvements of the 6MST and 6MWT after PR were significantly correlated (r=0.34; P=0.03.Conclusion: The results of this study show that the 6MST is a valid test to evaluate exercise tolerance in COPD patients. The use of this test in clinical practice appears to be particularly relevant for the assessment of patients managed by home PR. Keywords: 6-minute stepper test, 6-minute walk test, exercise tolerance, pulmonary rehabilitation, cardiopulmonary exercise testing, validity

  20. Evolution of Clinical Enzymology

    OpenAIRE

    Büttner, J

    1981-01-01

    The evolution of clinical enzymology is discussed in relation to the history of general enzymology and clinical chemistry. The discussion is limited to the period from 1835 (definition of catalysis by Berzelius) to 1935 (description of the optical test by Warburg). In conclusion, a general account is given of the introduction of the concept of quantitative enzyme activity determination into clinical medicine.

  1. Oral maintenance clinical trial with miglustat for type I Gaucher disease: switch from or combination with intravenous enzyme replacement

    NARCIS (Netherlands)

    D. Elstein; A. Dweck; D. Attias; I. Hadas-Halpern; S. Zevin; G. Altarescu; J.F.M.G. Aerts; S. van Weely; A. Zimran

    2007-01-01

    Enzyme replacement therapy (ERT) with imiglucerase reduces hepatosplenomegaly and improves hematologic parameters in Gaucher disease type 1 within 6-24 months. Miglustat reduces organomegaly, improves hematologic parameters, and reverses bone marrow infiltration. This trial evaluates miglustat in pa

  2. Reflection on design and testing of pancreatic alpha-amylase inhibitors: an in silico comparison between rat and rabbit enzyme models

    Directory of Open Access Journals (Sweden)

    Khalil-Moghaddam Shiva

    2012-11-01

    Full Text Available Abstract Background Inhibitors of pancreatic alpha-amylase are potential drugs to treat diabetes and obesity. In order to find compounds that would be effective amylase inhibitors, in vitro and in vivo models are usually used. The accuracy of models is limited, but these tools are nonetheless valuable. In vitro models could be used in large screenings involving thousands of chemicals that are tested to find potential lead compounds. In vivo models are still used as preliminary mean of testing compounds behavior in the whole organism. In the case of alpha-amylase inhibitors, both rats and rabbits could be chosen as in vivo models. The question was which animal could present more accuracy with regard to its pancreatic alpha-amylase. Results As there is no crystal structure of these enzymes, a molecular modeling study was done in order to compare the rabbit and rat enzymes with the human one. The overall result is that rabbit enzyme could probably be a better choice in this regard, but in the case of large ligands, which could make putative interactions with the −4 subsite of pancreatic alpha-amylase, interpretation of results should be made cautiously. Conclusion Molecular modeling tools could be used to choose the most suitable model enzyme that would help to identify new enzyme inhibitors. In the case of alpha-amylase, three-dimensional structures of animal enzymes show differences with the human one which should be taken into account when testing potential new drugs.

  3. Counseling for HIV Prevention: Clinical Interventions and HIV Antibody Testing.

    Science.gov (United States)

    Craig, Donald H.; And Others

    1996-01-01

    Describes some developmental foundations for HIV counseling. Asserts that, in both formal sessions and moments of opportunity, educators, clinicians, and counselors can use the counseling relationship to promote healthy behavior change. This clinical process depends on careful self-appraisal, good counseling skills, and responsiveness to the…

  4. Clinical Teaching Effectiveness Instrument: Development and Psychometric Testing.

    Science.gov (United States)

    Copeland, H. Liesel; Hewson, Mariana

    This report describes the development and psychometric qualities of a new instrument to assess clinical teaching effectiveness in medical education. The strength of the instrument is seen to lie in the qualitative development process involving iterative checking with key stakeholders; its high reliability, validity, and feasibility; and its ease…

  5. New PCR Test That Recognizes All Human Prototypes of Enterovirus: Application for Clinical Diagnosis

    OpenAIRE

    Bourlet, Thomas; Caro, Valerie; Minjolle, Sophie; Jusselin, Isabelle; Pozzetto, Bruno; Crainic, Radu; Colimon, Ronald

    2003-01-01

    We describe a new PCR test (Penter RT-PCR) that recognizes all 64 prototypes of enterovirus. Sixty clinical samples were analyzed in parallel with this Penter RT-PCR and previously described PCR tests: 34 and 32 samples tested positive, respectively. This assay is suitable for use in clinical diagnosis, and its ability to amplify all known serotypes makes it more useful than other consensus PCR tests.

  6. Clinical value of exercise testing in elderly patients

    NARCIS (Netherlands)

    J. Pool (Jan); M.G. Scheffer; M.L. Simoons (Maarten); N. Patijn

    1984-01-01

    textabstractBetween 1978 and 1983, 1391 exercise tests were performed by 1083 males and 308 females over 64 years of age. This represents 17% of the total number of 8213 exercise tests. A history of myocardial infarction was present in 53% of the males and 30% of the females, while 12% of patients h

  7. Evaluation of Anti-Nuclear antibody test results in clinical practice

    Directory of Open Access Journals (Sweden)

    Nevreste Çelikbilek

    2015-06-01

    Full Text Available Objective: Aim of this study is to evaluate anti-nuclear antibody (ANA test results obtained between 2009 and 2011. Methods: Of a totally 5068 cases tested for ANA by indirect immunofluorescence method (IIFA, randomly chosen 982 ANA-positive cases were reviewed in terms of gender, level and pattern of fluorescence, anti-dsDNA (anti-double stranded DNA and anti-extractable nuclear antigen (ENA profile. Anti-dsDNA levels and anti-ENA profiles were determined by enzyme linked immune assay (ELISA and immune-blotting (IB, respectively. Results: Sex distribution of ANA positive patients was determined as 756 (77% females and 226 (23% males. Fifty per cent of the cases were from rheumatology department, 20% from gastroenterology and 30% from other units. Fluorescence levels were considered borderline or weak positive in 62.6% of the samples. The most frequent patterns were homogeneous (23%, speckled (22%, homogeneous-speckled (15.5% and nucleolar (13.5%. Anti-dsDNA were studied in 759 ANA positive patients and 66 (8.7% samples were found positive, being 44 of them (68.8% with homogeneous pattern and the rest with speckled, nucleolar, nuclear dots, centromeric or midbody patterns. Totally 131 (31.6% of 414 samples studied for anti-ENA profile were found positive. The first four frequent profiles were SSA (34.4%, SSA-SSB (16.8%, Scl70 (16% and Sm/RNP (9.2%. Conclusion: Our results are similar with the current related literature. It is known that autoantibodies can be detectable before clinical symptoms being apparent, especially in SLE. Therefore, borderline or weak fluorescence levels should also be reported and the patients having them should be followed-up carefully. J Microbiol Infect Dis 2015;5(2: 63-68

  8. GA(2)LEN skin test study II: clinical relevance of inhalant allergen sensitizations in Europe

    DEFF Research Database (Denmark)

    Burbach, G J; Heinzerling, L M; Edenharter, G;

    2009-01-01

    BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance...... the clinical relevance of positive skin prick test reactions against inhalant allergens considering the predominating type of symptoms in a pan-European population of patients presenting with suspected allergic disease. METHODS: Clinical relevance of skin prick tests was recorded with regard to patient history...

  9. What is the role of clinical tests and ultrasound in acetabular labral tear diagnostics?

    DEFF Research Database (Denmark)

    Troelsen, Anders; Mechlenburg, Inger; Gelineck, John;

    2009-01-01

    BACKGROUND AND PURPOSE: An acetabular labral tear is a diagnostic challenge. Various clinical tests have been described, but little is known about their diagnostic sensitivity and specificity. We investigated the diagnostic validity of clinical tests and ultrasound as compared with MR arthrograph...

  10. 42 CFR 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... laboratory must have a clinical consultant who meets the qualification requirements of § 493.1417 of this... complexity testing; clinical consultant. 493.1415 Section 493.1415 Public Health CENTERS FOR MEDICARE... LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity...

  11. Quality assessment in in vivo NMR spectroscopy: III. Clinical test objects: design, construction, and solutions

    DEFF Research Database (Denmark)

    Leach, M.O.; Collins, D.J.; Keevil, S;

    1995-01-01

    Based on the requirements of test protocols developed to evaluate clinical MRS single slice and volume localisation sequences, two clinical test objects, STO1 and STO2 have been developed. The properties of a range of potential construction materials have been assessed, demonstrating that the water...

  12. On masculinities, technologies, and pain: the testing of male contraceptives in the clinic and the media

    NARCIS (Netherlands)

    Oudshoorn, Nelly

    1999-01-01

    In the last fifteen years, testing has attracted much attention in science and technology studies. Most researchers have focused almost exclusively on testing in the laboratory, specifically designed test locations, and, for medical technologies, the clinic. What counts as testing has largely been d

  13. Use of a new enzyme extraction system to improve the sensitivity of SOS/umu test and application to environmental samples.

    Science.gov (United States)

    Tian, Zhe; Oda, Yoshimitsu; Zhang, Yu; Yang, Min; Li, Hongyan

    2015-03-01

    The purpose of this study was to find a better enzyme extraction reagent for the SOS/umu test to replace the conventional one (the combination of sodium dodecyl sulfate (SDS) and Z-buffer), which has the disadvantage of denaturing β-galactosidase leading to decreased measurement sensitivity. By adopting a microplate system, the performance of the umu test using BugBuster Master Mix, a commercially available enzyme extraction reagent, was compared with that using the conventional reagent for detecting the genotoxicity of known mutagens as well as environmental samples. BugBuster Master Mix was found to increase the detection sensitivities of the selected genotoxins and environmental water samples, due to the fact that it doesn't denature β-galactosidase. The result of this study showed that BugBuster Master Mix could be a better enzyme extraction reagent for umu test.

  14. Use of clinical movement screening tests to predict injury in sport

    OpenAIRE

    Chimera, Nicole J.; Warren, Meghan

    2016-01-01

    Clinical movement screening tests are gaining popularity as a means to determine injury risk and to implement training programs to prevent sport injury. While these screens are being used readily in the clinical field, it is only recently that some of these have started to gain attention from a research perspective. This limits applicability and poses questions to the validity, and in some cases the reliability, of the clinical movement tests as they relate to injury prediction, intervention,...

  15. Clinical Performance of Roche Cobas 4800 HPV Test

    Science.gov (United States)

    Cui, Miao; Chan, Nicholas; Liu, Momo; Thai, Khanh; Malaczynska, Joanna; Singh, Ila; Zhang, David

    2014-01-01

    Evaluation of the Cobas 4800 test demonstrated that Cobas had a low rate of cross-reactivity with low-risk human papillomavirus (lrHPV), a 3.74% disconcordance rate between prealiquots and postaliquots, and failure rates of 4.57% and 1.16%, respectively, after vortexing and swirling. This study demonstrated that the Cobas test has good sensitivity, accuracy, and reproducibility for detecting 14 high-risk HPV (hrHPV) genotypes. PMID:24719443

  16. [Clinical testing of a new local corticoid: desoximethasone].

    Science.gov (United States)

    Camarasa, G

    1975-01-01

    In a double-blind comparative trial on 37 patients with symetric dermatoses, the clinical effect of desoximetasone (0.25%) has been compared to fluocinolone acetonide (0.2%). After 7 days of treatment an improvement or cure of the lesions could be seen in 34 patients treated with desoximetasone, and only on 22 patients treated with fluocinolone acetonide (0.2%). The better effect of desoximetasone was especially evident on erythema and pruritus. Differences between the drugs were statistically significant. PMID:132780

  17. Clinical evaluation of a new enzyme immunoassay for hepatitis B virus core-related antigen; a marker distinct from viral DNA for monitoring lamivudine treatment.

    Science.gov (United States)

    Rokuhara, A; Tanaka, E; Matsumoto, A; Kimura, T; Yamaura, T; Orii, K; Sun, X; Yagi, S; Maki, N; Kiyosawa, K

    2003-07-01

    We aimed to assess the clinical performance of a newly developed chemiluminescence enzyme immunoassay (CLEIA) for the detection of hepatitis B virus (HBV) core-related antigen (HBcrAg) in patients with chronic HBV infection. A total of 82 patients with chronic HBV infection and 167 HBV-negative controls were studied. HBcrAg was measured by CLEIA with monoclonal antibodies to hepatitis B e antigen (HBeAg) and hepatitis B core antigen (HBcAg), and HBV DNA was measured by transcription-mediated amplification assay (TMA) and in-house real-time detection polymerase chain reaction (RTD-PCR). The HBcrAg assay detected viremia in 189 of 216 samples (88%) collected from 72 patients whilst the TMA assay detected viremia in 178 of the 216 samples (82%) (P = 0.019). The HBcrAg concentration correlated linearly with the HBV DNA concentration (P HBcrAg assay was not affected by the absence of hepatitis B e antigen from the serum or the presence of precore mutations in the HBV genome. In patients without anti-viral drugs, changes in their serum HBcrAg concentration over time corresponded to their HBV DNA concentration. In six additional patients who were later treated with lamivudine, HBV DNA concentration declined more rapidly than their HBcrAg concentration. Three months after treatment commenced, the ratio of HBcrAg: HBV DNA had increased in all six patients (P = 0.031). The HBcrAg assay is a sensitive and useful test for the assessment of a patient's HBV load. When monitoring the anti-viral effect of lamivudine, HBcrAg provides a viral marker which is independent of HBV DNA.

  18. Clinical 13CO2 breath tests: methodology and limitations

    International Nuclear Information System (INIS)

    Methods were developed to perform 13CO2 breath tests and the limitations and sources of error in these tests were explored. The random error introduced during each step of the analysis was determined and it was found that the precision was limited by the fluctuations in the isotope ratio of the patient's endogenous CO2. The detection limit was a 1.4 percent increase in the isotope ratio. This corresponds to an oxidation rate of 140 nmoles/kg-hr of singly labeled substrate to CO2. The use of stable isotope 13C provides a safe and sensitive alternative to the use of the radionuclide 14C and extends the utility of CO2 breath tests to the previously exempted populations of children and pregnant women

  19. Investigation of diagnosis and treatment of hemolysis-elevated liver enzymes-low platelet counts (HELLP) syndrome: clinical analysis of 59 cases

    Institute of Scientific and Technical Information of China (English)

    WANG Yong-qing; WANG Jing; YE Rong-hua; ZHAO Yang-yu

    2010-01-01

    Background Hemolysis-elevated liver enzymes-low platelet counts (HELLP) syndrome is a clinical condition occurring in middle and late stage pregnancy.It is characterized by hemolysis, elevated liver enzymes and low platelet counts.This study involves the analysis of the diagnosis, clinical characteristics and treatment of 59 cases of HELLP syndrome as well as the clinical classification, method of delivery and gestational age at delivery.Methods Clinical data from 59 cases of HELLP syndrome occurring from January 2000 to December 2009 were analyzed retrospectively.Thirty-five cases were classified as complete HELLP syndrome and 24 cases were considered partial HELLP syndrome.Results Twenty-six of the 59 analyzed patients (44%) with complete HELLP syndrome showed rapid onset, severe signs, symptoms, and complications in addition to a poor clinical outcome.Complications included multiple organ dysfunction syndrome (MODS) occurring in 18 cases, eclampsia (3 cases), placental abruption (3 cases), and perinatal death (4 cases).The remaining 33 cases (24 with partial and 9 with complete HELLP) were characterized by less severe signs, symptoms, complications and progression of the condition.Two of these cases were complicated with MODS (6.1%), and 1 with perinatal death (3.0%).Twelve non-radical-type cases received conservative treatment.The remaining 4 patients had recurring HELLP syndrome (6.78%).Conclusions HELLP syndrome is classified as the radical type and non-radical-type according to clinical characteristics and outcome.Classification of HELLP syndrome cases according to clinical features can help in the monitoring and treatment of the disease.Active termination of pregnancy should be considered for radical-type cases.Non-radical-type cases can undergo conservative treatment with close monitoring in an attempt to improve perinatal outcome without increasing maternal morbidity.

  20. Apnoea testing to confirm brain death in clinical practice.

    Science.gov (United States)

    van Donselaar, C A; Meerwaldt, J D; van Gijn, J

    1986-09-01

    In six patients an apnoea test was carried out to confirm brain death according to a protocol recommended in the USA. After ten minutes' apnoea the pCO2 did not reach the target value of 7.98 kPa (60 mm Hg) in any of these patients. This was caused by the low initial value and the slow increase of the pCO2. Moreover, we could not confirm the belief that the necessary duration of the apnoea test can be predicted by assuming a rise of the pCO2 of 0.33 kPa (2.5 mm Hg) per minute.

  1. Apnoea testing to confirm brain death in clinical practice.

    Science.gov (United States)

    van Donselaar, C A; Meerwaldt, J D; van Gijn, J

    1986-01-01

    In six patients an apnoea test was carried out to confirm brain death according to a protocol recommended in the USA. After ten minutes' apnoea the pCO2 did not reach the target value of 7.98 kPa (60 mm Hg) in any of these patients. This was caused by the low initial value and the slow increase of the pCO2. Moreover, we could not confirm the belief that the necessary duration of the apnoea test can be predicted by assuming a rise of the pCO2 of 0.33 kPa (2.5 mm Hg) per minute. PMID:3093640

  2. 150例手足口病心肌酶谱临床分析%Clinical Analysis of 150 Cases of Hand Foot Mouth Disease Myocardial Enzyme Spectrum

    Institute of Scientific and Technical Information of China (English)

    王淑清

    2014-01-01

    目的:了解手足口病患儿心肌酶谱的临床特点,为临床诊治提供依据。方法回顾性我科2012年4月~2013年10月收治的150例确诊为手足口病患儿的心肌酶谱变化分析。结果150例患儿住院5d后给予心肌酶检查其AST、LDCK、CK-MBH有所下降,均达临床治愈标准出院。结论手足口病急性期心肌酶谱明显升高,而治疗后随体温降至正常,皮疹消退,心肌酶下降至正常,无1例死亡,无并发心肌炎病例,提示我们心肌酶升高在普通手足口病例中以应视为特征性症状,而不是并发症。%Objective To study the clinical characteristics of hand foot and mouth disease spectrum of myocardial enzymes in children, provide the basis for clinical diagnosis and treatment. Methods 150 cases of retrospective in 2012 April to 2013 October were myocardial enzyme in patients with hand foot mouth disease spectrum change analysis. Results 150 children were hospitalized for 5 days to check the AST of myocardial enzymes, LDCK, CK-MBH decreased, reached the clinical cure standard discharge. Conclusion Myocardial enzyme spectrum was significantly higher in acute stage of hand foot mouth disease, and as the temperature dropped to normal after treatment, the rash subsided, myocardial enzymes decreased to normal in 1 cases, no death, no concur ent myocarditis, prompted us to elevated cardiac enzymes in ordinary cases of HFMD in should be regarded as the characteristic symptoms, not complications.

  3. Genetic counselors' (GC) knowledge, awareness, understanding of clinical next-generation sequencing (NGS) genomic testing.

    Science.gov (United States)

    Boland, P M; Ruth, K; Matro, J M; Rainey, K L; Fang, C Y; Wong, Y N; Daly, M B; Hall, M J

    2015-12-01

    Genomic tests are increasingly complex, less expensive, and more widely available with the advent of next-generation sequencing (NGS). We assessed knowledge and perceptions among genetic counselors pertaining to NGS genomic testing via an online survey. Associations between selected characteristics and perceptions were examined. Recent education on NGS testing was common, but practical experience limited. Perceived understanding of clinical NGS was modest, specifically concerning tumor testing. Greater perceived understanding of clinical NGS testing correlated with more time spent in cancer-related counseling, exposure to NGS testing, and NGS-focused education. Substantial disagreement about the role of counseling for tumor-based testing was seen. Finally, a majority of counselors agreed with the need for more education about clinical NGS testing, supporting this approach to optimizing implementation.

  4. A Clinical Perspective on Ethical Issues in Genetic Testing

    NARCIS (Netherlands)

    Sijmons, R. H.; Van Langen, I. M.; Sijmons, J. G.

    2011-01-01

    Genetic testing is traditionally preceded by counselling to discuss its advantages and disadvantages with individuals so they can make informed decisions. The new technique of whole genome or exome sequencing, which is currently only used in research settings, can identify many gene mutations, inclu

  5. Pros and Cons of Clinical Basophil Testing (BAT)

    DEFF Research Database (Denmark)

    Hoffmann, Hans Jürgen; Knol, Edward F; Ferrer, Martha;

    2016-01-01

    PURPOSE OF REVIEW: We review basophil testing by flow cytometry with an emphasis on advantages and disadvantages. RECENT FINDINGS: There are many tools available to assess the presence and severity of allergic diseases in patients. For 50 years, peripheral blood basophils have been used as tools ...

  6. CLINICAL APPLICATION AND EVALUATION OF SALIVAFERNING TEST IN SJOGREN'S SYNDROME

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    Objective To evaluate the saliva ferning test (SFT) as diagnostic test for xerostomia in patients with Sjogren 's Syndrome (SS). Methods In this study, dried samples of freshly produced saliva from 78 patients with established SS according to European Community criteria and 80 healthy controls were examined by light microscopy. The crystallization was classified into 4 types according to the ferning phenomenon: uniformity, branching, spreading and integrity (type Ⅰ normal and type Ⅱ ,III ,Ⅳ abnormal ). Then , the 78 patients underwent labial salivary gland biopsy. According to Tarpley' s classifica tion, minor salivary gland biopsy (≥2+) was considered to be positive. Results 1. The sensitivity of SFT was high (70/ 78 = 89.74% ). And the specificity was also high (67/80 = 83.75% ). 2. Abnormal SFT was observed in 70/78(89.74%) samples from patients group and in 13/80 ( 16.25% ) samples from healthy controls. The differences of SFT in patients group versus controls were statistically significant (P0.05) as diagnostic tests in SS. Conclusion SFT was simple , sensitive and specific as diagnostic test in SS suspect patients just as mini labial gland biopsy.

  7. Clinical genetic testing for familial melanoma in Italy: a cooperative study

    OpenAIRE

    W.Bruno, P.Ghiorzo, L.Battistuzzi, P.A.Ascierto, M.Barile, S.Gargiulo, F.Gensini, S.Gliori, M.Guida, M.Lombardo, S.Manoukian, C.Menin, S.Nasti, P.Origone, B.Pasini,L. Pastorino, B.Peissel, M.A.Pizzichetta, P.Queirolo, M.Rodolfo, A.Romanini, M.C.Scaini, A.Testori, M.G.Tibiletti, D.Turchetti, S.A.Leachman, G.Bianchi Scarrà; IMI, Italian Melanoma Intergroup

    2009-01-01

    Background: The Italian Society of Human Genetics’ (SIGU) recommendations on genetic counseling and testing for hereditary melanoma state that clinical genetic testing can be offered to Italian melanoma families with at least two affected members. Objective: In the framework of a cooperative study, we sought to establish the frequency of cyclindependent kinase inhibitor 2A mutations in melanoma families that underwent clinical genetic counseling and testing in accordance with t...

  8. [Familial Mediterranean fever--from gene test to clinical aspects].

    Science.gov (United States)

    Sudeck, H

    2000-10-26

    Familial Mediterranean Fever (FMF) is a genetically defined disease affecting mostly families of jewish, turkish or armenian origin whose ancestors originate from the mediterranean basin. The first officially acknowledged description was given by SIEGAL in 1945 but previous cases were reported since 1908. The main clinical signs which are very varying in intensity and appearance are periodic attacks of fever with peritonitis, pleurisy and arthritis. The classical but not always found complication is amyloidosis with renal failure which is preventable by lifelong colchicine therapy. By using a novel genetest it is now possible to definitely diagnose FMF instead of relying on a diagnosis made merely by exclusion. This will emphasize the use of colchicine and should bring us nearer to the pathophysiology of this interesting disease. PMID:11103618

  9. Diagnostic Accuracy of Clinical Tests for Morton's Neuroma Compared With Ultrasonography.

    Science.gov (United States)

    Mahadevan, Devendra; Venkatesan, Muralidharan; Bhatt, Raj; Bhatia, Maneesh

    2015-01-01

    The aim of the present study was to assess the diagnostic accuracy of 7 clinical tests for Morton's neuroma (MN) compared with ultrasonography (US). Forty patients (54 feet) were diagnosed with MN using predetermined clinical criteria. These patients were subsequently referred for US, which was performed by a single, experienced musculoskeletal radiologist. The clinical test results were compared against the US findings. MN was confirmed on US at the site of clinical diagnosis in 53 feet (98%). The operational characteristics of the clinical tests performed were as follows: thumb index finger squeeze (96% sensitivity, 96% accuracy), Mulder's click (61% sensitivity, 62% accuracy), foot squeeze (41% sensitivity, 41% accuracy), plantar percussion (37% sensitivity, 36% accuracy), dorsal percussion (33% sensitivity, 26% accuracy), and light touch and pin prick (26% sensitivity, 25% accuracy). No correlation was found between the size of MN on US and the positive clinical tests, except for Mulder's click. The size of MN was significantly larger in patients with a positive Mulder's click (10.9 versus 8.5 mm, p = .016). The clinical assessment was comparable to US in diagnosing MN. The thumb index finger squeeze test was the most sensitive screening test for the clinical diagnosis of MN. PMID:25432459

  10. Utilization of ionizing radiation to obtention of polymeric supports for the enzyme immobilization with clinical potential use

    International Nuclear Information System (INIS)

    In the development of polymers with biological activity, it was studied the grafting of acrylic acid monomer onto polyethylene and polypropylene pellets by mutual radiation grafting technique. The effect of dose rate, irradiation total dose, and monomer concentration were studied. With the Pp pellets the best grafting yield occurred at dose rate of 0.25 kGy/h and with the PE pellets the dose rate was lower. The irradiation dose from 8 to 10 kGy was sufficient to obtain the highest grafting degree, and the AA concentration of 40% v/v was suitable. The graft of poly (acrylic acid) was chemically modified for the immobilization of two enzymes, the glucose oxidase and the urease. For both enzymes the increasing of grafting degree onto the pellets, increased the enzyme immobilization yield. The immobilized glucose oxidase showed the best activity when immobilized onto Pp-A A supports with grafting degree around 2%. The optimum p H and temperature profiles, and the Km and Vmax for free and immobilized enzyme were determined. The supports grafted with A A were not suitable for the chemical immobilization of urease. (author)

  11. Comparison of a Recombinant-antigen Enzyme Immunoassay with Treponema pallidum Hemagglutination Test for Serological Confirmation of Syphilis

    Directory of Open Access Journals (Sweden)

    Rodríguez Islay

    2002-01-01

    Full Text Available A recombinant-antigen enzyme immunoassay (EIA, BioSCREEN TM anti-Treponema pallidum, was compared favorably with the T. pallidum hemagglutination test, in the detection of specific antibodies in different groups of sera from patients with primary (n = 38, secondary (n = 10, early latent (n = 28 and congenital syphilis (n = 2, patients with leptospirosis ( n= 8, infectious mononucleosis (n = 7, hepatitis (n = 9, diabetes mellitus (n = 11, rheumatoid arthritis (n = 13, leprosy (n = 11, tuberculosis (n = 9, HIV/Aids ( n= 12, systemic lupus erythematosus (n = 4, rheumatic fever (n = 3, old-persons (n = 9, pregnant women (n = 29 and blood donors (n = 164. The coincidence between them was 95.1%. The sensitivity and specificity of the EIA were 93.3% and 95.5%, respectively. Fifteen serum specimens belonging to old-persons, pregnant women, blood donors, and patients with human leptospirosis, hepatitis, diabetes mellitus, tuberculosis and rheumatic fever gave false-positive results by Venereal Disease Research Laboratory and/or Rapid Plasma Reagin. The EIA can be used as alternative method for the serological confirmation of syphilis.

  12. Tilt table testing in neurology and clinical neurophysiology.

    Science.gov (United States)

    Saal, D P; Thijs, R D; van Dijk, J G

    2016-02-01

    Reflex syncope is responsible for 1-6% of hospital admissions and the economic burden of syncope is huge. A considerable part of these high costs is still spent on tests that are not indicated. Till now few neurologists have taken an interest in syncope and tilt table testing (TTT). However, reflex syncope and epilepsy are often in each other's differential diagnosis and require a similar emphasis on history taking and deductive reasoning. A TTT can be helpful for diagnosis and treatment. The pathophysiological rationale behind the TTT is the fact that it uses gravity to provoke a downwards shift of blood that in turn triggers syncope. Various indications and methods of the TTT are discussed in this paper. PMID:26404035

  13. Potential clinical impact of normal-tissue intrinsic radiosensitivity testing

    International Nuclear Information System (INIS)

    A critical appraisal is given of the possible benefit from a reliable pre-treatment knowledge of individual normal-tissue sensitivity to radiotherapy. The considerations are in part, but not exclusively, based on the recent experience with in vitro colony-forming assays of the surviving fraction at 2 Gy, the SF2. Three strategies are reviewed: (1) to screen for rare cases with extreme radiosensitivity, so-called over-reactors, and treat these with reduced total dose, (2) to identify the sensitive tail of the distribution of 'normal' radiosensitivities, refer these patients to other treatment, and to escalate the dose to the remaining patients, or (3) to individualize dose prescriptions based on individual radiosensitivity, i.e. treating to isoeffect rather than to a specific dose-fractionation schedule. It is shown that these strategies will have a small, if any, impact on routine radiotherapy. Screening for over-reactors is hampered by the low prevalence of these among otherwise un-selected patients that leads to a low positive predictive value of in vitro radiosensitivity assays. It is argued, that this problem may persist even if the noise on current assays could be reduced to (the unrealistic value of) zero, simply because of the large biological variation in SF2. Removing the sensitive tail of the patient population, will only have a minor effect on the dose that could be delivered to the remaining patients, because of the sigmoid shape of empirical dose-response relationships. Finally, individualizing dose prescriptions based exclusively on information from a normal-tissue radiosensitivity assay, leads to a nearly symmetrical distribution of dose-changes that would produce a very small gain, or even a loss, of tumor control probability if implemented in the clinic. From a theoretical point of view, other strategies could be devised and some of these are considered in this review. Right now the most promising clinical use of in vitro radiosensitivity assays

  14. Performance of genotype-MTBDR test directly on clinical specimens

    Directory of Open Access Journals (Sweden)

    Gülden Yılmaz

    2012-12-01

    Full Text Available Objectives: Most important point for the control and effective treatment of multidrug resistant tuberculosis (MDR-TBis early diagnosis and rapid determination of the resistance. The aim of this study is to assess the performance of theGenotype-MTBDR assay applied directly on sputum samples and compare the results with those obtained by DNA sequencingand phenotypic susceptibility testing.Materials and methods: Between November 2005 and February 2006, 93 smear and culture positive sputum sampleswere included in the study. Drug susceptibility results for rifampin (RIF and isoniazid (INH, obtained by proportionmethod on L-J medium, Genotype-MTBDR and DNA sequencing were compared.Results: The rate of concordance between the results of the Genotype-MTBDR and DNA sequencing was 93.5% and96.7% for RIF and INH, respectively. Moreover, Genotype-MTBDR detected all the RIF (24 and INH (18 resistant strainsobtained by sequencing (100%. Compared to the DNA sequencing method; the sensitivity, specificity, positive predictiveand negative predictive value for RIF and INH were 100%, 91.3%, 80%, 100% and 100%, 96%, 85.7%, 100% respectively.Conclusion: Genotype-MTBDR, one of molecular assays, distinctly shortens the time for diagnosis and detection of resistanceto INH and RIF, essential for management of MDR-TB. The test appears to have good sensitivity and specificitywhen also used directly on sputum specimens. J Microbiol Infect Dis 2012; 2(4: 135-141Key words: Mycobacterium tuberculosis; drug resistance; genotype-MTBDR.

  15. Comparison of an enzyme-linked immunoassay and a quantitative indirect fluorescent-antibody test with the conventional indirect fluorescent-antibody test for detecting antibodies to Toxoplasma gondii.

    OpenAIRE

    Violand, S A; Mitchell, T G; Kleeman, K T

    1982-01-01

    Two new methods for the detection of antibodies to Toxoplasma gondii, an enzyme-linked immunosorbent assay and a quantitative immunofluorescence assay, were evaluated and compared with the conventional indirect fluorescent-antibody slide test. Each of 100 human sera was assayed twice by the three procedures. Both the enzyme-linked immunosorbent assay and the quantitative immunofluorescence assay correlated well with serologically positive (indirect fluorescent-antibody titer greater than or e...

  16. Changes in CYP2C19 enzyme activity evaluated by the [(13)C]-pantoprazole breath test after co-administration of clopidogrel and proton pump inhibitors following percutaneous coronary intervention and correlation to platelet reactivity.

    Science.gov (United States)

    Harvey, Adrien; Modak, Anil; Déry, Ugo; Roy, Mélanie; Rinfret, Stéphane; Bertrand, Olivier F; Larose, Éric; Rodés-Cabau, Josep; Barbeau, Gérald; Gleeton, Onil; Nguyen, Can Manh; Proulx, Guy; Noël, Bernard; Roy, Louis; Paradis, Jean-Michel; De Larochellière, Robert; Déry, Jean-Pierre

    2016-03-01

    Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is used for the prevention of cardiovascular events following percutaneous coronary intervention (PCI). These agents increase the risk of gastrointestinal bleeding. To prevent these events, proton pump inhibitors (PPI) are routinely prescribed. It has been reported that with the exception of pantoprazole and dexlanzoprazole, PPIs can impede conversion of clopidogrel by cytochrome P450 2C19 (CYP2C19) to its active metabolite, a critical step required for clopidogrel efficacy. Changes in CYP2C19 enzyme activity (phenotype) and its correlation with platelet reactivity following PPI therapy has not yet been fully described. In this study we attempted to determine if the [ (13)C]-pantoprazole breath test (Ptz-BT) can evaluate changes in CYP2C19 enzyme activity (phenoconversion) following the administration of PPI in coronary artery disease (CAD) patients treated with DAPT after PCI. Thirty (30) days after successful PCI with stent placement, 59 patients enrolled in the Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects (SPICE) trial (ClinicalTrials.gov Identifier: NCT00930670) were recruited to participate in this sub study. Patients were randomized to one of 4 antacid therapies (omeprazole, esomeprazole. pantoprazole or ranitidine). Subjects were administered the Ptz-BT and platelet function was evaluated by vasodilator-stimulated phosphoprotein (VASP) phosphorylation and light transmittance aggregometry before and 30 d after treatment with antacid therapy. Patients randomized to esomeprazole and omeprazole had greater high on-treatment platelet reactivity and lowering of CYP2C19 enzyme activity at Day 60 after 30 d of PPI therapy. Patients randomized to ranitidine and pantoprazole did not show any changes in platelet activity or CYP 2C19 enzyme activity. In patients treated with esomeprazole and omeprazole, changes in CYP2C19 enzyme activity

  17. Elevation in liver enzymes is associated with increased IL-2 and predicts severe outcomes in clinically apparent dengue virus infection.

    Science.gov (United States)

    Senaratne, Thamarasi; Carr, Jillian; Noordeen, Faseeha

    2016-07-01

    The objective of the present study was to assess the circulating TNF-α and IL-2 levels in dengue virus (DENV) infected patients and to correlate these with clinical severity of DENV infections. A single analyte quantitative immunoassay was used to detect TNF-α and IL-2 in 24 dengue fever (DF) and 43 dengue haemorrhagic fever (DHF) patients, 15 healthy adults and 6 typhoid patients. The mean TNF-α and IL-2 levels of DENV- infected patients were higher than that of healthy adults and typhoid patients. No significant difference in TNF-α levels was noted between DF and DHF patients (p=0.5) but a significant increase in IL-2 levels was observed in DHF compared with DF patients (mean of DF=59.7pg/mL, mean of DHF=166.9pg/mL; p=0.02). No significant association of TNF-α or IL-2 levels was noted with packed cell volume (>45), thrombocytopenia, leucopenia or the presence of viraemia. The liver function tests measuring AST (aspartate aminotransferase) (p=0.01) and ALT (alanine aminotransferase) (p=0.02) levels were significantly elevated in DENV-infected patients. AST:ALT was significantly elevated in DHF/DSS (dengue shock syndrome) compared with DF patients. A significant positive linear correlation was noted between AST and IL-2 (r=0.31; p=0.01) and ALT and IL-2 elevations (r=0.2; p=0.02). Thus, AST and ALT levels correlate with both disease severity and circulating IL-2 levels. We suggest a role for circulating IL-2 in liver dysfunction and propose that a combined assessment of AST/ALT in conjunction with IL-2 at the early stages of symptomatic DENV infection may be useful to predict the severe forms of dengue. PMID:27155816

  18. The 14C-monomethylamino-antipyrine breath test as in vivo parameter for characterizing the induction of the drug catabolizing enzyme system in the guinea pig

    International Nuclear Information System (INIS)

    The aim of these investigations was to help clarify the following questions: 1) Does MAAP, following 14C labelling of the exocyclic aminomethyl group, offer a suitable substrate for a breath test in guinea pigs. 2) Which procedures for evaluating the 14C exhalation curves of the breath test are especially valid. 3) Can an induction of the drug catabolizing enzyme system following pre-treatment with various inducing substances be detected by the 14C-MAAP breath test. 4) Do inducer-specific differences arise in response to the 14C-MAAP breath test by which the inducers can be characterized. 5) Is monomethylamino-antipyrine similar to amidopyrine in that it is a suitable independent in vivo parameter for the drug metasbolizing enzyme system in the liver of guinea pigs. (orig./MG)

  19. The clinical significance of myocardial enzymes in measles patients%麻疹患者心肌酶检测的临床意义

    Institute of Scientific and Technical Information of China (English)

    古巧燕; 蔡波; 徐光华; 任迎全

    2012-01-01

    Objective To explore the clinical significance of myocardial enzymes in measles patients. Methods Making correlation analysis with hospital clinical data from the 188 cases of measles patients in 2011. 1-2011. 5. Results Adults measles and children measles differ in condition of abnormal myocardial enzymes j abnormal myocardial enzymes differences between patients in feve period, rash period and patients in recovery period) abnormal myocardial enzymes in measles patients has no correlation with abnormal ECG. There is no difference between measles polarization liquid treatment group and observation group in myocardial enzyme recovery. Conclusion Myocardial damage in children measles patients seems more common than adult measles patients, then the monitoring of myocardial enzymes has larger clinical significance to children measles patients; Measles patients myocardial damage usually occurs in fever and rash period, to some extent.it has positive correlation with the condition of measles patients; also it can reflect the clinical progress of measles; Measles patients with severe myocardial enzymes can lead to the appear of ECG abnormalities appear; 4. The myocardial injury in measles patients has self-healing recovery trend.%目的 探讨麻疹患者心肌酶异常的临床意义.方法 对188例住院麻疹患者的临床资料进行回顾分析.结果 成人麻疹心肌酶谱异常与儿童心肌酶谱异常存在差异(P<0.01);麻疹发热期与出疹期心肌酶谱异常比较差异无统计学意义(P>0.05);发热期与恢复期、出疹期与恢复期比较,差异有统计学意义(均P<0.01);麻疹患者心肌酶谱异常与心电图异常无明显相关性;麻疹患者极化液治疗组与观察组心肌酶恢复情况无差异.结论 ①儿童麻疹患者的心肌损害较成年麻疹患者更普遍,故心肌酶的监测对儿童麻疹患者的临床意义更大.②麻疹患者心肌损害的出现多发生在发热期、出疹期,一定程度

  20. The next controversy in genetic testing: clinical data as trade secrets?

    OpenAIRE

    Cook-Deegan, Robert; Conley, John M.; Evans, James P.; Vorhaus, Daniel

    2012-01-01

    Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered th...

  1. Medical Physics: Forming and testing solutions to clinical problems.

    Science.gov (United States)

    Tsapaki, Virginia; Bayford, Richard

    2015-11-01

    According to the European Federation of Organizations for Medical Physics (EFOMP) policy statement No. 13, "The rapid advance in the use of highly sophisticated equipment and procedures in the medical field increasingly depends on information and communication technology. In spite of the fact that the safety and quality of such technology is vigorously tested before it is placed on the market, it often turns out that the safety and quality is not sufficient when used under hospital working conditions. To improve safety and quality for patient and users, additional safeguards and related monitoring, as well as measures to enhance quality, are required. Furthermore a large number of accidents and incidents happen every year in hospitals and as a consequence a number of patients die or are injured. Medical Physicists are well positioned to contribute towards preventing these kinds of events". The newest developments related to this increasingly important medical speciality were presented during the 8th European Conference of Medical Physics 2014 which was held in Athens, 11-13 September 2014 and hosted by the Hellenic Association of Medical Physicists (HAMP) in collaboration with the EFOMP and are summarized in this issue.

  2. Neurophysiological testing correlates with clinical examination according to fibre type involvement and severity in sensory neuropathy

    OpenAIRE

    Lefaucheur, J.; Creange, A.

    2004-01-01

    Objective: To investigate a comprehensive battery of neurophysiological tests for objective evaluation of sensory neuropathies including fibre type involvement and severity, and to determine the relation between neurophysiological data and clinical examination.

  3. Clinical experience from Thailand noninvasive prenatal testing as screening tests for trisomies 21, 18 and 13 in 4736 pregnancies

    DEFF Research Database (Denmark)

    Manotaya, S.; Uerpairojkit, B.; Chen, F.;

    2016-01-01

    PurposeThe purpose of this article is to report the clinical experience and performance of massively parallel sequencing-based noninvasive prenatal testing (NIPT) as a screening method in detecting trisomy 21, 18, and 13 (T21/T18/T13) in a mixed-risk population in Thailand. MethodsIn a 30-month...... as the screening test in a large-scale mixed-risk population in Thailand for the first time. It provides the experience of implementing NIPT in a developing country with patient-funded prenatal screening system and continuous quests for applicable nationwide uptake of prenatal screening and diagnosis....... period, 121 medical centers in Thailand offered NIPT as clinical screening tests for fetal T21, T18, and T13 in the mixed-risk population. All NIPT-positive cases were recommended to undergo invasive prenatal diagnosis. ResultsA total of 4736 participants received the NIPT test, including 2840 high...

  4. Sarcoidosis: correlation of HRCT findings with results of pulmonary function tests and serum angiotensin-converting enzyme assay.

    Science.gov (United States)

    Mimori, Y

    1998-01-01

    We examined correlations between findings on chest high resolution computed tomography (HRCT), pulmonary function and values of serum angiotensin converting enzyme (ACE) in 25 patients with sarcoidosis. The most frequent CT features were small nodular opacities. The small nodules, representing the confluence of epithelioid granulomas, are strongly correlated with peribronchovascular, perilobular, and centrilobular lesions, where there is an abundance of lymphatic plexus. This strongly suggests the importance of the lymph vessels in the pathogenesis of sarcoidosis. The pulmonary functions tests showed obstructive defects in 6 and mixed-type defects in 2 of the 25 patients. Furthermore, an elevation of V50/V25 ratio suggesting small-airway disease was detected in many patients who showed normal values of FEV1.0% and %VC. This fact indicates that small-airway disease was manifested earlier in sarcoidosis patients. Statistically significant negative correlations were found between visual score and %VC, %FVC, FEV1.0%, %TLC, and %DLco, but there was no significant correlation between visual score and serum ACE. ACE is derived from granuloma-forming epithelioid cells, and the activity of ACE decreased rapidly in mature granulomas. Epithelioid cells in the mature granulomas which can be recognized on HRCT scan have stopped or are about to stop the release of ACE. In this study, serum ACE activity was found to be elevated and correlated with %V25 and V50/V25 at an early stage of the disease. The results of this study provide meaningful insights into the process of sarcoidosis in lung.

  5. A standardized framework for the validation and verification of clinical molecular genetic tests.

    NARCIS (Netherlands)

    Mattocks, C.J.; Morris, M.A.; Matthijs, G.; Swinnen, E.; Corveleyn, A.; Dequeker, E.; Muller, C.R.; Pratt, V.; Wallace, A.

    2010-01-01

    The validation and verification of laboratory methods and procedures before their use in clinical testing is essential for providing a safe and useful service to clinicians and patients. This paper outlines the principles of validation and verification in the context of clinical human molecular gene

  6. Catheter-based flow measurements in hemodialysis fistulas - Bench testing and clinical performance

    DEFF Research Database (Denmark)

    Heerwagen, Søren T; Lönn, Lars; Schroeder, Torben V;

    2012-01-01

    Purpose: The purpose of this study was to perform bench and clinical testing of a catheter-based intravascular system capable of measuring blood flow in hemodialysis vascular accesses during endovascular procedures. Methods: We tested the Transonic ReoCath Flow Catheter System which uses the ther......Purpose: The purpose of this study was to perform bench and clinical testing of a catheter-based intravascular system capable of measuring blood flow in hemodialysis vascular accesses during endovascular procedures. Methods: We tested the Transonic ReoCath Flow Catheter System which uses...

  7. [Importance of realistic tests for drug allergy: apropos of a clinical case].

    Science.gov (United States)

    Hassoun, S

    1998-11-01

    Drug allergy is the most difficult area in Allergology because: Clinical polymorphism and specially physiopathology (IgE-dependent hypersensibility reaction, cyclo-oxygenase inhibitor, etc.). Feeble specificity and sensitivity in the basic immunoallergic investigation (Skin tests, specific IgE). Very frequently his necessitates recourse to REALISTIC TESTS of drug re-introduction under clinical and biological surveillance (HSI mediators: histamine/tryptase/urinary methyl histamine) to produce a diagnosis. PMID:9887987

  8. Optimisation and Assessment of Three Modern Touch Screen Tablet Computers for Clinical Vision Testing

    OpenAIRE

    Tahir, Humza J.; Murray, Ian J.; Parry, Neil R. A.; Aslam, Tariq M

    2014-01-01

    Technological advances have led to the development of powerful yet portable tablet computers whose touch-screen resolutions now permit the presentation of targets small enough to test the limits of normal visual acuity. Such devices have become ubiquitous in daily life and are moving into the clinical space. However, in order to produce clinically valid tests, it is important to identify the limits imposed by the screen characteristics, such as resolution, brightness uniformity, contrast line...

  9. 应用酶工程技术去除牙齿色斑临床研究%Clinical Research on the Application of Enzyme Engineering Technology to Remove Teeth Stains

    Institute of Scientific and Technical Information of China (English)

    梁玉伏; 胡光耀

    2015-01-01

    目的 根据牙齿色斑的本质,选择不同种类的酶溶液对牙齿色斑进行处理,筛选出科学、有效的口腔液体含漱液,用于临床,并为其在去除牙齿色斑上的应用提供理论依据.方法 用0. 9%的生理盐水与不同种类的酶进行配比,在带有色斑的羟基磷灰石模板、离体牙及志愿者身上分别进行试验.结果 筛查出能有效去除牙齿色斑对人体无毒副作用的酶溶液用于临床.结论 柠檬酸锌盐溶液能安全有效地去除牙齿色斑.%Objective Different kinds of enzyme solution were chosen to deal with teeth stains according to their characteristics. To screen a scientific and effective gargle, and to provide theoretical basis for its clinical application on the removal of teeth stains. Method Different kinds of enzyme were mixed with 0. 9% normal saline, of which the effectiveness were tested on hydroxyapatite templates and isolated teeth with stains, respectively. Results The enzyme solution was selected, which can be applied in clinical trials without side effect. Conclusion Citric acid zinc salt solution is safe and effective to remove teeth stains.

  10. The ANA-reflex test as a model for improving clinical appropriateness in autoimmune diagnostics.

    Science.gov (United States)

    Tonutti, Elio; Bizzaro, Nicola; Morozzi, Gabriella; Radice, Antonella; Cinquanta, Luigi; Villalta, Danilo; Tozzoli, Renato; Tampoia, Marilina; Porcelli, Brunetta; Fabris, Martina; Brusca, Ignazio; Alessio, Maria Grazia; Barberio, Giuseppina; Sorrentino, Maria Concetta; Antico, Antonio; Bassetti, Danila; Fontana, Desré Ethel; Imbastaro, Tiziana; Visentini, Daniela; Pesce, Giampaola; Bagnasco, Marcello

    2016-12-01

    Reflex tests are widely used in clinical laboratories, for example, to diagnose thyroid disorders or in the follow-up of prostate cancer. Reflex tests for antinuclear antibodies (ANA) have recently gained attention as a way to improve appropriateness in the immunological diagnosis of autoimmune rheumatic diseases and avoid waste of resources. However, the ANA-reflex test is not as simple as other consolidated reflex tests (the TSH-reflex tests or the PSA-reflex tests) because of the intrinsic complexity of the ANA test performed by the indirect immunofluorescence method on cellular substrates. The wide heterogeneity of the ANA patterns, which need correct interpretation, and the subsequent choice of the most appropriate confirmatory test (ANA subserology), which depend on the pattern feature and on clinical information, hinder any informatics automation, and require the pathologist's intervention. In this review, the Study Group on Autoimmune Diseases of the Italian Society of Clinical Pathology and Laboratory Medicine provides some indications on the configuration of the ANA-reflex test, using two different approaches depending on whether clinical information is available or not. We further give some suggestions on how to report results of the ANA-reflex test. PMID:27423928

  11. Importance of head thrust test like bedside test in ENT outpatient clinic

    Directory of Open Access Journals (Sweden)

    Batuecas-Caletrio A, Muñoz Herrera A

    2012-11-01

    Full Text Available Head thrust test is a simple test that provides great information in the studyof patients with vestibular pathology. Despite a relatively low sensitivity, thespecificity is very high so it can be helpful in diagnosing severe vestibulardeficit as in the differential diagnosis of acute vestibular disorders such asneuritis vestibular. In this paper we review the physiology vestibulooculomotorreflex, performing the test, the interpretation of the results andthe advantages of its realization

  12. Clinical significance of liver enzyme spectrum in diagnosis of liver diseases%肝脏酶谱诊断肝病在临床的应用

    Institute of Scientific and Technical Information of China (English)

    黎海东; 谢文锐; 郑丹

    2012-01-01

    目的 探讨肝脏酶谱在诊断肝病中的应用价值.方法 对270例不同肝病患者进行血清肝脏酶谱酶活性的鉴定,并将其与108例非肝病患者的肝脏酶谱进行分析,观察不同肝病患者的肝脏酶谱与非肝病患者有无明显区别.结果 肝病患者的血清肝脏酶谱均出现增高,不同疾病的肝脏酶谱增高幅度不同,与非肝脏疾病的患者相比,差异无统计学意义,其中,急性肝炎的天门冬氨酸氨基转移酶( AST)为(356.28±162.54) U/L,肝硬化碱性磷酸酶(ALP)和谷酰转肽酶(GGT)分别为(87.38±90.46)U/L和(109.21±73.64)U/L,肝癌的ALP和GGT分别为(110.24±109.41)U/L和(138.44±46.26)U/L,乙醇性肝炎GGT、丙氨酸氨基转移酶(ALT)和AST分别为(157.35±68.38)U/L、(89.34±59.52) U/L和(78.66±61.64)U/L,其他肝病的ALP及GGT和ALP与非肝病患者相比,差异有统计学意义.结论 肝脏酶谱在肝病的临床诊断和治疗中有很大的临床应用价值.%OBJECTIVE To investigate the clinical value of S liver enzyme spectrum in the diagnosis of liver diseases. METHODS A total of 270 cases of patients with different liver diseases were taken for the identification of serum liver enzyme spectrum of activity, and then were compared with the liver enzyme spectrum of 108 patients without liver diseases, the liver enzyme spectrum was observed to see whether there was significant difference between the patients with liver diseases and without liver diseases. RESULTS Serum liver enzymes in the patients with liver disease spectrum were increased. Different diseases of the liver enzyme spectrum were of different amplitude. Compared with non-liver disease patients, the differences were not with statistically significant. Of these with acute hepatitis, the aspartate aminotransf erase (AST) was (356. 28 ± 162. 54)U/L, cirrhosis of liver alkaline phosphatase (ALP) and of glutamyl transpeptidase(GGT) liver cirrhosis were (87. 38 ± 90. 46)U/L and (109. 21±73. 64)U

  13. Skin signs in Ehlers-Danlos syndrome: clinical tests and para-clinical methods

    DEFF Research Database (Denmark)

    Remvig, L; Duhn, Ph; Ullman, S;

    2010-01-01

    The criteria for Ehlers-Danlos syndrome (EDS) and the hypermobility syndrome (HMS) should be reliable. Examination for general joint hypermobility has high reliability but there is only sparse information on the reliability of skin tests, and no information on the level of normal skin extensibility...

  14. Thoracic outlet syndrome: do we have clinical tests as predictors for the outcome after surgery?

    Directory of Open Access Journals (Sweden)

    Sadeghi-Azandaryani M

    2009-09-01

    Full Text Available Abstract Objective Thoracic outlet syndrome (TOS is a clinical phenomenon resulting from compression of the neurovascular structures at the superior aperture of the thorax which presents with varying symptoms. Regarding to the varying symptoms, the diagnosis of TOS seems to be a challenge and predictors for the outcome are rare. The purpose of this study was therefore to analyze the different clinical examinations and tests relative to their prediction of the clinical outcome subsequent to surgery. Methods During a period of five years, 56 patients were diagnosed with TOS. Medical history, clinical tests, operative procedure and complications were recorded and analysed. Mean follow-up of the patients was 55.6 ± 45.5 months, median age of the patients was 36.4 ± 12.5 years. Results Different clinical tests for TOS showed an acceptable sensitivity overall, but a poor specificity. A positive test was not associated with a poor outcome. Analyses of the systolic blood pressure before and after exercise showed, that a distinct decrease in blood pressure of the affected side after exercises was associated with a poor outcome (p = 0.0027. Conclusions Clinical tests for TOS show a good sensitivity, but a poor specificity and cannot be used as predictors for the outcome. A distinct decrease in blood pressure of the affected side after exercises was associated with poor outcome and might be useful to predict the patients' outcome.

  15. Development and application of radioimmunoassay and enzyme immunoassays in microbiological and immunological diagnosis. 3. Comparative studies for the detection of virus antibodies with passive hemagglutination test, radioimmunoassay and enzyme immunoassay, resp

    Energy Technology Data Exchange (ETDEWEB)

    Lauf, H.; Struy, H.; Morenz, J. (Medizinische Akademie, Magdeburg (German Democratic Republic))

    1982-06-01

    Radioimmuno- and enzyme immunoassays (solid phase RIA and ELISA) developed by the authors for the determination of antibodies of adeno-2- and parainfluenza-1-viruses are described and the detection sensibility for antibodies is compared with that of the conventional passive hemagglutination test. The sensibility of the radioimmunoassay for the detection of IgG antibodies against adeno-2-viruses is nearly 10 times higher than that of the passive hemagglutination. RIA and ELISA show no essential differences in their detection sensibilities in the detection of IgG antibodies against parainfluenza-1-viruses.

  16. Lack of Correlation between Severity of Clinical Symptoms, Skin Test Reactivity, and Radioallergosorbent Test Results in Venom-Allergic Patients

    Directory of Open Access Journals (Sweden)

    Warrington RJ

    2006-06-01

    Full Text Available Abstract Purpose To retrospectively examine the relation between skin test reactivity, venom-specific immunoglobulin E (IgE antibody levels, and severity of clinical reaction in patients with insect venom allergy. Method Thirty-six patients (including 15 females who presented with a history of allergic reactions to insect stings were assessed. The mean age at the time of the reactions was 33.4 ± 15.1 years (range, 4-76 years, and patients were evaluated 43.6 ± 90 months (range, 1-300 months after the reactions. Clinical reactions were scored according to severity, from 1 (cutaneous manifestations only to 3 (anaphylaxis with shock. These scores were compared to scores for skin test reactivity (0 to 5, indicating the log increase in sensitivity from 1 μg/mL to 0.0001 μg/mL and radioallergosorbent test (RAST levels (0 to 4, indicating venom-specific IgE levels, from undetectable to >17.5 kilounits of antigen per litre [kUA/L]. Results No correlation was found between skin test reactivity (Spearman's coefficient = 0.15, p = .377 or RAST level (Spearman's coefficient = 0.32, p = .061 and the severity of reaction. Skin test and RAST scores both differed significantly from clinical severity (p p = .042. There was no correlation between skin test reactivity and time since reaction (Spearman's coefficient = 0.18, p = .294 nor between RAST and time since reaction (r = 0.1353, p = .438. Elimination of patients tested more than 12 months after their reaction still produced no correlation between skin test reactivity (p = .681 or RAST score (p = .183 and the severity of the clinical reaction. Conclusion In venom-allergic patients (in contrast to reported findings in cases of inhalant IgE-mediated allergy, there appears to be no significant correlation between the degree of skin test reactivity or levels of venom-specific IgE (determined by RAST and the severity of the clinical reaction.

  17. HIV Rapid Testing in Substance Abuse Treatment: Implementation Following a Clinical Trial

    Science.gov (United States)

    Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.

    2011-01-01

    The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…

  18. Bile acid malabsorption in patients with chronic diarrhoea: clinical value of SeHCAT test

    DEFF Research Database (Denmark)

    Wildt, Signe; Nørby Rasmussen, S; Madsen, Jan Lysgård;

    2003-01-01

    BACKGROUND: Bile acid malabsorption (BAM), a cause of chronic diarrhoea, can be diagnosed by the SeHCAT test. The purpose of this study was to evaluate the usefulness of SeHCAT testing by assessing the extent of BAM and describing the clinical characteristics in a group of patients with chronic...

  19. Kunstige Enzymer

    DEFF Research Database (Denmark)

    Bols, Mikael; Bjerre, Jeannette; Marinescu, Lavinia

    2007-01-01

    Enzymer har en enestående evne til at accelerere kemiske processer. Der forskes målrettet i at optimere enzymer baseret på cyclodextrin.......Enzymer har en enestående evne til at accelerere kemiske processer. Der forskes målrettet i at optimere enzymer baseret på cyclodextrin....

  20. Evidence of zoonotic Poxviridae coinfections in clinically diagnosed papillomas using a newly developed mini-array test.

    Science.gov (United States)

    Scagliarini, Alessandra; Casà, Giovanni; Trentin, Bernadette; Gallina, Laura; Savini, Federica; Morent, Marine; Lavazza, Antonio; Puleio, Roberto; Buttaci, Calogera; Cannella, Vincenza; Purpari, Giuseppa; Di Marco, Patrizia; Piquemal, David; Guercio, Annalisa

    2016-01-01

    Our study describes a newly developed mini-array test for the rapid detection of poxviruses in animals and humans. The method is based on detection that combines target nucleic acid amplification by polymerase chain reaction and specific hybridization, using enzyme-linked antibodies, allowing identification of zoonotic orthopoxviruses and parapoxviruses in animal and human biological samples. With 100% specificity, the test rules out the possibility of cross-reactions with viral agents causing look-alike diseases. The assay was employed in the field to investigate the causes of several outbreaks of a malignant proliferative skin disease that affected domestic ruminants in Sicily during 2011-2014. Due to specific aspects of the lesions, the animals were clinically diagnosed with papillomatosis. The mini-array test allowed the identification of coinfections caused by more than 1 viral species belonging to the Parapoxvirus and Orthopoxvirus genera, either in goats or in cattle. Our study suggests that the so-called "papillomatosis" can be the result of multiple infections with epitheliotropic viruses, including zoonotic poxviruses that cannot be properly identified with classical diagnostic techniques. PMID:26699526

  1. EVALUATION OF VITEK 2 SYSTEM FOR CLINICAL IDENTIFICATION OF CANDIDA SPECIES AND THEIR ANTIFUNGAL SUSCEPTIBILITY TEST

    OpenAIRE

    Mohan,, V.; Ram Murugan

    2016-01-01

    BJECTIVES 1. To evaluate the Vitek 2 system for clinical identification of Candida species and their antifungal susceptibility test; 2. To study the incidence of various types of Candida species in this part of Tamilnadu. METHODS Samples collected from different wards were subjected for culture, isolation and identification of Candida Species and Antifungal Susceptibility testing by Vitek System. Vitek 2 test was carried out in Apollo Specialty Hospital Lab Services, Madurai....

  2. Design and Testing of an Assessment Instrument to Measure Understanding of Protein Structure and Enzyme Inhibition in a New Context

    Science.gov (United States)

    Villafañe, Sachel M.; Heyen, Bruce J.; Lewis, Jennifer E.; Loertscher, Jennifer; Minderhout, Vicky; Murray, Tracey Arnold

    2016-01-01

    Assessment instruments designed to measure student conceptual understanding and skills proficiency related to biochemistry are important to transform undergraduate biochemistry education. The purpose of this study was to develop an assessment instrument to measure student understanding of protein structure and enzyme inhibition in a new context,…

  3. Similar clinical features among patients with severe adult growth hormone deficiency diagnosed with insulin tolerance test or arginine or glucagon stimulation tests

    DEFF Research Database (Denmark)

    Toogood, Andrew; Brabant, Georg; Maiter, Dominique;

    2012-01-01

    To determine whether insulin tolerance tests (ITTs), arginine stimulation tests (ASTs), and glucagon stimulation tests (GST) identify patients who have similar clinical features of growth hormone (GH) deficiency when a diagnostic GH threshold of 3 μg/L is used.......To determine whether insulin tolerance tests (ITTs), arginine stimulation tests (ASTs), and glucagon stimulation tests (GST) identify patients who have similar clinical features of growth hormone (GH) deficiency when a diagnostic GH threshold of 3 μg/L is used....

  4. Vestibular Function Tests for Vestibular Migraine: Clinical Implication of Video Head Impulse and Caloric Tests

    Science.gov (United States)

    Kang, Woo Seok; Lee, Sang Hun; Yang, Chan Joo; Ahn, Joong Ho; Chung, Jong Woo; Park, Hong Ju

    2016-01-01

    Vestibular migraine (VM) is one of the most common causes of episodic vertigo. We reviewed the results of multiple vestibular function tests in a cohort of VM patients who were diagnosed with VM according to the diagnostic criteria of the Barany Society and the International Headache Society and assessed the efficacy of each for predicting the prognosis in VM patients. A retrospective chart analysis was performed on 81 VM patients at a tertiary care center from June 2014 to July 2015. Patients were assessed by the video head impulse test (vHIT), caloric test, vestibular-evoked myogenic potentials (VEMPs), and sensory organization test (SOT) at the initial visit and then evaluated for symptomatic improvement after 6 months. Complete response (CR) was defined as no need for continued medication, partial response (PR) as improved symptoms but need for continued medication, and no response (NR) as no symptomatic improvement and requiring increased dosage or change in medications. At the initial evaluation, 9 of 81 patients (11%) exhibited abnormal vHIT results, 14 of 73 (19%) exhibited abnormal caloric test results, 25 of 65 (38%) exhibited abnormal SOT results, 8 of 75 (11%) exhibited abnormal cervical VEMP results, and 20 of 75 (27%) exhibited abnormal ocular VEMP results. Six months later, 63 of 81 patients (78%) no longer required medication (CR), while 18 (22%) still required medication, including 7 PR and 11 NR patients. Abnormal vHIT gain and abnormal caloric results were significantly related to the necessity for continued medication at 6-month follow-up (OR = 5.67 and 4.36, respectively). Abnormal vHIT and caloric test results revealed semicircular canal dysfunction in VM patients and predicted prolonged preventive medication requirement. These results suggest that peripheral vestibular abnormalities are closely related to the development of vertigo in VM patients.

  5. Clinical relevance is associated with allergen-specific wheal size in skin prick testing

    DEFF Research Database (Denmark)

    Haahtela, T.; Burbach, G. J.; Bachert, C.;

    2014-01-01

    BackgroundWithin a large prospective study, the Global Asthma and Allergy European Network (GA(2)LEN) has collected skin prick test (SPT) data throughout Europe to make recommendations for SPT in clinical settings. ObjectiveTo improve clinical interpretation of SPT results for inhalant allergens...... by providing quantitative decision points. MethodsThe GA(2)LEN SPT study with 3068 valid data sets was used to investigate the relationship between SPT results and patient-reported clinical relevance for each of the 18 inhalant allergens as well as SPT wheal size and physician-diagnosed allergy (rhinitis......) to 87-89% (grass, mites) of the positive SPT reactions (wheal size3mm) were associated with patient-reported clinical symptoms when exposed to the respective allergen. The risk of allergic symptoms increased significantly with larger wheal sizes for 17 of the 18 allergens tested. Children with positive...

  6. [Morquio disease (Mucopolysaccharidosis type IV-A): clinical aspects, diagnosis and new treatment with enzyme replacement therapy].

    Science.gov (United States)

    Politei, Juan; Schenone, Andrea B; Guelbert, Norberto; Fainboim, Alejandro; Szlago, Marina

    2015-08-01

    Mucopolysaccharidosis type IV-A (Morquio A disease) is an autosomal recessive lysosomal storage disease caused by mutations in the gene encoding the N-acetylgalactosamine-6-sulfate sulfatase, that results in impaired catabolism of two glycosaminoglycans, chondroitin-6-sulfate and keratan sulfate. Clinical presentations reflect a spectrum of progression from a severe phenotype to an attenuated expression. Accumulation of substrate manifests predominantly as short stature and skeletal dysplasia, including atlantoaxial instability and cervical cord compression. Other abnormalities in the visual, auditory, cardiovascular and respiratory systems can also affect individuals with Morquio disease. Elosulfase alfa showed in clinical trials in children and adults a significant and sustained improvement in endurance and urinary levels of keratan sulfate. Data from the ongoing observational, multinational Morquio A Registry Study will provide valuable information on the long-term efficacy and safety of elosulfase alfa in patients, as well as on the natural history of this very rare disease. PMID:26172013

  7. Clinical Research of Enzyme Linked Immunosorbent Assay for The Detection of Hepatitis B Virus Surface Antigen False Positive%酶联免疫法检测HBsAg假阳性临床研究

    Institute of Scientific and Technical Information of China (English)

    张海军

    2013-01-01

    目的:研究分析酶联免疫法(ELISA)检测乙肝病毒表面抗原(HBsAg)的假阳性情况.方法:对酶联免疫法检测HBsAg结果为阳性的1500例血清标本用金标法验证,并用化学发光仪微粒子捕捉免疫发光法(MEIA)定量检测HBsAg的含量,以确认酶联免疫法检测结果的假阳性.结果:1500例酶联免疫法检测HBsAg阳性的血清标本,其中1479例为真阳性,真阳性率为98.6%(1479/1500);21例为假阳性,假阳性率为1.4%(21/1500).结论:酶联免疫法检测HBsAg有一定的假阳性,临床检测时应高度注意,避免错报误诊.%Objective: To study enzyme linked immunosorbent assay ( ELISA ) in detecting hepatitis B virus surface antigen ( HBsAg ) of the false positive cases. Method: ELISA for detection of HBsAg results for 1500 cases with positive serum samples using the colloidal gold method validation, and using chemical luminous instrument microparticle enzyme lmmunoassay ( MEIA ) for quantitative detection of HBsAg content, to confirm the enzyme-linked immunosorbent assay for detection of false positive results. Result: 1500 cases of enzyme-linked immunosorbent assay for detection of HBsAg positive serum samples, including 1479 cases of true positive, true positive rate was 98. 6% ( 1479/1500 ); 21 were false positive, false positive rate was 1. 4% ( 21/1500 ). Conclusion: Enzyme-linked immunosorbent assay for detection of HBsAg have false positive, clinical test should be highly attention, avoid the error diagnosis.

  8. Rotational laxity after anterior cruciate ligament injury by kinematic evaluation of clinical tests.

    Science.gov (United States)

    Zaffagnini, S; Martelli, S; Falcioni, B; Motta, M; Marcacci, M

    2000-01-01

    Despite the numerous studies on anterior cruciate ligament biomechanics and clinical tests, some disagreements still exist in the literature on the role of ACL in restraining rotations and which kinematic test after ACL injuries is the most suitable to evaluate this instability. This work analyses the capability of passive clinical and stress tests to detect an ACL state quantifying rotational instability. The study was conducted on animal knees with a new protocol. We found that an internal-external stress test can give a useful indication on the ACL state when used to estimate the side to side differences while varus-valgus laxity and secondary motions in standard kinematic tests did not seem to be affected by ACL injury. The kinematic protocol performed could be used intra-operatively to quantify rotations, allowing a more accurate evaluation of knee instability to guide surgical reconstruction and improve its final outcome. PMID:11204247

  9. Current practices and guidelines for clinical next-generation sequencing oncology testing

    Institute of Scientific and Technical Information of China (English)

    Samuel P. Strom

    2016-01-01

    Next-generation sequencing (NGS) has been rapidly integrated into molecular pathology, dramatically increasing the breadth genomic of information available to oncologists and their patients. This review will explore the ways in which this new technology is currently applied to bolster care for patients with solid tumors and hematological malignancies, focusing on practices and guidelines for assessing the technical validity and clinical utility of DNA variants identified during clinical NGS oncology testing.

  10. Unexplained exertional dyspnea caused by low ventricular filling pressures: results from clinical invasive cardiopulmonary exercise testing

    OpenAIRE

    Oldham, William M.; Lewis, Gregory D.; Opotowsky, Alexander R.; Waxman, Aaron B.; Systrom, David M.

    2016-01-01

    To determine whether low ventricular filling pressures are a clinically relevant etiology of unexplained dyspnea on exertion, a database of 619 consecutive, clinically indicated invasive cardiopulmonary exercise tests (iCPETs) was reviewed to identify patients with low maximum aerobic capacity (V̇o2max) due to inadequate peak cardiac output (Qtmax) with normal biventricular ejection fractions and without pulmonary hypertension (impaired: n = 49, V̇o2max = 53% predicted [interquartile range (I...

  11. Role of clinical neurophysiological tests in evaluation of erectile dysfunction in people with spinal cord disorders

    OpenAIRE

    Ashraf V; Taly Arun Kumar; Sivaraman Nair K; Rao Shivaji; Sridhar

    2005-01-01

    BACKGROUND: While erectile dysfunction is frequent among people with disorders of the spinal cord, the role of various clinical neurophysiological tests in assessment is not clear. AIMS: To study the role of clinical neurophysiological investigations in assessing erectile dysfunction among men with spinal cord disorders. SETTING: National Institute of Mental Health and Neurosciences, India. DESIGN: Survey. MATERIALS AND METHODS: Subjects with a score of 21 or less on the International Index ...

  12. The modification of the thrombin generation test for the clinical assessment of dabigatran etexilate efficiency

    OpenAIRE

    Gribkova, Irina V.; Lipets, Elena N; Rekhtina, Irina G.; Alex I. Bernakevich; Ayusheev, Dorzho B.; Ruzanna A. Ovsepyan; Ataullakhanov, Fazoil I.; Elena I Sinauridze

    2016-01-01

    A new oral anticoagulant, dabigatran etexilate (DE, a prodrug of direct thrombin inhibitor (DTI) dabigatran), has been used clinically to prevent thrombosis. The assessment of dabigatran efficiency is necessary in some clinical cases, such as renal insufficiency, risk of bleeding, and drug interactions. However, a specific thrombin generation test (TGT) that is one of the most informative and sensitive to anticoagulant therapy (calibrated automated thrombinography (САТ)) shows a paradoxical i...

  13. What every clinical geneticist should know about testing for osteogenesis imperfecta in suspected child abuse cases.

    Science.gov (United States)

    Pepin, Melanie G; Byers, Peter H

    2015-12-01

    Non-accidental injury (NAI) is a major medical concern in the United States. One of the challenges in evaluation of children with unexplained fractures is that genetic forms of bone fragility are one of the differential diagnoses. Infants who present with fractures with mild forms of osteogenesis imperfecta (OI) (OI type I or OI type IV), the most common genetic form of bone disease leading to fractures might be missed if clinical evaluation alone is used to make the diagnosis. Diagnostic clinical features (blue sclera, dentinogenesis imperfecta, Wormian bones on X-rays or positive family history) may not be present or apparent at the age of evaluation. The evaluating clinician faces the decision about whether genetic testing is necessary in certain NAI cases. In this review, we outline clinical presentations of mild OI and review the history of genetic testing for OI in the NAI versus OI setting. We summarize our data of molecular testing in the Collagen Diagnostic Laboratory (CDL) from 2008 to 2014 where NAI was noted on the request for DNA sequencing of COL1A1 and COL1A2. We provide recommendations for molecular testing in the NAI versus OI setting. First, DNA sequencing of COL1A1, COL1A2, and IFITM5 simultaneously and duplication/deletion testing is recommended. If a causative variant is not identified, in the absence of a pathologic clinical phenotype, no additional gene testing is indicated. If a VUS is found, parental segregation studies are recommended.

  14. 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

    OpenAIRE

    Anju Mohan; Hari Mohan Saxena; Puneet Malhotra

    2016-01-01

    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 cat...

  15. Clinical Characteristics of Patients Who Test Positive for Clostridium difficile by Repeat PCR

    Science.gov (United States)

    Stotler, Brie; Jackman, Dana; Whittier, Susan; Della-Latta, Phyllis

    2014-01-01

    The high sensitivity of PCR assays for diagnosing Clostridium difficile infection (CDI) has greatly reduced the need for repeat testing after a negative result. Nevertheless, a small subset of patients do test positive within 7 days of a negative test. The aim of this study was to evaluate the clinical characteristics of these patients to determine when repeat testing may be appropriate. The results of all Xpert C. difficile PCR (Cepheid, Sunnyvale CA) tests performed in the clinical microbiology laboratory at New York-Presbyterian Hospital, Columbia University Medical Center (NYPH/CUMC) from 1 May 2011 through 6 September 2013, were reviewed. A retrospective case-control study was performed, comparing patients who tested positive within 7 days of a negative test result to a random selection of 50 controls who tested negative within 7 days of a negative test result. During the study period, a total of 14,875 tests were performed, of which 1,066 were repeat tests (7.2%). Eleven of these repeat tests results were positive (1.0%). The only risk factor independently associated with repeat testing positive was history of a prior CDI (odds ratio [OR], 19.6 [95% confidence interval {CI}, 4.0 to 19.5], P < 0.001). We found that patients who test positive for C. difficile by PCR within 7 days of a negative test are more likely to have a history of CDI than are patients who test negative with repeat PCR. This finding may be due to the high rate of disease relapse or the increased likelihood of empirical therapy leading to false-negative results in these patients. PMID:25122866

  16. Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double- Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Jafarpour-Sadegh, Farnaz; Montazeri, Vahid; Adili, Ali; Esfehani, Ali; Rashidi, Mohammad-Reza; Mesgari, Mehran; Pirouzpanah, Saeed

    2015-01-01

    Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy. PMID:26625755

  17. The intra- and inter-rater reliability of five clinical muscle performance tests in patients with and without neck pain

    DEFF Research Database (Denmark)

    Juul, Tina; Langberg, Henning; Enoch, Flemming;

    2013-01-01

    This study investigates the reliability of muscle performance tests using cost- and time-effective methods similar to those used in clinical practice. When conducting reliability studies, great effort goes into standardising test procedures to facilitate a stable outcome. Therefore, several test...... trials are often performed. However, when muscle performance tests are applied in the clinical setting, clinicians often only conduct a muscle performance test once as repeated testing may produce fatigue and pain, thus variation in test results. We aimed to investigate whether cervical muscle...... performance tests, which have shown promising psychometric properties, would remain reliable when examined under conditions similar to those of daily clinical practice....

  18. Clinical characteristics of patients who test positive for Clostridium difficile by repeat PCR.

    Science.gov (United States)

    Green, Daniel A; Stotler, Brie; Jackman, Dana; Whittier, Susan; Della-Latta, Phyllis

    2014-11-01

    The high sensitivity of PCR assays for diagnosing Clostridium difficile infection (CDI) has greatly reduced the need for repeat testing after a negative result. Nevertheless, a small subset of patients do test positive within 7 days of a negative test. The aim of this study was to evaluate the clinical characteristics of these patients to determine when repeat testing may be appropriate. The results of all Xpert C. difficile PCR (Cepheid, Sunnyvale CA) tests performed in the clinical microbiology laboratory at New York-Presbyterian Hospital, Columbia University Medical Center (NYPH/CUMC) from 1 May 2011 through 6 September 2013, were reviewed. A retrospective case-control study was performed, comparing patients who tested positive within 7 days of a negative test result to a random selection of 50 controls who tested negative within 7 days of a negative test result. During the study period, a total of 14,875 tests were performed, of which 1,066 were repeat tests (7.2%). Eleven of these repeat tests results were positive (1.0%). The only risk factor independently associated with repeat testing positive was history of a prior CDI (odds ratio [OR], 19.6 [95% confidence interval {CI}, 4.0 to 19.5], P PCR within 7 days of a negative test are more likely to have a history of CDI than are patients who test negative with repeat PCR. This finding may be due to the high rate of disease relapse or the increased likelihood of empirical therapy leading to false-negative results in these patients.

  19. Point-of-care continuous 13C-methacetin breath test improves decision making in acute liver disease: Results of a pilot clinical trial

    Institute of Scientific and Technical Information of China (English)

    Gadi Lalazar; Tomer Adar; Yaron Ilan

    2009-01-01

    AIM: To assess the role of the 13C-methacetin breath test (MBT) in patients with acute liver disease. METHODS: Fifteen patients with severe acute liver disease from diverse etiologies were followed-up with 13C-MBT during the acute phase of their illnesses (range 3-116 d after treatment). Patients fasted for 8 h and ingested 75 mg of methacetin prior to the MBT. We compared results from standard clinical assessment, serum liver enzymes, synthetic function, and breath test scores. RESULTS: Thirteen patients recovered and two patients died. In patients that recovered, MBT parameters improved in parallel with improvements in lab results. Evidence of consistent improvement began on day 3 for MBT parameters and between days 7 and 9 for blood tests. Later convergence to normality occurred at an average of 9 d for MBT parameters and from 13 to 28 d for blood tests. In both patients that died, MBT parameters remained low despite fluctuating laboratory values. CONCLUSION: The 13C-MBT provides a rapid, noninvasive assessment of liver function in acute severe liver disease of diverse etiologies. The results of this pilot clinical trial suggest that the MBT may offer greater sensitivity than standard clinical tests for managing patients with severe acute liver disease.

  20. Chemotherapy-induced monoamine oxidase expression in prostate carcinoma functions as a cytoprotective resistance enzyme and associates with clinical outcomes.

    Directory of Open Access Journals (Sweden)

    Ryan R Gordon

    Full Text Available To identify molecular alterations in prostate cancers associating with relapse following neoadjuvant chemotherapy and radical prostatectomy patients with high-risk localized prostate cancer were enrolled into a phase I-II clinical trial of neoadjuvant chemotherapy with docetaxel and mitoxantrone followed by prostatectomy. Pre-treatment prostate tissue was acquired by needle biopsy and post-treatment tissue was acquired by prostatectomy. Prostate cancer gene expression measurements were determined in 31 patients who completed 4 cycles of neoadjuvant chemotherapy. We identified 141 genes with significant transcript level alterations following chemotherapy that associated with subsequent biochemical relapse. This group included the transcript encoding monoamine oxidase A (MAOA. In vitro, cytotoxic chemotherapy induced the expression of MAOA and elevated MAOA levels enhanced cell survival following docetaxel exposure. MAOA activity increased the levels of reactive oxygen species and increased the expression and nuclear translocation of HIF1α. The suppression of MAOA activity using the irreversible inhibitor clorgyline augmented the apoptotic responses induced by docetaxel. In summary, we determined that the expression of MAOA is induced by exposure to cytotoxic chemotherapy, increases HIF1α, and contributes to docetaxel resistance. As MAOA inhibitors have been approved for human use, regimens combining MAOA inhibitors with docetaxel may improve clinical outcomes.

  1. Contribution of a Real Depth Distance Stereoacuity Test to Clinical Management

    Directory of Open Access Journals (Sweden)

    B. J. Young

    2009-01-01

    Full Text Available Measurement of Stereopsis forms an important part of the clinical assessment of patients with disorders of ocular motility. The introduction of a real depth distance stereoacuity test (FD2 was evaluated in clinical practice and to what extent the introduction affected clinical management. Seventy-three patients under evaluation before and following the introduction of the test were included. Combined thresholds were measured at near using the Frisby and TNO test and at distance using the FD2. Fifty healthy controls were included. Forty-five patients demonstrated Stereopsis using the FD2 and 23 of these had a change in their management based in part on their responses using the FD2. Patients with evidence of Stereopsis using the FD2 were significantly more likely to have change in their management than expected from the whole sample (=.02. The introduction of a real depth distance stereoacuity test into clinical practice contributed to a change in management when used in conjunction with other tests. The usefulness of the FD2 is limited by its range at 6 m. Use at closer distances necessitates the calculation of binocular threshold from the combined and monocular threshold.

  2. Introduction and Administration of the Clinical Skill Test of the Medical Licensing Examination, Republic of Korea (2009)

    OpenAIRE

    Kun Sang Kim

    2010-01-01

    The first trial of the clinical skill test as part of the Korean Medical Licensing Examination was done from September 23 to December 1, 2009, in the clinical skill test center located in the National Health Personnel Licensing Examination Board (NHPLEB) building, Seoul. Korea is the first country to introduce the clinical skill test as part of the medical licensing examination in Asia. It is a report on the introduction and administration of the test. The NHPLEB launched researches on the va...

  3. Bile acid malabsorption in patients with chronic diarrhoea: clinical value of SeHCAT test

    DEFF Research Database (Denmark)

    Wildt, Signe; Nørby Rasmussen, S; Madsen, Jan Lysgård;

    2003-01-01

    BACKGROUND: Bile acid malabsorption (BAM), a cause of chronic diarrhoea, can be diagnosed by the SeHCAT test. The purpose of this study was to evaluate the usefulness of SeHCAT testing by assessing the extent of BAM and describing the clinical characteristics in a group of patients with chronic...... diarrhoea. Clinical outcome after treatment with cholestyramine was also evaluated. METHODS: During a 5-year period (1997-2001) the SeHCAT test was performed in 135 patients in whom a primary programme for diagnostic evaluation of chronic diarrhoea had not revealed a cause. File data from 133 patients could...... as a second-line investigation with a high diagnostic yield. The only a priori parameter to predict BAM was the existence of ileocaecal resections. The result of the SeHCAT test seems to predict the benefit of treatment with cholestyramine....

  4. 10 CFR 31.11 - General license for use of byproduct material for certain in vitro clinical or laboratory testing.

    Science.gov (United States)

    2010-01-01

    ... in vitro clinical or laboratory testing. 31.11 Section 31.11 Energy NUCLEAR REGULATORY COMMISSION... certain in vitro clinical or laboratory testing. (a) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive,...

  5. 42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

    Science.gov (United States)

    2010-10-01

    ... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic...

  6. 77 FR 31620 - Medicare Program; Public Meeting in Calendar Year 2012 for New Clinical Laboratory Tests Payment...

    Science.gov (United States)

    2012-05-29

    ... Year 2012 for New Clinical Laboratory Tests Payment Determinations AGENCY: Centers for Medicare... for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2013... determinations for new clinical diagnostic laboratory tests under Part B of title XVIII of the Social...

  7. 42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

    Science.gov (United States)

    2010-10-01

    ... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory...

  8. 76 FR 10600 - Medicare Program; Public Meeting in Calendar Year 2011 for New Clinical Laboratory Tests Payment...

    Science.gov (United States)

    2011-02-25

    ... Year 2011 for New Clinical Laboratory Tests Payment Determinations AGENCY: Centers for Medicare... Procedural Terminology (CPT) codes for clinical laboratory tests in calendar year (CY) 2012. The meeting... that will be included in Medicare's Clinical Laboratory Fee Schedule for CY 2012, which will...

  9. 78 FR 31560 - Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test Payment...

    Science.gov (United States)

    2013-05-24

    ... Year 2013 for New Clinical Laboratory Test Payment Determinations AGENCY: Centers for Medicare... clinical laboratory fee schedule (CLFS) for calendar year (CY) 2014. DATES: Meeting Date: The public... clinical diagnostic laboratory tests under Part B of title XVIII of the Social Security Act (the Act)...

  10. Need for an Ethical Framework for Testing for Systemic Diseases in Dental Clinics

    OpenAIRE

    Silveira, Marushka Leanne; Chattopadhyay, Amit

    2011-01-01

    Testing for systemic diseases in dental clinics is a potentially attractive avenue for oral health professionals and may be viewed as an opportunity to increase professional reach, expand practice, and improve financial returns. However, several ethical questions arise that must be addressed before such activities are adopted. (1) What should be the level of training dentists must acquire to deal with challenges associated with testing? (2) How well are dental practices aware of and compliant...

  11. Intraocular pressure dynamics with prostaglandin analogs: a clinical application of water-drinking test

    OpenAIRE

    Özyol P; Özyol E; Baldemir E

    2016-01-01

    Pelin Özyol,1 Erhan Özyol,1 Ercan Baldemir2 1Ophthalmology Department, 2Biostatistics Department, Faculty of Medicine, Mugla Sitki Kocman University, Mugla, Turkey Aim: To evaluate the clinical applicability of the water-drinking test in treatment-naive primary open-angle glaucoma patients. Methods: Twenty newly diagnosed primary open-angle glaucoma patients and 20 healthy controls were enrolled in this prospective study. The water-drinking test was performed at baseline and 6&nbs...

  12. Evaluation of an egg yolk enzyme-linked immunosorbent assay antibody test and its use to assess the prevalence of Mycoplasma gallisepticum infection in laying hens in Italy

    Directory of Open Access Journals (Sweden)

    Marco Tamba

    2010-01-01

    Full Text Available The prevalence of Mycoplasma gallisepticum infection in commercial layers was established by the presence of antibodies in eggs. Saline-extracted yolks were used with a commercial enzyme-linked immunosorbent assay kit. For the prevalence study, yolks from 30 eggs were obtained from each of 66 flocks coming from 36 layer farms. The prevalence of egg antibodies to Mycoplasma gallisepticum was 33.3% in single-age farms and 77.8% in multi-age farms. In 27 flocks, antibody titers were compared with results obtained from blood samples taken in the same flock and in the same period and analyzed with the same kit. This study has confirmed that egg yolk enzyme-linked immunosorbent assay antibody test is a suitable and practical approach for assessing the flock prevalence of Mycoplasma gallisepticum infection in layer hens.

  13. PSA testing without clinical indication for prostate cancer in relation to socio-demographic and clinical characteristics in the Danish Diet, Cancer and Health Study

    DEFF Research Database (Denmark)

    Karlsen, Randi V; Larsen, Signe B; Christensen, Jane;

    2013-01-01

    associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Material and methods. In the Danish Diet, Cancer and Health Cohort, we identified 1051 men with PC diagnosed in 1993-2008. Diagnostic and clinical characteristics were obtained from medical records......, and socio-demographic information was retrieved from administrative registers. We used general logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Cox......Background. Social differences in prostate cancer (PC) incidence and mortality might be related to testing for prostate-specific antigen (PSA). Although routine PSA screening is not recommended in Denmark, testing without clinical indication increased during the past decade. We evaluated...

  14. [Clinical Application of Non-invasive Diagnostic Tests for Liver Fibrosis].

    Science.gov (United States)

    Shin, Jung Woo; Park, Neung Hwa

    2016-07-25

    The diagnostic assessment of liver fibrosis is an important step in the management of patients with chronic liver diseases. Liver biopsy is considered the gold standard to assess necroinflammation and fibrosis. However, recent technical advances have introduced numerous serum biomarkers and imaging tools using elastography as noninvasive alternatives to biopsy. Serum markers can be direct or indirect markers of the fibrosis process. The elastography-based studies include transient elastography, acoustic radiation force imaging, supersonic shear wave imaging and magnetic resonance elastography. As accumulation of clinical data shows that noninvasive tests provide prognostic information of clinical relevance, non-invasive diagnostic tools have been incorporated into clinical guidelines and practice. Here, the authors review noninvasive tests for the diagnosis of liver fibrosis. PMID:27443617

  15. Patch test results of hand eczema patients : relation to clinical types

    NARCIS (Netherlands)

    Boonstra, M B; Christoffers, W A; Coenraads, P J; Schuttelaar, M L A

    2015-01-01

    BACKGROUND: Allergic contact dermatitis is a well-known cause of hand eczema, although the influence of contact allergens on different clinical types of hand eczema remains still unclear. OBJECTIVE: To identify most common positive tested allergens among hand eczema patients and to define the relati

  16. Relationship Between Upper Respiratory Tract Influenza Test Result and Clinical Outcomes Among Critically Ill Influenza Patients

    OpenAIRE

    Reddy, Krishna P.; Bajwa, Ednan K.; Parker, Robert A.; Andrew B Onderdonk; Walensky, Rochelle P.

    2016-01-01

    Among critically ill patients with lower respiratory tract (LRT)-confirmed influenza, we retrospectively observed worse 28-day clinical outcomes in upper respiratory tract (URT)-negative versus URT-positive subjects. This finding may reflect disease progression and highlights the need for influenza testing of both URT and LRT specimens to improve diagnostic yield and possibly inform prognosis.

  17. 78 FR 53773 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular...

    Science.gov (United States)

    2013-08-30

    ... HUMAN SERVICES Food and Drug Administration Select Updates for Non-Clinical Engineering Tests and... Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  18. Bridging the gap between clinical failure and laboratory fracture strength tests using a fractographic approach

    NARCIS (Netherlands)

    M.N. Aboushelib; A.J. Feilzer; C.J. Kleverlaan

    2009-01-01

    Objective: The aim of this study was to analyze and to compare the fracture type and the stress at failure of clinically fractured zirconia-based all ceramic restorations with that of morphologically similar replicas tested in a laboratory setup. Methods: Replicas of the same shape and dimensions we

  19. Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System. Final rule.

    Science.gov (United States)

    2016-06-23

    This final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an implementation date of January 1, 2018 for the private payor rate-based fee schedule required by PAMA.

  20. Knowledge of the D-dimer test result influences clinical probability assessment of pulmonary embolism

    NARCIS (Netherlands)

    R.A. Douma; J.B.F. Kessels; H.R. Büller; V.E.A. Gerdes

    2010-01-01

    Background: In patients with suspected pulmonary embolism (PE), an unlikely or non-high probability assessment combined with a normal D-dimer test can safely exclude the diagnosis. We studied the influence of early D-dimer knowledge on clinical probability assessment. Methods: A questionnaire was se

  1. Clinical evaluation of a dynamic test for lateral ankle ligament laxity

    NARCIS (Netherlands)

    J.S. de Vries; G.M.M.J. Kerkhoffs; L. Blankevoort; C.N. van Dijk

    2010-01-01

    The dynamic anterior ankle tester (DAAT) has shown a good reliability in testing anterior talar translation in earlier studies. The goal of the present study was first to evaluate the reliability of the DAAT in a clinical setting and second to analyze its ability to detect increased ligament laxity.

  2. The role of KRAS rs61764370 in invasive epithelial ovarian cancer: implications for clinical testing

    NARCIS (Netherlands)

    Pharoah, P.D.; Palmieri, R.T.; Ramus, S.J.; Gayther, S.A.; Andrulis, I.L.; Anton-Culver, H.; Antonenkova, N.; Antoniou, A.C.; Goldgar, D.; Beattie, M.S.; Beckmann, M.W.; Birrer, M.J.; Bogdanova, N.; Bolton, K.L.; Brewster, W.; Brooks-Wilson, A.; Brown, R.; Butzow, R.; Caldes, T.; Caligo, M.A.; Campbell, I.; Chang-Claude, J.; Chen, Y.A.; Cook, L.S.; Couch, F.J.; Cramer, D.W; Cunningham, J.M.; Despierre, E.; Doherty, J.A.; Dork, T.; Durst, M.; Eccles, D.M.; Ekici, A.B.; Easton, D.; Fasching, P.A.; Fazio, A. de; Fenstermacher, D.A.; Flanagan, J.M.; Fridley, B.L.; Friedman, E.; Gao, B.; Sinilnikova, O.; Gentry-Maharaj, A.; Godwin, A.K.; Goode, E.L.; Goodman, M.T.; Gross, J.; Hansen, T.V.; Harnett, P.; Rookus, M.; Heikkinen, T.; Hein, R.; Hogdall, C.; Hogdall, E.; Iversen, E.S.; Jakubowska, A.; Johnatty, S.E.; Karlan, B.Y.; Kauff, N.D.; Kaye, S.B.; Chenevix-Trench, G.; Kelemen, L.E.; Kiemeney, L.A.L.M.; Kjaer, S.K.; Lambrechts, D.; Lapolla, J.P.; Lazaro, C.; Le, N.D.; Leminen, A.; Leunen, K.; Levine, D.A.; Lu, Y.; Lundvall, L.; MacGregor, S.; Marees, T.; Massuger, L.F.A.G.; McLaughlin, J.R.; Menon, U.; Montagna, M.; Moysich, K.B.; Narod, S.A.; Nathanson, K.L.; Nedergaard, L.; Ness, R.B.; Nevanlinna, H.; Nickels, S.; Osorio, A.; Paul, J.; Pearce, C.L.; Phelan, C.M.; Pike, M.C.; Radice, P.; Rossing, M.A.; Schildkraut, J.M.; Sellers, T.A.; Singer, C.F.; Song, H.; Stram, D.O.; Sutphen, R.; Lindblom, A.

    2011-01-01

    PURPOSE: An assay for the single-nucleotide polymorphism (SNP), rs61764370, has recently been commercially marketed as a clinical test to aid ovarian cancer risk evaluation in women with family histories of the disease. rs67164370 is in a 3'-UTR miRNA binding site of the KRAS oncogene and is a candi

  3. The role of KRAS rs61764370 in invasive epithelial ovarian cancer: implications for clinical testing

    DEFF Research Database (Denmark)

    Pharoah, Paul D P; Palmieri, Rachel T; Ramus, Susan J;

    2011-01-01

    PURPOSE: An assay for the single nucleotide polymorphism (SNP) rs61764370 has recently been commercially marketed as a clinical test to aid ovarian cancer risk evaluation in women with family histories of the disease. rs67164370 is in a 3'UTR miRNA binding site of the KRAS oncogene, and is a cand...

  4. Protease activity measurement in milk as a diagnostic test for clinical mastitis in dairy cows

    NARCIS (Netherlands)

    Koop, G.; Werven, van T.; Roffel, S.; Hogeveen, H.; Nazmi, K.; Bikker, F.J.

    2015-01-01

    Due to the increasing use of automated milking systems, automated detection of clinical mastitis is becoming more important. Various in- or on-line diagnostic tests are in use, but generally suffer from false mastitis alerts. In this study, we explored a new diagnostic approach based on measureme

  5. Use of the Falcon assay screening test--enzyme-linked immunosorbent assay (FAST-ELISA) and the enzyme-linked immunoelectrotransfer blot (EITB) to determine the prevalence of human fascioliasis in the Bolivian Altiplano.

    Science.gov (United States)

    Hillyer, G V; Soler de Galanes, M; Rodriguez-Perez, J; Bjorland, J; Silva de Lagrava, M; Ramirez Guzman, S; Bryan, R T

    1992-05-01

    A collaborative study between the University of Puerto Rico School of Medicine, the Centers for Disease Control, the Bolivian Ministry of Health, and private voluntary organizations (Foster Parents Plan International and Danchurchaid) working in Bolivia has identified a region in the northwestern Altiplano of Bolivia near Lake Titicaca as harboring the highest prevalence of human fascioliasis in the world reported to date. Two serologic techniques (the Falcon assay screening test-enzyme-linked immunosorbent assay [FAST-ELISA] and the enzyme-linked immunoelectrotransfer blot [EITB]) were used in the determination of its prevalence. One hundred serum samples and 73 stool samples were obtained from Aymara Indians from Corapata, Bolivia. Antibody absorbance levels to Fasciola hepatica excretion-secretion antigens were compared with EITB banding patterns using the same antigen preparation. A positive FAST-ELISA result was defined as an absorbance value greater than the mean plus three standard deviations of two sets of normal negative controls (Puerto Rican and Bolivian). Using this criterion, 53 of 100 sera tested were found positive by this technique. Within this group, 19 (95%) of 20 individuals who were parasite positive were also positive by FAST-ELISA. An additional 24 individuals who were negative for F. hepatica eggs and 10 individuals for whom no specimens were received were also positive by FAST-ELISA. Among the 53 individuals negative for F. hepatica eggs, 29 were also negative by FAST-ELISA. The EITB analysis of the sera from confirmed infected individuals revealed at least three F. hepatica (Fh) bands with molecular weights of 12, 17, and 63 kD, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. TEST RORSCHACHA W DIAGNOSTYCE KLINICZNEJ I BADANIACH MIEDZYKULTUROWYCH [THE RORSCHACH TEST IN CLINICAL DIAGNOSIS AND CROSS-CULTURAL RESEARCH

    Directory of Open Access Journals (Sweden)

    Waszkiewicz, Ewa

    2012-06-01

    Full Text Available This article reviews the application of the Rorschach Inkblot Test in clinical practice. It concerns specificity of this test, its advantages, disadvantages and diagnostic value in assessment of mental disorders. Such an review seems to be important in face of controversies this tool has been evoking since its conceptualization in 1921 by Hermann Rorschach and current rising popularity of quantitative methods, which are often perceived as having more evidence-based psychometric foundations and demanding less clinical experience when it comes to analysis. The first part of this article is focused on methodological aspects of the Rorschach Test: specificity of its application, the most important variables and theoretical approaches. Also the arguments of Rorschach opponents and proponents will be discussed. The most important argument of its proponents is the variety of information about unconscious processes. The main argument of its opponents is the lack of validity, reliability and adequate norms for particular mental disorders. In the following paragraphs, the most crucial criteria for diagnosis of schizophrenia, affective and personality disorders will be described. This scope of disorders is reflected in typical traits found in the Rorschach scoring protocol. The second part of the article will be focused on the implementation of the method in cross-cultural and acculturation research. The results of some research imply that there are many of cross-cultural differences in norms and there was evidence found that the results, in case of individuals who go through the process of acculturation, especially biculturals, are strongly influenced by culture.

  7. Water syphon test and gastrooesophageal reflux during childhood (correlation with the clinical findings and oesophageal manometry)

    International Nuclear Information System (INIS)

    The water syphon test is a simple and easily performed method for demonstrating gastro-oesophageal reflux with a high degree of reliability. It is carried out following a conventional barium swallow. Compared with clinical findings and oesophageal manometry, the water syphon test is very reliable for demonstrating gastro-oesophageal reflux during childhood. Prolonged irradiation in order to see spontaneous reflux becomes unnecessary. This results in a significant reduction in radiation dose. Barium swallow and the water syphon test are the most useful initial examinations in children with symptoms which suggest reflux. (orig.)

  8. Computerized Neuropsychological Assessment in Aging: Testing Efficacy and Clinical Ecology of Different Interfaces

    Directory of Open Access Journals (Sweden)

    Matteo Canini

    2014-01-01

    Full Text Available Digital technologies have opened new opportunities for psychological testing, allowing new computerized testing tools to be developed and/or paper and pencil testing tools to be translated to new computerized devices. The question that rises is whether these implementations may introduce some technology-specific effects to be considered in neuropsychological evaluations. Two core aspects have been investigated in this work: the efficacy of tests and the clinical ecology of their administration (the ability to measure real-world test performance, specifically (1 the testing efficacy of a computerized test when response to stimuli is measured using a touch-screen compared to a conventional mouse-control response device; (2 the testing efficacy of a computerized test with respect to different input modalities (visual versus verbal; and (3 the ecology of two computerized assessment modalities (touch-screen and mouse-control, including preference measurements of participants. Our results suggest that (1 touch-screen devices are suitable for administering experimental tasks requiring precise timings for detection, (2 intrinsic nature of neuropsychological tests should always be respected in terms of stimuli presentation when translated to new digitalized environment, and (3 touch-screen devices result in ecological instruments being proposed for the computerized administration of neuropsychological tests with a high level of preference from elderly people.

  9. Computerized neuropsychological assessment in aging: testing efficacy and clinical ecology of different interfaces.

    Science.gov (United States)

    Canini, Matteo; Battista, Petronilla; Della Rosa, Pasquale Anthony; Catricalà, Eleonora; Salvatore, Christian; Gilardi, Maria Carla; Castiglioni, Isabella

    2014-01-01

    Digital technologies have opened new opportunities for psychological testing, allowing new computerized testing tools to be developed and/or paper and pencil testing tools to be translated to new computerized devices. The question that rises is whether these implementations may introduce some technology-specific effects to be considered in neuropsychological evaluations. Two core aspects have been investigated in this work: the efficacy of tests and the clinical ecology of their administration (the ability to measure real-world test performance), specifically (1) the testing efficacy of a computerized test when response to stimuli is measured using a touch-screen compared to a conventional mouse-control response device; (2) the testing efficacy of a computerized test with respect to different input modalities (visual versus verbal); and (3) the ecology of two computerized assessment modalities (touch-screen and mouse-control), including preference measurements of participants. Our results suggest that (1) touch-screen devices are suitable for administering experimental tasks requiring precise timings for detection, (2) intrinsic nature of neuropsychological tests should always be respected in terms of stimuli presentation when translated to new digitalized environment, and (3) touch-screen devices result in ecological instruments being proposed for the computerized administration of neuropsychological tests with a high level of preference from elderly people. PMID:25147578

  10. Clinical tests for differentiating between patients with and without patellofemoral pain syndrome

    Directory of Open Access Journals (Sweden)

    Konstantinos Papadopoulos, MSc

    2014-06-01

    Full Text Available Patellofemoral pain syndrome (PFPS is a very common knee condition with various aetiologies. Because of the nebulous factors of the syndrome, physiotherapists often find it difficult to assess and treat these patients. The aim of this study was to identify the clinical assessment tool that can differentiate PFPS patients from patients with other lower limb conditions. Fifty-two patients from the National Health System (26 with PFPS and 26 with other lower limb conditions took part in this study. They underwent a series of strength, flexibility, and stress tests. Their pain levels were also recorded. The results showed that among the various clinical tests, only the hip flexion component of the Thomas test was able to differentiate between the two groups. In addition, the stress test showed that the PFPS group could not recover their gluteal muscle strength in the same way the group with the other lower limb conditions did. The Lower Extremity Functional Scale was found to be more able to differentiate between the two groups than the Anterior Knee Pain Scale. This study has shown that it is difficult to find specific clinical tests to diagnose PFPS. More research is needed in this important area.

  11. Test-retest reliability of the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale.

    Science.gov (United States)

    Gustafsson, Margareta; Blomberg, Karin; Holmefur, Marie

    2015-07-01

    The Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale evaluates the student nurses' perception of the learning environment and supervision within the clinical placement. It has never been tested in a replication study. The aim of the present study was to evaluate the test-retest reliability of the CLES + T scale. The CLES + T scale was administered twice to a group of 42 student nurses, with a one-week interval. Test-retest reliability was determined by calculations of Intraclass Correlation Coefficients (ICCs) and weighted Kappa coefficients. Standard Error of Measurements (SEM) and Smallest Detectable Difference (SDD) determined the precision of individual scores. Bland-Altman plots were created for analyses of systematic differences between the test occasions. The results of the study showed that the stability over time was good to excellent (ICC 0.88-0.96) in the sub-dimensions "Supervisory relationship", "Pedagogical atmosphere on the ward" and "Role of the nurse teacher". Measurements of "Premises of nursing on the ward" and "Leadership style of the manager" had lower but still acceptable stability (ICC 0.70-0.75). No systematic differences occurred between the test occasions. This study supports the usefulness of the CLES + T scale as a reliable measure of the student nurses' perception of the learning environment within the clinical placement at a hospital. PMID:25814151

  12. [Quality use of commercial laboratory for clinical testing services - considering laboratory's role].

    Science.gov (United States)

    Ogawa, Shinji

    2014-12-01

    The number of commercial laboratories for clinical testing in Japan run privately has decreased to about 30 companies, and their business is getting tougher. Branch Lab. and FMS businesses have not expanded recently due to the new reimbursement system which adds an additional sample management fee, becoming effective in 2010. This presentation gives an outline of each role for hospital and commercial laboratories, and their pros & cons considering the current medical situation. Commercial laboratories have investigated how to utilize ICT systems for sharing test information between hospitals and our facilities. It would be very helpful to clarify issues for each hospital. We will develop and create new values for clinical laboratory testing services and forge mutually beneficial relationships with medical institutions. (Review). PMID:25823243

  13. Scapular dyskinesis in trapezius myalgia and intraexaminer reproducibility of clinical tests

    DEFF Research Database (Denmark)

    Juul-Kristensen, Birgit; Hilt, Kenneth; Enoch, Flemming;

    2011-01-01

    The aims were to test the intraexaminer reproducibility and report the presence of specific clinical variables of scapular dyskinesis in cases with trapezius myalgia and healthy controls, along with general health and work ability. A total of 38 cases and 23 controls were tested for scapular...... (ICC 0.42-0.74), test for muscular weakness having the lowest ICC (0.42). Cases showed significantly larger medial border misalignment, larger lower horizontal distance of the inferior scapular angle and larger passive shoulder internal rotation, by 110% (1.02 cm), 15% (1.38 cm), and 8% (5.......5°), respectively. Cases with the highest degree of scapular dyskinesis showed reduced work ability and general health. The present specific clinical variables on scapular dyskinesis showed satisfactory intraexaminer reproducibility. An increased standardization must be implemented to increase reproducibility...

  14. [Performance evaluation of VITEK 2 system in meropenem susceptibility testing of clinical Pseudomonas aeruginosa isolates].

    Science.gov (United States)

    Acuner, Ibrahim Cağatay; Bayramoğlu, Gülçin; Birinci, Asuman; Cekiç Cihan, Ciğdem; Bek, Yüksel; Durupınar, Belma

    2011-07-01

    Pseudomonas aeruginosa is an important opportunistic pathogen associated with various community-acquired or nosocomial infections. Multi-drug resistant P.aeruginosa strains increasingly cause epidemics and spread in various hospital wards and geographic regions. Carbapenems are among the most effective antimicrobials in the treatment of multi-drug resistant P.aeruginosa infections, and meropenem is the most successful among alternatives in initial therapy. Particularly in severe infections, inappropriate or inadequate initial antimicrobial therapy is independently associated with adverse clinical and economic outcomes. Availability of accurate and rapid susceptibility testing is a priority. Most of the automated microbiology systems can provide rapid results within 8 to 12 hours. In comparison to standard methods, problems in the antimicrobial susceptibility testing of particular microorganisms and antimicrobial agents have been reported for automated microbiology systems. Failures have been reported previously especially in the susceptibility testing of P.aeruginosa versus carbapenem. Most of these studies are designed according to the Food and Drug Administration (FDA, USA) performance analysis scheme (Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems) in a simplified form. However, there are many lacking issues in the design of most of these studies. Among these, insufficient sample size, use of inappropriate reference method, lack of reproducibility testing, and inadequate distribution of study isolates in interpretative categories are of notice. There are only few studies in the literature that evaluate the performance of automated systems in antimicrobial susceptibility testing of carbapenems in clinical P.aeruginosa isolates with a sufficient sample size (n ? 100). However, most of these studies still have one or more major deficiencies in the study design. Furthermore, none of these studies evaluate the performance of

  15. Usefulness of the thyrotropin-releasing hormone test in pre-clinical acromegaly.

    Science.gov (United States)

    Kageyama, Kazunori; Moriyama, Takako; Sakihara, Satoru; Takayasu, Shinobu; Nigawara, Takeshi; Suda, Toshihiro

    2005-08-01

    Acromegaly is caused primarily by pituitary growth hormone (GH)-secreting tumors. It is usually recognized because of characteristic manifestations, and diagnosed clinically. However, there exists a mild stage of acromegaly, which poses a diagnostic problem due to the absence of typical clinical manifestations. Here we present four patients with pre-clinical acromegaly, who showed minimal acromegaloid features with elevated levels of insulin-like growth factor-I. Basal GH levels were within normal levels in 3 of 4 cases, while insulin-like growth factor-I levels were elevated above normal in all cases. Plasma GH levels were elevated in response to thyrotropin-releasing hormone (TRH) in all cases, indicating a diagnostic value of the TRH stimulation test. In contrast, an oral glucose tolerance test was not useful for the diagnosis, because of the low GH levels (less than 1 ng/ml) and/or secondary to diabetes mellitus. In response to a dopamine agonist, GH levels were increased in the two cases, whereas GH levels were decreased or remained unchanged in the other two cases. We therefore suggest that the TRH stimulation test would be helpful to examine the presence of pre-clinical acromegaly. Diagnosis of the early stages of acromegaly is important to prevent progression to overt acromegaly. PMID:15997199

  16. Rapid identification of Enterobacteriaceae with microbial enzyme activity profiles.

    OpenAIRE

    Godsey, J H; Matteo, M R; Shen, D; Tolman, G; Gohlke, J R

    1981-01-01

    A total of 539 clinical isolates belonging to 10 species of the Enterobacteriaceae family were identified by enzyme activity profiles within 30 min of test inoculation. Each isolate was grown at 37 degrees C for 18 h on Mueller-Hinton agar and suspended to an optical density of 200 Klett units on 0.85% saline. Enzyme activity profiles were obtained by inoculating 18 fluorogenic substrates with the standardized bacterial suspension and monitoring initial rates of hydrolysis over the first 30 m...

  17. 线粒体呼吸链酶缺陷临床分析%Clinical Analysis of Mitochondrial Respiratory Chain Enzyme Deficiency in Children: Report of 7 Cases

    Institute of Scientific and Technical Information of China (English)

    朱彦丽; 彭晓音; 谷为岳; 戚豫; 宋福英; 万乃君; 王立文

    2012-01-01

    Objective To investigate the clinical features of the non-syndromie mitochondrial disease in children which were identified by mitochondrial respiratory chain enzyme complex activity assay.Methods From March 2010 to April 2011,seven children who were diagnosed as non-syndromic mitochondrial disease were included into this study.The enzyme activity of respiratory chain enzyme complexes (Ⅰ-Ⅳ) and ATP synthase (complex Ⅴ ) in peripheral blood leukocytes of 7 children were determined. All the children whose routine screening of mitochondrial genes were negative. Children's clinical data were retrospectively analyzed.Results ①There were intelligence backwards after infection in 5 cases,combined seizures in 4 cases, paralysis in 6 cases; deafness, ataxia in 2 cases, combining anterior pituitary hypofunction/episodes of hypoglycemia in 1 case; myodynamia and hypomyotonia in 7 cases.The findings of brain MRI were abnormal in 6 cases,the findings of electroencephalogram (EEG) were abnormal in 5 cases and abnormal findings of electromyography (EMG) in 3 cases.Blood lactate increased slightly in 3 cases,the level of myocardial enzyme were abnormal in 2 cases.②Conventional mitochondrial genes screening was negative.③4 childen had isolated complex defects:complex Ⅱ deficiency (2 cases),complex deficiency of Ⅰ or Ⅳ (1 case,respectively); 3 cases were found to have combined deficiencies:2 cases had combined deficiencies of complex Ⅰ and Ⅲ,1 case had combined deficiencies of complex Ⅱ and Ⅴ.Conclusions Mitochondrial respiratory chain enzyme deficiency in children may present non-specific neurological symptoms,the clinical features were extensive involvement of multi-system,and regular screening of mitochondrial gene was negative,the mitochondrial respiratory chain enzyme activity assay of peripheral leukocyte may help to identify the non-syndromic mitochondrial disease.%目的 探讨经线粒体呼吸链酶复合物活性测定确诊的非综合征型线

  18. American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility.

    Science.gov (United States)

    2003-06-15

    As the leading organization representing cancer specialists involved in patient care and clinical research, the American Society of Clinical Oncology (ASCO) reaffirms its commitment to integrating cancer risk assessment and management, including molecular analysis of cancer predisposition genes, into the practice of oncology and preventive medicine. The primary goal of this effort is to foster expanded access to, and continued advances in, medical care provided to patients and families affected by hereditary cancer syndromes. The 1996 ASCO Statement on Genetic Testing for Cancer Susceptibility set forth specific recommendations relating to clinical practice, research needs, educational opportunities, requirement for informed consent, indications for genetic testing, regulation of laboratories, and protection from discrimination, as well as access to and reimbursement for cancer genetics services. In updating this Statement, ASCO endorses the following principles: Indications for Genetic Testing: ASCO recommends that genetic testing be offered when 1) the individual has personal or family history features suggestive of a genetic cancer susceptibility condition, 2) the test can be adequately interpreted, and 3) the results will aid in diagnosis or influence the medical or surgical management of the patient or family members at hereditary risk of cancer. ASCO recommends that genetic testing only be done in the setting of pre- and post-test counseling, which should include discussion of possible risks and benefits of cancer early detection and prevention modalities. Special Issues in Testing Children for Cancer Susceptibility: ASCO recommends that the decision to offer testing to potentially affected children should take into account the availability of evidence-based risk-reduction strategies and the probability of developing a malignancy during childhood. Where risk-reduction strategies are available or cancer predominantly develops in childhood, ASCO believes that

  19. Utility and necessity of repeat testing of critical values in the clinical chemistry laboratory.

    Directory of Open Access Journals (Sweden)

    Aijun Niu

    Full Text Available CONTEXT: Routine repeat testing of critical values is a long-standing practice in many clinical laboratories; however, its usefulness and necessity remain to be empirically established and no regulatory requirements yet exist for verification of the critical value results obtained by repeat analysis. OBJECTIVE: To determine whether repeat testing of critical values is useful and necessary in a clinical chemistry laboratory. METHODS: A total of 601 chemistry critical values (potassium, n = 255; sodium, n = 132; calcium, n = 108; glucose, n = 106 obtained from 72,259 routine clinical chemistry specimens were repeat tested. The absolute value and the percentage of difference between the two testing runs were calculated for each of the four critical values and then compared with the allowable error limit put forth in the College of American Pathologists (CAP. RESULTS: Among the repeat data for the 601 critical values, a total of 24 showed large differences between the initial result and the repeated result which exceeded the CAP limits for allowable error. The number and rates (% of large differences for within and outside the analytical measurement range (AMR were 12 (2.1% and 12 (41.4%, respectively. For the 572 critical values within the AMR for each test category, the mean absolute difference (mmol/L and difference(% between the two testing runs were: potassium, 0.1 mmol/L (2.7%; sodium, 2.1 mmol/L (1.7%; calcium, 0.05 mmol/L (3.0%; glucose, 0.18 mmol/L (2.6%. CONCLUSIONS: When the initial chemistry critical values are within the AMR, repeated testing does not improve accuracy and is therefore unnecessary. When the initial chemistry critical values are outside the AMR, however, the benefit of repeated testing justifies its performance and makes it necessary. Performing repeat clinical testing on a case-by-case, rather than routine, basis can improve patient care by delivering critical values more rapidly while providing savings

  20. Laboratory tests in the detection of extended spectrum beta-lactamase production: National Committee for Clinical Laboratory Standards (NCCLS screening test, the E-test, the double disk confirmatory test, and cefoxitin susceptibility testing

    Directory of Open Access Journals (Sweden)

    Pedro A. d'Azevedo

    2004-10-01

    Full Text Available Extended spectrum beta-lactamase (ESBL production by Klebsiella sp. and E. coli is an emerging problem. In this study, 107 clinical isolates (53 E. coli, 47 K. pneumoniae and 7 K. oxytoca screened as ESBL producers by the NCCLS disk diffusion procedure were submitted to a double disk confirmatory test (DDT and to the E-test double strip for confirmation of ESBL production by demonstration of clavulanic acid inhibition effect (CAIE. Only 72/107 (67% of the isolates were confirmed as ESBL producers by DDT, with diverse results among species. By the E-test, 58/107 (54% isolates were confirmed as ESBL producers, and 18/107 (17% were not determinable. Susceptibility to cefoxitin was found in 57/68 (83% of strains that did not show CAIE. ESBL detection remains a controversial issue and clinical laboratories are in need of a simple and effective way to recognize strains with this kind of resistance.

  1. The next controversy in genetic testing: clinical data as trade secrets?

    Science.gov (United States)

    Cook-Deegan, Robert; Conley, John M; Evans, James P; Vorhaus, Daniel

    2013-06-01

    Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing - and compelling participation in - resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure. PMID:23150081

  2. Idiopathic normal pressure hydrocephalus: diagnostic and predictive value of clinical testing, lumbar drainage, and CSF dynamics.

    Science.gov (United States)

    Mahr, Cynthia V; Dengl, Markus; Nestler, Ulf; Reiss-Zimmermann, Martin; Eichner, Gerrit; Preuß, Matthias; Meixensberger, Jürgen

    2016-09-01

    OBJECTIVE The aim of the study was to analyze the diagnostic and predictive values of clinical tests, CSF dynamics, and intracranial pulsatility tests, compared with external lumbar drainage (ELD), for shunt response in patients with idiopathic normal pressure hydrocephalus (iNPH). METHODS Sixty-eight consecutive patients with suspected iNPH were prospectively evaluated. Preoperative assessment included clinical tests, overnight intracranial pressure (ICP) monitoring, lumbar infusion test (LIFT), and ELD for 24-72 hours. Simple and multiple linear regression analyses were conducted to identify predictive parameters concerning the outcome after shunt therapy. RESULTS Positive response to ELD correctly predicted improvement after CSF diversion in 87.9% of the patients. A Mini-Mental State Examination (MMSE) value below 21 was associated with nonresponse after shunt insertion (specificity 93%, sensitivity 67%). Resistance to outflow of CSF (ROut) > 12 mm Hg/ml/min was false negative in 21% of patients. Intracranial pulsatility parameters yielded different results in various parameters (correlation coefficient between pulse amplitude and ICP, slow wave amplitude, and mean ICP) but did not correlate to outcome. In multiple linear regression analysis, a calculation of presurgical MMSE versus the value after ELD, ROut, and ICP amplitude quotient during LIFT was significantly associated with outcome (p = 0.04). CONCLUSIONS Despite a multitude of invasive tests, presurgical clinical testing and response to ELD yielded the best prediction for improvement of symptoms following surgery. The complication rate of invasive testing was 5.4%. Multiple and simple linear regression analyses indicated that outcome can only be predicted by a combination of parameters, in accordance with a multifactorial pathogenesis of iNPH. PMID:26824377

  3. Improving Decision Making about Genetic Testing in the Clinic: An Overview of Effective Knowledge Translation Interventions

    Science.gov (United States)

    Légaré, France; Robitaille, Hubert; Gane, Claire; Hébert, Jessica; Labrecque, Michel; Rousseau, François

    2016-01-01

    Background Knowledge translation (KT) interventions are attempts to change behavior in keeping with scientific evidence. While genetic tests are increasingly available to healthcare consumers in the clinic, evidence about their benefits is unclear and decisions about genetic testing are thus difficult for all parties. Objective We sought to identify KT interventions that involved decisions about genetic testing in the clinical context and to assess their effectiveness for improving decision making in terms of behavior change, increased knowledge and wellbeing. Methods We searched for trials assessing KT interventions in the context of genetic testing up to March 2014 in all systematic reviews (n = 153) published by two Cochrane review groups: Effective Practice and Organisation of Care (EPOC) and Consumers and Communication. Results We retrieved 2473 unique trials of which we retained only 28 (1%). Two EPOC reviews yielded two trials of KT interventions: audit and feedback (n = 1) and educational outreach (n = 1). Both targeted health professionals and the KT intervention they assessed was found to be effective. Four Consumers and Communication reviews yielded 26 trials: decision aids (n = 15), communication of DNA-based disease risk estimates (n = 7), personalized risk communication (n = 3) and mobile phone messaging (n = 1). Among these, 25 trials targeted only health consumers or patients and the KT interventions were found to be effective in four trials, partly effective in seven, and ineffective in four. Lastly, only one trial targeted both physicians and patients and was found to be effective. Conclusions More research on the effectiveness of KT interventions regarding genetic testing in the clinical context may contribute to patients making informed value-based decisions and drawing the maximum benefit from clinical applications of genetic and genomic innovations. PMID:26938633

  4. Analysis of clinical features, serologic and cerebrospinal fluid tests in patients with neurosyphilis at different stages

    Directory of Open Access Journals (Sweden)

    Bao-jie WANG

    2016-08-01

    Full Text Available Objective To summarize the clinical features, serologic, cerebrospinal fluid (CSF tests in patients with neurosyphilis at different stages.  Methods A retrospective analysis was made on the clinical features, imaging, serologic and CSF tests, treatment and prognosis of 12 cases diagnosed as neurosyphilis. In those cases, 5 cases were early-stage neurosyphilis, including 4 syphilitic meningitis (meningomyelitis and one meningovascular syphilis; 7 cases were late-stage neurosyphilis, all of whom were general paresis.  Results The serum Treponema pallidum antibody (TP-Ab and rapid plasma regain (RPR tests were positive in all 12 cases. The CSF TP-Ab tests of 12 cases were all positive and CSF RPR tests were positive in 9 cases. In 5 cases of early-stage neurosyphilis, one case had elevated intracranial pressure (ICP, 3 cases presented with elevated white blood cell (WBC, 4 cases had elevated protein concentration. In 7 cases of late-stage neurosyphilis, one case had elevated ICP, 7 cases presented with elevated WBC and protein concentration. CSF cytology showed lymphocyte reaction, mainly small lymphocytes. All cases were treated with different doses of intravenous penicillin or ceftriaxone sodium by intramuscular injection, among whom 8 cases presented improved neuropsychiatric symptoms, while 4 cases had no significant improvement.  Conclusions Neurosyphilis is easy to be misdiagnosed because of various styles of onset and nontypical clinical manifestations. A definite diagnosis depends on clinical manifestations and serologic and CSF examinations. Early diagnosis and standard treatment is essential for improving prognosis and reducing complications. DOI: 10.3969/j.issn.1672-6731.2016.07.005

  5. Assessment of reactivity of three treponemal tests in non-treponemal non-reactive cases from sexually transmitted diseases clinic, antenatal clinic, integrated counselling and testing centre, other different outdoor patient departments/indoor patients of a tertiary care centre and peripheral health clinic attendees

    Directory of Open Access Journals (Sweden)

    M Bala

    2013-01-01

    Full Text Available In India, many state reference centres for sexually transmitted infections perform only a single screening assay for syphilis diagnosis. In this study, Treponema pallidum haemagglutination (TPHA was performed on 1115 Venereal Disease Research Laboratory (VDRL/rapid plasma regain (RPR non-reactive and 107 reactive sera out of 10,489 tested by VDRL/RPR according to the National AIDS Control Organisation syphilis testing protocol. A total of 47 Specimens reactive in TPHA and non-reactive with VDRL test were subjected to fluorescent treponemal antibody absorption and enzyme-immunoassay. Seroprevalence considering both VDRL and TPHA positivity was highest (4.4% in sexually transmitted diseases clinic attendees than in other subject groups. Positivity by two treponemal tests in 24 (2.2% cases non-reactive by VDRL/RPR was representative of the fully treated patients or latent or late syphilis cases. The findings highlight that a suitable treponemal confirmatory test should be performed in all the diagnostic laboratories.

  6. Summarising and validating test accuracy results across multiple studies for use in clinical practice.

    Science.gov (United States)

    Riley, Richard D; Ahmed, Ikhlaaq; Debray, Thomas P A; Willis, Brian H; Noordzij, J Pieter; Higgins, Julian P T; Deeks, Jonathan J

    2015-06-15

    Following a meta-analysis of test accuracy studies, the translation of summary results into clinical practice is potentially problematic. The sensitivity, specificity and positive (PPV) and negative (NPV) predictive values of a test may differ substantially from the average meta-analysis findings, because of heterogeneity. Clinicians thus need more guidance: given the meta-analysis, is a test likely to be useful in new populations, and if so, how should test results inform the probability of existing disease (for a diagnostic test) or future adverse outcome (for a prognostic test)? We propose ways to address this. Firstly, following a meta-analysis, we suggest deriving prediction intervals and probability statements about the potential accuracy of a test in a new population. Secondly, we suggest strategies on how clinicians should derive post-test probabilities (PPV and NPV) in a new population based on existing meta-analysis results and propose a cross-validation approach for examining and comparing their calibration performance. Application is made to two clinical examples. In the first example, the joint probability that both sensitivity and specificity will be >80% in a new population is just 0.19, because of a low sensitivity. However, the summary PPV of 0.97 is high and calibrates well in new populations, with a probability of 0.78 that the true PPV will be at least 0.95. In the second example, post-test probabilities calibrate better when tailored to the prevalence in the new population, with cross-validation revealing a probability of 0.97 that the observed NPV will be within 10% of the predicted NPV.

  7. Evaluation of Methacholine Challenge Test Results in Chronic Cough Patients Referring to Clinic of Pulmonary Disease

    Directory of Open Access Journals (Sweden)

    Derakhshan Deilami Gholamreza

    2009-10-01

    Full Text Available Chronic cough is a common problem in patients visiting physicians and its prevalence in different populations range from 3 to 40%. Postnasal drip, asthma and gastroesophageal reflux are the known cause of chronic cough. Although diagnosis of asthma is usually made by clinical signs and spirometeric results, methacholine challenge test is a good diagnostic test in patients who show normal physical examination and spirometeric results. In this study, the results of methacholine challenge test in chronic cough patients are investigated. This is a cross sectional study performed on patients suffering from chronic cough (over 8 weeks, who went to Pulmonary Disease Clinic of Imam Khomeini Hospital in 2006. Postnasal drip, gastroesophageal reflux was evaluated and ruled out in all patients. Then they were tested by methacholine inhalation using low to high doses of methacholine. The results of test was defined as 20% fall in FEV1 and its relationship with age, sex, history of allergic disease, family history of asthma and smoking status was investigated. 81 patients (36 female and 45 male entered this study who had mean age of 32.5 ± 13.06 years. 81.5% of patients had never smoked or closed contact with smokers, 6.2% were passive smokers, 8.6% were smokers and 3.7% had quit smoking. 37% had suffered from chronic cough less than 6 months, 11% for 6-11 months and 52% for more than 12 months. In 26% of patients, family history of asthma was present and 34.5% had a history of one type of allergy. In 29.5% the results of methacholine challenge test was positive, among them 45.8% showed an intense response and 54.2% a moderate response. The test results and its intensity had no statistically significant relationship with age, sex, smoking status, the duration of cough and family history of asthma, but the relationship between methacholine challenge test and the history of allergic disease was significant. Methacholine challenge test can be used as a

  8. Current practices and challenges in the standardization and harmonization of clinical laboratory tests.

    Science.gov (United States)

    Vesper, Hubert W; Myers, Gary L; Miller, W Greg

    2016-09-01

    Effective patient care, clinical research, and public health efforts require comparability of laboratory results independent of time, place, and measurement procedure. Comparability is achieved by establishing metrological traceability, which ensures that measurement procedures measure the same quantity and that the calibration of measurement procedures is traceable to a common reference system consisting of reference methods and materials. Whereas standardization ensures traceability to the International System of Units, harmonization ensures traceability to a reference system agreed on by convention. This article provides an overview of standardization and harmonization with an emphasis on commutability as an important variable that affects testing accuracy. Commutability of reference materials is required to ensure that traceability is established appropriately and that laboratory results are comparable. The use of noncommutable reference materials leads to inaccurate results. Whereas procedures and protocols for standardizing measurements are established and have been successfully applied in efforts such as the Hormones Standardization Program of the CDC, harmonization activities require new, more complex procedures and approaches. The American Association for Clinical Chemistry, together with its domestic and international partners, formed the International Consortium for Harmonization of Clinical Laboratory Results to coordinate harmonization efforts. Reference systems, as well as procedures and protocols to establish traceability of clinical laboratory tests, have been established and continue to be developed by national and international groups and organizations. Serum tests of thyroid function, including those for the thyroid hormones thyroxine and triiodothyronine, are among the clinical procedures for which standardization efforts are well under way. Approaches to the harmonization of measurement procedures for serum concentrations of thyroid

  9. Angiotensin-converting enzyme

    DEFF Research Database (Denmark)

    Sørensen, P G; Rømer, F K; Cortes, D

    1984-01-01

    In order to evaluate bleomycin-associated lung damage in humans, lung function parameters and serum levels of the endothelial-bound angiotensin-converting enzyme (ACE) were determined by serial measurements in 11 patients who were treated for testicular cancer. None developed clinical or radiolog......In order to evaluate bleomycin-associated lung damage in humans, lung function parameters and serum levels of the endothelial-bound angiotensin-converting enzyme (ACE) were determined by serial measurements in 11 patients who were treated for testicular cancer. None developed clinical...

  10. Comparison between magnetic enzyme-linked immunosorbent assay (MELISA) and complement fixation test (CF) in the diagnosis of paracoccidioidomycosis.

    Science.gov (United States)

    Pires de Camargo, Z; Unterkircher, C; Drouhet, E

    1986-02-01

    MELISA and CF were compared using sera from paracoccidioidomycosis patients before treatment and patients undergoing antimycotic treatment. With MELISA it was possible to distinguish different antibody levels in both groups of patients whereas such distinction was not observed by using CF tests. MELISA is thus an advantageous alternative to CF in the diagnosis of paracoccidioidomycosis, including the possibility of testing sera with anticomplementary activity. PMID:3701544

  11. Investigation of the application of an enzyme-based biodegradability test method to a municipal solid waste biodrying process

    OpenAIRE

    Wagland, Stuart Thomas; Godley, Andrew R.; Tyrrel, Sean F.

    2011-01-01

    This paper presents a study to evaluate the recently developed enzymatic hydrolysis test (EHT) through its repeated application to a waste treatment process. A single waste treatment facility, involving a biodrying process, has been monitored using three different methods to assess the biodegradable content of the organic waste fractions. These test methods were the anaerobic BMc, aerobic DR4 and the EHT, which is a method based on the enzymatic hydrolysis of the cellulosic ...

  12. Rapid antimicrobial susceptibility testing of clinical isolates by digital time-lapse microscopy

    DEFF Research Database (Denmark)

    Fredborg, M; Rosenvinge, F S; Spillum, E;

    2015-01-01

    (168 antimicrobial agent-organism combinations) demonstrated 3.6 % minor, no major and 1.2 % very major errors of the oCelloScope system compared to conventional susceptibility testing, as well as a rapid and correct phenotypic detection of strains with methicillin-resistant Staphylococcus aureus (MRSA......Rapid antimicrobial susceptibility testing (AST) is essential for early and appropriate therapy. Methods with short detection time enabling same-day treatment optimisation are highly favourable. In this study, we evaluated the potential of a digital time-lapse microscope system, the o......CelloScope system, to perform rapid AST. The oCelloScope system demonstrated a very high accuracy (96 % overall agreement) when determining the resistance profiles of four reference strains, nine clinical isolates, including multi-drug-resistant isolates, and three positive blood cultures. AST of clinical isolates...

  13. Selection and Test of L-histidine Decarboxylase Enzyme Activity of Six Isolates of Histamine Forming Bacteria

    Directory of Open Access Journals (Sweden)

    Romauli Aya Sophia

    2007-11-01

    Full Text Available Six isolates of histamine forming bacteria were screened to see the degree of ability in producing histamine on modified Niven's medium. The result showed that the six bacteria were able to produce histamine by giving a pinkish color on the medium, which could be used as a preliminary identification of histamine-forming bacteria (HFB. The isolates were grown in liquid modified Niven medium to measure the production of histamine. The histamine produced were determined by Hardy and Smith method. The result showed that all of the isolates produced high level of histamine (92.35 - 305.49 mg/100 ml of the medium. From all of them, Enterobacter spp. produced the highest level of histamine (305.49 mg/100 ml. A synthetic medium was used to measure the growth pattern and optimum time required by Enterobacter spp and Morganella morganii (as control bacteria to produce the L-histidine decarboxylase enzyme (HDC which is responsible for histamine production. The result showed that for both bacteria, the optimum enzim production was 8 hours after incubation.

  14. Culinary Spice Plants in Dietary Supplement Products and Tested in Clinical Trials.

    Science.gov (United States)

    Saldanha, Leila G; Dwyer, Johanna T; Betz, Joseph M

    2016-03-01

    Dried plant parts used as culinary spices (CSs) in food are permitted as dietary ingredients in dietary supplements (DSs) within certain constraints in the United States. We reviewed the amounts, forms, and nutritional support (structure/function) claims of DSs that contain CS plants listed in the Dietary Supplement Label Database (DSLD) and compared this label information with trial doses and health endpoints for CS plants that were the subject of clinical trials listed in clinicaltrials.gov. According to the DSLD, the CS plants occurring most frequently in DSs were cayenne, cinnamon, garlic, ginger, pepper, rosemary, and turmeric. Identifying the botanical species, categorizing the forms used, and determining the amounts from the information provided on DS labels was challenging. CS plants were typically added as a component of a blend, as the powered biomass, dried extracts, and isolated phytochemicals. The amounts added were declared on about 55% of the labels, rendering it difficult to determine the amount of the CS plant used in many DSs. Clinicaltrials.gov provided little information about the composition of test articles in the intervention studies. When plant names were listed on DS labels and in clinical trials, generally the common name and not the Latin binomial name was given. In order to arrive at exposure estimates and enable researchers to reproduce clinical trials, the Latin binomial name, form, and amount of the CS plant used in DSs and tested in clinical trials must be specified. PMID:26980817

  15. Bisphenol A alters n-6 fatty acid composition and decreases antioxidant enzyme levels in rat testes: a LC-QTOF-based metabolomics study.

    Directory of Open Access Journals (Sweden)

    Minjian Chen

    Full Text Available BACKGROUND: Male reproductive toxicity induced by exposure to bisphenol A (BPA has been widely reported. The testes have proven to be a major target organ of BPA toxicity, so studying testicular metabolite variation holds promise for the discovery of mechanisms linked to the toxic effects of BPA on reproduction. METHODOLOGY/PRINCIPAL FINDINGS: Male Sprague-Dawley rats were orally administered doses of BPA at the levels of 0, 50 mg/kg/d for 8 weeks. We used an unbiased liquid chromatography-quadrupole time-of-flight (LC-QTOF-based metabolomics approach to discover, identify, and analyze the variation of testicular metabolites. Two n-6 fatty acids, linoleic acid (LA and arachidonic acid (AA were identified as potential testicular biomarkers. Decreased levels of LA and increased levels of AA as well as AA/LA ratio were observed in the testes of the exposed group. According to these suggestions, testicular antioxidant enzyme levels were detected. Testicular superoxide dismutase (SOD declined significantly in the exposed group compared with that in the non-exposed group, and the glutathione peroxidase (GSH-Px as well as catalase (CAT also showed a decreasing trend in BPA treated group. CONCLUSIONS/SIGNIFICANCE: BPA caused testicular n-6 fatty acid composition variation and decreased antioxidant enzyme levels. This study emphasizes that metabolomics brings the promise of biomarkers identification for the discovery of mechanisms underlying reproductive toxicity.

  16. A multi-centre phase IIa clinical study of predictive testing for preeclampsia

    DEFF Research Database (Denmark)

    Navaratnam, Kate; Alfirevic, Zarko; Baker, Philip N;

    2013-01-01

    5% of first time pregnancies are complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful screening test exists; consequentially clinicians are unable to offer targeted surveillance or preventative strategies. IMPROvED Consortium members have pioneered...... a personalised medicine approach to identifying blood-borne biomarkers through recent technological advancements, involving mapping of the blood metabolome and proteome. The key objective is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia....

  17. Chlamydia trachomatis Laboratory Strains versus Recent Clinical Isolates: Implications for Routine Microbicide Testing

    OpenAIRE

    Skinner, M. C.; Stamm, W. E.; Lampe, M. L.

    2009-01-01

    A topical microbicide that women can use to prevent sexually transmitted diseases (STDs) is essential, and many microbicide candidates are being tested for activity against human immunodeficiency virus and other STDs, including Chlamydia trachomatis. Screening assays for assessing the activity of microbicides against C. trachomatis are typically done with laboratory-adapted strains, but it is possible that recent clinical isolates may have different susceptibilities to microbicides, as has be...

  18. Laboratory and clinical tests of a prototype pressure sensor for clincial assessment of prosthetic socket fit.

    Science.gov (United States)

    Polliack, A A; Craig, D D; Sieh, R C; Landsberger, S; Mcneal, D R

    2002-04-01

    Lower limb prosthetic socket fabrication is a highly refined process relying on the prosthetist's skill and experience. Despite their best efforts, patients often return with complications. Additionally, clinical application of technological advances for the quantification of biomechanical factors at the socket interface has not changed in practice. Measuring pressure levels at the stump/socket interface could provide valuable information in the process of prosthetic socket fabrication, fit and modification. This paper presents findings on the performance of a prototype capacitance pressure sensor designed for prosthetic socket use. Bench tests using compressed air were performed to measure accuracy, hysteresis and drift responses in both a flatbed chamber and a custom-modified pressure vessel. For the contoured testing, the sensors were placed on nine sites on a positive trans-tibial stump mould and enveloped with a silicone liner. Additionally, a preliminary clinical evaluation was performed with two trans-tibial amputee subjects at the nine sites during normal ambulation. Bench test results showed that the prototype capacitance sensor performed well in all categories, exhibiting a 2.42% (flatbed) and 9.96% (contoured) accuracy error, a 12.93% (flatbed) and 12.95% (contoured) hysteresis error, and a 4.40% (flatbed) and 6.20% (contoured) drift error. The clinical study showed that after three hours of continual use, no noticeable sensor drift occurred between pre and post-test calibration values. The results from this study were encouraging and the authors hope to conduct further laboratory and clinical trials to assess the influence of shear force and dynamic loading on sensor response.

  19. Public health clinic-based hepatitis C testing and linkage to care in Baltimore.

    Science.gov (United States)

    Falade-Nwulia, O; Mehta, S H; Lasola, J; Latkin, C; Niculescu, A; O'Connor, C; Chaulk, P; Ghanem, K; Page, K R; Sulkowski, M S; Thomas, D L

    2016-05-01

    Testing and linkage to care are important determinants of hepatitis C virus (HCV) treatment effectiveness. Public health clinics serve populations at high risk of HCV. We investigated their potential to serve as sites for HCV testing, initiation of and linkage to HCV care. Cross-sectional study of patients accessing sexually transmitted infection (STI) care at the Baltimore City Health Department (BCHD) STI clinics, from June 2013 through April 2014 was conducted. Logistic regression was used to assess factors associated with HCV infection and specialist linkage to care. Between 24 June 2013 and 15 April 2014, 2681 patients were screened for HCV infection. Overall, 189 (7%) were anti-HCV positive, of whom 185 (98%) received follow-up HCV RNA testing, with 155 (84%) testing RNA positive. Of 155 RNA-positive individuals, 138 (89%) returned to the STI clinic for HCV RNA results and initial HCV care including counselling regarding transmission and harm reduction in alcohol, and 132 (85%) were referred to a specialist for HCV care. With provision of patient navigation services, 81 (52%) attended an offsite HCV specialist appointment. Alcohol use and lack of insurance coverage were associated with lower rates of specialist linkage (OR 0.4 [95% CI 0.1-0.9] and OR 0.4 [95% CI 0.1-0.9], respectively). We identified a high prevalence of HCV infection in BCHD STI clinics. With availability of patient navigation services, a large proportion of HCV-infected patients linked to off-site specialist care. PMID:26840570

  20. Coracoid pain test: a new clinical sign of shoulder adhesive capsulitis

    OpenAIRE

    S. Carbone; Gumina, S.; Vestri, A. R.; Postacchini, R.

    2009-01-01

    Patients with adhesive capsulitis were clinically evaluated to establish whether pain elicited by pressure on the coracoid area may be considered a pathognomonic sign of this condition. The study group included 85 patients with primary adhesive capsulitis, 465 with rotator cuff tear, 48 with calcifying tendonitis, 16 with glenohumeral arthritis, 66 with acromioclavicular arthropathy and 150 asymptomatic subjects. The test was considered positive when pain on the coracoid region was more sever...

  1. Perception of HIV testing among attendees at an STD clinic in India.

    Science.gov (United States)

    Subramanian, T; Gupte, M D; Mathai, A K; Boopathi, K; Dorairaj, V S

    2008-01-01

    This study reports perception of STD clinic attendees of Government General hospital, Chennai, India towards free HIV testing. All STD clinic attendees who were eligible for the study (511), from January to April 2001 formed the study subjects. In all, 362 (71%) subjects responded to the question on perception of risk in getting HIV/AIDS. Among them 36% perceived that they were at risk of getting infected with HIV. There was a significant difference (P=0.01) between the genders, as more males perceived risk of getting HIV than females and, with the increase in number of sexual partners in a lifetime there was an increasing trend (pwilling for HIV testing. A significant difference between the genders (pwilling to accept free HIV testing than males. When adjusting the effect of co-variates such as gender, age, marital status and perception of risk in getting HIV, persons having two or more sexual partners in their life time were four times more willing to be HIV tested than persons with one sexual partner (OR=4; p=0.001). The findings in this study will help optimize HIV testing in at risk patient populations in India. PMID:18278612

  2. Diagnostic tests for influenza and other respiratory viruses: determining performance specifications based on clinical setting.

    Science.gov (United States)

    Takahashi, Hiroshi; Otsuka, Yoshihito; Patterson, Bruce K

    2010-06-01

    The lack of sensitivity of rapid immunoassays in detecting the novel 2009 H1N1 influenza virus infection has led to recommendations on influenza diagnostic testing for clinicians treating patients as well as advising clinicians on testing decisions. Studies have also shown that rapid immunoassays for seasonal influenza virus show considerable variability in performance characteristics, based on age of patient, prevalence of disease, course of infection, and the quality of the kit used. While public health authorities are currently focused on influenza virus diagnostics, a lack of sensitivity of rapid immunoassays for other viral respiratory pathogens has been widely reported, such as the very limited value of rapid immunoassays for the detection of respiratory syncytial virus in adults. In light of the lack of sensitivity of diagnostic tests for suspected 2009 H1N1 influenza virus infection, as well as their variable performance characteristics for seasonal influenza virus, a number of recommendations have been made by public health authorities advising clinicians on the need for clinical judgment as an important part of testing and treatment decisions as well as reliance on local epidemiologic and surveillance data. With the availability of new molecular methodologies that are user-friendly and allow the front-line physician as well as hospital infection control programs to significantly improve respiratory viral diagnostics, there is a need to carefully determine the most optimal diagnostic testing methodology based on the clinical setting. This review will describe the historical, current, and changing dynamics of respiratory virus infection diagnostics.

  3. Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial.

    Science.gov (United States)

    Nadjarzadeh, A; Shidfar, F; Amirjannati, N; Vafa, M R; Motevalian, S A; Gohari, M R; Nazeri Kakhki, S A; Akhondi, M M; Sadeghi, M R

    2014-03-01

    Low seminal plasma concentrations of coenzyme Q10 (CoQ10) have been correlated with impaired sperm parameters, but the exact mechanism remains of dominating interest. This randomised, placebo-controlled study examined the effect of CoQ10 on catalase, superoxide dismutase (SOD) and F2 -isoprostanes in seminal plasma in infertile men and their relation with CoQ10 concentration. Sixty infertile men with idiopathic oligoasthenoteratozoospermia (OAT) were randomised to receive 200 mg d(-1) of CoQ10 or placebo for 3 months. 47 persons of them completed the study. Semen analysis, anthropometric measurements, diet and physical activity assessment were performed for subjects before and after treatment. Independent and paired t-test, chi-square test and ancova were compared outcomes of supplementation between two groups. CoQ10 levels increased from 44.74 ± 36.47 to 68.17 ± 42.41 ng ml(-1) following supplementation in CoQ10 (P concentration and normal sperm morphology (P = 0.037), catalase (P = 0.041) and SOD (P enzymes activity.

  4. An integrated electrochemical device based on immunochromatographic test strip and enzyme labels for sensitive detection of disease-related biomarkers

    Energy Technology Data Exchange (ETDEWEB)

    Zou, Zhexiang; Wang, Jun; Wang, Hua; Li, Yao Q.; Lin, Yuehe

    2012-05-30

    A novel electrochemical biosensing device that integrates an immunochromatographic test strip and a screen-printed electrode (SPE) connected to a portable electrochemical analyzer was presented for rapid, sensitive, and quantitative detection of disease-related biomarker in human blood samples. The principle of the sensor is based on sandwich immunoreactions between a biomarker and a pair of its antibodies on the test strip, followed by highly sensitive square-wave voltammetry (SWV) detection. Horseradish peroxidase (HRP) was used as a signal reporter for electrochemical readout. Hepatitis B surface antigen (HBsAg) was employed as a model protein biomarker to demonstrate the analytical performance of the sensor in this study. Some critical parameters governing the performance of the sensor were investigated in detail. The sensor was further utilized to detect HBsAg in human plasma with an average recovery of 91.3%. In comparison, a colorimetric immunochromatographic test strip assay (ITSA) was also conducted. The result shows that the SWV detection in the electrochemical sensor is much more sensitive for the quantitative determination of HBsAg than the colorimetric detection, indicating that such a sensor is a promising platform for rapid and sensitive point-of-care testing/screening of disease-related biomarkers in a large population

  5. Testing the effect of different enzyme blends on increasing the biogas yield of straw and digested manure fibers

    DEFF Research Database (Denmark)

    Njoku, Stephen Ikechukwu; Jurado, Esperanza; Malmgren-Hansen, Bjørn;

    In this study, enzymatic treatment was tested to increase the biogas yield of wheat straw (WS) and digested manure fibers (DMF) in the Re-Injection Loop Concept, which combines anaerobic digestion with solid separation to enhance the biogas yield per ton of manure by: 1. Digestion of the easily d...

  6. Clinical neuropathology practice guide 06-2012: MGMT testing in elderly glioblastoma patients – yes, but how?

    OpenAIRE

    Berghoff, Anna S.; Preusser, Matthias

    2012-01-01

    Abstract. In 2005, a seminal paper showed that glioblastoma patients aged 18 to 70, whose tumors have a methylated MGMT promoter have a better prognosis than patients with tumors carrying an unmethylated MGMT promoter. As a consequence of this and several confirmatory studies, routine MGMT testing in the clinical setting was promoted. However, only few centers have indeed implemented routine clinical MGMT testing, mostly due the lack of clear clinical consequence and because of considerable t...

  7. Optimisation and assessment of three modern touch screen tablet computers for clinical vision testing.

    Directory of Open Access Journals (Sweden)

    Humza J Tahir

    Full Text Available Technological advances have led to the development of powerful yet portable tablet computers whose touch-screen resolutions now permit the presentation of targets small enough to test the limits of normal visual acuity. Such devices have become ubiquitous in daily life and are moving into the clinical space. However, in order to produce clinically valid tests, it is important to identify the limits imposed by the screen characteristics, such as resolution, brightness uniformity, contrast linearity and the effect of viewing angle. Previously we have conducted such tests on the iPad 3. Here we extend our investigations to 2 other devices and outline a protocol for calibrating such screens, using standardised methods to measure the gamma function, warm up time, screen uniformity and the effects of viewing angle and screen reflections. We demonstrate that all three devices manifest typical gamma functions for voltage and luminance with warm up times of approximately 15 minutes. However, there were differences in homogeneity and reflectance among the displays. We suggest practical means to optimise quality of display for vision testing including screen calibration.

  8. Clinically available RNA profiling tests of prostate tumors: utility and comparison

    Directory of Open Access Journals (Sweden)

    Rong Na

    2016-01-01

    Full Text Available In the postscreening era, physicians are in need of methods to discriminate aggressive from nonaggressive prostate cancer (PCa to reduce overdiagnosis and overtreatment. However, studies have shown that prognoses (e.g., progression and mortality differ even among individuals with similar clinical and pathological characteristics. Existing risk classifiers (TMN grading system, Gleason score, etc. are not accurately enough to represent the biological features of PCa. Using new genomic technologies, novel biomarkers and classifiers have been developed and shown to add value to clinical or pathological risk factors for predicting aggressive disease. Among them, RNA testing (gene expression analysis is useful because it can not only reflect genetic variations but also reflect epigenetic regulations. Commercially available RNA profiling tests (Oncotype Dx, Prolaris, and Decipher have demonstrated strong abilities to discriminate PCa with poor prognosis from less aggressive diseases. For instance, these RNA profiling tests can predict disease progression in active surveillance patients or early recurrence after radical treatments. These tests may offer more dependable methods for PCa prognosis prediction to make more accurate and personal medical decisions.

  9. Optimisation and assessment of three modern touch screen tablet computers for clinical vision testing.

    Science.gov (United States)

    Tahir, Humza J; Murray, Ian J; Parry, Neil R A; Aslam, Tariq M

    2014-01-01

    Technological advances have led to the development of powerful yet portable tablet computers whose touch-screen resolutions now permit the presentation of targets small enough to test the limits of normal visual acuity. Such devices have become ubiquitous in daily life and are moving into the clinical space. However, in order to produce clinically valid tests, it is important to identify the limits imposed by the screen characteristics, such as resolution, brightness uniformity, contrast linearity and the effect of viewing angle. Previously we have conducted such tests on the iPad 3. Here we extend our investigations to 2 other devices and outline a protocol for calibrating such screens, using standardised methods to measure the gamma function, warm up time, screen uniformity and the effects of viewing angle and screen reflections. We demonstrate that all three devices manifest typical gamma functions for voltage and luminance with warm up times of approximately 15 minutes. However, there were differences in homogeneity and reflectance among the displays. We suggest practical means to optimise quality of display for vision testing including screen calibration.

  10. Clinically available RNA profiling tests of prostate tumors: utility and comparison

    Science.gov (United States)

    Na, Rong; Wu, Yishuo; Ding, Qiang; Xu, Jianfeng

    2016-01-01

    In the postscreening era, physicians are in need of methods to discriminate aggressive from nonaggressive prostate cancer (PCa) to reduce overdiagnosis and overtreatment. However, studies have shown that prognoses (e.g., progression and mortality) differ even among individuals with similar clinical and pathological characteristics. Existing risk classifiers (TMN grading system, Gleason score, etc.) are not accurately enough to represent the biological features of PCa. Using new genomic technologies, novel biomarkers and classifiers have been developed and shown to add value to clinical or pathological risk factors for predicting aggressive disease. Among them, RNA testing (gene expression analysis) is useful because it can not only reflect genetic variations but also reflect epigenetic regulations. Commercially available RNA profiling tests (Oncotype Dx, Prolaris, and Decipher) have demonstrated strong abilities to discriminate PCa with poor prognosis from less aggressive diseases. For instance, these RNA profiling tests can predict disease progression in active surveillance patients or early recurrence after radical treatments. These tests may offer more dependable methods for PCa prognosis prediction to make more accurate and personal medical decisions. PMID:26975490

  11. Optimization of alkylating agent prodrugs derived from phenol and aniline mustards: a new clinical candidate prodrug (ZD2767) for antibody-directed enzyme prodrug therapy (ADEPT).

    Science.gov (United States)

    Springer, C J; Dowell, R; Burke, P J; Hadley, E; Davis, D H; Blakey, D C; Melton, R G; Niculescu-Duvaz, I

    1995-12-22

    Sixteen novel potential prodrugs derived from phenol or aniline mustards and their 16 corresponding drugs with ring substitution and/or different alkylating functionalities were designed. The [[[4-]bis(2-bromoethyl)-(1a), [[[4-[bis(2-iodoethyl)-(1b), and [[[4-[(2-chloroethyl)-[2-(mesyloxy)ethyl]amino]phenyl]oxy] carbonyl]-L-glutamic acids (1c), their [[[2- and 3-substituted-4-[bis(2-chloroethyl)amino]phenyl]oxy]carbonyl]-L- glutamic acids (1e-1), and the [[3-substituted-4-[bis(2-chloroethyl)amino]phenyl]carbamoyl]-L- glutamic acids (1o-r) were synthesized. They are bifunctional alkylating agents in which the activating effect of the phenolic hydroxyl or amino function is masked through an oxycarbonyl or a carbamoyl bond to a glutamic acid. These prodrugs were designed to be activated to their corresponding phenol and aniline nitrogen mustard drugs at a tumor site by prior administration of a monoclonal antibody conjugated to the bacterial enzyme carboxypeptidase G2 (CPG2) in antibody-directed enzyme prodrug therapy (ADEPT). The synthesis of the analogous novel parent drugs (2a-r) is also described. The viability of a colorectal cell line (LoVo) was monitored with the potential prodrugs and the parent drugs. The differential in the cytotoxicity between the potential prodrugs and their corresponding active drugs ranged between 12 and > 195 fold. Compounds 1b-d,f,o exhibited substantial prodrug activity, since a cytotoxicity differential of > 100 was achieved compared to 2b-d,f,o respectively. The ability of the potential prodrugs to act as substrates for CPG2 was determined (kinetic parameters KM and kcat), and the chemical stability was measured for all the compounds. The unsubstituted phenols with different alkylating functionalities (1a-c) proved to have the highest ratio of the substrates kcat:KM. From these studies [[[4-[bis(2-iodoethyl)amino]phenyl]oxy]carbonyl]-L-glutamic acid (1b) emerges as a new ADEPT clinical trial candidate due to its physicochemical and

  12. COMPARATIVE EFFICIENCY OF SOME INDIRECT DIAGNOSTIC TESTS FOR THE DETECTION OF SUB-CLINICAL MASTITIS IN COWS AND BUFFALOES

    OpenAIRE

    M. IQBAL, M. AMJED1, M. A. KHAN, M. S. QURESHI1 AND U. SADIQUE1

    2006-01-01

    The present study was undertaken to compare five laboratory diagnostic tests for sub-clinical mastitis in cattle and buffaloes and to compute cost, time taken by each test and its ranking for availability, adoptability, interpretability and sensitivity. There were 352 cases with each test type viz. California Mastitis Test (CMT), White Side Test (WST), White Side + Dye (WSTD), Surf Test and Surf + Dye, and 880 cases with each species type (cattle and buffaloes). Result scores (1760 ) for sub...

  13. Clinically isolated laryngeal sarcoidosis

    DEFF Research Database (Denmark)

    Plaschke, Christina Caroline; Owen, Hanne Hoejris; Rasmussen, Niels

    2011-01-01

    to a combination of CO(2)-laser excision of supraglottic tissue and closure of the incision with sutures. All serological tests were negative or normal, including angiotensin 1 converting enzyme. The clinical expression was uniform with pale, smooth swellings of the supraglottic structures. Surgery proved...

  14. Impact of molybdenum nanoparticles on survival, activity of enzymes, and chemical elements in Eisenia fetida using test on artificial substrata.

    Science.gov (United States)

    Lebedev, Sviatoslav; Yausheva, Elena; Galaktionova, Lyudmila; Sizova, Elena

    2016-09-01

    The influence of molybdenum oxide nanoparticles (MoO3) on the growth and survival of Eisenia fetida was established. The activity of antioxidant enzymes and changes in concentration of molybdenum in the body of E. fetida were determined. The degree of bacterial bioluminescence inhibition in extracts of substrates and worm was studied using luminescent strain Escherichia coli K12 TG1. The enzymatic activity of substrates before and after exposure with nanoparticles and worms was assessed. Nanoparticles have concentrations of 10, 40, and 500 mg/kg of dry matter, and substrata are made of artificial soil (substrate A) and microcrystalline cellulose (substrate B). Spherical nanoparticles MoO3, yellow in color, with size 92 ± 0.3 nm, Z-potential 42 ± 0.52 mV, molybdenum content 99.8 mass/%, and specific area 12 m(2)/g were used in the study. A significant decrease by 23.3 % in weight was registered (for MoO3 NPs at 500 mg/kg) on substrate A (p ≤ 0.05). On substrate B, the maximum decrease in weight by 20.5, 33.3, and 16.9 % (p ≤ 0.05) was registered at a dose of 10, 40, and 500 mg/kg, respectively; mortality was from 6.6 to 73 %. After the assessment of bacterial bioluminescence inhibition in substrates A and B (extracts) and before worms were put, the toxicity of substrates was established at doses of 40 and 500 mg/kg, expressed in inhibitory concentration (IC) 30 and IC 50 values. Comparatively, on days 7 and 14, after exposure in the presence of E. fetida, no inhibition of bioluminescence was registered in extracts of substrates A and B, indicating the reduction in toxicity of substrates. The initial content of molybdenum in E. fetida was 0.9 ± 0.018 mg/kg of dry matter. The degree of molybdenum accumulation in worm tissue was dependent on the dose and substrate quality. In particular, 2-7 mg/kg of molybdenum accumulated from substrate A, while up to 15 kg/kg of molybdenum accumulated from substrate B (day 7). Molybdenum

  15. Impact of molybdenum nanoparticles on survival, activity of enzymes, and chemical elements in Eisenia fetida using test on artificial substrata.

    Science.gov (United States)

    Lebedev, Sviatoslav; Yausheva, Elena; Galaktionova, Lyudmila; Sizova, Elena

    2016-09-01

    The influence of molybdenum oxide nanoparticles (MoO3) on the growth and survival of Eisenia fetida was established. The activity of antioxidant enzymes and changes in concentration of molybdenum in the body of E. fetida were determined. The degree of bacterial bioluminescence inhibition in extracts of substrates and worm was studied using luminescent strain Escherichia coli K12 TG1. The enzymatic activity of substrates before and after exposure with nanoparticles and worms was assessed. Nanoparticles have concentrations of 10, 40, and 500 mg/kg of dry matter, and substrata are made of artificial soil (substrate A) and microcrystalline cellulose (substrate B). Spherical nanoparticles MoO3, yellow in color, with size 92 ± 0.3 nm, Z-potential 42 ± 0.52 mV, molybdenum content 99.8 mass/%, and specific area 12 m(2)/g were used in the study. A significant decrease by 23.3 % in weight was registered (for MoO3 NPs at 500 mg/kg) on substrate A (p ≤ 0.05). On substrate B, the maximum decrease in weight by 20.5, 33.3, and 16.9 % (p ≤ 0.05) was registered at a dose of 10, 40, and 500 mg/kg, respectively; mortality was from 6.6 to 73 %. After the assessment of bacterial bioluminescence inhibition in substrates A and B (extracts) and before worms were put, the toxicity of substrates was established at doses of 40 and 500 mg/kg, expressed in inhibitory concentration (IC) 30 and IC 50 values. Comparatively, on days 7 and 14, after exposure in the presence of E. fetida, no inhibition of bioluminescence was registered in extracts of substrates A and B, indicating the reduction in toxicity of substrates. The initial content of molybdenum in E. fetida was 0.9 ± 0.018 mg/kg of dry matter. The degree of molybdenum accumulation in worm tissue was dependent on the dose and substrate quality. In particular, 2-7 mg/kg of molybdenum accumulated from substrate A, while up to 15 kg/kg of molybdenum accumulated from substrate B (day 7). Molybdenum

  16. Targeted testing with diethylthiourea often reveals clinically relevant allergic contact dermatitis caused by neoprene rubber

    DEFF Research Database (Denmark)

    Dall, Anne B-H; Andersen, Klaus Ejner; Mortz, Charlotte G

    2012-01-01

    Background. Diethylthiourea is widely used in the rubber industry, particularly in neoprene rubber, and may cause allergic contact dermatitis. However, as thiourea allergens are not part of the European baseline series, the diagnosis of allergic contact dermatitis caused by thiourea compounds...... depends on clinical suspicion and aimed testing. Objectives. The aims of this study were to evaluate the occurrence of sensitization to diethylthiourea during a 19-year period by using data from the Allergen Bank database at the Department of Dermatology and Allergy Centre, Odense University Hospital, and...... Bank. The records for patients with positive reactions were evaluated retrospectively. Results. One hundred and fifty-one patients were tested by 27 different dermatologists in private practice, and positive reactions were found in 16% (24/151) of the patients; 88 patients were tested at the...

  17. Validation of the Danish Addenbrooke's Cognitive Examination as a screening test in a memory clinic

    DEFF Research Database (Denmark)

    Stokholm, Jette; Vogel, Asmus; Johannsen, Peter;

    2009-01-01

    BACKGROUND: Addenbrooke's Cognitive Examination (ACE) is a cognitive screening test developed to detect dementia. It has been validated in several countries. Validation studies have predominantly included patients with various degrees of dementia and healthy controls. OBJECTIVE: The aim...... of this study was to evaluate the Danish version of ACE as a screening test for early dementia in an outpatient memory clinic. Further, we wanted to investigate the ability of the ACE to discriminate patients with early Alzheimer's disease (AD) from patients with depression. METHOD: 78 patients with mild AD......-off points for optimal trade-off between sensitivity and specificity for ACE were 85/86 (sensitivity 0.99, specificity 0.94). When these cut-off points were applied to the group of depressive patients, the specificity dropped to 0.64, indicating a great overlap in individual test scores for demented...

  18. Validity of Commonly Used Clinical Tests to Diagnose and Screen for Spinal Pain in Adolescents

    DEFF Research Database (Denmark)

    Aartun, Ellen; Hartvigsen, Jan; Hestbaek, Lise

    2016-01-01

    OBJECTIVE: The overall aim of this study was to determine the ability of 2 selected clinical tests to detect or predict neck pain, mid back pain, and low back pain in a school-based cohort of Danish 11- to 15-year-olds. METHODS: A school-based 2-year prospective cohort study was conducted. Data...... were collected at the age of 11 to 13 (n = 1224) and 2 years later (n = 963). Spinal pain (neck pain, mid back pain, and low back pain) was assessed by an electronic survey completed during school time, and reference standard was defined as both lifetime prevalence and frequent pain as a proxy...... of severity. The tests included assessments of scoliosis, hypermobility, global mobility, intersegmental mobility, end range pain, and isometric endurance of back extensors. Sensitivity, specificity, negative and positive predictive values, and odds ratios were calculated for each test individually, and area...

  19. A Rapid In-Clinic Test Detects Acute Leptospirosis in Dogs with High Sensitivity and Specificity

    Directory of Open Access Journals (Sweden)

    Angeli Kodjo

    2016-01-01

    Full Text Available A rapid IgM-detection immunochromatographic test (WITNESS® Lepto, Zoetis has recently become available to identify acute canine leptospirosis at the point of care. Diagnostic sensitivity and specificity of the test were evaluated by comparison with the microscopic agglutination assay (MAT, using a positive cut-off titer of ≥800. Banked serum samples from dogs exhibiting clinical signs and suspected leptospirosis were selected to form three groups based on MAT titer: (1 positive (n=50; (2 borderline (n=35; and (3 negative (n=50. Using an analysis to weight group sizes to reflect French prevalence, the sensitivity and specificity were 98% and 93.5% (88.2% unweighted, respectively. This test rapidly identifies cases of acute canine leptospirosis with high levels of sensitivity and specificity with no interference from previous vaccination.

  20. A Rapid In-Clinic Test Detects Acute Leptospirosis in Dogs with High Sensitivity and Specificity.

    Science.gov (United States)

    Kodjo, Angeli; Calleja, Christophe; Loenser, Michael; Lin, Dan; Lizer, Joshua

    2016-01-01

    A rapid IgM-detection immunochromatographic test (WITNESS® Lepto, Zoetis) has recently become available to identify acute canine leptospirosis at the point of care. Diagnostic sensitivity and specificity of the test were evaluated by comparison with the microscopic agglutination assay (MAT), using a positive cut-off titer of ≥800. Banked serum samples from dogs exhibiting clinical signs and suspected leptospirosis were selected to form three groups based on MAT titer: (1) positive (n = 50); (2) borderline (n = 35); and (3) negative (n = 50). Using an analysis to weight group sizes to reflect French prevalence, the sensitivity and specificity were 98% and 93.5% (88.2% unweighted), respectively. This test rapidly identifies cases of acute canine leptospirosis with high levels of sensitivity and specificity with no interference from previous vaccination. PMID:27110562

  1. Use of enzyme immunoassay (ELISA) for monitoring effectiveness of rinderpest vaccination and comparative evaluation with Agar-Gel immunodiffusion test

    International Nuclear Information System (INIS)

    In line with other countries participating in the Pan African Rinderpest Campaign, Ghana wishes to monitor the success of a national rinderpest vaccination campaign. This involves the collection of sera from throughout the country in an epidemiologically acceptable manner and the use of a serological procedure that can test the sera for the presence of antibodies to the rinderpest virus. A comparison was carried out between an FAO/IAEA ELISA based system and an Agar-Gel Immunodiffusion test for the detection of antibodies to rinderpest virus in cattle. the ELISA was found to be faster than the Agar-Gel test, could handle larger number of samples in a short time and could detect lower levels than of immunoglobulins. Utilising the ELISA system to examine sera collected in two surveys of 3,500 and 1,818 samples from three regions (Greater Accra, Central and Volta regions) a very marked variable rate of seroconversion was demonstrated with levels lower than the desired 85%. It would appear that the primary cause of these lower than expected levels was related to an inadequate cold-chain. (author). 7 refs, 1 fig., 4 tabs

  2. Impact of clinical awareness and diagnostic tests on the underdiagnosis of Clostridium difficile infection.

    Science.gov (United States)

    Alcalá, L; Reigadas, E; Marín, M; Martín, A; Catalán, P; Bouza, E

    2015-08-01

    A multicenter study of Clostridium difficile infection (CDI) performed during 2008 in Spain revealed that two of every three episodes went undiagnosed or were misdiagnosed owing to nonsensitive diagnostic tests or lack of clinical suspicion and request. Since then, efforts have been made to improve the diagnostic tests used by laboratories and to increase the awareness of this disease among both clinicians and microbiologists. Our objective was to evaluate the impact of these efforts by assessing the current magnitude of underdiagnosis of CDI in Spain using two point-prevalence studies performed on one day each in January and July of 2013. A total of 111 Spanish laboratories selected all unformed stool specimens received for microbiological diagnosis on these days, and toxigenic culture was performed at a central reference laboratory. Toxigenic isolates were characterized both pheno- and genotypically. The reference laboratory detected 103 episodes of CDI in patients aged 2 years or more. Half (50.5 %) of the episodes were not diagnosed in the participating laboratories, owing to insensitive diagnostic tests (15.5 %) or the lack of clinical suspicion and request (35.0 %). The main ribotypes were 014, 078/126, 001/072, and 106. Ribotype 027 caused 2.9 % of all cases. Despite all the interventions undertaken, CDI remains a highly neglected disease because of the lack of sensitive diagnostic tests in some institutions and, especially, the absence of clinical suspicion, mainly in patients with community-associated CDI. Toxigenic C. difficile should be routinely sought in unformed stools sent for microbiological diagnosis, regardless of their origin.

  3. Genetic Testing as a New Standard for Clinical Diagnosis of Color Vision Deficiencies

    Science.gov (United States)

    Davidoff, Candice; Neitz, Maureen; Neitz, Jay

    2016-01-01

    Purpose The genetics underlying inherited color vision deficiencies is well understood: causative mutations change the copy number or sequence of the long (L), middle (M), or short (S) wavelength sensitive cone opsin genes. This study evaluated the potential of opsin gene analyses for use in clinical diagnosis of color vision defects. Methods We tested 1872 human subjects using direct sequencing of opsin genes and a novel genetic assay that characterizes single nucleotide polymorphisms (SNPs) using the MassArray system. Of the subjects, 1074 also were given standard psychophysical color vision tests for a direct comparison with current clinical methods. Results Protan and deutan deficiencies were classified correctly in all subjects identified by MassArray as having red–green defects. Estimates of defect severity based on SNPs that control photopigment spectral tuning correlated with estimates derived from Nagel anomaloscopy. Conclusions The MassArray assay provides genetic information that can be useful in the diagnosis of inherited color vision deficiency including presence versus absence, type, and severity, and it provides information to patients about the underlying pathobiology of their disease. Translational Relevance The MassArray assay provides a method that directly analyzes the molecular substrates of color vision that could be used in combination with, or as an alternative to current clinical diagnosis of color defects.

  4. The clinical utility of HPV DNA testing in cervical cancer screening strategies.

    Science.gov (United States)

    Bhatla, Neerja; Moda, Nidhi

    2009-09-01

    Cervical cancer continues to be the commonest cause of death among women in developing countries, largely due to the failure to the inability to sustain effective cytology-based screening programs. While this burden may come down following implementation of the human papillomavirus (HPV) vaccine, screening will still be required. HPV DNA testing is a promising new technology for cervical cancer prevention and is the most reproducible of all cervical cancer screening tests. Presently, the two assays most widely used for the detection of genital types are the polymerase chain reaction (PCR) and Hybrid Capture 2 assays (hc2). Rapid, affordable tests are expected to be available soon. HPV DNA testing can be used in a variety of clinical scenarios that include primary screening in women older than 30 yr; as an adjunctive test to cytology; in the triage of women with an equivocal cytologic report, e.g., ASC-US; or for follow-up post-treatment for cervical intraepithelial neoplasia (CIN). HPV DNA testing can also be performed on self-collected samples, which allows screening in remote areas and also in women who refuse gynecologic examination. PMID:19901435

  5. The clinical utility of HPV DNA testing in cervical cancer screening strategies.

    Science.gov (United States)

    Bhatla, Neerja; Moda, Nidhi

    2009-09-01

    Cervical cancer continues to be the commonest cause of death among women in developing countries, largely due to the failure to the inability to sustain effective cytology-based screening programs. While this burden may come down following implementation of the human papillomavirus (HPV) vaccine, screening will still be required. HPV DNA testing is a promising new technology for cervical cancer prevention and is the most reproducible of all cervical cancer screening tests. Presently, the two assays most widely used for the detection of genital types are the polymerase chain reaction (PCR) and Hybrid Capture 2 assays (hc2). Rapid, affordable tests are expected to be available soon. HPV DNA testing can be used in a variety of clinical scenarios that include primary screening in women older than 30 yr; as an adjunctive test to cytology; in the triage of women with an equivocal cytologic report, e.g., ASC-US; or for follow-up post-treatment for cervical intraepithelial neoplasia (CIN). HPV DNA testing can also be performed on self-collected samples, which allows screening in remote areas and also in women who refuse gynecologic examination.

  6. Feasibility of HIV Universal Voluntary Counseling and Testing in a Thai General Practice Clinic.

    Science.gov (United States)

    Khawcharoenporn, Thana; Apisarnthanarak, Anucha; Chunloy, Krongtip; Smith, Kimberly

    2016-05-01

    An HIV transmission prevention program incorporating universal voluntary counseling and testing (UVCT) was conducted in a general practice (GP) clinic of a Thai hospital. Of the 494 participating patients, 356 (72%) accepted HIV-UVCT. Independent factors associated with HIV-UVCT acceptance included participating in the program after office hours (4-8 pm; P marriage (P = .01), and having primary school education or less (P = .02). The main reasons for declining HIV-UVCT were time constraint (38%) and perceiving self as no risk (35%). Among the 356 patients undergoing HIV-UVCT, having moderate to high HIV risk (P homosexual men. The findings suggest feasibility of HIV-UVCT in our GP clinic and factors to be considered for improving the program. PMID:24759448

  7. Evaluation of oxidative stress and whole blood viscosity for clinical laboratory testing of smoking toxicity

    Directory of Open Access Journals (Sweden)

    Ezekiel U. Nwose

    2016-06-01

    Full Text Available Background: There are no clearly established clinical biochemical markers for cigarette smoking despite the knowledge that cigarette smoking is a risk factor for various diseases, especially cardiovascular complications of respiratory pathologies. However, there are reports of significant increases in blood viscosity and oxidative stress among smokers. The main objective of the study was to ascertain the association of toxicity from cigarette smoking on whole blood viscosity in our data. Methods: This study analysed the archived clinical data of 20 cigarette smokers and 20 apparently healthy individuals. Results: The data show that on average, oxidative stress levels are relatively the same between groups, while whole blood viscosity is statistically significantly lower in non-smokers compared to smokers. Conclusions: This report suggests that oxidative stress induced whole blood hyper-viscosity could be a valid biomarker for laboratory testing of smoking toxicity among cigarette smokers. [Int J Res Med Sci 2016; 4(6.000: 2332-2336

  8. Evaluation of Clinical Decision Rules for Bone Mineral Density Testing among White Women

    Directory of Open Access Journals (Sweden)

    Michael E. Anders

    2013-01-01

    Full Text Available Background. Osteoporosis is a devastating, insidious disease that causes skeletal fragility. Half of women will suffer osteoporotic fractures during their lifetimes. Many fractures occur needlessly, because of inattentiveness to assessment, diagnosis, prevention, and treatment of osteoporosis. Study Purpose. Study Purpose. To evaluate the discriminatory performance of clinical decision rules to determine the need to undergo bone mineral density testing. Methods. A nationally representative sample from the Third National Health and Nutrition Examination Survey consisted of 14,060 subjects who completed surveys, physical examinations, laboratory tests, and bone mineral density exams. Multivariable linear regression tested the correlation of covariates that composed the clinical decision rules with bone mineral density. Results. Increased age and decreased weight were variables in the final regression models for each gender and race/ethnicity. Among the indices, the Osteoporosis Self-Assessment Tool, which is composed of age and weight, performed best for White women. Study Implications. These results have implications for the prevention, assessment, diagnosis, and treatment of osteoporosis. The Osteoporosis Self-Assessment Tool performed best and is inexpensive and the least time consuming to implement.

  9. Clinically significant anaerobic bacteria isolated from patients in a South African academic hospital: antimicrobial susceptibility testing.

    Science.gov (United States)

    Naidoo, S; Perovic, O; Richards, G A; Duse, A G

    2011-09-27

    BACKGROUND. Increasing resistance to some antimicrobial agents among anaerobic bacteria has made susceptibility patterns less predictable. METHOD. This was a prospective study of the susceptibility data of anaerobic organisms isolated from clinical specimens from patients with suspected anaerobic infections from June 2005 until February 2007. Specimens were submitted to the microbiology laboratory at Charlotte Maxeke Johannesburg Academic Hospital, where microscopy, culture and susceptibility testing were performed the using E test® strip minimum inhibitory concentration method. Results were interpreted with reference to Clinical and Laboratory Standards Institute guidelines for amoxicillin-clavulanate, clindamycin, metronidazole, penicillin, ertapenem, cefoxitin, ceftriaxone, chloramphenicol and piperacillin-tazobactam. RESULTS. One hundred and eighty anaerobic isolates were submitted from 165 patients. The most active antimicrobial agents were chloramphenicol (100% susceptible), ertapenem (97.2%), piperacillin-tazobactam (99.4%) and amoxicillin-clavulanic acid (96.7%). Less active were metronidazole (89.4%), cefoxitin (85%), clindamycin (81.7%), ceftriaxone (68.3%) and penicillin (33.3%). CONCLUSION. Susceptibility testing should be performed periodically to identify emerging trends in resistance and to modify empirical treatment of anaerobic infections.

  10. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. Trandolapril Cardiac Evaluation (TRACE) Study Group

    DEFF Research Database (Denmark)

    Køber, L; Torp-Pedersen, C; Carlsen, J E;

    1995-01-01

    BACKGROUND. Treatment with angiotensin-converting-enzyme (ACE) inhibitors reduces mortality among survivors of acute myocardial infarction, but whether to use ACE inhibitors in all patients or only in selected patients is uncertain. METHODS. We screened 6676 consecutive patients with 7001...... myocardial infarctions confirmed by enzyme studies. A total of 2606 patients had echocardiographic evidence of left ventricular systolic dysfunction (ejection fraction,

  11. Evaluation of enzyme-linked immunosorbent assays and a haemagglutination inhibition tests for the detection of antibodies to Newcastle disease virus in village chickens using a Bayesian approach.

    Science.gov (United States)

    Chaka, H; Thompson, P N; Goutard, F; Grosbois, V

    2015-04-01

    Newcastle disease (ND) is an endemic disease in village chickens in Ethiopia with substantial economic importance. The sensitivity (Se) and specificity (Sp) of a blocking enzyme-linked immunosorbent assay (bELISA, Svanova Biotech), indirect ELISA (iELISA, Laboratoire Service International) and haemagglutination inhibition (HI) test for ND virus (NDV) antibody detection were evaluated in a Bayesian framework in the absence of a gold standard test, on sera collected from unvaccinated chickens kept under the village production system in household flocks and at markets in two woredas (i.e. districts) of the Eastern Shewa zone, Ethiopia. The outcomes of the iELISA test differed dramatically from those of the two other tests with 92% of the samples testing positive as compared with less than 15% for bELISA and HI. iELISA results were also inconsistent with previous estimations of Newcastle serological prevalence. The information provided by the iELISA test was thus considered as highly unreliable, probably due to an extremely low specificity, and thus not considered in the Bayesian models aiming at estimating serological prevalence and test performance parameters. Bayesian modelling of HI and bELISA test results suggested that bELISA had both the highest Se (86.6%; 95% posterior credible interval (PCI): 61.8%; 98.5%), and the highest Sp (98.3%; 95% PCI: 97.2%; 99.5%), while HI had a Se of 80.2% (95% PCI: 59.1%; 94.3%), and a Sp of 96.1% (95% PCI: 95.1%; 97.4%). Model selection and the range of the posterior distribution of the correlation between bELISA and HI test outcomes for truly seropositive animals (median at 0.461; PCI: -0.055; 0.894) suggested a tendency for bELISA and HI to detect the same truly positive animals and to fail to detect the same truly positive animals. The use of bELISA in screening and surveillance for NDV antibodies is indicated given its high Se and Sp, in addition to its ease of automation to handle large numbers of samples compared to HI. The

  12. Clinical Validation of 4-Dimensional Computed Tomography Ventilation With Pulmonary Function Test Data

    International Nuclear Information System (INIS)

    Purpose: A new form of functional imaging has been proposed in the form of 4-dimensional computed tomography (4DCT) ventilation. Because 4DCTs are acquired as part of routine care for lung cancer patients, calculating ventilation maps from 4DCTs provides spatial lung function information without added dosimetric or monetary cost to the patient. Before 4DCT-ventilation is implemented it needs to be clinically validated. Pulmonary function tests (PFTs) provide a clinically established way of evaluating lung function. The purpose of our work was to perform a clinical validation by comparing 4DCT-ventilation metrics with PFT data. Methods and Materials: Ninety-eight lung cancer patients with pretreatment 4DCT and PFT data were included in the study. Pulmonary function test metrics used to diagnose obstructive lung disease were recorded: forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity. Four-dimensional CT data sets and spatial registration were used to compute 4DCT-ventilation images using a density change–based and a Jacobian-based model. The ventilation maps were reduced to single metrics intended to reflect the degree of ventilation obstruction. Specifically, we computed the coefficient of variation (SD/mean), ventilation V20 (volume of lung ≤20% ventilation), and correlated the ventilation metrics with PFT data. Regression analysis was used to determine whether 4DCT ventilation data could predict for normal versus abnormal lung function using PFT thresholds. Results: Correlation coefficients comparing 4DCT-ventilation with PFT data ranged from 0.63 to 0.72, with the best agreement between FEV1 and coefficient of variation. Four-dimensional CT ventilation metrics were able to significantly delineate between clinically normal versus abnormal PFT results. Conclusions: Validation of 4DCT ventilation with clinically relevant metrics is essential. We demonstrate good global agreement between PFTs and 4DCT-ventilation, indicating that 4DCT

  13. Clinical Validation of 4-Dimensional Computed Tomography Ventilation With Pulmonary Function Test Data

    Energy Technology Data Exchange (ETDEWEB)

    Brennan, Douglas [University of Colorado School of Medicine, Aurora, Colorado (United States); Schubert, Leah; Diot, Quentin [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States); Castillo, Richard [Department of Radiation Oncology, The University of Texas Medical Branch, Galveston, Texas (United States); Castillo, Edward; Guerrero, Thomas [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, Michigan (United States); Martel, Mary K. [Department of Radiation Physics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Linderman, Derek; Gaspar, Laurie E.; Miften, Moyed; Kavanagh, Brian D. [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States); Vinogradskiy, Yevgeniy, E-mail: yevgeniy.vinogradskiy@ucdenver.edu [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States)

    2015-06-01

    Purpose: A new form of functional imaging has been proposed in the form of 4-dimensional computed tomography (4DCT) ventilation. Because 4DCTs are acquired as part of routine care for lung cancer patients, calculating ventilation maps from 4DCTs provides spatial lung function information without added dosimetric or monetary cost to the patient. Before 4DCT-ventilation is implemented it needs to be clinically validated. Pulmonary function tests (PFTs) provide a clinically established way of evaluating lung function. The purpose of our work was to perform a clinical validation by comparing 4DCT-ventilation metrics with PFT data. Methods and Materials: Ninety-eight lung cancer patients with pretreatment 4DCT and PFT data were included in the study. Pulmonary function test metrics used to diagnose obstructive lung disease were recorded: forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity. Four-dimensional CT data sets and spatial registration were used to compute 4DCT-ventilation images using a density change–based and a Jacobian-based model. The ventilation maps were reduced to single metrics intended to reflect the degree of ventilation obstruction. Specifically, we computed the coefficient of variation (SD/mean), ventilation V20 (volume of lung ≤20% ventilation), and correlated the ventilation metrics with PFT data. Regression analysis was used to determine whether 4DCT ventilation data could predict for normal versus abnormal lung function using PFT thresholds. Results: Correlation coefficients comparing 4DCT-ventilation with PFT data ranged from 0.63 to 0.72, with the best agreement between FEV1 and coefficient of variation. Four-dimensional CT ventilation metrics were able to significantly delineate between clinically normal versus abnormal PFT results. Conclusions: Validation of 4DCT ventilation with clinically relevant metrics is essential. We demonstrate good global agreement between PFTs and 4DCT-ventilation, indicating that 4DCT

  14. Studying Evolutionary Dynamics of Gene Families Encoding SUMO-Activating Enzymes with SeaView and ProtTest.

    Science.gov (United States)

    Carretero-Paulet, Lorenzo; Albert, Victor A

    2016-01-01

    Molecular evolutionary analysis of gene families commonly involves a sequence of steps including multiple sequence alignment (MSA) and reconstructing phylogenetic trees, using any of the multiple algorithms available. SeaView is a multiplatform program that integrates different methods for performing the above tasks, and others, within a friendly and simple-to-use graphical user interface (Gouy et al. Mol Biol Evol 27(2):221-224, 2010). By using SeaView, we will investigate the evolutionary relationships among SAE1 genes in Brassicaceae species by means of two alternative methods of phylogenetic reconstruction: Maximum Likelihood (ML) and Neighbor-Joining (NJ). Prior to ML phylogenetic analysis (Guindon and Gascuel. Syst Biol 52(5):696-704, 2003), we will use ProtTest to select the best-fit evolutionary model of amino acid substitution for the MSA of SAE1 proteins (Abascal et al. Bioinformatics 21(9):2104-2105, 2005). PMID:27424762

  15. Drug susceptibility testing of clinical isolates of streptococci and enterococci by the Phoenix automated microbiology system

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    Sokeng Gertrude

    2007-05-01

    Full Text Available Abstract Background Drug resistance is an emerging problem among streptococcal and enterococcal species. Automated diagnostic systems for species identification and antimicrobial susceptibility testing (AST have become recently available. We evaluated drug susceptibility of clinical isolates of streptococci and enterococci using the recent Phoenix system (BD, Sparks, MD. Diagnostic tools included the new SMIC/ID-2 panel for streptococci, and the PMIC/ID-14 for enterococci. Two-hundred and fifty isolates have been investigated: β-hemolytic streptococci (n = 65, Streptococcus pneumoniae (n = 50, viridans group streptococci (n = 32, Enterococcus faecium (n = 40, Enterococcus faecalis (n = 43, other catalase-negative cocci (n = 20. When needed, species ID was determined using molecular methods. Test bacterial strains were chosen among those carrying clinically-relevant resistance determinants (penicillin, macrolides, fluoroquinolones, glycopeptides. AST results of the Phoenix system were compared to minimal inhibitory concentration (MIC values measured by the Etest method (AB Biodisk, Solna, Sweden. Results Streptococci: essential agreement (EA and categorical agreement (CA were 91.9% and 98.8%, respectively. Major (ME and minor errors (mE accounted for 0.1% and 1.1% of isolates, respectively. No very major errors (VME were produced. Enterococci: EA was 97%, CA 96%. Small numbers of VME (0.9%, ME (1.4% and mE (2.8% were obtained. Overall, EA and CA rates for most drugs were above 90% for both genera. A few VME were found: a teicoplanin and high-level streptomycin for E. faecalis, b high-level gentamicin for E. faecium. The mean time to results (± SD was 11.8 ± 0.9 h, with minor differences between streptococci and enterococci. Conclusion The Phoenix system emerged as an effective tool for quantitative AST. Panels based on dilution tests provided rapid and accurate MIC values with regard to clinically-relevant streptococcal and enterococcal

  16. Impact of HFE genetic testing on clinical presentation of hereditary hemochromatosis: new epidemiological data

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    Ka Chandran

    2005-06-01

    Full Text Available Abstract Background Hereditary hemochromatosis (HH is a common inherited disorder of iron metabolism in Northern European populations. The discovery of a candidate gene in 1996 (HFE, and of its main mutation (C282Y, has radically altered the way to diagnose this disease. The aim of this study was to assess the impact of the HFE gene discovery on the clinical presentation and epidemiology of HH. Methods We studied our cohort of 415 patients homozygous for the C282Y allele and included in a phlebotomy program in a blood centre in western Brittany, France. Results In this cohort, 56.9% of the patients were male and 21.9% began their phlebotomy program before the implementation of the genetic test. A significant decrease in the sex ratio was noticed following implementation of this DNA test, from 3.79 to 1.03 (p -5, meaning that the proportion of diagnosed females relatives to males greatly increased. The profile of HH patients at diagnosis changed after the DNA test became available. Serum ferritin and iron values were lower and there was a reduced frequency of clinical signs displayed at diagnosis, particularly skin pigmentation (20.1 vs. 40.4%, OR = 0.37, p Conclusion This study highlights the importance of the HFE gene discovery, which has simplified the diagnosis of HH and modified its clinical presentation and epidemiology. This study precisely measures these changes. Enhanced diagnosis of HFE-related HH at an early stage and implementation of phlebotomy treatment are anticipated to maintain normal life expectancy for these patients.

  17. Impact of the clinical context on the 14-3-3 test for the diagnosis of sporadic CJD

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    Sierra-Moros Maríajosé

    2006-07-01

    Full Text Available Abstract Background The 14-3-3 test appears to be a valuable aid for the clinical diagnosis of sporadic Creutzfeldt-Jakob disease (sCJD in selected populations. However, its usefulness in routine practice has been challenged. In this study, the influence of the clinical context on the performance of the 14-3-3 test for the diagnosis of sCJD is investigated through the analysis of a large prospective clinical series. Methods Six hundred seventy-two Spanish patients with clinically suspected sCJD were analyzed. Clinical classification at sample reception according to the World Health Organization's (WHO criteria (excluding the 14-3-3 test result was used to explore the influence of the clinical context on the pre-test probabilities, and positive (PPV and negative (NPV predictive values of the 14-3-3 test. Results Predictive values of the test varied greatly according to the initial clinical classification: PPV of 98.8%, 96.5% and 45.0%, and NPV of 26.1%, 66.6% and 100% for probable sCJDi (n = 115, possible sCJDi (n = 73 and non-sCJDi (n = 484 cases, respectively. According to multivariate and Bayesian analyses, these values represent an improvement of diagnostic certainty compared to clinical data alone. Conclusion In three different contexts of sCJD suspicion, the 14-3-3 assay provides useful information complementary to clinical and electroencephalographic (EEG data. The test is most useful supporting a clinical impression, whilst it may show deceptive when it is not in agreement with clinical data.

  18. The significance of indirect costs—application to clinical laboratory test economics using computer facilities

    OpenAIRE

    Hindriks, F. R.; Bosman, A.; Rademaker, P. F.

    1989-01-01

    The significance of indirect costs in the cost price calculation of clinical chemistry laboratory tests by way of the production centres method has been investigated. A cost structure model based on the ‘production centres’ method, the Academisch Ziekenhuis Groningen (AZG) 1-2-3 model, is used for the calculation of cost and cost prices as an add-in tool to the spreadsheet program Lotus 1-2-3. The system specifications of the AZG 1-2-3 cost structure model have been extended with facilities t...

  19. Handgrip strength test as a complementary tool in monitoring asthma in daily clinical practice in children.

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    Pedro Ángel Latorre-Román

    2014-12-01

    Full Text Available The aim of this study was to demonstrate that handgrip strength test can discriminate the presence/absence of asthma and between intermittent and moderate persistent asthma in children. 140 children (70 healthy and 70 with asthma completed the Pediatric Asthma Quality of Life Questionnaire (PAQLQ and performed the handgrip strength test. Forty-eight hours later, subjects performed spirometry. The results showed Handgrip strength was significantly lower (p<0.001 in children with asthma compared with healthy ones. There were also significant differences (p= 0.024 according to the severity of the disease; children with moderate persistent asthma performed worse than children with intermittent asthma. Binary logistic regression analysis and ROC curve analysis revealed that the result in handgrip strength test was a predictive factor for asthma (cut-off at 16.84 kg and for severity of pathology (cut-off at 15.06 kg. Handgrip strength was reduced in children with asthma. Handgrip strength was positively associated with lung capacity and quality of life. The fact that the handgrip strength test was able to discriminate between presence/absence of asthma and between intermittent and moderate persistent asthma in children suggested that this test could be used as a complementary tool in the monitoring of asthma in daily clinical practice.

  20. Clinical usefulness of the clock drawing test applying rasch analysis in predicting of cognitive impairment.

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    Yoo, Doo Han; Lee, Jae Shin

    2016-07-01

    [Purpose] This study examined the clinical usefulness of the clock drawing test applying Rasch analysis for predicting the level of cognitive impairment. [Subjects and Methods] A total of 187 stroke patients with cognitive impairment were enrolled in this study. The 187 patients were evaluated by the clock drawing test developed through Rasch analysis along with the mini-mental state examination of cognitive evaluation tool. An analysis of the variance was performed to examine the significance of the mini-mental state examination and the clock drawing test according to the general characteristics of the subjects. Receiver operating characteristic analysis was performed to determine the cutoff point for cognitive impairment and to calculate the sensitivity and specificity values. [Results] The results of comparison of the clock drawing test with the mini-mental state showed significant differences in according to gender, age, education, and affected side. A total CDT of 10.5, which was selected as the cutoff point to identify cognitive impairement, showed a sensitivity, specificity, Youden index, positive predictive, and negative predicive values of 86.4%, 91.5%, 0.8, 95%, and 88.2%. [Conclusion] The clock drawing test is believed to be useful in assessments and interventions based on its excellent ability to identify cognitive disorders.

  1. EVALUATION OF VITEK 2 SYSTEM FOR CLINICAL IDENTIFICATION OF CANDIDA SPECIES AND THEIR ANTIFUNGAL SUSCEPTIBILITY TEST

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    Mohan

    2016-06-01

    Full Text Available BJECTIVES 1. To evaluate the Vitek 2 system for clinical identification of Candida species and their antifungal susceptibility test; 2. To study the incidence of various types of Candida species in this part of Tamilnadu. METHODS Samples collected from different wards were subjected for culture, isolation and identification of Candida Species and Antifungal Susceptibility testing by Vitek System. Vitek 2 test was carried out in Apollo Specialty Hospital Lab Services, Madurai. The cost per test is Rs. 200 (Subsidized rate. The expenses for the lab tests (Vitek were borne by the author himself. RESULTS 124 samples were collected from urine, sputum, blood, pus and wounds. Candida albicans formed 43% of the samples. Among the 57% of Non-Candida albicans, Candida tropicalis formed 42%, Candida krusei formed 6%, Candida guilliermondii formed 4%, Candida inconspicua, Candida parapsilosis, Candida glabrata, Candida rugosa and Candida lusitaniae formed 1% each. Candida albicans and C. tropicalis showed high sensitivity to Voriconazole, Flucytosine, Amphotericin B and Fluconazole. CONCLUSION Candida tropicalis was identified as the most common Candida non-albicans species. Candida albicans and C. tropicalis showed high sensitivity to Voriconazole, Flucytosine, Amphotericin B and Fluconazole. This study was helpful to treat Candida albicans and Non-Candida albicans species patients accurately and earlier by Vitek method.

  2. The Effect of Provocative Tests on Electrodiognosis of Clinical Carpal Tunnel Syndrome

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    MR Emad

    2006-04-01

    Full Text Available ABSTRACT: Introduction & Objective: Nerve conduction study is the most sensitive test for diagnosis of carpal tunnel syndrome (CTS. This test is normal in some patients with mild CTS. Median nerve conduction study evaluation after a provocative test (e.g. wrist flexion may be helpful for diagnosis of mild CTS. This study aimed to determine the effect of wrist flexion on median nerve conduction in patients suspected to CTS and in healthy subjects. Materials & Methods: In this case-controlled study, 20 patients (20 hands with clinical signs of CTS and normal routine electrodiagnosis test results and 20 healthy subjects were investigated. Measured parameters included: median nerve distal sensory latency (DSL, nerve conduction velocity (NCV, compound nerve action potential (CNAP, distal motor latency (DML and compound muscle action potential amplitude (CMAP AMP. The above noted parameters were measured before and after 5 minutes of full wrist flexion. Data were collected by filling out a questionnaire and were analyzed using Paired T-test. Results: Distal Sensory Latency increment and NCV decrement after 5 minutes wrist flexion in the patients group were statistically significant (p<0.05. The same parameters did not show a significant incremental or decremental change in the control group. Conclusion: Median nerve DSL and NCV measurement after 5 minutes wrist flexion may be helpful in determining more sensitive parameters in the electrodiagnosis of CTS.

  3. Diagnosing Clostridium difficile-associated diarrhea using enzyme immunoassay: the clinical significance of toxin negativity in glutamate dehydrogenase-positive patients

    Science.gov (United States)

    Yuhashi, Kazuhito; Yagihara, Yuka; Misawa, Yoshiki; Sato, Tomoaki; Saito, Ryoichi; Okugawa, Shu; Moriya, Kyoji

    2016-01-01

    Purpose The enzyme immunoassay (EIA) has lower sensitivity for Clostridium difficile toxins A and B than the polymerase chain reaction in the diagnosis of C. difficile-associated diarrhea (CDAD). Furthermore, toxin positivity with EIA performed on C. difficile isolates from stool cultures may be observed even in patients with EIA glutamate dehydrogenase (GDH)-positive and toxin-negative stool specimens. It is unclear whether such patients should be treated as having CDAD. Methods The present study retrospectively compared patient characteristics, treatment, and diarrhea duration among three groups of patients who underwent stool EIA testing for CDAD diagnosis: a toxin-positive stool group (positive stool group; n=39); a toxin-negative stool/toxin-positive isolate group (discrepant negative/positive group, n=14); and a dual toxin-negative stool and isolate group (dual negative group, n=15). All cases included were confirmed to be GDH positive on EIA test. Results Patients’ backgrounds and comorbidities were not significantly different among three groups. No difference was observed among the three groups with regard to antimicrobial drug use before diarrhea onset. Treatment was received by 82.1% of the positive stool group compared to 7.1% of the discrepant positive/negative group and 0% of the dual negative group, while mean diarrhea duration was 10.6 days compared to 7.9 days (P=0.6006) and 3.4 days (P=0.0312), respectively. Conclusion Even without treatment, patients with toxin-negative stool specimens had shorter diarrhea duration than those with toxin-positive stool specimens even with toxin-positive isolates. These findings may suggest a limited need for CDAD treatment for GDH-positive patients and toxin-negative stool specimens. PMID:27313472

  4. Intraocular pressure dynamics with prostaglandin analogs: a clinical application of water-drinking test

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    Özyol P

    2016-07-01

    Full Text Available Pelin Özyol,1 Erhan Özyol,1 Ercan Baldemir2 1Ophthalmology Department, 2Biostatistics Department, Faculty of Medicine, Mugla Sitki Kocman University, Mugla, Turkey Aim: To evaluate the clinical applicability of the water-drinking test in treatment-naive primary open-angle glaucoma patients. Methods: Twenty newly diagnosed primary open-angle glaucoma patients and 20 healthy controls were enrolled in this prospective study. The water-drinking test was performed at baseline and 6 weeks and 3 months after prostaglandin analog treatment. Peak and fluctuation of intraocular pressure (IOP measurements obtained with the water-drinking test during follow-up were analyzed. Analysis of variance for repeated measures and paired and unpaired t-tests were used for statistical analysis. Results: The mean baseline IOP values in patients with primary open-angle glaucoma were 25.1±4.6 mmHg before prostaglandin analog treatment, 19.8±3.7 mmHg at week 6, and 17.9±2.2 mmHg at month 3 after treatment. The difference in mean baseline IOP of the water-drinking tests was statistically significant (P<0.001. At 6 weeks of prostaglandin analog treatment, two patients had high peak and fluctuation of IOP measurements despite a reduction in baseline IOP. After modifying treatment, patients had lower peak and fluctuation of IOP values at month 3 of the study. Conclusion: Peak and fluctuation of IOP in response to the water-drinking test were lower with prostaglandin analogs compared with before medication. The water-drinking test can represent an additional benefit in the management of glaucoma patients, especially by detecting higher peak and fluctuation of IOP values despite a reduced mean IOP. Therefore, it could be helpful as a supplementary method in monitoring IOP in the clinical practice. Keywords: glaucoma, intraocular pressure, water-drinking test, prostaglandin analog, intra­ocular pressure fluctuation

  5. Evaluation of three enzyme immunoassays and a nucleic acid amplification test for the diagnosis of Clostridium difficile-associated diarrhea at a university hospital in Brazil

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    Rodrigo Otávio Silveira Silva

    2014-07-01

    Full Text Available Introduction Despite the known importance of Clostridium difficile as a nosocomial pathogen, few studies regarding Clostridium difficile infection (CDI in Brazil have been conducted. To date, the diagnostic tests that are available on the Brazilian market for the diagnosis of CDI have not been evaluated. The aim of this study was to compare the performances of four commercial methods for the diagnosis of CDI in patients from a university hospital in Brazil. Methods Three enzyme immunoassays (EIAs and one nucleic acid amplification test (NAAT were evaluated against a cytotoxicity assay (CTA and toxigenic culture (TC. Stool samples from 92 patients with suspected CDI were used in this study. Results Twenty-five (27.2% of 92 samples were positive according to the CTA, and 23 (25% were positive according to the TC. All EIAs and the NAAT test demonstrated sensitivities between 59 and 68% and specificities greater than 91%. Conclusions All four methods exhibited low sensitivities for the diagnosis of CDI, which could lead to a large number of false-negative results, an increased risk of cross-infection to other patients, and overtreatment with empirical antibiotics.

  6. Development of a Novel Cocktail Enzyme-Linked Immunosorbent Assay and a Field-Applicable Lateral-Flow Rapid Test for Diagnosis of Contagious Bovine Pleuropneumonia.

    Science.gov (United States)

    Heller, Martin; Gicheru, Nimmo; Tjipura-Zaire, Georgina; Muriuki, Cecilia; Yu, Mingyan; Botelho, Ana; Naessens, Jan; Jores, Joerg; Liljander, Anne

    2016-06-01

    Contagious bovine pleuropneumonia (CBPP) is a severe respiratory disease that is widespread in sub-Saharan Africa. It is caused by Mycoplasma mycoides subsp. mycoides, a bacterium belonging to the Mycoplasma mycoides cluster. In the absence of an efficient CBPP vaccine, improved and easy-to-use diagnostic assays for recurrent testing combined with isolation and treatment of positive animals represent an option for CBPP control in Africa. Here we describe the comprehensive screening of 17 immunogenic Mycoplasma mycoides subsp. mycoides proteins using well-characterized bovine sera for the development of a novel cocktail enzyme-linked immunosorbent assay (ELISA) for laboratory use. Two recombinant Mycoplasma immunogens, MSC_0136 and MSC_0636, were used to set up a standardized cocktail ELISA protocol. According to the results from more than 100 serum samples tested, the sensitivity and specificity of the novel cocktail ELISA were 85.6% and 96.4%, respectively, with an overall diagnostic accuracy comparable to that of the Office International des Epizooties (OIE)-prescribed serological assays. In addition, we provide a proof of principle for a field-applicable, easy-to-use commercially produced prototype lateral-flow test for rapid (<30-min) diagnosis of CBPP.

  7. Comparison of indirect immunofluorescence (IF) test with enzyme-linked immunosorbent assay (ELISA) in screening of hybridomas to very virulent Marek's disease virus.

    Science.gov (United States)

    Nakajima, K; Shibayama, T; Naito, M; Kurimura, T; Hirai, K

    1992-01-01

    For identifying virus-specific antigens of Marek's disease virus (MDV), monoclonal antibodies (MAbs) against strain Md5 of serotype 1, which is known to be a very virulent MDV (vvMDV), were isolated. Fifty-eight hybridoma clones that secreted MAbs against vvMDV were obtained. Of these MAbs, 36 gave positive reactions in an immunofluorescence (IF) test, and 22 gave positive reactions on enzyme-linked immunosorbent assay (ELISA). None of these MAbs gave positive reactions in both the IF test and ELISA. Of the MAbs that gave positive reactions in the IF test, 33 clones reacted with MDV1-specific epitopes, the other three reacting with MDV1-HVT intertypic epitopes. None of the clones reacted with MDV1-MDV2 intertypic epitopes. Three virus-specific polypeptides were identified by radioimmunoprecipitation and sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) or immunoblotting. These polypeptides were recognized by 12 MAbs giving positive reactions by IF, but by none of those giving positive reactions by ELISA. In addition, size heterogeneity of the MDV1-specific phosphorylated polypeptides in the MDV1 strains was shown using the MAbs against Md5.

  8. Development of a Novel Cocktail Enzyme-Linked Immunosorbent Assay and a Field-Applicable Lateral-Flow Rapid Test for Diagnosis of Contagious Bovine Pleuropneumonia.

    Science.gov (United States)

    Heller, Martin; Gicheru, Nimmo; Tjipura-Zaire, Georgina; Muriuki, Cecilia; Yu, Mingyan; Botelho, Ana; Naessens, Jan; Jores, Joerg; Liljander, Anne

    2016-06-01

    Contagious bovine pleuropneumonia (CBPP) is a severe respiratory disease that is widespread in sub-Saharan Africa. It is caused by Mycoplasma mycoides subsp. mycoides, a bacterium belonging to the Mycoplasma mycoides cluster. In the absence of an efficient CBPP vaccine, improved and easy-to-use diagnostic assays for recurrent testing combined with isolation and treatment of positive animals represent an option for CBPP control in Africa. Here we describe the comprehensive screening of 17 immunogenic Mycoplasma mycoides subsp. mycoides proteins using well-characterized bovine sera for the development of a novel cocktail enzyme-linked immunosorbent assay (ELISA) for laboratory use. Two recombinant Mycoplasma immunogens, MSC_0136 and MSC_0636, were used to set up a standardized cocktail ELISA protocol. According to the results from more than 100 serum samples tested, the sensitivity and specificity of the novel cocktail ELISA were 85.6% and 96.4%, respectively, with an overall diagnostic accuracy comparable to that of the Office International des Epizooties (OIE)-prescribed serological assays. In addition, we provide a proof of principle for a field-applicable, easy-to-use commercially produced prototype lateral-flow test for rapid (<30-min) diagnosis of CBPP. PMID:27053669

  9. The value of the UK Clinical Aptitude Test in predicting pre-clinical performance: a prospective cohort study at Nottingham Medical School

    OpenAIRE

    James David; Yates Janet

    2010-01-01

    Abstract Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Quantitative Reasoning, Verbal Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admissions panels in advance of the selection process. As yet the predictive validity of the test against course performance is largely unknown. The study objective was to d...

  10. Testing of evaluation bias for progression free survival endpoint in oncology clinical trials.

    Science.gov (United States)

    Sun, Yan; Wu, Wenting; Sargent, Daniel

    2016-09-30

    Progression-free survival is an increasingly popular end point in oncology clinical trials. A complete blinded independent central review (BICR) is often required by regulators in an attempt to reduce the bias in progression-free survival (PFS) assessment. In this paper, we propose a new methodology that uses a sample-based BICR as an audit tool to decide whether a complete BICR is needed. More specifically, we propose a new index, the differential risk, to measure the reading discordance pattern, and develop a corresponding hypothesis testing procedure to decide whether the bias in local evaluation is acceptable. Simulation results demonstrate that our new index is sensitive to the change of discordance pattern; type I error is well controlled in the hypothesis testing procedure, and the calculated sample size provides the desired power. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27089832

  11. Prostate Cancer Specificity of PCA3 Gene Testing: Examples from Clinical Practice

    Science.gov (United States)

    Marks, Leonard S; Bostwick, David G

    2008-01-01

    A specific marker for early prostate cancer would fill an important void. In initial evaluations of the prostate cancer antigen 3 (PCA3) gene vis-à-vis serum prostate-specific antigen (PSA) levels, the gene offers great promise. At the cellular level, PCA3 specificity for cancer is nearly perfect because of the gross overexpression of the gene by cancer cells. As a clinical test for early prostate cancer, heightened specificity is also seen in urine containing prostate cells from men with the disease. PCA3 gene testing holds valuable potential in PSA quandary situations: (1) men with elevated PSA levels but no cancer on initial biopsy; (2) men found to have cancer despite normal levels of PSA; (3) men with PSA elevations associated with varying degrees of prostatitis; and (4) men undergoing active surveillance for presumed microfocal disease. PMID:18836536

  12. Internet-facilitated, voluntary counseling and testing (VCT clinic-based HIV testing among men who have sex with men in China.

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    Huachun Zou

    Full Text Available OBJECTIVE: To explore the feasibility of using Internet outreach to encourage men who have sex with men (MSM to get tested for HIV at voluntary counseling and testing (VCT clinics in Beijing and Urumqi, China. METHODS: From June to August 2007, two volunteers contacted MSM using instant messaging, online chat rooms, mobile phone, and e-mail (active recruitment. Banners with study information were put at the front pages of three major Chinese gay websites (passive recruitment. Those contacted were offered a modest financial incentive to seek HIV testing at existing VCT clinics. Those who subsequently sought HIV testing services at VCT clinics and provided informed consent completed a questionnaire and a blood draw to test for HIV and syphilis. RESULTS: A total of 3,332 MSM were contacted and 429 attended VCT clinics. One out of every 4 men that were recruited through instant messaging actually went for HIV testing, while the recruitment yields for online gay chat rooms, mobile phone contact, and email were 1∶6, 1∶10, and 1∶140, respectively. The majority of participants (80%, 317/399 reported being motivated to seek HIV testing out of concern for their health, and only 3% (11/399 reported being motivated by the financial incentive. Active recruitment tend to recruit MSM who are younger (X(2 = 11.400, P = 0.001, never tested for HIV (X(2 = 4.281, P = 0.039, tested less often (X(2 = 5.638, P = 0.018. CONCLUSION: Internet outreach is a promising way to encourage MSM to seek HIV testing at existing VCT clinics. Active recruitment can target MSM who are younger, never tested for HIV and tested less often.

  13. Clinical testing of propofol geriatic dose for sedation designed via in silico trial.

    Science.gov (United States)

    Gallardo-Hernandez, Ana Gabriela; Hernandez-Perez, Ana Luisa; Ordoñez-Espinosa, German; Sanchez-Lopez, Antonio; Revilla-Monsalve, Cristina; Islas-Andrade, Sergio

    2016-08-01

    The geriatric population shows significant physiological changes due to aging and the multiple co-morbidities that they often present. Conventionally the propofol sedation dose for patients older than 65 years is 80% of the adult dose. We performed an in silico trial for elderly population and the results showed that the necessary simulated dose of propofol was lower than the conventional dose; therefore, a clinical trial was implemented to test three different propofol doses, two of them lower than the conventional dose, during a pacemaker implantation. The clinical trial showed that there was no clinical difference between the effects of the doses. A BIS monitor was used to measure the level of sedation, which proved to be adequate and well maintained by all patients. All the patients maintained an acceptable level of sedation, measured by a BIS monitor. Since propofol has some dose-dependent secondary effects, the use of lower doses, especially the ones designed for this age group, helps to avoid them. PMID:27282224

  14. The modification of the thrombin generation test for the clinical assessment of dabigatran etexilate efficiency.

    Science.gov (United States)

    Gribkova, Irina V; Lipets, Elena N; Rekhtina, Irina G; Bernakevich, Alex I; Ayusheev, Dorzho B; Ovsepyan, Ruzanna A; Ataullakhanov, Fazoil I; Sinauridze, Elena I

    2016-01-01

    A new oral anticoagulant, dabigatran etexilate (DE, a prodrug of direct thrombin inhibitor (DTI) dabigatran), has been used clinically to prevent thrombosis. The assessment of dabigatran efficiency is necessary in some clinical cases, such as renal insufficiency, risk of bleeding, and drug interactions. However, a specific thrombin generation test (TGT) that is one of the most informative and sensitive to anticoagulant therapy (calibrated automated thrombinography (САТ)) shows a paradoxical increase of test parameters, such as endogenous thrombin potential (ETP) and peak thrombin, in patients receiving DE. The paradoxical behaviour of ETP and peak thrombin in these patients in the presence of DTIs is mostly caused by a decrease in the activity of thrombin in the α2-macroglobulin-thrombin complex that is used as a calibrator in CAT. For a correct estimation of the TGT parameters in patient's plasma containing DTIs we proposed to use our previously described alternative calibration method that is based on the measurement of the fluorescence signal of a well-known concentration of the reaction product (7-amino-4-methylcoumarin). In this study, the validity of such approach was demonstrated in an ex vivo study in patients with knee replacement and two special patients with multiple myeloma, who received DE for thrombosis prophylaxis. PMID:27377013

  15. The modification of the thrombin generation test for the clinical assessment of dabigatran etexilate efficiency

    Science.gov (United States)

    Gribkova, Irina V.; Lipets, Elena N.; Rekhtina, Irina G.; Bernakevich, Alex I.; Ayusheev, Dorzho B.; Ovsepyan, Ruzanna A.; Ataullakhanov, Fazoil I.; Sinauridze, Elena I.

    2016-01-01

    A new oral anticoagulant, dabigatran etexilate (DE, a prodrug of direct thrombin inhibitor (DTI) dabigatran), has been used clinically to prevent thrombosis. The assessment of dabigatran efficiency is necessary in some clinical cases, such as renal insufficiency, risk of bleeding, and drug interactions. However, a specific thrombin generation test (TGT) that is one of the most informative and sensitive to anticoagulant therapy (calibrated automated thrombinography (САТ)) shows a paradoxical increase of test parameters, such as endogenous thrombin potential (ETP) and peak thrombin, in patients receiving DE. The paradoxical behaviour of ETP and peak thrombin in these patients in the presence of DTIs is mostly caused by a decrease in the activity of thrombin in the α2-macroglobulin-thrombin complex that is used as a calibrator in CAT. For a correct estimation of the TGT parameters in patient’s plasma containing DTIs we proposed to use our previously described alternative calibration method that is based on the measurement of the fluorescence signal of a well-known concentration of the reaction product (7-amino-4-methylcoumarin). In this study, the validity of such approach was demonstrated in an ex vivo study in patients with knee replacement and two special patients with multiple myeloma, who received DE for thrombosis prophylaxis. PMID:27377013

  16. A Laboratory Test Expert System for Clinical Diagnosis Support in Primary Health Care

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    Rodrigo Fernandez-Millan

    2015-08-01

    Full Text Available Clinical Decision Support Systems have the potential to reduce lack of communication and errors in diagnostic steps in primary health care. Literature reports have showed great advances in clinical decision support systems in the recent years, which have proven its usefulness in improving the quality of care. However, most of these systems are focused on specific areas of diseases. In this way, we propose a rule-based expert system, which supports clinicians in primary health care, providing a list of possible diseases regarding patient’s laboratory tests results in order to assist previous diagnosis. Our system also allows storing and retrieving patient’s data and the history of patient’s analyses, establishing a basis for coordination between the various health care levels. A validation step and speed performance tests were made to check the quality of the system. We conclude that our system could improve clinician accuracy and speed, resulting in more efficiency and better quality of service. Finally, we propose some recommendations for further research.

  17. American Society of Clinical Oncology Policy Statement Update: Genetic and Genomic Testing for Cancer Susceptibility.

    Science.gov (United States)

    Robson, Mark E; Bradbury, Angela R; Arun, Banu; Domchek, Susan M; Ford, James M; Hampel, Heather L; Lipkin, Stephen M; Syngal, Sapna; Wollins, Dana S; Lindor, Noralane M

    2015-11-01

    The American Society of Clinical Oncology (ASCO) has long affirmed that the recognition and management of individuals with an inherited susceptibility to cancer are core elements of oncology care. ASCO released its first statement on genetic testing in 1996 and updated that statement in 2003 and 2010 in response to developments in the field. In 2014, the Cancer Prevention and Ethics Committees of ASCO commissioned another update to reflect the impact of advances in this area on oncology practice. In particular, there was an interest in addressing the opportunities and challenges arising from the application of massively parallel sequencing-also known as next-generation sequencing-to cancer susceptibility testing. This technology introduces a new level of complexity into the practice of cancer risk assessment and management, requiring renewed effort on the part of ASCO to ensure that those providing care to patients with cancer receive the necessary education to use this new technology in the most effective, beneficial manner. The purpose of this statement is to explore the challenges of new and emerging technologies in cancer genetics and provide recommendations to ensure their optimal deployment in oncology practice. Specifically, the statement makes recommendations in the following areas: germline implications of somatic mutation profiling, multigene panel testing for cancer susceptibility, quality assurance in genetic testing, education of oncology professionals, and access to cancer genetic services.

  18. Clinical efficiency of the Auditory Verbal Learning Test for patients with internal carotid artery stenosis

    International Nuclear Information System (INIS)

    Most patients who have an internal carotid artery (ICA) stenosis with cerebral lesion have some cognitive dysfunction. To clarify the clinical efficiency of the Auditory Verbal Learning Test (AVLT) and to assess the relationship between AVLT and cerebral damage, we examined AVLT in patients with ICA stenosis. 44 patients (35 males and 9 females) with ICA stenosis aged 56 to 83 (69.6±6.5) years old were evaluated. The educational periods were from 9 to 16 (12.3±2.8) years. Their activities of daily living (ADL) were independent. We assessed cognitive function with neuropsychological tests including AVLT, Mini-mental State Examination (MMSE), Raven's coloured progressive matrices (RCPM) and Frontal Assessment Battery (FAB), etc. We assessed cerebral damage (periventricular high intensity; PVH and white matter hyperintensity; WMH) with MRI. Then, we investigated the relationship between AVLT and other neuropsychological tests, and the relationship between AVLT and carotid/cerebral lesion. There was no association with lesion side of ICA stenosis and the scores of AVLT. In patients with ICA stenosis and cerebral damage (PVH and/or WMH), there was a significant relationship between the severity of cerebral damage and the scores in AVLT. AVLT had a significant relationship to other neuropsychological tests. AVLT might be a good cognitive assessment for patients who have cerebral damage due to ICA stenosis. (author)

  19. Approaches to informed consent for hypothesis-testing and hypothesis-generating clinical genomics research

    Directory of Open Access Journals (Sweden)

    Facio Flavia M

    2012-10-01

    Full Text Available Abstract Background Massively-parallel sequencing (MPS technologies create challenges for informed consent of research participants given the enormous scale of the data and the wide range of potential results. Discussion We propose that the consent process in these studies be based on whether they use MPS to test a hypothesis or to generate hypotheses. To demonstrate the differences in these approaches to informed consent, we describe the consent processes for two MPS studies. The purpose of our hypothesis-testing study is to elucidate the etiology of rare phenotypes using MPS. The purpose of our hypothesis-generating study is to test the feasibility of using MPS to generate clinical hypotheses, and to approach the return of results as an experimental manipulation. Issues to consider in both designs include: volume and nature of the potential results, primary versus secondary results, return of individual results, duty to warn, length of interaction, target population, and privacy and confidentiality. Summary The categorization of MPS studies as hypothesis-testing versus hypothesis-generating can help to clarify the issue of so-called incidental or secondary results for the consent process, and aid the communication of the research goals to study participants.

  20. Comprehensive genetic testing in the clinical evaluation of 1119 patients with hearing loss.

    Science.gov (United States)

    Sloan-Heggen, Christina M; Bierer, Amanda O; Shearer, A Eliot; Kolbe, Diana L; Nishimura, Carla J; Frees, Kathy L; Ephraim, Sean S; Shibata, Seiji B; Booth, Kevin T; Campbell, Colleen A; Ranum, Paul T; Weaver, Amy E; Black-Ziegelbein, E Ann; Wang, Donghong; Azaiez, Hela; Smith, Richard J H

    2016-04-01

    Hearing loss is the most common sensory deficit in humans, affecting 1 in 500 newborns. Due to its genetic heterogeneity, comprehensive diagnostic testing has not previously been completed in a large multiethnic cohort. To determine the aggregate contribution inheritance makes to non-syndromic hearing loss, we performed comprehensive clinical genetic testing with targeted genomic enrichment and massively parallel sequencing on 1119 sequentially accrued patients. No patient was excluded based on phenotype, inheritance or previous testing. Testing resulted in identification of the underlying genetic cause for hearing loss in 440 patients (39%). Pathogenic variants were found in 49 genes and included missense variants (49%), large copy number changes (18%), small insertions and deletions (18%), nonsense variants (8%), splice-site alterations (6%), and promoter variants (<1%). The diagnostic rate varied considerably based on phenotype and was highest for patients with a positive family history of hearing loss or when the loss was congenital and symmetric. The spectrum of implicated genes showed wide ethnic variability. These findings support the more efficient utilization of medical resources through the development of evidence-based algorithms for the diagnosis of hearing loss. PMID:26969326

  1. Clinical value of MRI and acute madopar responsiveness test in diagnosing progressive supranuclear palsy

    Directory of Open Access Journals (Sweden)

    LI Xiao-hong

    2013-07-01

    Full Text Available Objective To investigate the MRI abnormalities and acute madopar responsiveness test in diagnosing progressive supranuclear palsy (PSP and Parkinson's disease (PD. Methods Seventeen patients with PSP and 17 gender and age matched patients with PD were studied with cranial MRI examinations and results of acute madopar responsiveness test, and the clinical manifestations of PSP were summarized. Results The atrophy of the midbrain tegmentum and hummingbird sign was demonstrated in all of the PSP patients in our study, but was not observed in the PD patients. The areas of the midbrain on mid-sagittal MRI in PSP patients [(77.35 ± 15.30 mm2] were significantly smaller than that in those with PD [(142.35 ± 31.49 mm2]. The average ratio of the area of the midbrain to the area of pons in the patients with PSP [(14.31 ± 2.47%] was significantly smaller than that in those with PD [(24.08 ± 4.73%; P = 0.000, for all]. According to the result of acute madopar responsiveness test, the maximum Unified Parkinson's Disease Rating Scale (UPDRS Ⅲ improvement rate of 2 patients with PSP and 16 patients with PD was more than 30% (χ2 = 23.142, P = 0.000. Conclusion The assessment of the mid-sagittal MRI and acute madopar responsiveness test may be a useful method to differentiate PSP from PD.

  2. Chromosomal microarray analysis as a first-tier clinical diagnostic test: Estonian experience.

    Science.gov (United States)

    Zilina, Olga; Teek, Rita; Tammur, Pille; Kuuse, Kati; Yakoreva, Maria; Vaidla, Eve; Mölter-Väär, Triin; Reimand, Tiia; Kurg, Ants; Ounap, Katrin

    2014-03-01

    Chromosomal microarray analysis (CMA) is now established as the first-tier cytogenetic diagnostic test for fast and accurate detection of chromosomal abnormalities in patients with developmental delay/intellectual disability (DD/ID), multiple congenital anomalies (MCA), and autism spectrum disorders (ASD). We present our experience with using CMA for postnatal and prenatal diagnosis in Estonian patients during 2009-2012. Since 2011, CMA is on the official service list of the Estonian Health Insurance Fund and is performed as the first-tier cytogenetic test for patients with DD/ID, MCA or ASD. A total of 1191 patients were analyzed, including postnatal (1072 [90%] patients and 59 [5%] family members) and prenatal referrals (60 [5%] fetuses). Abnormal results were reported in 298 (25%) patients, with a total of 351 findings (1-3 per individual): 147 (42%) deletions, 106 (30%) duplications, 89 (25%) long contiguous stretches of homozygosity (LCSH) events (>5 Mb), and nine (3%) aneuploidies. Of all findings, 143 (41%) were defined as pathogenic or likely pathogenic; for another 143 findings (41%), most of which were LCSH, the clinical significance remained unknown, while 61 (18%) reported findings can now be reclassified as benign or likely benign. Clinically relevant findings were detected in 126 (11%) patients. However, the proportion of variants of unknown clinical significance was quite high (41% of all findings). It seems that our ability to detect chromosomal abnormalities has far outpaced our ability to understand their role in disease. Thus, the interpretation of CMA findings remains a rather difficult task requiring a close collaboration between clinicians and cytogeneticists.

  3. Vestibular migraine in children and adolescents: clinical findings and laboratory tests

    Directory of Open Access Journals (Sweden)

    Thyra eLanghagen

    2015-01-01

    Full Text Available Introduction: Vestibular migraine (VM is the most common cause of episodic vertigo in children. We summarize the clinical findings and of laboratory test results in a cohort of children and adolescents with VM. We discuss the limitations of current classification criteria for dizzy children. Methods: A retrospective chart analysis was performed on 118 children with suspected VM at a tertiary care center. Patients with complaints related to migraine and who presented with vertigo/dizziness were grouped in the following categories: (1 definite vestibular migraine (dVM; (2 probable vestibular migraine (pVM; (3 suspected vestibular migraine (sVM; (4 benign paroxysmal vertigo (BPV; and (5 migraine with/without aura (oM according to the International Classification of Headache Disorders, 3rd edition (beta version. Results: The mean age of all patients was 12±3 years (range 3-18 years, 70 females. 36 patients (30% fulfilled criteria for dVM, 33 (28% for pVM, 34 (29% for sVM, 7 (6% for BPV, and 8 (7% for oM. Somatoform vertigo co-occurred in 27% patients. Episodic syndromes were reported in 8%; the family history of migraine was positive in 65%. Mild central ocular motor signs were found in 24% (most frequently horizontal saccadic pursuit. Laboratory tests showed that about 20% had pathological function of the horizontal vestibulo-ocular reflex, and almost 50% had abnormal postural sway patterns. Conclusion: Patients with definite, probable, and suspected VM do not differ in the frequency of ocular motor, vestibular, or postural abnormalities. VM is the best explanation for their symptoms. It is essential to establish diagnostic criteria in clinical studies. In clinical practice, however, the most reasonable diagnosis should be made in order to begin treatment. Such a procedure also minimizes the fear of the parents and children, reduces the need to interrupt leisure time and school activities, and prevents the development of somatoform vertigo.

  4. Clinical validation of 4DCT-ventilation with pulmonary function test data

    Science.gov (United States)

    Brennen, Douglas; Schubert, Leah; Diot, Quentin; Castillo, Richard; Castillo, Edward; Guerrero, Thomas; Martel, Mary K.; Linderman, Derek; Gaspar, Laurie E.; Miften, Moyed; Kavanagh, Brian D.; Vinogradskiy, Yevgeniy

    2015-01-01

    Purpose A new form of functional imaging has been proposed in the form of 4DCT-ventilation. Because 4DCTs are acquired as part of routine care for lung cancer patients, calculating ventilation maps from 4DCTs provides spatial lung function information without added dosimetric or monetary cost to the patient. Before 4DCT-ventilation is implemented it needs to be clinically validated. Pulmonary function tests (PFTs) provide a clinically established way of evaluating lung function. The purpose of our work was to perform a clinical validation by comparing 4DCT-ventilation metrics with PFT data. Methods and Materials Ninety-eight lung cancer patients with pre-treatment 4DCT and PFT data were included in the study. PFT metrics used to diagnose obstructive lung disease were recorded: forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FEV1/FVC). 4DCT data sets and spatial registration were used to compute 4DCT-ventilation images using a density-change based and a Jacobian-based model. The ventilation maps were reduced to single metrics intended to reflect the degree of ventilation obstruction. Specifically, we computed the coefficient of variation (CoV) (standard deviation/mean), ventilation V20 (volume of lung ≤20% ventilation), and correlated the ventilation metrics with PFT data. Regression analysis was used to determine whether 4DCT-ventilation data could predict for normal versus abnormal lung function using PFT thresholds. Results Correlation coefficients comparing 4DCT-ventilation to PFT data ranged from 0.63–0.72 with the best agreement between FEV1 and CoV. 4DCT-ventilation metrics were able to significantly delineate between clinically normal versus abnormal PFT results. Conclusions Validation of 4DCT-ventilation with clinically relevant metrics is essential. We demonstrate good global agreement between PFTs and 4DCT-ventilation, indicating that 4DCT ventilation provides a reliable assessment of lung function. 4DCT-ventilation enables

  5. Combined array CGH plus SNP genome analyses in a single assay for optimized clinical testing.

    Science.gov (United States)

    Wiszniewska, Joanna; Bi, Weimin; Shaw, Chad; Stankiewicz, Pawel; Kang, Sung-Hae L; Pursley, Amber N; Lalani, Seema; Hixson, Patricia; Gambin, Tomasz; Tsai, Chun-hui; Bock, Hans-Georg; Descartes, Maria; Probst, Frank J; Scaglia, Fernando; Beaudet, Arthur L; Lupski, James R; Eng, Christine; Cheung, Sau Wai; Bacino, Carlos; Patel, Ankita

    2014-01-01

    In clinical diagnostics, both array comparative genomic hybridization (array CGH) and single nucleotide polymorphism (SNP) genotyping have proven to be powerful genomic technologies utilized for the evaluation of developmental delay, multiple congenital anomalies, and neuropsychiatric disorders. Differences in the ability to resolve genomic changes between these arrays may constitute an implementation challenge for clinicians: which platform (SNP vs array CGH) might best detect the underlying genetic cause for the disease in the patient? While only SNP arrays enable the detection of copy number neutral regions of absence of heterozygosity (AOH), they have limited ability to detect single-exon copy number variants (CNVs) due to the distribution of SNPs across the genome. To provide comprehensive clinical testing for both CNVs and copy-neutral AOH, we enhanced our custom-designed high-resolution oligonucleotide array that has exon-targeted coverage of 1860 genes with 60,000 SNP probes, referred to as Chromosomal Microarray Analysis - Comprehensive (CMA-COMP). Of the 3240 cases evaluated by this array, clinically significant CNVs were detected in 445 cases including 21 cases with exonic events. In addition, 162 cases (5.0%) showed at least one AOH region >10 Mb. We demonstrate that even though this array has a lower density of SNP probes than other commercially available SNP arrays, it reliably detected AOH events >10 Mb as well as exonic CNVs beyond the detection limitations of SNP genotyping. Thus, combining SNP probes and exon-targeted array CGH into one platform provides clinically useful genetic screening in an efficient manner.

  6. Membrane Assisted Enzyme Fractionation

    DEFF Research Database (Denmark)

    Yuan, Linfeng

    . In this thesis, separations using crossflow elecro-membrane filtration (EMF) of amino acids, bovine serum albumin (BSA) and industrial enzymes from Novozymes were performed. The main objective of this study was to investigate the technological feasibility of EMF in the application of industrial enzyme...... fractionation, such as removal of a side activity from the main enzyme activity. As a proof-of-concept, amino acids were used as model solution to test the feasibility of EMF in the application of amphoteric molecule separation. A single amino acid was used to illustrate the effect of an electric field...... on the separation performance were very small in the investigated range. The mass transport of each enzyme can be well explained by the Extended-Nernst-Planck equation. Better separation was observed at lower feed concentration, higher solution pH in the investigated range and with a polysulfone (PS) MF membrane...

  7. Reliability of clinical tests to evaluate nerve function and mechanosensitivity of the upper limb peripheral nervous system

    Directory of Open Access Journals (Sweden)

    Bachmann Lucas M

    2009-01-01

    Full Text Available Abstract Background Clinical tests to assess peripheral nerve disorders can be classified into two categories: tests for afferent/efferent nerve function such as nerve conduction (bedside neurological examination and tests for increased mechanosensitivity (e.g. upper limb neurodynamic tests (ULNTs and nerve palpation. Reliability reports of nerve palpation and the interpretation of neurodynamic tests are scarce. This study therefore investigated the intertester reliability of nerve palpation and ULNTs. ULNTs were interpreted based on symptom reproduction and structural differentiation. To put the reliability of these tests in perspective, a comparison with the reliability of clinical tests for nerve function was made. Methods Two experienced clinicians examined 31 patients with unilateral arm and/or neck pain. The examination included clinical tests for nerve function (sensory testing, reflexes and manual muscle testing (MMT and mechanosensitivity (ULNTs and palpation of the median, radial and ulnar nerve. Kappa statistics were calculated to evaluate intertester reliability. A meta-analysis determined an overall kappa for the domains with multiple kappa values (MMT, ULNT, palpation. We then compared the difference in reliability between the tests of mechanosensitivity and nerve function using a one-sample t-test. Results We observed moderate to substantial reliability for the tests for afferent/efferent nerve function (sensory testing: kappa = 0.53; MMT: kappa = 0.68; no kappa was calculated for reflexes due to a lack of variation. Tests to investigate mechanosensitivity demonstrated moderate reliability (ULNT: kappa = 0.45; palpation: kappa = 0.59. When compared statistically, there was no difference in reliability for tests for nerve function and mechanosensitivity (p = 0.06. Conclusion This study demonstrates that clinical tests which evaluate increased nerve mechanosensitivity and afferent/efferent nerve function have comparable moderate to

  8. Clinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening

    NARCIS (Netherlands)

    Boers, Aniek; Wang, Rong; Slagter-Menkema, Lorian; van Hemel, Bettien M.; Ghyssaert, Hilde; van der Zee, Ate G. J.; Schuurs-Wisman, G. Bea A.; Schuuring, Ed

    2014-01-01

    This study demonstrates that both the clinical sensitivity and specificity of the Cervista HPV HR test for high-risk human papillomavirus (HPV) detection are not inferior to those of the Hybrid Capture 2 (HC2) test. The intra- and interlaboratory reproducibilities of Cervista were 92.0% (kappa, 0.83

  9. Complete definite positive spasm on acetylcholine spasm provocation tests: comparison of clinical positive spasm.

    Science.gov (United States)

    Sueda, Shozo; Miyoshi, Toru; Sasaki, Yasuhiro; Ohshima, Kousei; Sakaue, Tomoki; Habara, Hirokazu; Kohno, Hiroaki

    2016-02-01

    In the clinical grounds, patients with ≥90 % luminal narrowing during acetylcholine (ACh) testing had variable response. We investigated ischemic findings and chest symptoms in patients with ≥90 % luminal narrowing when performing ACh tests, retrospectively. We performed 763 ACh tests over 13 years (2001-2013). We analyzed chest symptoms and positive ischemic ECG changes during ACh tests. More than 90 % luminal narrowing was found in 441 patients (57.8 %) including 355 patients in the right coronary artery (RCA) and 363 patients in the left coronary artery (LCA). Chest symptom was observed in 386 patients (87.5 %) including 293 patients in the RCA and 304 patients in the LCA. ST elevation was found in 161 patients including 110 in the RCA and 85 patients in the LCA, while ST depression was recognized in 146 patients including 119 patients in the RCA and 117 patients in the LCA. Three quarter of patients with ≥90 % luminal narrowing had significant ischemic ECG changes, whereas two-third of patients with ≥90 % luminal narrowing complained usual chest pain accompanied with significant ischemic ECG changes. Unusual chest symptom was complained in 7.3 % patients with ≥90 % luminal narrowing. Neither chest symptom nor ECG changes were found in 30 patients (6.8 %) with ≥90 % luminal narrowing. A third of these patients had ischemic findings on non-invasive tests before catheterization and six patients had subtotal or total occlusion. We should realize some limitation to define positive coronary spasm based on the ischemic ECG change and chest symptom during ACh tests. PMID:25366988

  10. 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

    Science.gov (United States)

    Mohan, Anju; Saxena, Hari Mohan; Malhotra, Puneet

    2016-01-01

    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 (pBrucella organisms. Conclusion: The brucellosis infected animals showed very high titers of agglutinating antibodies compared to the vaccinated animals. PMID:27536032

  11. Forensic Luminol Blood Test for Preventing Cross-contamination in Dentistry: An Evaluation of a Dental School Clinic

    OpenAIRE

    Marcelo Carlos Bortoluzzi; Peterson Cadore; Andrea Gallon; Soraia Almeida Watanabe Imanishi

    2014-01-01

    Background: More than 200 different diseases may be transmitted from exposure to blood in the dental setting. The aim of this study is to identify possible faults in the cross-contamination chain control in a dental school clinic searching for traces of blood in the clinical contact surfaces (CCS) through forensic luminol blood test. Methods: Traces of invisible blood where randomly searched in CCS of one dental school clinic. Results: Forty eight surfaces areas in the CCS were tes...

  12. Interaction between Red Yeast Rice and CYP450 Enzymes/P-Glycoprotein and Its Implication for the Clinical Pharmacokinetics of Lovastatin

    OpenAIRE

    Chia-Hao Chen; Yow-Shieng Uang; Shang-Ta Wang; Jyh-Chin Yang; Chun-Jung Lin

    2012-01-01

    Red yeast rice (RYR) can reduce cholesterol through its active component, lovastatin. This study was to investigate the pharmacokinetic properties of lovastatin in RYR products and potential RYR-drug interactions. Extracts of three registered RYR products (LipoCol Forte, Cholestin, and Xuezhikang) were more effective than pure lovastatin in inhibiting the activities of cytochrome P450 enzymes and P-glycoprotein. Among CYP450 enzymes, RYR showed the highest inhibition on CYP1A2 and CYP2C19, wi...

  13. An In-House RD1-Based Enzyme-Linked Immunospot-Gamma Interferon Assay Instead of the Tuberculin Skin Test for Diagnosis of Latent Mycobacterium tuberculosis Infection

    Science.gov (United States)

    Codecasa, Luigi; Mantegani, Paola; Galli, Laura; Lazzarin, Adriano; Scarpellini, Paolo; Fortis, Claudio

    2006-01-01

    Identification of individuals infected with Mycobacterium tuberculosis is essential for the control of tuberculosis (TB). The specificity of the currently used tuberculin skin test (TST) is poor because of the broad antigenic cross-reactivity of purified protein derivative (PPD) with BCG vaccine strains and environmental mycobacteria. Both ESAT-6 and CFP-10, two secretory proteins that are highly specific for M. tuberculosis complex, elicit strong T-cell responses in subjects with TB. Using an enzyme-linked immunospot (ELISPOT)-IFN-γ assay and a restricted pool of peptides derived from ESAT-6 and CFP-10, we have previously demonstrated a high degree of specificity and sensitivity of the test for the diagnosis of TB. Here, 119 contacts of individuals with contagious TB who underwent TST and the ELISPOT-IFN-γ assay were consecutively recruited. We compared the efficacy of the two tests in detecting latent TB infection and defined a more appropriate TST cutoff point. There was little agreement between the tests (k = 0.33, P < 0.0001): 53% of the contacts with a positive TST were ELISPOT negative, and 7% with a negative TST were ELISPOT positive. Furthermore, respectively 76 and 59% of the ELISPOT-negative contacts responded in vitro to BCG and PPD, suggesting that most of them were BCG vaccinated or infected with nontuberculous mycobacteria. The number of spot-forming cells significantly correlated with TST induration (P < 0.0001). Our in-house ELISPOT assay based on a restricted pool of highly selected peptides is more accurate than TST for identifying individuals with latent TB infection and could improve chemoprophylaxis for the control of TB. PMID:16757583

  14. The clinical candidate VT-1161 is a highly potent inhibitor of Candida albicans CYP51 but fails to bind the human enzyme.

    Science.gov (United States)

    Warrilow, A G S; Hull, C M; Parker, J E; Garvey, E P; Hoekstra, W J; Moore, W R; Schotzinger, R J; Kelly, D E; Kelly, S L

    2014-12-01

    The binding and cytochrome P45051 (CYP51) inhibition properties of a novel antifungal compound, VT-1161, against purified recombinant Candida albicans CYP51 (ERG11) and Homo sapiens CYP51 were compared with those of clotrimazole, fluconazole, itraconazole, and voriconazole. VT-1161 produced a type II binding spectrum with Candida albicans CYP51, characteristic of heme iron coordination. The binding affinity of VT-1161 for Candida albicans CYP51 was high (dissociation constant [Kd], ≤ 39 nM) and similar to that of the pharmaceutical azole antifungals (Kd, ≤ 50 nM). In stark contrast, VT-1161 at concentrations up to 86 μM did not perturb the spectrum of recombinant human CYP51, whereas all the pharmaceutical azoles bound to human CYP51. In reconstitution assays, VT-1161 inhibited Candida albicans CYP51 activity in a tight-binding fashion with a potency similar to that of the pharmaceutical azoles but failed to inhibit the human enzyme at the highest concentration tested (50 μM). In addition, VT-1161 (MIC = 0.002 μg ml(-1)) had a more pronounced fungal sterol disruption profile (increased levels of methylated sterols and decreased levels of ergosterol) than the known CYP51 inhibitor voriconazole (MIC = 0.004 μg ml(-1)). Furthermore, VT-1161 weakly inhibited human CYP2C9, CYP2C19, and CYP3A4, suggesting a low drug-drug interaction potential. In summary, VT-1161 potently inhibited Candida albicans CYP51 and culture growth but did not inhibit human CYP51, demonstrating a >2,000-fold selectivity. This degree of potency and selectivity strongly supports the potential utility of VT-1161 in the treatment of Candida infections. PMID:25224009

  15. Molecular identification of aminoglycoside-modifying enzymes in clinical isolates of Escherichia coli resistant to amoxicillin/clavulanic acid isolated in Spain.

    Science.gov (United States)

    Fernández-Martínez, Marta; Miró, Elisenda; Ortega, Adriana; Bou, Germán; González-López, Juan José; Oliver, Antonio; Pascual, Alvaro; Cercenado, Emilia; Oteo, Jesús; Martínez-Martínez, Luis; Navarro, Ferran

    2015-08-01

    The activity of eight aminoglycosides (amikacin, apramycin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin and tobramycin) against a collection of 257 amoxicillin/clavulanic acid (AMC)-resistant Escherichia coli isolates was determined by microdilution. Aminoglycoside resistance rates, the prevalence of aminoglycoside-modifying enzyme (AME) genes, the relationship between AME gene detection and resistance phenotype to aminoglycosides, and the association of AME genes with mechanisms of AMC resistance in E. coli isolates in Spain were investigated. Aminoglycoside-resistant isolates were screened for the presence of genes encoding common AMEs [aac(3)-Ia, aac(3)-IIa, aac(3)-IVa, aac(6')-Ib, ant(2″)-Ia, ant(4')-IIa and aph(3')-Ia] or 16S rRNA methylases (armA, rmtB, rmtC and npmA). In total, 105 isolates (40.9%) were resistant to at least one of the aminoglycosides tested. Amikacin, apramycin and arbekacin showed better activity, with MIC90 values of 2mg/L (arbekacin) and 8mg/L (amikacin and apramycin). Kanamycin presented the highest MIC90 (128mg/L). The most common AME gene was aac(6')-Ib (36 strains; 34.3%), followed by aph(3')-Ia (31 strains; 29.5%), ant(2″)-Ia (29 strains; 27.6%) and aac(3)-IIa (23 strains; 21.9%). aac(3)-Ia, aac(3)-IVa, ant(4')-IIa and the four methylases were not detected. The ant(2″)-Ia gene was usually associated with OXA-1 [21/30; 70%], whilst 23/25 (92%) strains producing CTX-M-15 had the aac(6')-Ib gene. The most prevalent AME gene was aac(6')-Ib (18/41; 44%) in nosocomial isolates, whilst ant(2″)-Ia and aph(3')-Ia genes (20/64; 31%) were more frequent in strains of community origin. In 64.6% isolates the phenotypic profile correlated with the presence of commonly encountered AMEs.

  16. Will sacubitril-valsartan diminish the clinical utility of B-type natriuretic peptide testing in acute cardiac care?

    DEFF Research Database (Denmark)

    Mair, Johannes; Lindahl, Bertil; Giannitsis, Evangelos;

    2016-01-01

    Since the approval of sacubitril-valsartan for the treatment of chronic heart failure with reduced ejection fraction, a commonly raised suspicion is that a wider clinical use of this new drug may diminish the clinical utility of B-type natriuretic peptide testing as sacubitril may interfere with ...

  17. 75 FR 30041 - Medicare Program; Public Meeting in Calendar Year 2010 for New Clinical Laboratory Tests Payment...

    Science.gov (United States)

    2010-05-28

    ...This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for a specified list of new Clinical Procedural Terminology (CPT) codes for clinical laboratory tests in calendar year (CY) 2011. The meeting provides a forum for interested......

  18. From Usability Testing to Clinical Simulations: Bringing Context into the Design and Evaluation of Usable and Safe Health Information Technologies

    DEFF Research Database (Denmark)

    Kushniruk, Andre; Nøhr, Christian; Jensen, Sanne;

    2013-01-01

    of clinical context into stronger focus. This involves testing of systems with representative users doing representative tasks, in representative settings/environments. Results: Application of methods where realistic clinical scenarios are used to drive the study of users interacting with systems under...

  19. Restoration of non-carious cervical lesions with ceramic inlays: A possible model for clinical testing of adhesive cements

    OpenAIRE

    Michal Staninec; Tsuji, Grant H.

    2012-01-01

    Introduction: There are many luting cements coming to market which claim to be adhesive, but there is no clinical protocol currently for testing these claims. There is a standardized protocol for testing direct restorations bonded to dentin and it is used extensively. Case Report: We describe a clinical procedure for restoring a non-carious cervical lesion (NCCL) with a ceramic inlay using Computer-Aided Design and Computer-Aided Manufacturing (CAD-CAM) technology and an adhesive resin cement...

  20. Impact of a Routine, Opt-Out HIV Testing Program on HIV Testing and Case Detection in North Carolina Sexually-Transmitted Disease Clinics

    Science.gov (United States)

    Klein, Pamela W.; Messer, Lynne C.; Myers, Evan R.; Weber, David J.; Leone, Peter A.; Miller, William C.

    2016-01-01

    The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection. Adults aged 18–64 who received an HIV test in a North Carolina STD clinic July 1, 2005 through June 30, 2011 were included in this analysis, dichotomized at the date of implementation on November 1, 2007. HIV testing and case detection counts and rates were analyzed using interrupted time series analysis, and Poisson and multilevel logistic regression. Pre-intervention, 426 new HIV-infected cases were identified from 128,029 tests (0.33%), whereas 816 new HIV-infected cases were found from 274,745 tests post-intervention (0.30%). Pre-intervention, HIV testing increased by 55 tests per month (95% confidence interval [CI]: 41, 72), but only 34 tests per month (95% CI: 26, 42) post-intervention. Increases in HIV testing rates were most pronounced in females and non-Hispanic whites. A slight pre-intervention decline in case detection was mitigated by the intervention (mean difference [MD]=0.01; 95% CI: −0.02, 0.05). Increases in case detection rates were observed among females and non-Hispanic blacks. The impact of a routine HIV screening in North Carolina STD clinics was marginal, with the greatest benefit among persons not traditionally targeted for HIV testing. The use of a pre-intervention comparison period identified important temporal trends that otherwise would have been ignored. PMID:24825338

  1. Trend of glycated hemoglobin testing in diabetic patients: to assess compliance with clinical practice guidelines

    International Nuclear Information System (INIS)

    Objective: To determine appropriate use of glycated hemoglobin (HbA1c) testing in accordance with current recommended guidelines. Study Design: Descriptive study. Place and Duration of Study: Chemical Pathology Department Shifa International Hospital, Islamabad from Oct 2011 to Oct 2012. Material and Methods: We randomly selected 170 known diabetic patients' data from our Laboratory Information System (LIS) who were retrospective analyzed for HbA1c to check for intervals and test frequency for each patient in one year. Patients with follow-up for at least one year at Shifa International Hospital, Islamabad and having their routine investigations in our chemical pathology laboratory were included. The concentrations of HbA1c for all the specimens were measured immunoturbidimetrically using a microparticle agglutination inhibition method. Four guidelines namely World Health Organization (WHO), American Diabetic Association (ADA), Canadian Diabetic Association (CDA) and National Institute for Health and Clinical Excellence (NICE) about HbA1c testing were utilized for data interpretation. All tests ordered within a 2 months period or more than 6 months following the previous order were labeled as inappropriate. Results: Only 35.8% of the patients were being properly monitored as per guidelines. Out of 64% patients who were inappropriately monitored, 12.9% had repeat orders within 2 months while 51.1% of patients were being monitored at longer interval against recommended guidelines. Conclusions: Glycated hemoglobin is a useful tool to objectively assess the prior glycemic control of patients with type 1 and type 2 diabetes. The study highlights that in large proportion of diabetic patients, HbA1c is not utilized properly as a tool to assess the risk of diabetic complications but in a small proportion is also tested unnecessarily which adds to avoidable health expenditure. (author)

  2. Correlation of accelerometry with clinical balance tests in older fallers and non-fallers.

    LENUS (Irish Health Repository)

    O'Sullivan, Maura

    2012-02-01

    BACKGROUND: falls are a common cause of injury and decreased functional independence in the older adult. Diagnosis and treatment of fallers require tools that accurately assess physiological parameters associated with balance. Validated clinical tools include the Berg Balance Scale (BBS) and the Timed Up and Go test (TUG); however, the BBS tends to be subjective in nature, while the TUG quantifies an individuals functional impairment but requires further subjective evaluation for balance assessment. Other quantitative alternatives to date require expensive, sophisticated equipment. Measurement of the acceleration of centre of mass, with relatively inexpensive, lightweight, body-mounted accelerometers is a potential solution to this problem. OBJECTIVES: to determine (i) if accelerometry correlates with standard clinical tests (BBS and TUG), (ii) to characterise accelerometer responses to increasingly difficult challenges to balance and (iii) to characterise acceleration patterns between fallers and non-fallers. Study design and setting: torso accelerations were measured at the level of L3 using a tri-axial accelerometer under four conditions; standing unsupported with eyes open (EO), eyes closed (EC) and on a mat with eyes open (MAT EO) and closed (MAT EC). Older patients (n = 21, 8 males, 13 females) with a mean age of 78 (SD +\\/- 7.6) years who attended a day hospital were recruited for this study. Patients were identified as fallers or non-fallers based on a comprehensive falls history. MEASUREMENTS: Spearman\\'s rank correlation analysis examined the relationship between acceleration root mean square (RMS) data and the BBS while Pearson\\'s correlation was used with TUG scores. Differences in accelerometer RMS between fallers and non-fallers and between test conditions were examined using t-test and non-parametric alternatives where appropriate. RESULTS: there was a stepwise increase in accelerometer RMS with increasing task complexity, and the accelerometer

  3. The use of rapid dengue diagnostic tests in a routine clinical setting in a dengue-endemic area of Colombia

    OpenAIRE

    Lyda Osorio; Marcela Uribe; Gloria Ines Ardila; Yaneth Orejuela; Margarita Velasco; Anilza Bonelo; Beatriz Parra

    2015-01-01

    There is insufficient evidence of the usefulness of dengue diagnostic tests under routine conditions. We sought to analyse how physicians are using dengue diagnostics to inform research and development. Subjects attending 14 health institutions in an endemic area of Colombia with either a clinical diagnosis of dengue or for whom a dengue test was ordered were included in the study. Patterns of test-use are described herein. Factors associated with the ordering of dengue diagnostic tests were ...

  4. Laboratory demonstration of a prozone-like effect in HRP2-detecting malaria rapid diagnostic tests: implications for clinical management

    OpenAIRE

    McCarthy James S; Cheng Qin; Belizario Vicente; Alcantara Sheila; Baker Joanne; Luchavez Jennifer; Bell David

    2011-01-01

    Abstract Background Malaria rapid diagnostic tests (RDTs) are now widely used for prompt on-site diagnosis in remote endemic areas where reliable microscopy is absent. Aberrant results, whereby negative test results occur at high parasite densities, have been variously reported for over a decade and have led to questions regarding the reliability of the tests in clinical use. Methods In the first trial, serial dilutions of recombinant HRP2 antigen were tested on an HRP2-detectiing RDT. In a s...

  5. Clinical Neuropathology practice news 1-2014: Pyrosequencing meets clinical and analytical performance criteria for routine testing of MGMT promoter methylation status in glioblastoma

    Science.gov (United States)

    Preusser, Matthias; Berghoff, Anna S.; Manzl, Claudia; Filipits, Martin; Weinhäusel, Andreas; Pulverer, Walter; Dieckmann, Karin; Widhalm, Georg; Wöhrer, Adelheid; Knosp, Engelbert; Marosi, Christine; Hainfellner, Johannes A.

    2014-01-01

    Testing of the MGMT promoter methylation status in glioblastoma is relevant for clinical decision making and research applications. Two recent and independent phase III therapy trials confirmed a prognostic and predictive value of the MGMT promoter methylation status in elderly glioblastoma patients. Several methods for MGMT promoter methylation testing have been proposed, but seem to be of limited test reliability. Therefore, and also due to feasibility reasons, translation of MGMT methylation testing into routine use has been protracted so far. Pyrosequencing after prior DNA bisulfite modification has emerged as a reliable, accurate, fast and easy-to-use method for MGMT promoter methylation testing in tumor tissues (including formalin-fixed and paraffin-embedded samples). We performed an intra- and inter-laboratory ring trial which demonstrates a high analytical performance of this technique. Thus, pyrosequencing-based assessment of MGMT promoter methylation status in glioblastoma meets the criteria of high analytical test performance and can be recommended for clinical application, provided that strict quality control is performed. Our article summarizes clinical indications, practical instructions and open issues for MGMT promoter methylation testing in glioblastoma using pyrosequencing. PMID:24359605

  6. SUSCEPTIBILITY TEST FOR FUNGI: CLINICAL AND LABORATORIAL CORRELATIONS IN MEDICAL MYCOLOGY

    Directory of Open Access Journals (Sweden)

    Ana ALASTRUEY-IZQUIERDO

    2015-09-01

    Full Text Available SUMMARYDuring recent decades, antifungal susceptibility testing has become standardized and nowadays has the same role of the antibacterial susceptibility testing in microbiology laboratories. American and European standards have been developed, as well as equivalent commercial systems which are more appropriate for clinical laboratories. The detection of resistant strains by means of these systems has allowed the study and understanding of the molecular basis and the mechanisms of resistance of fungal species to antifungal agents. In addition, many studies on the correlation of in vitro results with the outcome of patients have been performed, reaching the conclusion that infections caused by resistant strains have worse outcome than those caused by susceptible fungal isolates. These studies have allowed the development of interpretative breakpoints for Candida spp. and Aspergillus spp., the most frequent agents of fungal infections in the world. In summary, antifungal susceptibility tests have become essential tools to guide the treatment of fungal diseases, to know the local and global disease epidemiology, and to identify resistance to antifungals.

  7. Initial clinical testing of a multi-spectral imaging system built on a smartphone platform

    Science.gov (United States)

    Mink, Jonah W.; Wexler, Shraga; Bolton, Frank J.; Hummel, Charles; Kahn, Bruce S.; Levitz, David

    2016-03-01

    Multi-spectral imaging systems are often expensive and bulky. An innovative multi-spectral imaging system was fitted onto a mobile colposcope, an imaging system built around a smartphone in order to image the uterine cervix from outside the body. The multi-spectral mobile colposcope (MSMC) acquires images at different wavelengths. This paper presents the clinical testing of MSMC imaging (technical validation of the MSMC system is described elsewhere 1 ). Patients who were referred to colposcopy following abnormal screening test (Pap or HPV DNA test) according to the standard of care were enrolled. Multi-spectral image sets of the cervix were acquired, consisting of images from the various wavelengths. Image acquisition took 1-2 sec. Areas suspected for dysplasia under white light imaging were biopsied, according to the standard of care. Biopsied sites were recorded on a clockface map of the cervix. Following the procedure, MSMC data was processed from the sites of biopsied sites. To date, the initial histopathological results are still outstanding. Qualitatively, structures in the cervical images were sharper at lower wavelengths than higher wavelengths. Patients tolerated imaging well. The result suggests MSMC holds promise for cervical imaging.

  8. Food Enzymes

    Science.gov (United States)

    McBroom, Rachel; Oliver-Hoyo, Maria T.

    2007-01-01

    Many students view biology and chemistry as two unrelated, separate sciences; how these courses are generally taught in high schools may do little to change that impression. The study of enzymes provide a great opportunity for both biology and chemistry teachers to share with students the interdisciplinary nature of science. This article describes…

  9. Unexplained exertional dyspnea caused by low ventricular filling pressures: results from clinical invasive cardiopulmonary exercise testing.

    Science.gov (United States)

    Oldham, William M; Lewis, Gregory D; Opotowsky, Alexander R; Waxman, Aaron B; Systrom, David M

    2016-03-01

    To determine whether low ventricular filling pressures are a clinically relevant etiology of unexplained dyspnea on exertion, a database of 619 consecutive, clinically indicated invasive cardiopulmonary exercise tests (iCPETs) was reviewed to identify patients with low maximum aerobic capacity (V̇o2max) due to inadequate peak cardiac output (Qtmax) with normal biventricular ejection fractions and without pulmonary hypertension (impaired: n = 49, V̇o2max = 53% predicted [interquartile range (IQR): 47%-64%], Qtmax = 72% predicted [62%-76%]). These were compared to patients with a normal exercise response (normal: n = 28, V̇o2max = 86% predicted [84%-97%], Qtmax = 108% predicted [97%-115%]). Before exercise, all patients received up to 2 L of intravenous normal saline to target an upright pulmonary capillary wedge pressure (PCWP) of ≥5 mmHg. Despite this treatment, biventricular filling pressures at peak exercise were lower in the impaired group than in the normal group (right atrial pressure [RAP]: 6 [IQR: 5-8] vs. 9 [7-10] mmHg, P = 0.004; PCWP: 12 [10-16] vs. 17 [14-19] mmHg, P volume (SV) augmentation with exercise (+13 ± 10 [standard deviation (SD)] vs. +18 ± 10 mL/m(2), P = 0.014). A review of hemodynamic data from 23 patients with low RAP on an initial iCPET who underwent a second iCPET after saline infusion (2.0 ± 0.5 L) demonstrated that 16 of 23 patients responded with increases in Qtmax ([+24% predicted [IQR: 14%-34%]), V̇o2max (+10% predicted [7%-12%]), and maximum SV (+26% ± 17% [SD]). These data suggest that inadequate ventricular filling related to low venous pressure is a clinically relevant cause of exercise intolerance. PMID:27162614

  10. Unexplained exertional dyspnea caused by low ventricular filling pressures: results from clinical invasive cardiopulmonary exercise testing

    Science.gov (United States)

    Lewis, Gregory D.; Opotowsky, Alexander R.; Waxman, Aaron B.; Systrom, David M.

    2016-01-01

    Abstract To determine whether low ventricular filling pressures are a clinically relevant etiology of unexplained dyspnea on exertion, a database of 619 consecutive, clinically indicated invasive cardiopulmonary exercise tests (iCPETs) was reviewed to identify patients with low maximum aerobic capacity (V̇o2max) due to inadequate peak cardiac output (Qtmax) with normal biventricular ejection fractions and without pulmonary hypertension (impaired: n = 49, V̇o2max = 53% predicted [interquartile range (IQR): 47%–64%], Qtmax = 72% predicted [62%–76%]). These were compared to patients with a normal exercise response (normal: n = 28, V̇o2max = 86% predicted [84%–97%], Qtmax = 108% predicted [97%–115%]). Before exercise, all patients received up to 2 L of intravenous normal saline to target an upright pulmonary capillary wedge pressure (PCWP) of ≥5 mmHg. Despite this treatment, biventricular filling pressures at peak exercise were lower in the impaired group than in the normal group (right atrial pressure [RAP]: 6 [IQR: 5–8] vs. 9 [7–10] mmHg, P = 0.004; PCWP: 12 [10–16] vs. 17 [14–19] mmHg, P < 0.001), associated with decreased stroke volume (SV) augmentation with exercise (+13 ± 10 [standard deviation (SD)] vs. +18 ± 10 mL/m2, P = 0.014). A review of hemodynamic data from 23 patients with low RAP on an initial iCPET who underwent a second iCPET after saline infusion (2.0 ± 0.5 L) demonstrated that 16 of 23 patients responded with increases in Qtmax ([+24% predicted [IQR: 14%–34%]), V̇o2max (+10% predicted [7%–12%]), and maximum SV (+26% ± 17% [SD]). These data suggest that inadequate ventricular filling related to low venous pressure is a clinically relevant cause of exercise intolerance. PMID:27162614

  11. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues

    Directory of Open Access Journals (Sweden)

    Gekas J

    2016-02-01

    Full Text Available Jean Gekas,1,2 Sylvie Langlois,3 Vardit Ravitsky,4 François Audibert,5 David Gradus van den Berg,6 Hazar Haidar,4 François Rousseau2,7 1Prenatal Diagnosis Unit, Department of Medical Genetics and Pediatrics, Faculty of Medicine, Université Laval, Québec City, QC, Canada; 2Department of Medical Biology, CHU de Québec, Québec City, QC, Canada; 3Department of Medical Genetics, University of British Columbia, Vancouver, BC, Canada; 4Bioethics Program, Department of Social and Preventive Medicine, School of Public Health, University of Montreal, Montreal, QC, Canada; 5Department of Obstetrics and Gynecology, Hospital Sainte-Justine, Montreal, QC, Canada; 6Department of Social and Preventive Medicine, Faculty of Medicine, Université Laval, Québec City, QC, Canada; 7Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Université Laval, Québec City, QC, Canada Abstract: Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women. Keywords: prenatal diagnosis, Down syndrome, non-invasive prenatal testing, cell-free fetal DNA, informed consent, reproductive autonomy

  12. Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic

    Directory of Open Access Journals (Sweden)

    A. Jewett

    2013-01-01

    Full Text Available Background. The Centers for Disease Control and Prevention (CDC recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV, including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC testing into standard operations at an urban STD clinic. Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC. All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative. Focus groups were conducted with triage staff, providers, and linkage-to-care counselors. Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care. Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection.

  13. Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic.

    Science.gov (United States)

    Jewett, A; Al-Tayyib, A A; Ginnett, L; Smith, B D

    2013-01-01

    Background. The Centers for Disease Control and Prevention (CDC) recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV), including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC) testing into standard operations at an urban STD clinic. Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC). All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative). Focus groups were conducted with triage staff, providers, and linkage-to-care counselors. Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care. Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection. PMID:24455220

  14. Quantitative testing of physiotherapy ultrasound beam patterns within a clinical environment using a thermochromic tile.

    Science.gov (United States)

    Žauhar, Gordana; Radojčić, Đeni Smilović; Dobravac, Denis; Jurković, Slaven

    2015-04-01

    The implementation of the non-standardized method developed at the National Physical Laboratory (UK) supporting the quality assurance of therapeutic ultrasonic beam parameters within a clinical environment is presented. The method consists of exposing an acoustic absorber tile, part of which contains a thermochromic pigment, to the ultrasonic beam, thereby forming an image of the two-dimensional intensity profile of the transducer. Nine different physiotherapy ultrasound treatment heads currently used clinically were tested using this method. Thermochromic images were postprocessed in order to estimate the Effective Radiating Area (ERA) for treatment heads operating within the frequency range from 1 MHz to 3.2 MHz, and nominal applied intensities in the range of 1-3 W/cm(2). Experimental results and comparisons with manufacturer specified values of ERA are presented. Differences in the experimentally derived results and the manufacturer values are typically well within 25%. The root-mean squared difference calculated over the nine treatment heads is 15.1%, with the thermochromic material tended to underestimate the ERA. PMID:25638714

  15. Clinical testing of combined vaccine against enzootic pneumonia in industrial pig farming in Bulgaria

    Directory of Open Access Journals (Sweden)

    Roman Pepovich

    2015-10-01

    Full Text Available In the pig farm with signs of a respiratory disease complex and laboratory confirmed enzootic pneumonia, the prophylactic efficacy of the combination vaccine (M. hyo+PCV2, a single injection administered intramuscularly 21 days after birth, at a dose of 2 ml was tested. The clinical condition, pathological changes in the lungs and some epidemiological and economic results were reported. It was found that vaccinated pigs are in a better clinical condition in comparison with the control group. Morbidity in the rearing period was reduced from 16.3% in the control group to 6.0% in vaccinated pigs, and in the fattening period, respectively, from 30.6% in the control group to 10.0% in the vaccinated group. Pathological features in the lung characteristic for the enzootic pneumonia in the vaccinated pigs were reduced from 25.5%±7.24 to 4.0%±2.44, and PCVI - from 13.0%±4.66 to 0%. Vaccination of pigs has been received and a higher average daily gain in groups for rearing (0.624 kg and for fattening (0.723 kg was recorded.

  16. Performance of the DTL electrode compared to the jet contact lens electrode in clinical testing.

    Science.gov (United States)

    Yin, Hang; Pardue, Machelle T

    2004-01-01

    To compare the recording characteristics of the DTL fiber and Jet contact lens electrodes, ERG responses were recorded from 20 normal subjects using the ISCEV standard clinical protocol. In each subject, the DTL electrode was placed in the right eye and the Jet contact lens in the left eye after 30 min of dark-adaptation. After presenting standard dark- and light-adapted stimuli, each response was analyzed for a- and b-wave amplitude and implicit time. Each subject was then asked to rate the comfort of each electrode. Responses recorded with the DTL are larger and faster for the dark-adapted dim white and red flashes. In contrast, the Jet electrode records larger responses for the dark-adapted standard flash and light-adapted flashes. Of these differences, only the standard flash is statistically significant. However, overall the DTL electrode has greater variability than the Jet electrode across all recordings. The DTL and Jet electrodes cannot be used interchangeably as demonstrated by a Bland and Altman analysis of agreement. Thus, separate normative values need to be collected for each type of electrode to accurately assess retinal function. Based on the comfort assessment of the two electrodes, the subjects preferred the DTL electrode over the Jet electrode. Due to the superior comfort level of the DTL and its similarities to the Jet contact lens electrode in ERG recordings, the DTL electrode appears to be a good alternative to the Jet electrode in routine clinical testing when used with the appropriate normative values.

  17. Clinical implementation of genetic testing in medicine: a US regulatory science perspective.

    Science.gov (United States)

    Lesko, Lawrence J; Schmidt, Stephan

    2014-04-01

    Heterogeneity of treatment effects in unselected patient populations has stimulated various strategic approaches to reduce variability and uncertainty and improve individualization of drug selection and dosing. The rapid growth of DNA sequencing and related technologies has ramped up progress in interpreting germline and somatic mutations and has begun to reshape medicine, especially in oncology. Over the past decade, regulatory agencies realized that they needed to be proactive and not reactive if personalized medicine was to become a reality. The US Food and Drug Administration, in particular, took steps to nurture the field through peer-reviewed publications, co-sponsoring public workshops and issuing guidance for industry. The following two major approaches to personalized medicine were taken: (i) encouragement of de novo co-development of drug-genetic test combinations by industry; and (ii) retrospective assessment of legacy genetic data for the purpose of updating drug labels. The former strategy has been more successful in getting new targeted therapies to the marketplace with successful adoption, while the latter, as evidenced by the low adoption rate of pharmacogenetic testing, has been less successful. This reflection piece makes clear that several important things need to happen to make personalized medicine diffuse in more geographical areas and among more therapeutic specialties. The debate over clinical utility of genetic tests needs to be resolved with consensus on evidentiary standards. Physicians, as gatekeepers of prescription medicines, need to increase their knowledge of genetics and the application of the information to patient care. An infrastructure needs to be developed to make access to genetic tests and decision-support tools available to primary practitioners and specialists outside major medical centres and metropolitan areas. PMID:24286486

  18. Routine implementation of EGFR mutation testing in clinical practice in Flanders: 'HERMES' project.

    Science.gov (United States)

    Janssens, A; De Droogh, E; Lefebure, A; Kockx, M; Pauwels, P; Germonpre, P; van Meerbeeck, J P

    2014-04-01

    Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is the recommended first-line treatment in metastatic EGFR-mutation-positive non-small cell lung cancer (NSCLC) patients. Such a personalized treatment requires fast EGFR mutation testing. This study was performed to determine the turn around time (TAT) for EGFR mutation testing on tumour samples of NSCLC in the clinical care in the region of Antwerp (Belgium). The secondary aim was to determine the frequency of EGFR mutations in this Flemish population. Tumour tissue was prospectively obtained from lung cancer patients in participating hospitals and sent from the local pathology laboratory (lab) to two central laboratories (labs) where EGFR-mutation analysis was performed. Results were returned from the central labs to the clinicians and the local pathology lab. TAT was defined as the interval between the request from the oncologist and the result obtained by the oncologist. One hundred and seven specimens were analysed. The clinician got the result from the local lab in a median time of 10 days (3-37 days) and from the central lab in 9 days (3-29 days). We detected seven mutations (7%) in this study population, all occurring in tumours with an adenocarcinoma histology, four (57%) in men and five (71%) in (ex-)smokers. There were six exon 19 deletions and one L858R mutation. It is possible to implement EGFR-mutation testing with timely reporting of the EGFR-mutation status. EGFR-mutation occurs in 7% of Flemish patients with NSCLC. Patients with advanced non-squamous NSCLC should be tested for EGFR mutation regardless of their gender and smoking history. PMID:24724747

  19. Population-based Tay-Sachs screening among Ashkenazi Jewish young adults in the 21st century: Hexosaminidase A enzyme assay is essential for accurate testing.

    Science.gov (United States)

    Schneider, Adele; Nakagawa, Sachiko; Keep, Rosanne; Dorsainville, Darnelle; Charrow, Joel; Aleck, Kirk; Hoffman, Jodi; Minkoff, Sherman; Finegold, David; Sun, Wei; Spencer, Andrew; Lebow, Johannah; Zhan, Jie; Apfelroth, Stephen; Schreiber-Agus, Nicole; Gross, Susan

    2009-11-01

    Tay-Sachs disease (TSD) carrier screening, initiated in the 1970s, has reduced the birth-rate of Ashkenazi Jews with TSD worldwide by 90%. Recently, several nationwide programs have been established that provide carrier screening for the updated panel of Jewish genetic diseases on college campuses and in Jewish community settings. The goals of this study were to determine the performance characteristics of clinical TSD testing in college- and community-based screening programs and to determine if molecular testing alone is adequate in those settings. Clinical data for TSD testing were retrospectively anonymized and subsequently analyzed for 1,036 individuals who participated in these programs. The performance characteristics of the serum and the platelet Hexosaminidase assays were compared, and also correlated with the results of targeted DNA analysis. The serum assay identified 29 carriers and the platelet assay identified 35 carriers for carrier rates of 1/36 and 1/29, respectively. One hundred sixty-nine samples (16.3%) were inconclusive by serum assay in marked contrast to four inconclusive samples (0.4%) by the platelet assay. Molecular analysis alone would have missed four of the 35 carriers detected by the platelet assay, yielding a false negative rate of 11.4% with a sensitivity of 88.6%. Based on the results of this study, platelet assay was superior to serum with a minimal inconclusive rate. Due to changing demographics of the Ashkenazi Jewish population, molecular testing alone in the setting of broad-based population screening programs is not sufficient, and biochemical analysis should be the assay of choice. PMID:19876898

  20. Differential Reinforcement of Alternative Behavior Increases Resistance to Extinction: Clinical Demonstration, Animal Modeling, and Clinical Test of One Solution

    Science.gov (United States)

    Mace, F. Charles; McComas, Jennifer J.; Mauro, Benjamin C.; Progar, Patrick R.; Taylor, Bridget; Ervin, Ruth; Zangrillo, Amanda N.

    2010-01-01

    Basic research with pigeons on behavioral momentum suggests that differential reinforcement of alternative behavior (DRA) can increase the resistance of target behavior to change. This finding suggests that clinical applications of DRA may inadvertently increase the persistence of target behavior even as it decreases its frequency. We conducted…

  1. SU-E-T-150: End to End Tests On the First Clinical EDGETM

    Energy Technology Data Exchange (ETDEWEB)

    Scheib, S; Schmelzer, P [Varian Medical Systems, Baden - Daettwil (Switzerland); Vieira, S; Greco, C [Champalimaud Foundation, Lisbon (Portugal)

    2014-06-01

    Purpose: To quantify the sub millimeter overall accuracy of EDGETM, the dedicated linac based SRS/SABR treatment platform from Varian, using a novel End-to-End (E2E) test phantom. Methods: The new E2E test phantom developed by Varian consists of a cube with an outer dimension of 15x15x15 cm3. The phantom is equipped with an exchangable inner cube (7×7×7 cm3) to hold radiochromic films or a tungsten ball (diameter = 5 mm) for Winston-Lutz tests. 16 ceramic balls (diameter = 5 mm) are embedded in the outer cube. Three embedded Calypso transponders allow for Calypso based monitoring. The outer surface of the phantom is tracked using the Optical Surface Monitoring System (OSMS). The phantom is positioned using kV, MV and CBCT images. A simCT of the phantom was acquired and SRS/SABR plans were treated using the new phantom on the first clinical installed EDGETM. As a first step a series of EPID based Winston-Lutz tests have been performed. As a second step the calculated dose distribution applied to the phantom was verified with radiochromic films in orthogonal planes. The measured dose distribution is compared with the calculated (Eclipse) one based on the known isocenter on both dose distributions. The geometrical shift needed to match both dose distributions is the overall accuracy and is determined using dose profiles, isodose lines or gamma pass rates (3%, 1 mm). Results: Winston-Lutz tests using the central tungsten BB demonstrated a targeting accuracy of 0.44±0.18mm for jaw (2cm × 2cm) defined 0.39±0.19mm for MLC (2cm × 2cm) defined and 0.37±0.15mm for cone (12.5 mm) defined fields. A treated patient plan (spinal metastases lesion with integrated boost) showed a dosimetric dose localization accuracy of 0.6mm. Conclusion: Geometric and dosimetric E2E tests on EDGETM, show sub-millimeter E2E targeting and dose localisation accuracy.

  2. 26 CFR 1.28-1 - Credit for clinical testing expenses for certain drugs for rare diseases or conditions.

    Science.gov (United States)

    2010-04-01

    ... regulations relating thereto (21 CFR part 312) for the purpose of testing a drug for a rare disease or... drugs for rare diseases or conditions. 1.28-1 Section 1.28-1 Internal Revenue INTERNAL REVENUE SERVICE... clinical testing expenses for certain drugs for rare diseases or conditions. (a) General rule. Section...

  3. Alkylating enzymes.

    Science.gov (United States)

    Wessjohann, Ludger A; Keim, Jeanette; Weigel, Benjamin; Dippe, Martin

    2013-04-01

    Chemospecific and regiospecific modifications of natural products by methyl, prenyl, or C-glycosyl moieties are a challenging and cumbersome task in organic synthesis. Because of the availability of an increasing number of stable and selective transferases and cofactor regeneration processes, enzyme-assisted strategies turn out to be promising alternatives to classical synthesis. Two categories of alkylating enzymes become increasingly relevant for applications: firstly prenyltransferases and terpene synthases (including terpene cyclases), which are used in the production of terpenoids such as artemisinin, or meroterpenoids like alkylated phenolics and indoles, and secondly methyltransferases, which modify flavonoids and alkaloids to yield products with a specific methylation pattern such as 7-O-methylaromadendrin and scopolamine.

  4. Noninvasive cerebral blood oxygenation monitoring: clinical test of multiwavelength optoacoustic system

    Science.gov (United States)

    Petrov, Y. Y.; Prough, D. S.; Petrova, I.; Patrikeev, I. A.; Cicenaite, I.; Esenaliev, R. O.

    2007-02-01

    Continuous monitoring of cerebral blood oxygenation is critically important for treatment of patients with life-threatening conditions like severe brain injury or during cardiac surgery. We designed and built a novel multiwavelength optoacoustic system for noninvasive, continuous, and accurate monitoring of cerebral blood oxygenation. We use an Optical Parametric Oscillator as a light source. We successfully tested the system in vitro as well as in vivo in large animals (sheep) through thick tissues overlying blood vessels which drain venous blood out of the brain (e.g., superior sagittal sinus or jugular vein). Here we present the results of clinical tests of the system for continuous noninvasive cerebral blood oxygenation monitoring in the internal jugular vein of healthy volunteers. We applied our custom-built optoacoustic probe (which incorporated a wide-band acoustic transducer and an optical fiber) to the neck area overlying the internal jugular vein. We performed measurements with volunteers at 18 wavelengths in the near-infrared spectral range. Despite a thick layer of overlying connective tissue and low energy used in the experiments, we recorded signals with high signal-to-noise ratios for all volunteers. We found that the temporal (independent of signal amplitude) parameters of recorded profiles for different levels of blood oxygenation correlated well with the spectrum of effective attenuation coefficients of blood.

  5. Clinical utility of the Multiple Errands Test in schizophrenia: A preliminary assessment.

    Science.gov (United States)

    Bulzacka, Ewa; Delourme, Gwenaëlle; Hutin, Valérie; Burban, Nathalie; Méary, Alexandre; Lajnef, Mohamed; Leboyer, Marion; Schürhoff, Franck

    2016-06-30

    Schizophrenia (SZ) is a chronic, severe disease, which results in misperception of reality, major social withdrawal, and cognitive disturbances. One type of cognitive disturbance, known as executive dysfunction, is widely considered as a primary determinant of functional outcome. However, classic neuropsychological measures of executive functioning (EF) poorly represent patients' functional outcome, and thus seem inappropriate for evaluating the real-world functional impact of diseases such as SZ. We hypothesized that the Multiple Errands Test (MET), an ecological assessment of executive function would show greater ability to measure everyday adaptive functioning SZ, compared to conventional EF assessment methods. 100 clinically stable SZ patients were administered the MET, Wisconsin Card Sorting Test - 64 and a paper version of MET. Correlation analyses were performed between each EF measure and functional outcome, as measured by the Social Autonomy Scale (SAS). After adjusting for age, education, IQ and illness duration, SAS was significantly predicted by MET global score. No other EF measure correlated with SAS. Results from this study suggest that MET offers a valuable prediction of daily life functional outcome in this large sample of SZ patients. Therefore, it could be used as a complementary measure to improve the identification of executive dysfunctions prior to psychosocial interventions. PMID:27138836

  6. Alpha-1 Antitrypsin Deficiency Targeted Testing and Augmentation Therapy: A Canadian Thoracic Society Clinical Practice Guideline

    Directory of Open Access Journals (Sweden)

    DD Marciniuk

    2012-01-01

    Full Text Available Alpha-1 antitrypsin (A1AT functions primarily to inhibit neutrophil elastase, and deficiency predisposes individuals to the development of chronic obstructive pulmonary disease (COPD. Severe A1AT deficiency occurs in one in 5000 to one in 5500 of the North American population. While the exact prevalence of A1AT deficiency in patients with diagnosed COPD is not known, results from small studies provide estimates of 1% to 5%. The present document updates a previous Canadian Thoracic Society position statement from 2001, and was initiated because of lack of consensus and understanding of appropriate patients suitable for targeted testing for A1AT deficiency, and for the use of A1AT augmentation therapy. Using revised guideline development methodology, the present clinical practice guideline document systematically reviews the published literature and provides an evidence-based update. The evidence supports the practice that targeted testing for A1AT deficiency be considered in individuals with COPD diagnosed before 65 years of age or with a smoking history of <20 pack years. The evidence also supports consideration of A1AT augmentation therapy in nonsmoking or exsmoking patients with COPD (forced expiratory volume in 1 s of 25% to 80% predicted attributable to emphysema and documented A1AT deficiency (level ≤11 μmol/L who are receiving optimal pharmacological and nonpharmacological therapies (including comprehensive case management and pulmonary rehabilitation because of benefits in computed tomography scan lung density and mortality.

  7. Modified bathroom scale and balance assessment: a comparison with clinical tests.

    Science.gov (United States)

    Duchêne, Jacques; Hewson, David; Rumeau, Pierre

    2016-01-01

    Frailty and detection of fall risk are major issues in preventive gerontology. A simple tool frequently used in daily life, a bathroom scale (balance quality tester: BQT), was modified to obtain information on the balance of 84 outpatients consulting at a geriatric clinic. The results computed from the BQT were compared to the values of three geriatric tests that are widely used either to detect a fall risk or frailty (timed get up and go: TUG; 10 m walking speed: WS; walking time: WT; one-leg stand: OS). The BQT calculates four parameters that are then scored and weighted, thus creating an overall indicator of balance quality. Raw data, partial scores and the global score were compared with the results of the three geriatric tests. The WT values had the highest correlation with BQT raw data (r = 0.55), while TUG (r = 0.53) and WS (r = 0.56) had the highest correlation with BQT partial scores. ROC curves for OS cut-off values (4 and 5 s) were produced, with the best results obtained for a 5 s cut-off, both with the partial scores combined using Fisher's combination (specificity 85 %: 0.48), and with the empirical score (specificity 85 %: 8). A BQT empirical score of less than seven can detect fall risk in a community dwelling population. PMID:27217987

  8. Engineering enzymes

    OpenAIRE

    Dutton, P. Leslie; Moser, Christopher C.

    2011-01-01

    Fundamental research into bioinorganic catalysis of the kind presented at this Faraday Discussion has the potential to turn inspiration drawn from impressive natural energy and chemical transformations into artificial catalyst constructions useful to mankind. Creating bio-inspired artificial constructions requires a level of understanding well beyond simple description of structures and mechanisms of natural enzymes. To be useful, such description must be augmented by a practical sense of str...

  9. COMPARATIVE EFFICIENCY OF SOME INDIRECT DIAGNOSTIC TESTS FOR THE DETECTION OF SUB-CLINICAL MASTITIS IN COWS AND BUFFALOES

    Directory of Open Access Journals (Sweden)

    M. IQBAL, M. AMJED1, M. A. KHAN, M. S. QURESHI1 AND U. SADIQUE1

    2006-04-01

    Full Text Available The present study was undertaken to compare five laboratory diagnostic tests for sub-clinical mastitis in cattle and buffaloes and to compute cost, time taken by each test and its ranking for availability, adoptability, interpretability and sensitivity. There were 352 cases with each test type viz. California Mastitis Test (CMT, White Side Test (WST, White Side + Dye (WSTD, Surf Test and Surf + Dye, and 880 cases with each species type (cattle and buffaloes. Result scores (1760 for sub-clinical mastitis in each category of negative, trace, single positive, double positive and triple positive by species, and laboratory tests, were analyzed using nonparametric tests. Chi-square statistics showed that CMT was equally effective at both locations (farm vs. laboratory. Correlation further suggested that the association was highly significant. Moreover, cases in category of negative, trace and single positive strongly differed (P0.05. The study further suggested that CMT was the most sensitive test, followed by WST/WSTD and Surf/Surf + Dye. Although, the five tests showed slight discrepancy in the trace category reaction, a strong relationship of Surf Test to CMT, its low cost, easy availability and readily adoptable qualities should spur the relevant authorities to recommend the use of Surf test as a routine practice in dairy farming and add this test in the curriculum of diploma and degree programmes.

  10. Evaluation of rapid alternative methods for drug susceptibility testing in clinical isolates of Mycobacterium tuberculosis

    Directory of Open Access Journals (Sweden)

    Luciano Mengatto

    2006-08-01

    Full Text Available A study was carried out to compare the performance of a commercial method (MGIT and four inexpensive drug susceptibility methods: nitrate reductase assay (NRA, microscopic observation drug susceptibility (MODS assay, MTT test, and broth microdilution method (BMM. A total of 64 clinical isolates of Mycobacterium tuberculosis were studied. The Lowenstein-Jensen proportion method (PM was used as gold standard. MGIT, NRA, MODS, and MTT results were available on an average of less than 10 days, whereas BMM results could be reported in about 20 days. Most of the evaluated tests showed excellent performance for isoniazid and rifampicin, with sensitivity and specificity values > 90%. With most of the assays, sensitivity for ethambutol was low (62-87% whereas for streptomycin, sensitivity values ranged from 84 to 100%; NRA-discrepancies were associated with cultures with a low proportion of EMB-resistant organisms while most discrepancies with quantitative tests (MMT and BMM were seen with isolates whose minimal inhibitory concentrations fell close the cutoff. MGIT is reliable but still expensive. NRA is the most inexpensive and easiest method to perform without changing the organization of the routine PM laboratory performance. While MODS, MTT, and BMM, have the disadvantage from the point of view of biosafety, they offer the possibility of detecting partial resistant strains. This study shows a very good level of agreement of the four low-cost methods compared to the PM for rapid detection of isoniazid, rifampicin and streptomycin resistance (Kappa values > 0.8; more standardization is needed for ethambutol.

  11. Development of an umami taste sensitivity test and its clinical use.

    Directory of Open Access Journals (Sweden)

    Shizuko Satoh-Kuriwada

    Full Text Available There is a close relationship between perception of umami, which has become recognized as the fifth taste, and the human physical condition. We have developed a clinical test for umami taste sensitivity using a filter paper disc with a range of six monosodium glutamate (MSG concentrations. We recruited 28 patients with taste disorders (45-78 years and 184 controls with no taste disorders (102 young [18-25 years] and 82 older [65-89 years] participants. Filter paper discs (5 mm dia. were soaked in aqueous MSG solutions (1, 5, 10, 50, 100 and 200 mM, then placed on three oral sites innervated by different taste nerves. The lowest concentration participants correctly identified was defined as the recognition threshold (RT for MSG. This test showed good reproducibility for inter- and intra-observer variability. We concluded that: (1 The RT of healthy controls differed at measurement sites innervated by different taste nerves; that is, the RT of the anterior tongue was higher than that of either the posterior tongue or the soft palate in both young and older individuals. (2 No significant difference in RT was found between young adults and older individuals at any measurement site. (3 The RT of patients with taste disorders was higher before treatment than that of the healthy controls at any measurement site. (4 The RT after treatment in these patients improved to the same level as that of the healthy controls. (5 The cutoff values of RT, showing the highest diagnostic accuracy (true positives + true negatives, were 200 mM MSG for AT and 50 mM MSG for PT and SP. The diagnostic accuracy at these cutoff values was 0.92, 0.87 and 0.86 for AT, PT and SP, respectively. Consequently, this umami taste sensitivity test is useful for discriminating between normal and abnormal umami taste sensations.

  12. SU-E-P-46: Clinical Acceptance Testing and Implementation of a Portable CT Unit

    Energy Technology Data Exchange (ETDEWEB)

    LaFrance, M; Marsh, S; Hicks, R; O’Donnell-Moran, G [Baystate Health Systems, Inc., Springfield, MA (United States)

    2015-06-15

    Purpose: Planning for the first installation in New England of a new portable CT unit to be used in the Operating Room required the integration of many departments including Surgery, Neurosurgery, Information Services, Clinical Engineering, Radiology and Medical Physics/Radiation Safety. Acceptance testing and the quality assurance procedures were designed to optimize image quality and patient and personnel radiation exposure. Methods: The vendor’s protocols were tested using the CT Dosimetry phantoms. The system displayed the CTDIw instead of the CTDIvol while testing the unit. Radiation exposure was compared to existing CT scanners from installed CT units throughout the facility. Brainlab measures all 4 periphery slots on the CT Dosimetry phantom. The ACR measures only the superior slot for the periphery measurement. A comprehensive radiation survey was also performed for several locations. Results: The CTDIvol measurements were comparable for the following studies: brain, C-Spine, and sinuses. However, the mobile CT measurements were slightly higher than other CT units but within acceptable tolerance if measured using the ACR method.Based on scatter measurements, it was determined if any personnel were to stay in the OR Suite during image acquisition that the appropriate lead apron and thyroid shields had to be worn.In addition, to reduce unnecessary scatter, there were two mobile 6 foot wide shields (1/16″ lead equivalent) available to protect personnel in the room and adjacent areas. Conclusion: Intraoperative CT provides the physician new opportunities for evaluation of the progression of surgical resections and device placement at the cost of increasing the amount of trained personnel required to perform this procedure. It also brings with it challenges to keep the radiation exposure to the patients and staff within reasonable limits.

  13. A multilaboratory evaluation of a commercial enzyme-linked immunosorbent assay test for the detection of antibodies against Mycobacterium avium subsp. paratuberculosis in cattle.

    Science.gov (United States)

    Dargatz, David A; Byrum, Beverly A; Collins, Michael T; Goyal, Sagar M; Hietala, Sharon K; Jacobson, Richard H; Kopral, Christine A; Martin, Barbara M; McCluskey, Brian J; Tewari, Deepanker

    2004-11-01

    Five laboratories participated in a study to evaluate sources of variation in results from an enzyme-linked immunosorbent assay (ELISA) for antibodies against Mycobacterium avium subsp. paratuberculosis. Each laboratory repeatedly tested duplicates of a negative, positive (P), and high-positive (HP) serum sample, which were supplied by the United States Department of Agriculture: Animal and Plant Health Inspection Service: Veterinary Services, National Veterinary Services Laboratories, Ames, IA, on all 96-well microtiter plates when routinely testing other samples for M. avium subsp. paratuberculosis antibodies. These 3 sera were aliquoted and sent to the 5 participating laboratories. This study focused on variation in test results because of assay reagents and laboratory techniques and did not account for biologic variability associated with the time course of infection in cattle. Overall, results from 868 microtiter plates were used in the study. For each sample a sample-to-positive (S/P) ratio was calculated according to the manufacturer's directions. The S/ P ratio for the P sample ranged from 0.06 to 1.039 (mean = 0.466 and 0.484 for wells 1 and 2, respectively) and those for the HP sample ranged from 2.446 to 8.727 (mean = 4.027 and 3.980 for wells 1 and 2, respectively). The majority of the variation in S/P ratio for the P sample was attributed to kit lot (37.5%), followed by random (unexplained) error (27.0%), laboratory (18.3%), and kit lot by laboratory (11.9%). By eliminating plates in which the separation between negative and positive control ODs was less than 0.4, the proportion of variation attributed to laboratory was reduced markedly. These results confirm that there is variability in M. avium subsp. paratuberculosis ELISA results and that several sources contribute to the observed variability. The study gives a relative estimate of the contribution of various sources to the overall variability observed in the M. avium subsp. paratuberculosis ELISA

  14. Clinical Efficacy of Various Diagnostic Tests for Small Bowel Tumors and Clinical Features of Tumors Missed by Capsule Endoscopy

    Directory of Open Access Journals (Sweden)

    Jung Wan Han

    2015-01-01

    Full Text Available Background. We aimed to evaluate the efficacy of various diagnostic tools such as computerized tomography (CT, small bowel follow-through (SBFT, and capsule endoscopy (CE in diagnosing small bowel tumors (SBTs. Additionally, we aimed to evaluate the clinical features of SBTs missed by CE. Methods. We retrospectively studied 79 patients with histologically proven SBT. Clinical data were analyzed with particular attention to the efficacy of CT, SBFT, and CE in detecting SBT preoperatively. We also analyzed the clinical features of SBTs missed by CE. Results. The most common symptoms of SBT were bleeding (43% and abdominal pain (13.9%. Diagnostic yields were as follows: CT detected 55.8% of proven SBTs; SBFT, 46.1%; and CE, 83.3%. The sensitivity for detecting SBTs was 40.4% for CT, 43.9% for SBFT, and 79.6% for CE. Two patients with nondiagnostic but suspicious findings on CE and seven patients with negative findings on CE were eventually found to have SBT. These nine patients were eventually diagnosed with gastrointestinal stromal tumor (4, small polyps (3, inflammatory fibroid polyp (1, and adenocarcinoma (1. These tumors were located in the proximal jejunum (5, middle jejunum (1, distal jejunum (1, and proximal ileum (1. Conclusion. CE is more efficacious than CT or SBFT for detecting SBTs. However, significant tumors may go undetected with CE, particularly when located in the proximal jejunum.

  15. Clinical Evaluation of the ZstatFlu-II Test: a Chemiluminescent Rapid Diagnostic Test for Influenza Virus

    OpenAIRE

    Hamilton, Marilyn S.; Abel, David M.; Ballam, Yolanda J.; Otto, Mary K.; Nickell, Angela F.; Pence, Lisa M.; Appleman, James R.; Shimasaki, Craig D.; Achyuthan, Komandoor E.

    2002-01-01

    Exploiting the high sensitivity of the chemiluminescence phenomenon, an accurate and sensitive point-of-care test, called the ZstatFlu-II test (ZymeTx, Inc., Oklahoma City, Okla.), was developed to detect influenza virus infections. The ZstatFlu-II test takes 20 min and requires approximately 2 min of “hands-on” time for operational steps. The ZstatFlu-II test does not distinguish between infections with influenza virus types A and B. ZstatFlu-II test results are printed on Polaroid High-Spee...

  16. Clostridium difficile testing algorithms using glutamate dehydrogenase antigen and C. difficile toxin enzyme immunoassays with C. difficile nucleic acid amplification testing increase diagnostic yield in a tertiary pediatric population.

    Science.gov (United States)

    Ota, Kaede V; McGowan, Karin L

    2012-04-01

    We evaluated the performance of the rapid C. diff Quik Chek Complete's glutamate dehydrogenase antigen (GDH) and toxin A/B (CDT) tests in two algorithmic approaches for a tertiary pediatric population: algorithm 1 entailed initial testing with GDH/CDT followed by loop-mediated isothermal amplification (LAMP), and algorithm 2 entailed GDH/CDT followed by cytotoxicity neutralization assay (CCNA) for adjudication of discrepant GDH-positive/CDT-negative results. A true positive (TP) was defined as positivity by CCNA or positivity by LAMP plus another test (GDH, CDT, or the Premier C. difficile toxin A and B enzyme immunoassay [P-EIA]). A total of 141 specimens from 141 patients yielded 27 TPs and 19% prevalence. Sensitivity, specificity, positive predictive value, and negative predictive value were 56%, 100%, 100%, and 90% for P-EIA and 81%, 100%, 100%, and 96% for both algorithm 1 and algorithm 2. In summary, GDH-based algorithms detected C. difficile infections with superior sensitivity compared to P-EIA. The algorithms allowed immediate reporting of half of all TPs, but LAMP or CCNA was required to confirm the presence or absence of toxigenic C. difficile in GDH-positive/CDT-negative specimens. PMID:22259201

  17. Clostridium difficile testing algorithms using glutamate dehydrogenase antigen and C. difficile toxin enzyme immunoassays with C. difficile nucleic acid amplification testing increase diagnostic yield in a tertiary pediatric population.

    Science.gov (United States)

    Ota, Kaede V; McGowan, Karin L

    2012-04-01

    We evaluated the performance of the rapid C. diff Quik Chek Complete's glutamate dehydrogenase antigen (GDH) and toxin A/B (CDT) tests in two algorithmic approaches for a tertiary pediatric population: algorithm 1 entailed initial testing with GDH/CDT followed by loop-mediated isothermal amplification (LAMP), and algorithm 2 entailed GDH/CDT followed by cytotoxicity neutralization assay (CCNA) for adjudication of discrepant GDH-positive/CDT-negative results. A true positive (TP) was defined as positivity by CCNA or positivity by LAMP plus another test (GDH, CDT, or the Premier C. difficile toxin A and B enzyme immunoassay [P-EIA]). A total of 141 specimens from 141 patients yielded 27 TPs and 19% prevalence. Sensitivity, specificity, positive predictive value, and negative predictive value were 56%, 100%, 100%, and 90% for P-EIA and 81%, 100%, 100%, and 96% for both algorithm 1 and algorithm 2. In summary, GDH-based algorithms detected C. difficile infections with superior sensitivity compared to P-EIA. The algorithms allowed immediate reporting of half of all TPs, but LAMP or CCNA was required to confirm the presence or absence of toxigenic C. difficile in GDH-positive/CDT-negative specimens.

  18. Clinical Evaluation of the ZstatFlu-II Test: a Chemiluminescent Rapid Diagnostic Test for Influenza Virus

    Science.gov (United States)

    Hamilton, Marilyn S.; Abel, David M.; Ballam, Yolanda J.; Otto, Mary K.; Nickell, Angela F.; Pence, Lisa M.; Appleman, James R.; Shimasaki, Craig D.; Achyuthan, Komandoor E.

    2002-01-01

    Exploiting the high sensitivity of the chemiluminescence phenomenon, an accurate and sensitive point-of-care test, called the ZstatFlu-II test (ZymeTx, Inc., Oklahoma City, Okla.), was developed to detect influenza virus infections. The ZstatFlu-II test takes 20 min and requires approximately 2 min of “hands-on” time for operational steps. The ZstatFlu-II test does not distinguish between infections with influenza virus types A and B. ZstatFlu-II test results are printed on Polaroid High-Speed Detector Film, allowing test results to be archived. A prototype version of the ZstatFlu-II test was evaluated during the 2000-to-2001 flu season with 300 nasal aspirate specimens from children at a pediatric hospital. Compared to culture, the ZstatFlu-II test had 88% sensitivity and 92% specificity. The Directigen test had a sensitivity of 75% and a specificity of 93%. The sensitivity of the ZstatFlu-II test was significantly higher than that of the Directigen test (P < 0.0574). PMID:12089243

  19. Barriers to HIV testing and characteristics associated with never testing among gay and bisexual men attending sexual health clinics in Sydney

    Directory of Open Access Journals (Sweden)

    Damian P Conway

    2015-08-01

    Full Text Available Introduction: HIV diagnoses among gay and bisexual men have increased over the past decade in Australia. HIV point-of-care testing (POCT was introduced in Australia in 2011 as a strategy to increase HIV testing by making the testing process more convenient. We surveyed gay and bisexual men undergoing POCT to assess barriers to HIV testing and characteristics associated with not having previously tested for HIV (never testing. Methods: During 2011 and 2012, gay and bisexual men who were undergoing POCT at four Sydney sexual health clinics self-completed questionnaires assessing testing history and psychological and structural barriers to HIV testing. Bivariate and multivariate logistic regression was used to assess associations between patient characteristics and never testing. Results: Of 1093 participants, 981 (89.9% reported ever testing for HIV and 110 (10.1% never testing. At least one barrier to testing was reported by 1046 men (95.7%, with only 47 men (4.3% not reporting any barrier to testing. The most commonly reported barriers to testing were annoyance at having to return for results (30.2%, not having done anything risky (29.6%, stress in waiting for results (28.4%, being afraid of testing positive (27.5% and having tested recently (23.2%. Never testing was independently associated with being non-gay-identified (adjusted odds ratio [AOR]: 1.9; 95% confidence interval [CI]: 1.1–3.2, being aged less than 25 years (AOR: 2.4; 95% CI: 1.6–3.8, living in a suburb with few gay couples (AOR: 1.9; 95% CI: 1.2–3.0, being afraid of testing HIV-positive (AOR: 1.6; 95% CI: 1.0–2.4, not knowing where to test (AOR: 3.8; 95% CI: 1.3–11.2 and reporting one or no sexual partners in the last six months (AOR: 2.7; 95% CI: 1.2–6.2. Conclusions: Barriers to HIV testing were commonly reported among the clinic-based gay and bisexual men in this study. Our findings suggest further health promotion and prevention strategies are needed to address the

  20. Test Sensitivity in the Computer-Aided Detection of Breast Cancer from Clinical Mammographic Screening: a Meta-analysis

    CERN Document Server

    Levman, Jacob

    2013-01-01

    Objectives: To assess evaluative methodologies for comparative measurements of test sensitivity in clinical mammographic screening trials of computer-aided detection (CAD) technologies. Materials and Methods: This meta-analysis was performed by analytically reviewing the relevant literature on the clinical application of computer-aided detection (CAD) technologies as part of a breast cancer screening program based on x-ray mammography. Each clinical study's method for measuring the CAD system's improvement in test sensitivity is examined in this meta-analysis. The impact of the chosen sensitivity measurement on the study's conclusions are analyzed. Results: This meta-analysis demonstrates that some studies have inappropriately compared sensitivity measurements between control groups and CAD enabled groups. The inappropriate comparison of control groups and CAD enabled groups can lead to an underestimation of the benefits of the clinical application of computer-aided detection technologies. Conclusions: The po...

  1. Metabolites in safety testing assessment in early clinical development: a case study with a glucokinase activator.

    Science.gov (United States)

    Sharma, Raman; Litchfield, John; Atkinson, Karen; Eng, Heather; Amin, Neeta B; Denney, William S; Pettersen, John C; Goosen, Theunis C; Di, Li; Lee, Esther; Pfefferkorn, Jeffrey A; Dalvie, Deepak K; Kalgutkar, Amit S

    2014-11-01

    The present article summarizes Metabolites in Safety Testing (MIST) studies on a glucokinase activator, N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide (PF-04937319), which is under development for the treatment of type 2 diametes mellitus. Metabolic profiling in rat, dog, and human hepatocytes revealed that PF-04937319 is metabolized via oxidative (major) and hydrolytic pathways (minor). N-Demethylation to metabolite M1 [N-methyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide] was the major metabolic fate of PF-04937319 in human (but not rat or dog) hepatocytes, and was catalyzed by CYP3A and CYP2C isoforms. Qualitative examination of circulating metabolites in humans at the 100- and 300-mg doses from a 14-day multiple dose study revealed unchanged parent drug and M1 as principal components. Because M1 accounted for 65% of the drug-related material at steady state, an authentic standard was synthesized and used for comparison of steady-state exposures in humans and the 3-month safety studies in rats and dogs at the no-observed-adverse-effect level. Although circulating levels of M1 were very low in beagle dogs and female rats, adequate coverage was obtained in terms of total maximal plasma concentration (∼7.7× and 1.8×) and area under the plasma concentration-time curve (AUC; 3.6× and 0.8× AUC) relative to the 100- and 300-mg doses, respectively, in male rats. Examination of primary pharmacology revealed M1 was less potent as a glucokinase activator than the parent drug (compound PF-04937319: EC50 = 0.17 μM; M1: EC50 = 4.69 μM). Furthermore, M1 did not inhibit major human P450 enzymes (IC50 > 30 μM), and was negative in the Salmonella Ames assay, with minimal off-target pharmacology, based on CEREP broad ligand profiling. Insights gained from this analysis should lead to a more efficient and focused development plan for fulfilling MIST requirements with

  2. 急性有机磷农药中毒患者心肌酶及心电图检测临床分析%CLINICAL ANALYSIS OF MYOCARDIAL ENZYME AND ECG OF ORGANOPHOSPHORUS PESTICIDE POISONING PATIENTS

    Institute of Scientific and Technical Information of China (English)

    王卫民; 何玉娟

    2011-01-01

    [Objective]To discuss the clinical significance of changes on myocardial enzymes and ECG in patients with acute organophosphorus pesticide poisoning and its relationship with prognosis.[Methods]From January 2006 -December 2009, 85 patients with acute organophosphorus pesticide poisoning were admitted to hospital and the dynamic observation of their enzymes was made, then compared clinical data to analyze.[Results]The serum enzyme of 85 cases of acute organophosphorus pesticide poisoning were increased with different levels, EKG changed obviously, 16 cases died.[Conclusion]The illness is severer, the more obvious increase of enzymes is found, and the prognosis is worse.It should protect the heart at early stage to reduce mortality and improve the cure rate.%[目的]探讨急性有机磷农药中毒患者心肌酶学及心电图改变的临床意义及预后的关系.[方法]对2006年1月~2009年12月85例急性有机磷农药中毒患者入院后作心肌酶动态观察并结合临床资料进行分析.[结果]85例急性有机磷农药中毒病人的血清心肌酶均有不同程度的升高,心电图发生明显改变,死亡16例.[结论]病情越重,心肌酶升高幅度越明显,预后越差,应早期应用保护心脏药物,降低死亡率,提高治愈率.

  3. Iranian Effective Clinical Nurse Instructor evaluation tool: Development and psychometric testing

    OpenAIRE

    Shahsavari, Hooman; Yekta, Zohreh Parsa; Zare, Zahra; Sigaroodi, Abdolhossain Emami

    2014-01-01

    Background: Clinical education is the heart of the nursing education program. Effective nursing clinical instructors are needed for graduating the future qualified nurses. There is a well-developed body of knowledge about the effectiveness of clinical teaching and the instructors. However, translating this knowledge into a context-based evaluation tool for measuring the effectiveness of Iranian clinical nursing instructors remains a deficiency. The purpose of this study is to describe the dev...

  4. Test Review: Advanced Clinical Solutions for WAIS-IV and WMS-IV

    Science.gov (United States)

    Chu, Yiting; Lai, Mark H. C.; Xu, Yining; Zhou, Yuanyuan

    2012-01-01

    The authors review the "Advanced Clinical Solutions for WAIS-IV and WMS-IV". The "Advanced Clinical Solutions (ACS) for the Wechsler Adult Intelligence Scale-Fourth Edition" (WAIS-IV; Wechsler, 2008) and the "Wechsler Memory Scale-Fourth Edition" (WMS-IV; Wechsler, 2009) was published by Pearson in 2009. It is a clinical tool for extending the…

  5. High Uptake of Systematic HIV Counseling and Testing and TB Symptom Screening at a Primary Care Clinic in South Africa

    OpenAIRE

    Annelies Van Rie; Kate Clouse; Colleen Hanrahan; Katerina Selibas; Ian Sanne; Sharon Williams; Peter Kim; Jean Bassett

    2014-01-01

    BACKGROUND: Timely diagnosis and treatment of tuberculosis (TB) and HIV is important to reduce morbidity and mortality, and break the cycle of ongoing transmission. METHODS: We performed an implementation research study to develop a model for systematic TB symptom screening and HIV counseling and testing (HCT) for all adult clients at a primary care clinic and prospectively evaluate the 6-month coverage and yield, and 18-month sustainability at a primary care clinic in Johannesburg, South Afr...

  6. Development and testing of an objective structured clinical exam (OSCE) to assess socio-cultural dimensions of patient safety competency

    OpenAIRE

    Ginsburg, Liane R; Tregunno, Deborah; Norton, Peter G.; Smee, Sydney; de Vries, Ingrid; Sebok, Stefanie S; VanDenKerkhof, Elizabeth G.; Luctkar-Flude, Marian; Medves, Jennifer

    2014-01-01

    Background Patient safety (PS) receives limited attention in health professional curricula. We developed and pilot tested four Objective Structured Clinical Examination (OSCE) stations intended to reflect socio-cultural dimensions in the Canadian Patient Safety Institute's Safety Competency Framework. Setting and participants 18 third year undergraduate medical and nursing students at a Canadian University. Methods OSCE cases were developed by faculty with clinical and PS expertise with assis...

  7. Electro-ultrafiltration of industrial enzyme solutions

    DEFF Research Database (Denmark)

    Enevoldsen, Ann Dorrit; Hansen, Erik Børresen; Jonsson, Gunnar Eigil

    2007-01-01

    To reduce the problems with fouling and concentration polarization during crossflow ultrafiltration of industrial enzyme solutions an electric field is applied across the membrane. The filtration performance during electro-ultrafiltration (EUF) has been tested with several enzymes. Results show...

  8. [Development and clinical testing of the Russian version of the Acute Cystitis Symptom Score - ACSS].

    Science.gov (United States)

    Alidjanov, J F; Abdufattaev, U A; Makhmudov, D Kh; Mirkhamidov, D Kh; Khadzhikhanov, F A; Azgamov, A V; Pilatz, A; Naber, K G; Wagenlehner, F M; Akilov, F A

    2014-01-01

    The Acute Cystitis Symptom Score - ACSS was originally developed in the Uzbek language and has demonstrated high reliability and validity. The study was aimed to develop a Russian version of the ACSS questionnaire and evaluate its psychometric properties. Translation and adaptation of the ACSS questionnaire containing 18 questions, 6 of them - for the typical symptoms of acute cystitis (AC), 4 - for the differential diagnosis; 3 - for the quality of life, and 5 - for the conditions that may affect the choice of treatment, were performed according to the recommendations developed by the Mapi Research Institute. Study involved 83 Russian-speaking women (mean age, 35.6 ±13.7 years); 38 (45.8%) patients were in the main group (patients with AC), and 45 (54.2%) - in the control group (without AC). Medical examination and appropriate treatment of the respondents were conducted in accordance with approved standards. After completing the course of therapy, 19 (50%) patients of the main group came for the control examination. There was statistically significant difference in the scores obtained in the two groups. Score profiles positively correlated with the results of laboratory tests (rho = 0.26-0.48). Cronbach's alpha for the Russian version of the questionnaire was 0.86 (95% CI, 0.81-0.91), area under the curve in the ROC analysis was 0.96. The results of testing the Russian version correspond to those of the original version. The Russian version of the ACSS questionnaire has high. reliability and validity, and can be recommended for clinical research and diagnosis of primary AC, and dynamic monitoring of the effectiveness of the treatment of the Russian-speaking population of patients.

  9. Lignolytic Enzymes Production from Selected Mushrooms

    Directory of Open Access Journals (Sweden)

    H.M. Shantaveera Swamy

    2015-06-01

    Full Text Available In this paper, ligninase enzymes produced by selected mushrooms have been reported. We collected mushrooms from Western Ghats, most of them were edible food. Thirty samples isolated were tested using a plate assay through direct agar plate assay by using ABTS, decolourisation containing the fifteen isolates were able to decolourise the dye, indicating a lignin-degrading ability. Spectrophotometric enzyme assays from all selected isolates were carried out to examine the production of Ligninolytic enzymes (Laccase, lignin peroxidase and manganese peroxidase. Ten selected isolates produced all three kinds of enzymes tested. Lignolytic enzymes are groups of enzymes these are actively involved in bioremediation.

  10. Aspergillus antigen testing in bone marrow transplant recipients

    OpenAIRE

    Williamson, E; Oliver, D.; Johnson, E.; Foot, A.; D. Marks; Warnock, D.

    2000-01-01

    Aims—To assess the clinical usefulness of a commercial aspergillus antigen enzyme linked immunosorbent assay (ELISA) in the diagnosis of invasive aspergillosis (IA) in bone marrow transplant recipients, and to compare it with a commercial latex agglutination (LA) test.

  11. Restoration of non-carious cervical lesions with ceramic inlays: A possible model for clinical testing of adhesive cements

    Directory of Open Access Journals (Sweden)

    Michal Staninec

    2012-01-01

    Full Text Available Introduction: There are many luting cements coming to market which claim to be adhesive, but there is no clinical protocol currently for testing these claims. There is a standardized protocol for testing direct restorations bonded to dentin and it is used extensively. Case Report: We describe a clinical procedure for restoring a non-carious cervical lesion (NCCL with a ceramic inlay using Computer-Aided Design and Computer-Aided Manufacturing (CAD-CAM technology and an adhesive resin cement.The procedure was straightforward and the result was good at one month. Discussion: NCCL′s can be restored with CAD-CAM technology in one appointment. This technique can be used to clinically test adhesion of luting cements to dentin, similarly to the current standard for direct restorations.

  12. Clinical uncertainties, health service challenges, and ethical complexities of HIV "test-and-treat": a systematic review.

    Science.gov (United States)

    Kulkarni, Sonali P; Shah, Kavita R; Sarma, Karthik V; Mahajan, Anish P

    2013-06-01

    Despite the HIV "test-and-treat" strategy's promise, questions about its clinical rationale, operational feasibility, and ethical appropriateness have led to vigorous debate in the global HIV community. We performed a systematic review of the literature published between January 2009 and May 2012 using PubMed, SCOPUS, Global Health, Web of Science, BIOSIS, Cochrane CENTRAL, EBSCO Africa-Wide Information, and EBSCO CINAHL Plus databases to summarize clinical uncertainties, health service challenges, and ethical complexities that may affect the test-and-treat strategy's success. A thoughtful approach to research and implementation to address clinical and health service questions and meaningful community engagement regarding ethical complexities may bring us closer to safe, feasible, and effective test-and-treat implementation.

  13. Enzyme-catalysed deposition of ultrathin silver shells on gold nanorods: a universal and highly efficient signal amplification strategy for translating immunoassay into a litmus-type test.

    Science.gov (United States)

    Yang, Xinjian; Gao, Zhiqiang

    2015-04-25

    On the basis of enzyme-catalysed reduction of silver ions and consequent deposition of ultrathin silver shells on gold nanorods, a highly efficient signal amplification method for immunoassay is developed. For a model analyte prostate-specific antigen, a 10(4)-fold improvement over conventional enzyme-linked immunosorbent assay is accomplished by leveraging on the cumulative nature of the enzymatic reaction and the sensitive response of plasnomic gold nanorods to the deposition the silver shells.

  14. Significance of Nueroelectrophysiological Tests in the Early Diagnosis of Sub-clinical Neuropathay with Diabetes Mellitus

    Institute of Scientific and Technical Information of China (English)

    LI Zhijun; HU Xiaoqing; TANG Nai

    2006-01-01

    To evaluate the application of nueroelectrophysiological tests in early diagnosis of sub-clinical neuropathy in diabetes mellitus (DM), The routine nerve conductive velocity (NCV),F-wave and sympathetic skin response (SSR) were detected in 27 patients with diabetes mellitus but without symptoms and signs of lesions of nerve system. Our results showed that 48.1%, 44.4 %, 51.9 % of the patients were found to have abnormal NCV, F-wave and SSR respectively. The abnormalities were mainly characterized by prolonged latency, reduced velocity and absence of wave-form.There were significant differences between the controls and the DM group (P<0.05). Both the distal and proximal segments of nerves were affected and the distal lesions took place earlier than proximal ones and the changes in low extremities were more severe than those of upper extremities. F-wave can be used as a sensitive indicator for the early diagnosis of peripheral neuropathy and it can help to detect the subclincial lesions. SSR can be used for the evaluation of functional status of autonomic nerves in DM patients.

  15. Season of birth, clinical manifestations and Dexamethasone Suppression Test in unipolar major depression

    Directory of Open Access Journals (Sweden)

    Kaprinis George S

    2007-08-01

    Full Text Available Abstract Background Reports in the literature suggest that the season of birth might constitute a risk factor for the development of a major psychiatric disorder, possibly because of the effect environmental factors have during the second trimester of gestation. The aim of the current paper was to study the possible relationship of the season of birth and current clinical symptoms in unipolar major depression. Methods The study sample included 45 DSM-IV major depressive patients and 90 matched controls. The SCAN v. 2.0, Hamilton Depression Rating Scale (HDRS and Hamilton Anxiety Scale (HAS were used to assess symptomatology, and the 1 mg Dexamethasone Suppression Test (DST was used to subcategorize patients. Results Depressed patients as a whole did not show differences in birth season from controls. However, those patients born during the spring manifested higher HDRS while those born during the summer manifested the lowest HAS scores. DST non-suppressors were almost exclusively (90% likely to be born during autumn and winter. No effect from the season of birth was found concerning the current severity of suicidal ideation or attempts. Discussion The current study is the first in this area of research using modern and rigid diagnostic methodology and a biological marker (DST to categorize patients. Its disadvantages are the lack of data concerning DST in controls and a relatively small size of patient sample. The results confirm the effect of seasonality of birth on patients suffering from specific types of depression.

  16. Usefulness of clinical data and rapid diagnostic tests to identify bacterial etiology in adult respiratory infections

    Directory of Open Access Journals (Sweden)

    Pilar Toledano-Sierra

    2015-01-01

    Full Text Available Respiratory tract infections are a common complaint and most of them, such as common cold and laryngitis, are viral in origin, so antibiotic use should be exceptional. However, there are other respiratory tract infections (sinusitis, pharyngitis, lower respiratory tract infections, and exacerbations of chronic obstructive pulmonary disease where a bacterial etiology is responsible for a non-negligible percentage, and antibiotics are often empirically indicated. The aim of the study is to identify the strength of the data obtained from the symptoms, physical examination and rapid diagnostic methods in respiratory infections in which antibiotic use is frequently proposed in order to improve diagnosis and influence the decision to prescribe these drugs. The review concludes that history, physical examination and rapid tests are useful to guide the need for antibiotic treatment in diseases such as acute sinusitis, acute pharyngitis, exacerbation of lower respiratory tract infection and chronic obstructive pulmonary disease. However, no isolated data is accurate enough by itself to confirm or rule out the need for antibiotics. Therefore, clinical prediction rules bring together history and physical examination, thereby improving the accuracy of the decision to indicate or not antibiotics.

  17. Interaction between Red Yeast Rice and CYP450 Enzymes/P-Glycoprotein and Its Implication for the Clinical Pharmacokinetics of Lovastatin

    Directory of Open Access Journals (Sweden)

    Chia-Hao Chen

    2012-01-01

    Full Text Available Red yeast rice (RYR can reduce cholesterol through its active component, lovastatin. This study was to investigate the pharmacokinetic properties of lovastatin in RYR products and potential RYR-drug interactions. Extracts of three registered RYR products (LipoCol Forte, Cholestin, and Xuezhikang were more effective than pure lovastatin in inhibiting the activities of cytochrome P450 enzymes and P-glycoprotein. Among CYP450 enzymes, RYR showed the highest inhibition on CYP1A2 and CYP2C19, with comparable inhibitory potencies to the corresponding typical inhibitors. In healthy volunteers taking the RYR product LipoCol Forte, the pharmacokinetic properties of lovastatin and lovastatin acid were linear in the dose range of 1 to 4 capsules taken as a single dose and no significant accumulation was observed after multiple dosing. Concomitant use of one LipoCol Forte capsule with nifedipine did not change the pharmacokinetics of nifedipine. Yet, concomitant use of gemfibrozil with LipoCol Forte resulted in a significant increase in the plasma concentration of lovastatin acid. These findings suggest that the use of RYR products may not have effects on the pharmacokinetics of concomitant comedications despite their effects to inhibit the activities of CYP450 enzymes and P-gp, whereas gemfibrozil affects the pharmacokinetics of lovastatin acid when used concomitantly with RYR products.

  18. Pain during ice water test distinguishes clinical bladder hypersensitivity from overactivity disorders

    Directory of Open Access Journals (Sweden)

    Bountra Chas

    2006-12-01

    of the control or overactive (NDO/IDO patients reported any pain during the IWT. Conclusion The BCR in DO may reflect loss of central inhibition, which appears necessary to elicit this reflex; the pain elicited in PBS suggests afferent sensitisation, hence sensory symptoms are evoked but not reflex detrusor contractions. The ice water test may be a useful and simple marker for clinical trials in PBS, particularly for novel selective TRPM8 antagonists.

  19. Prevalence of delirium among patients at a cancer ward: Clinical risk factors and prediction by bedside cognitive tests.

    Science.gov (United States)

    Grandahl, Mia Gall; Nielsen, Svend Erik; Koerner, Ejnar Alex; Schultz, Helga Holm; Arnfred, Sidse Marie

    2016-08-01

    Background Delirium is a frequent psychiatric complication to cancer, but rarely recognized by oncologists. Aims 1. To estimate the prevalence of delirium among inpatients admitted at an oncological cancer ward 2. To investigate whether simple clinical factors predict delirium 3. To examine the value of cognitive testing in the assessment of delirium. Methods On five different days, we interviewed and assessed patients admitted to a Danish cancer ward. The World Health Organization International Classification of Diseases Version 10, WHO ICD-10 Diagnostic System and the Confusion Assessment Method (CAM) were used for diagnostic categorization. Clinical information was gathered from medical records and all patients were tested with Mini Cognitive Test, The Clock Drawing Test, and the Digit Span Test. Results 81 cancer patients were assessed and 33% were diagnosed with delirium. All delirious participants were CAM positive. Poor performance on the cognitive tests was associated with delirium. Medical records describing CNS metastases, benzodiazepine or morphine treatment were associated with delirium. Conclusions Delirium is prevalent among cancer inpatients. The Mini Cognitive Test, The Clock Drawing Test, and the Digit Span Test can be used as screening tools for delirium among inpatients with cancer, but even in synergy, they lack specificity. Combining cognitive testing and attention to nurses' records might improve detection, yet further studies are needed to create a more detailed patient profile for the detection of delirium. PMID:26882016

  20. Early uptake of HIV clinical care after testing HIV-positive during home-based testing and counseling in western Kenya.

    Science.gov (United States)

    Medley, Amy; Ackers, Marta; Amolloh, Manase; Owuor, Patrick; Muttai, Helen; Audi, Beryl; Sewe, Manquins; Laserson, Kayla

    2013-01-01

    Home-based HIV testing and counseling (HBTC) has the potential to increase access to HIV testing. However, the extent to which HBTC programs successfully link HIV-positive individuals into clinical care remains unclear. To determine factors associated with early enrollment in HIV clinical care, adult residents (aged ≥13 years) in the Health and Demographic Surveillance System in Kisumu, Kenya were offered HBTC. All HIV-positive residents were referred to nearby HIV clinical care centers. Two to four months after HBTC, peer educators conducted home visits to consenting HIV-positive residents. Overall, 9,895 (82 %) of 12,035 residents accepted HBTC; 1,087 (11 %) were HIV-positive; and 737 (68 %) received home visits. Of those receiving home visits, 42 % reported HIV care attendance. Factors associated with care attendance included: having disclosed, living with someone attending HIV care, and wanting to seek care after diagnosis. Residents who reported their current health as excellent or who doubted their HBTC result were less likely to report care attendance. While findings indicate that HBTC was well-received in this setting, less than half of HIV-positive individuals reported current care attendance. Identification of effective strategies to increase early enrollment and retention in HIV clinical care is critical and will require coordination between testing and treatment program staff and systems.

  1. Clinical Functional Capacity Testing in Patients With Facioscapulohumeral Muscular Dystrophy: Construct Validity and Interrater Reliability of Antigravity Tests

    NARCIS (Netherlands)

    Rijken, N.H.M.; Engelen, B.G.M. van; Weerdesteyn, V.G.; Geurts, A.C.H.

    2015-01-01

    OBJECTIVE: To evaluate the construct validity and interrater reliability of 4 simple antigravity tests in a small group of patients with facioscapulohumeral muscular dystrophy (FSHD). DESIGN: Case-control study. SETTING: University medical center. PARTICIPANTS: Patients with various severity levels

  2. Rapid molecular diagnostic tests in patients with bacteremia: evaluation of their impact on decision making and clinical outcomes.

    Science.gov (United States)

    Vardakas, K Z; Anifantaki, F I; Trigkidis, K K; Falagas, M E

    2015-11-01

    We performed a systematic review of the data regarding rapid diagnostic tests and their advantages or limitations on patients' clinical outcomes. The PubMed and Scopus databases were searched independently by two reviewers. Mortality was the primary outcome. Most studies compared rapid tests with blood cultures. Although not observed in all studies, only studies comparing rapid tests in conjunction with antimicrobial stewardship programs (ASPs) showed a mortality benefit. A reduction in hospital or intensive care unit (ICU) length of stay was also observed in almost all studies when the rapid tests, with or without ASPs, were used. Finally, treatment decisions were taken earlier in the rapid test groups. Despite a faster treatment decision, a clear mortality benefit was not seen when rapid tests were used. It is crucial to differentiate the influence of rapid tests from that of ASPs and clarify the actual effect of each factor separately.

  3. Delayed heart rate recovery after treadmill test: comparison with clinical, exercise and myocardial perfusion parameters

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, S.Y.; Seo, J. H.; Bae, J. H.; Ahn, B. C.; Lee, J.; Lee, K. B.; Chae, S. C [Kyungpook National University Hospital, Daegu (Korea, Republic of)

    2004-07-01

    Imbalance autonomic nervous tone are fundamental risk factors for cardiac death. Recent studies reported abnormal heart rate recovery(HRR) after the treadmill exercise test is a powerful predictor of significant excess mortality. To evaluate HRR as an index of coronary artery disease(CAD). we have compared perfusion defect. 252 patients(147 men) underwent exercise myocardial perfusion imaging were included. The value for HRR was defined as the decrease in heart rate from peak exercise to 1 minute after termination of exercise. Myocardial perfusion imaging was acquired at 1 hour after 740MBq {sup 99m}Tc-MIBI injection using dual head gamma camera(Vertex Plus, ADAC, USA). Summed stress score(SSS) and stress ejection fraction(sEF) were obtained from AutoQUANT program. 23 beats/min was defined as the lowest normal value for HRR. Patients were divided two groups: abnormal HRR(abHRR) and normal HRR(nHRR). We compared clinical(age, sex, pervious CAD history, DM, HTN), exercise test(exercise capacity, duration) and myocardial perfusion parameters(SSS, sEF) between two groups. Mean value of HRR was 50.814.2 beat/min. There were 25 patients(9.9%) with an abHRR. Patient with abHRR were generally in older age(61.59.2 vs 54.48.9yr), were more likely men(72 vs 56.8%), had a higher frequency of DM(16.7 vs 9%), HTN(52 vs 27.6%) and CAD history (28 vs 7%) compared to nHRR. In exercise and myocardial perfusion parameters, abHRR were showed more positive result(60 vs 30%), had short exercise duration(7.0{+-}3.0 vs 9.1{+-}2.7min) and small exercise capacity(7.2{+-}2.3 vs 10.0{+-}2.7Mets) compared to nHRR, had a higher frequency of CAD(76 vs 41.4%) and multivessel disease(25 vs 6.5%), had larger SSS(8.1{+-}8.8 vs 3.7{+-}6.3) and had smaller sEF(47.7{+-}14.3 vs 57.9{+-}10.3%) compared to nHRR. AbHRR was frequently found in patients with CAD, large myocardial perfusion defect and decreased LV function. It seems that the HRR may be considered a reliable index of the severity of CAD.

  4. Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs.

    Science.gov (United States)

    De Buck, Stefan S; Sinha, Vikash K; Fenu, Luca A; Nijsen, Marjoleen J; Mackie, Claire E; Gilissen, Ron A H J

    2007-10-01

    The aim of this study was to evaluate different physiologically based modeling strategies for the prediction of human pharmacokinetics. Plasma profiles after intravenous and oral dosing were simulated for 26 clinically tested drugs. Two mechanism-based predictions of human tissue-to-plasma partitioning (P(tp)) from physicochemical input (method Vd1) were evaluated for their ability to describe human volume of distribution at steady state (V(ss)). This method was compared with a strategy that combined predicted and experimentally determined in vivo rat P(tp) data (method Vd2). Best V(ss) predictions were obtained using method Vd2, providing that rat P(tp) input was corrected for interspecies differences in plasma protein binding (84% within 2-fold). V(ss) predictions from physicochemical input alone were poor (32% within 2-fold). Total body clearance (CL) was predicted as the sum of scaled rat renal clearance and hepatic clearance projected from in vitro metabolism data. Best CL predictions were obtained by disregarding both blood and microsomal or hepatocyte binding (method CL2, 74% within 2-fold), whereas strong bias was seen using both blood and microsomal or hepatocyte binding (method CL1, 53% within 2-fold). The physiologically based pharmacokinetics (PBPK) model, which combined methods Vd2 and CL2 yielded the most accurate predictions of in vivo terminal half-life (69% within 2-fold). The Gastroplus advanced compartmental absorption and transit model was used to construct an absorption-disposition model and provided accurate predictions of area under the plasma concentration-time profile, oral apparent volume of distribution, and maximum plasma concentration after oral dosing, with 74%, 70%, and 65% within 2-fold, respectively. This evaluation demonstrates that PBPK models can lead to reasonable predictions of human pharmacokinetics. PMID:17620347

  5. The clinical utility of cardiopulmonary exercise testing: results of a university hospital

    Directory of Open Access Journals (Sweden)

    Tajana Jalusic-Gluncic

    2012-08-01

    Full Text Available Objective: To determine the main reasons for cardiopulmonary exercise test (CPET referrals in our hospital over the last two years; to evaluate clinical usefulness of CPET. Methods: We included 207 patients between 17 and 76 years of age. For every patient, we measured electrocardigraphy (ECG, arterial blood gases, spirometry, maximal voluntary ventilation (MVV and diffusing capacity. CPET was then performed; using a treadmill, according to the modified Bruce protocol; then spirometry and diffusing capacity were repeated. Results: The most common reason for sending patients for CPET was dyspnea during exertion (85%, then preoperative assessment of lung cancer patients (11.6%, and preoperative assessment of heart transplant candidates (3.4%. After CPET in a dyspnea group, 33.5% had normal findings, 22.2% had pulmonary limitation, 31.8% had non pulmonary pathology, and 12.5% reached submaximal effort due to subjective problems (poor condition, feeling discomfort but no objective reasons to stop. From a lung cancer group, 25% were deemed unsuitable surgical candidates, and 14.29% of a heart transplant group was recommended immediate surgery, the remainder needed re-evaluation. Conclusion: Dyspnea of unknown cause is optimally investigated with CPET, allowing us to differentiate between the major causes of limitation (lung, heart, cardiovascular, muscular and, within each area, the specific causes of limitation. The most common diagnoses after CPET are pulmonary and cardiac diagnoses. CPET helps us to detect concurrent cardiovascular disease at respiratory impaired patients. CPET is the gold standard for evaluation of morbidity and mortality risk of lung cancer surgery and for selection of patients for heart transplant. [J Exp Integr Med 2012; 2(4: 297-303

  6. Clinical Genetic Testing for the Cardiomyopathies and Arrhythmias: A Systematic Framework for Establishing Clinical Validity and Addressing Genotypic and Phenotypic Heterogeneity.

    Science.gov (United States)

    Garcia, John; Tahiliani, Jackie; Johnson, Nicole Marie; Aguilar, Sienna; Beltran, Daniel; Daly, Amy; Decker, Emily; Haverfield, Eden; Herrera, Blanca; Murillo, Laura; Nykamp, Keith; Topper, Scott

    2016-01-01

    Advances in DNA sequencing have made large, diagnostic gene panels affordable and efficient. Broad adoption of such panels has begun to deliver on the promises of personalized medicine, but has also brought new challenges such as the presence of unexpected results, or results of uncertain clinical significance. Genetic analysis of inherited cardiac conditions is particularly challenging due to the extensive genetic heterogeneity underlying cardiac phenotypes, and the overlapping, variable, and incompletely penetrant nature of their clinical presentations. The design of effective diagnostic tests and the effective use of the results depend on a clear understanding of the relationship between each gene and each considered condition. To address these issues, we developed simple, systematic approaches to three fundamental challenges: (1) evaluating the strength of the evidence suggesting that a particular condition is caused by pathogenic variants in a particular gene, (2) evaluating whether unusual genotype/phenotype observations represent a plausible expansion of clinical phenotype associated with a gene, and (3) establishing a molecular diagnostic strategy to capture overlapping clinical presentations. These approaches focus on the systematic evaluation of the pathogenicity of variants identified in clinically affected individuals, and the natural history of disease in those individuals. Here, we applied these approaches to the evaluation of more than 100 genes reported to be associated with inherited cardiomyopathies and arrhythmias including hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular dysplasia or cardiomyopathy, long QT syndrome, short QT syndrome, Brugada, and catecholaminergic polymorphic ventricular tachycardia, and to a set of related syndromes such as Noonan Syndrome and Fabry disease. These approaches provide a framework for delivering meaningful and accurate genetic test results to individuals with hereditary

  7. Phage lytic enzymes: a history

    Institute of Scientific and Technical Information of China (English)

    David; Trudil

    2015-01-01

    There are many recent studies regarding the efficacy of bacteriophage-related lytic enzymes: the enzymes of ‘bacteria-eaters’ or viruses that infect bacteria. By degrading the cell wall of the targeted bacteria, these lytic enzymes have been shown to efficiently lyse Gram-positive bacteria without affecting normal flora and non-related bacteria. Recent studies have suggested approaches for lysing Gram-negative bacteria as well(Briersa Y, et al., 2014). These enzymes include: phage-lysozyme, endolysin, lysozyme, lysin, phage lysin, phage lytic enzymes, phageassociated enzymes, enzybiotics, muralysin, muramidase, virolysin and designations such as Ply, PAE and others. Bacteriophages are viruses that kill bacteria, do not contribute to antimicrobial resistance, are easy to develop, inexpensive to manufacture and safe for humans, animals and the environment. The current focus on lytic enzymes has been on their use as anti-infectives in humans and more recently in agricultural research models. The initial translational application of lytic enzymes, however, was not associated with treating or preventing a specifi c disease but rather as an extraction method to be incorporated in a rapid bacterial detection assay(Bernstein D, 1997).The current review traces the translational history of phage lytic enzymes–from their initial discovery in 1986 for the rapid detection of group A streptococcus in clinical specimens to evolving applications in the detection and prevention of disease in humans and in agriculture.

  8. The effect of early, comprehensive genomic testing on clinical care in neonatal diabetes: an international cohort study

    Science.gov (United States)

    De Franco, Elisa; Flanagan, Sarah E; Houghton, Jayne AL; Allen, Hana Lango; Mackay, Deborah JG; Temple, I Karen; Ellard, Sian; Hattersley, Andrew T

    2015-01-01

    Summary Background Traditional genetic testing focusses on analysis of one or a few genes according to clinical features; this approach is changing as improved sequencing methods enable simultaneous analysis of several genes. Neonatal diabetes is the presenting feature of many discrete clinical phenotypes defined by different genetic causes. Genetic subtype defines treatment, with improved glycaemic control on sulfonylurea treatment for most patients with potassium channel mutations. We investigated the effect of early, comprehensive testing of all known genetic causes of neonatal diabetes. Methods In this large, international, cohort study, we studied patients with neonatal diabetes diagnosed with diabetes before 6 months of age who were referred from 79 countries. We identified mutations by comprehensive genetic testing including Sanger sequencing, 6q24 methylation analysis, and targeted next-generation sequencing of all known neonatal diabetes genes. Findings Between January, 2000, and August, 2013, genetic testing was done in 1020 patients (571 boys, 449 girls). Mutations in the potassium channel genes were the most common cause (n=390) of neonatal diabetes, but were identified less frequently in consanguineous families (12% in consanguineous families vs 46% in non-consanguineous families; pdiabetes at the time of genetic testing decreased from more than 4 years before 2005 to less than 3 months after 2012. Earlier referral for genetic testing affected the clinical phenotype. In patients with genetically diagnosed Wolcott-Rallison syndrome, 23 (88%) of 26 patients tested within 3 months from diagnosis had isolated diabetes, compared with three (17%) of 18 patients referred later (>4 years; pin whom skeletal and liver involvement was common. Similarly, for patients with genetically diagnosed transient neonatal diabetes, the diabetes had remitted in only ten (10%) of 101 patients tested early (diabetes. Comprehensive testing of all causes identified causal

  9. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Kristen Meldi Plasseraud

    2016-01-01

    Full Text Available Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p=0.003 with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher’s exact test p=2.1×10-13 and p=0.04, resp.. The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920.

  10. Comparison of Culture, Cytotoxin Assay and Two Eia Tests with Clinical Diagnosis of Clostridium difficile-Associated Diarrhea

    Directory of Open Access Journals (Sweden)

    Marilyn Binning

    1994-01-01

    Full Text Available Objective: The most common etiology of infectious diarrhea in hospitalized patients is Clostridium difficile. No single laboratory test yields a definitive diagnosis. Four methods were evaluated for their sensitivity and specificity in patients who had clinically defined C difficile-associated diarrhea.

  11. Clinical Utility of Short Social Cognitive Tests in Early Differentiation of Behavioral Variant Frontotemporal Dementia from Alzheimer’s Disease

    DEFF Research Database (Denmark)

    Buhl, Christian; Stokholm, Jette; Gade, Anders

    2013-01-01

    Traditional cognitive tests used in clinical practice may not be sensitive enough for the early differentiation of behavioral variant frontotemporal dementia (bvFTD) from Alzheimer's disease (AD). A growing body of literature has shown that deficits in various aspects of social cognition can be f...

  12. Predictors of Academic Success for the National Board Dental Hygiene Examination and the Southern Regional Testing Agency Clinical Exam

    Science.gov (United States)

    Efurd, Melissa G.

    2012-01-01

    The purpose for conducting this study was to investigate and describe the relationship between applicant criteria for a dental hygiene program and subsequent outcomes on credentialing exams: the National Board Dental Hygiene Exam and the Southern Regional Testing Agency clinical exam. Because admission criteria play a crucial role in applicant…

  13. Test Review: Bracken, B. A., & Keith, L. K. (2004). "Clinical Assessment of Behavior." Lutz, FL: Psychological Assessment Resources

    Science.gov (United States)

    Beran, Tanya N.

    2006-01-01

    The Clinical Assessment of Behavior (CAB) is designed to assess both adaptive and problematic behaviors of children and adolescents from age 2 to 18 years. It can be individually or group administered, measures behaviors in different contexts, and includes both parent and teacher forms. The test was developed to be consistent with current…

  14. Test Reviews: Bracken, B. A., & Howell, K. (2004). "Clinical Assessment of Depression." Odessa, FL: Psychological Assessment Resources

    Science.gov (United States)

    Aghakhani, Anoosha; Chan, Eric K.

    2007-01-01

    In this article, the authors review the Clinical Assessment of Depression (CAD), a 50-item self-report measure of depressive symptoms designed for children, adolescents, adults, and elderly adults from 8 to 79 years of age. Purporting to be sensitive to depressive symptomatology across the lifespan, the test items were written to reflect the…

  15. Skin and Environmental Contamination in Patients Diagnosed With Clostridium difficile Infection but Not Meeting Clinical Criteria for Testing.

    Science.gov (United States)

    Kundrapu, Sirisha; Sunkesula, Venkata; Tomas, Myreen; Donskey, Curtis J

    2015-11-01

    Of 134 patients diagnosed with Clostridium difficile infection, 30 (22%) did not meet clinical criteria for testing because they lacked significant diarrhea or had alternative explanations for diarrhea and no recent antibiotic exposure. For these patients, skin and/or environmental contamination was common only in those with prior antibiotic exposure.

  16. A Four- and Five-Factor Structural Model for Wechsler Tests: Does It Really Matter Clinically?

    Science.gov (United States)

    Schwartz, David M.

    2013-01-01

    The purpose of this commentary is to focus on the clinical utility of the four- and five-factor structural models for the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) and Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV). It provides a discussion of important considerations when evaluating the clinical utility of the…

  17. Estimation of bone mineral density by digital X-ray radiogrammetry: theoretical background and clinical testing

    DEFF Research Database (Denmark)

    Rosholm, A; Hyldstrup, L; Backsgaard, L;

    2002-01-01

    was observed to be 0.60% in a clinical study of 24 women and the in vitro variation over 12 different radiological clinics was found to be 1% of the young normal BMDDXR level. In a cohort of 416 women BMDDXR was found to be closely correlated with BMD at the distal forearm measured by dual-energy X...

  18. Patch testing with markers of fragrance contact allergy. Do clinical tests correspond to patients' self-reported problems?

    DEFF Research Database (Denmark)

    Johansen, J D; Andersen, T F; Veien, N;

    1997-01-01

    in a questionnaire prior to patch testing with the European standard series. The questionnaire contained questions about skin symptoms from the use of scented and unscented products as well as skin reactions from contact with spices, flowers and citrus fruits that could indicate fragrance sensitivity. A highly...

  19. Xenobiotic metabolism capacities of human skin in comparison with a 3D-epidermis model and keratinocyte-based cell culture as in vitro alternatives for chemical testing: phase II enzymes.

    Science.gov (United States)

    Götz, Christine; Pfeiffer, Roland; Tigges, Julia; Ruwiedel, Karsten; Hübenthal, Ulrike; Merk, Hans F; Krutmann, Jean; Edwards, Robert J; Abel, Josef; Pease, Camilla; Goebel, Carsten; Hewitt, Nicola; Fritsche, Ellen

    2012-05-01

    The 7th Amendment to the EU Cosmetics Directive prohibits the use of animals in cosmetic testing for certain endpoints, such as genotoxicity. Therefore, skin in vitro models have to replace chemical testing in vivo. However, the metabolic competence neither of human skin nor of alternative in vitro models has so far been fully characterized, although skin is the first-pass organ for accidentally or purposely (cosmetics and pharmaceuticals) applied chemicals. Thus, there is an urgent need to understand the xenobiotic-metabolizing capacities of human skin and to compare these activities to models developed to replace animal testing. We have measured the activity of the phase II enzymes glutathione S-transferase, UDP-glucuronosyltransferase and N-acetyltransferase in ex vivo human skin, the 3D epidermal model EpiDerm 200 (EPI-200), immortalized keratinocyte-based cell lines (HaCaT and NCTC 2544) and primary normal human epidermal keratinocytes. We show that all three phase II enzymes are present and highly active in skin as compared to phase I. Human skin, therefore, represents a more detoxifying than activating organ. This work systematically compares the activities of three important phase II enzymes in four different in vitro models directly to human skin. We conclude from our studies that 3D epidermal models, like the EPI-200 employed here, are superior over monolayer cultures in mimicking human skin xenobiotic metabolism and thus better suited for dermatotoxicity testing. PMID:22509834

  20. Sub-clinical mastitis prevalent in dairy cows in Chittagong district of Bangladesh: detection by different screening tests

    Directory of Open Access Journals (Sweden)

    Mukti Barua

    2014-07-01

    Full Text Available Aim: Mastitis is recognized as one of the most costly health disorder affecting dairy cows. An epidemiological study was carried out at some selected farms in Chittagong district of Bangladesh to determine the prevalence and risk factors of sub-clinical mastitis (SCM in dairy cows. Materials and Methods: For conducting the study, some dairy farms of Chittagong were selected from urban and periurban areas by stratified random sampling. A total of 444 quarter samples of 111 (56 from commercial dairy farms and 55 from backyards lactating dairy cows were considered. Sub-clinical mastitis (SCM was determined using three different indirect screening tests: California Mastitis Test (CMT, White Slide Test (WST and Surf Field Mastitis Test (SFMT. Sensitivity and specificity were also determined to measure the accuracy of those tests. Results: The prevalence of SCM by CMT, WST and SFMT were 32.43% (n=144, 33.56% (n=149 and 31.53% (n=140, respectively. Distribution of SCM in relation to different variables at quarter level and animal level was also recorded. The prevalence of SCM was significantly (P4 than others at quarter level. No significant difference (P>0.05 was found in relation to breed. Using CMT as a gold standard, sensitivity and specificity of WST and SFMT were also calculated at 95% confidence interval. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value and disease prevalence by WST and SFMT were comparable. Conclusion: This study recommends that regular screening of sub-clinical mastitis will reduce the prevalence of sub-clinical mastitis. The most effective way to control sub-clinical mastitis is to take preventive measures such as regular cleaning of the floor, keeping the udder clean, milkman's cleanliness, dry cow therapy specially in high yielding dairy cows.

  1. Quality Control and Performance of HIV Rapid Tests in a Microbicide Clinical Trial in Rural KwaZulu-Natal

    OpenAIRE

    Nina von Knorring; Mitzy Gafos; Motsei Ramokonupi; Ute Jentsch

    2012-01-01

    Background Quality control (QC) and evaluation of HIV rapid test procedures are an important aspect of HIV prevention trials. We describe QC and performance of two rapid tests, Determine™ and Uni-Gold™ used in a microbicide clinical trial in rural KwaZulu-Natal, South Africa. Methods/Results Internal QC of both HIV rapid tests was conducted at the trial site using a Uni-Gold control kit (Uni-Gold™Recombigen® HIV). Both assays produced the expected results for a total of 4637 QC tes...

  2. Silica Exposure and Serum Angiotensin Converting Enzyme Activity

    OpenAIRE

    YK Sharma; AB Karnik; RR Tiwari

    2010-01-01

    Background: Silicosis is known in industrial workers for centuries. Till recently, the mainstay of its diagnosis and progress was clinical examination of the respiratory system, pulmonary function test and chest radiography. Several biomarkers such as serum angiotensin converting enzyme (ACE) activity have been examined to determine the extent of silicosis. Objective: To elucidate the effect of age, gender, duration of exposure to silica dust, smoking habit, and pulmonary function status on t...

  3. The use of rapid dengue diagnostic tests in a routine clinical setting in a dengue-endemic area of Colombia.

    Science.gov (United States)

    Osorio, Lyda; Uribe, Marcela; Ardila, Gloria Ines; Orejuela, Yaneth; Velasco, Margarita; Bonelo, Anilza; Parra, Beatriz

    2015-06-01

    There is insufficient evidence of the usefulness of dengue diagnostic tests under routine conditions. We sought to analyse how physicians are using dengue diagnostics to inform research and development. Subjects attending 14 health institutions in an endemic area of Colombia with either a clinical diagnosis of dengue or for whom a dengue test was ordered were included in the study. Patterns of test-use are described herein. Factors associated with the ordering of dengue diagnostic tests were identified using contingency tables, nonparametric tests and logistic regression. A total of 778 subjects were diagnosed with dengue by the treating physician, of whom 386 (49.5%) were tested for dengue. Another 491 dengue tests were ordered in subjects whose primary diagnosis was not dengue. Severe dengue classification [odds ratio (OR) 2.2; 95% confidence interval (CI) 1.1-4.5], emergency consultation (OR 1.9; 95% CI 1.4-2.5) and month of the year (OR 3.1; 95% CI 1.7-5.5) were independently associated with ordering of dengue tests. Dengue tests were used both to rule in and rule out diagnosis. The latter use is not justified by the sensitivity of current rapid dengue diagnostic tests. Ordering of dengue tests appear to depend on a combination of factors, including physician and institutional preferences, as well as other patient and epidemiological factors.

  4. 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.

  5. Diffuse reflectance spectroscopy: a clinical study of tuberculin skin tests reading

    Science.gov (United States)

    Koenig, Anne; Grande, Sophie; Dahel, Karima; Planat-Chrétien, Anne; Poher, Vincent; Goujon, Catherine; Dinten, Jean-Marc

    2013-02-01

    Diffuse reflectance spectroscopy is a technique widely used to determine optical properties of tissues: scattering and absorption coefficients. In this study, we present the development of a low-cost optical instrument usable in a clinical environment based upon the spatially resolved diffuse reflectance spectroscopy approach. This instrument has been used in a clinical study to support the diagnosis of tuberculosis. The idea is to establish a new scanning method for an early detection of inflammation due to a reagent injection, before the onset of visual signs. Results comparing the instrumental and classical clinical readings are presented.

  6. The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology.

    Science.gov (United States)

    Joseph, Loren; Cankovic, Milena; Caughron, Samuel; Chandra, Pranil; Emmadi, Rajyasree; Hagenkord, Jill; Hallam, Stephanie; Jewell, Kay E; Klein, Roger D; Pratt, Victoria M; Rothberg, Paul G; Temple-Smolkin, Robyn L; Lyon, Elaine

    2016-09-01

    Clinical utility describes the benefits of each laboratory test for that patient. Many stakeholders have adopted narrow definitions for the clinical utility of molecular testing as applied to targeted pharmacotherapy in oncology, regardless of the population tested or the purpose of the testing. This definition does not address all of the important applications of molecular diagnostic testing. Definitions consistent with a patient-centered approach emphasize and recognize that a clinical test result's utility depends on the context in which it is used and are particularly relevant to molecular diagnostic testing because of the nature of the information they provide. Debates surrounding levels and types of evidence needed to properly evaluate the clinical value of molecular diagnostics are increasingly important because the growing body of knowledge, stemming from the increase of genomic medicine, provides many new opportunities for molecular testing to improve health care. We address the challenges in defining the clinical utility of molecular diagnostics for inherited diseases or cancer and provide assessment recommendations. Starting with a modified analytic validity, clinical validity, clinical utility, and ethical, legal, and social implications model for addressing clinical utility of molecular diagnostics with a variety of testing purposes, we recommend promotion of patient-centered definitions of clinical utility that appropriately recognize the valuable contribution of molecular diagnostic testing to improve patient care. PMID:27542512

  7. Evaluation of Factors Affecting Continuous Performance Test Identical Pairs Version Score of Schizophrenic Patients in a Japanese Clinical Sample

    Directory of Open Access Journals (Sweden)

    Takayoshi Koide

    2012-01-01

    Full Text Available Aim. Cognitive impairment in schizophrenia strongly relates to social outcome and is a good candidate for endophenotypes. When we accurately measure drug efficacy or effects of genes or variants relevant to schizophrenia on cognitive impairment, clinical factors that can affect scores on cognitive tests, such as age and severity of symptoms, should be considered. To elucidate the effect of clinical factors, we conducted multiple regression analysis using scores of the Continuous Performance Test Identical Pairs Version (CPT-IP, which is often used to measure attention/vigilance in schizophrenia. Methods. We conducted the CPT-IP (4-4 digit and examined clinical information (sex, age, education years, onset age, duration of illness, chlorpromazine-equivalent dose, and Positive and Negative Symptom Scale (PANSS scores in 126 schizophrenia patients in Japanese population. Multiple regression analysis was used to evaluate the effect of clinical factors. Results. Age, chlorpromazine-equivalent dose, and PANSS-negative symptom score were associated with mean d′ score in patients. These three clinical factors explained about 28% of the variance in mean d′ score. Conclusions. As conclusion, CPT-IP score in schizophrenia patients is influenced by age, chlorpromazine-equivalent dose and PANSS negative symptom score.

  8. Prevalence Of Lung Involvement Due To Rheumatoid Arthritis Based On Clinical, Radiographic And Pulmonary Functions Test

    Directory of Open Access Journals (Sweden)

    Sedighi N

    2004-07-01

    Full Text Available Background: Pulmonary involvement is a common and serious complication of rheumatoid arthritis. This cross sectional study sought to determine the prevalence of pulmonary disease in patients with rheumatoid arthritis on the basis of history, physical examination, chest X-ray and PFT. Materials and Methods: 103 patients (81 Women, 22 Men fulfilling the ACR (American College of Rheumatology criteria for RA (Rheumatoid arthritis were consecutively included in a cross sectional study. Detailed medical (including respiratory symptoms and the disease activity symptoms and drug and occupational histories and smoking were obtained. All patients underwent a complete pulmonary and rheumatologic examination and conventional chest radiography. All patients underwent PFT that comprised spirometry and body plethysmography. Results for PFTs were expressed as percentage of predicted values for each individual adjusted for age, sex, and height. Results: On the basis of history: Their mean age was 43.3 ± 2.6 years (range: 17-74 and the mean duration of the disease was 69.3 ± 15.6 months. Rheumatoid factor was positive in% 61.2. No patients were 0.5Pack/Year smoker in whole life. Prevalence of pulmonary involvement based on radiographic and pulmonary function test detected in 41 patients (39/7%. The most frequent respiratory clinical finding was dyspnea (33%, (NYHA grade I in 17.5% and NYHA grade II in 15.5%, Cough (with or without sputum in 13.6 %, Crackle was the most sign in pulmonary examination (5.8%. Chest X-ray was abnormal in 13.3 % that the most common finding in this study was reticulonodular pattern in 20 patients (19.4 %, and pleural effusion detected in 7 patients (6.7%. PFT was abnormal in 30 patients (29.1 %. A significant decrease of FEF 25%-75% below 1.64 SD. Small airway involvements was the most abnormal finding of PFT. No relation between rheumatoid arthritis disease activity (ESR>30, Morning stiffness>30', Anemia, thrombocytosis with

  9. Clinical laboratory experience of blood CRIM testing in infantile Pompe disease

    Directory of Open Access Journals (Sweden)

    Deeksha S. Bali

    2015-12-01

    Full Text Available Cross-reactive immunological material (CRIM status is an important prognostic factor in patients with infantile Pompe disease (IPD being treated with enzyme replacement therapy. Western blot analysis of cultured skin fibroblast lysates has been the gold standard for determining CRIM status. Here, we evaluated CRIM status using peripheral blood mononuclear cell (PBMC protein. For 6 of 33 patients (18% CRIM status determination using PBMC was either indeterminate or discordant with GAA genotype or fibroblast CRIM analysis results. While the use of PBMCs for CRIM determination has the advantage of a faster turnaround time, further evaluation is needed to ensure the accuracy of CRIM results.

  10. Diagnostic accuracy of clinical tests for the diagnosis of hip femoroacetabular impingement/labral tear

    DEFF Research Database (Denmark)

    Reiman, M P; Goode, A P; Cook, C E;

    2015-01-01

    BACKGROUND: Surgery for hip femoroacetabular impingement/acetabular labral tear (FAI/ALT) is exponentially increasing despite lacking investigation of the accuracy of various diagnostic measures. Useful clinical utility of these measures is necessary to support diagnostic imaging and subsequent...

  11. Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators

    DEFF Research Database (Denmark)

    Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan;

    2015-01-01

    AIMS: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. METHODS AND RESULTS: Between February 2011 and July 2013, 1077...... within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). CONCLUSION: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation...

  12. Performances of 27 MEDLINE systems tested by searches with clinical questions.

    OpenAIRE

    Haynes, R B; Walker, C J; McKibbon, K. A.; Johnston, M. E.; Willan, A R

    1994-01-01

    OBJECTIVE: To compare the performances of online and compact-disc (CD-ROM) versions of the National Library of Medicine's (NLM) MEDLINE database. DESIGN: Analytic survey. INTERVENTION: Clinical questions were drawn from 18 searches originally conducted spontaneously by clinicians from wards and clinics who had used Grateful Med Version 4.0. Clinicians' search strategies were translated to meet the specific requirements of 13 online and 14 CD-ROM MEDLINE systems. A senior librarian and vendors...

  13. Overcoming Challenges in Conducting Clinical Trials in Minority Populations: Identifying and Testing What Works

    Directory of Open Access Journals (Sweden)

    Romuladus E. Azuine, DrPH, RN

    2015-03-01

    Full Text Available Participation in clinical trials is one of the greatest gifts that humanity can give to the fields of medicine and public health. Clinical trials are central in public health’s mission to advance drug discovery. The enrollment and retention of participants, especially minority populations, is one of the most practical challenges of successfully implementing a clinical trial. In spite of these challenges, there are many reasons why a broader public participation in clinical trials is critical. The ability to generalize the scientific findings and the principles of equity, justice, and beneficence require an equitable distribution of the risks, benefits, and burdens of research for all classes and groups of people. A new methodology article published in this journal presents a promising framework for addressing minority recruitment and retention using what is known and using it innovatively to address a difficult problem facing clinical trials and public health. The innovative application of what is known in addressing a challenging problem, as this article presents, is worth the reading of all those interested in scientifically rigorous and ethically sound clinical trials that substantially comprise of diverse populations.

  14. The value of the UK Clinical Aptitude Test in predicting pre-clinical performance: a prospective cohort study at Nottingham Medical School

    Directory of Open Access Journals (Sweden)

    James David

    2010-07-01

    Full Text Available Abstract Background The UK Clinical Aptitude Test (UKCAT was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Quantitative Reasoning, Verbal Reasoning, Abstract Reasoning, and Decision Analysis, and the results are available to students and admissions panels in advance of the selection process. As yet the predictive validity of the test against course performance is largely unknown. The study objective was to determine whether UKCAT scores predict performance during the first two years of the 5-year undergraduate medical course at Nottingham. Methods We studied a single cohort of students, who entered Nottingham Medical School in October 2007 and had taken the UKCAT. We used linear regression analysis to identify independent predictors of marks for different parts of the 2-year preclinical course. Results Data were available for 204/260 (78% of the entry cohort. The UKCAT total score had little predictive value. Quantitative Reasoning was a significant independent predictor of course marks in Theme A ('The Cell', (p = 0.005, and Verbal Reasoning predicted Theme C ('The Community' (p Conclusion This limited study from a single entry cohort at one medical school suggests that the predictive value of the UKCAT, particularly the total score, is low. Section scores may predict success in specific types of course assessment. The ultimate test of validity will not be available for some years, when current cohorts of students graduate. However, if this test of mental ability does not predict preclinical performance, it is arguably less likely to predict the outcome in the clinical years. Further research from medical schools with different types of curriculum and assessment is needed, with longitudinal studies throughout the course.

  15. What is needed to incorporate clinical pharmacogenetic tests into the practice of psychopharmacotherapy?

    Science.gov (United States)

    de Leon, Jose; Spina, Edoardo

    2016-01-01

    This editorial considers two questions in psychopharmacotherapy: 1) What is needed to market pharmacogenetic tests in the US, since the US appears to lead other countries? and 2) What is needed for US-marketed pharmacogenetic tests to be incorporated by prescribers into long-term practice? US marketing of pharmacogenetic tests requires 1) understanding the pharmacological complexity of drug response, 2) modifying the oversight of non-FDA regulatory agencies, 3) clarifying the FDA's role and 4) promoting innovative marketing. The incorporation of pharmacogenetic tests into long-term practice requires 1) not jeopardizing pharmacogenetic testing by short-sighted marketing of non-validated tests, 2) educating prescribers about benefits, 3) educating patients about limitations and 4) considering the differences between isolated testing and generalized testing incorporating big data.

  16. European recommendations for the clinical use of HIV drug resistance testing: 2011 update

    DEFF Research Database (Denmark)

    Vandamme, Anne-Mieke; Camacho, Ricardo J; Ceccherini-Silberstein, Francesca;

    2011-01-01

    ; (iv) consider testing earliest detectable plasma RNA when a successful nonnucleoside reverse transcriptase inhibitor-containing therapy was inappropriately interrupted; (v) genotype source patient when postexposure prophylaxis is considered; for HIV-2, (vi) consider resistance testing where treatment...

  17. What is needed to incorporate clinical pharmacogenetic tests into the practice of psychopharmacotherapy?

    Science.gov (United States)

    de Leon, Jose; Spina, Edoardo

    2016-01-01

    This editorial considers two questions in psychopharmacotherapy: 1) What is needed to market pharmacogenetic tests in the US, since the US appears to lead other countries? and 2) What is needed for US-marketed pharmacogenetic tests to be incorporated by prescribers into long-term practice? US marketing of pharmacogenetic tests requires 1) understanding the pharmacological complexity of drug response, 2) modifying the oversight of non-FDA regulatory agencies, 3) clarifying the FDA's role and 4) promoting innovative marketing. The incorporation of pharmacogenetic tests into long-term practice requires 1) not jeopardizing pharmacogenetic testing by short-sighted marketing of non-validated tests, 2) educating prescribers about benefits, 3) educating patients about limitations and 4) considering the differences between isolated testing and generalized testing incorporating big data. PMID:26580456

  18. The Impact on Genetic Testing of Mutational Patterns of CFTR Gene in Different Clinical Macrocategories of Cystic Fibrosis.

    Science.gov (United States)

    Lucarelli, Marco; Bruno, Sabina M; Pierandrei, Silvia; Ferraguti, Giampiero; Testino, Giancarlo; Truglio, Gessica; Strom, Roberto; Quattrucci, Serena

    2016-07-01

    More than 2000 sequence variations of the cystic fibrosis transmembrane conductance regulator gene are known. The marked genetic heterogeneity, poor functional characterization of the vast majority of sequence variations, and an uncertain genotype-phenotype relationship complicate the definition of mutational search strategies. We studied the effect of the marked genetic heterogeneity detected in a case series comprising 610 patients of cystic fibrosis (CF), grouped in different clinical macrocategories, on the operative characteristics of the genetic test designed to fully characterize CF patients. The detection rate in each clinical macrocategory and at each mutational step was found to be influenced by genetic heterogeneity. The definition of a single mutational panel that is suitable for all clinical macrocategories proved impossible. Only for classic CF with pancreas insufficiency did a reduced number of mutations yield a detection rate of diagnostic value. All other clinical macrocategories required an extensive genetic search. The search for specific mutational classes appears to be useful only in specific CF clinical forms. A flowchart defining a mutational search that may be adopted for different CF clinical forms, optimized in respect to those already available, is proposed. The findings also have consequences for carrier screening strategies.

  19. Clinical Evaluation of 2 Point-of-Care Lateral Flow Tests for the Diagnosis of Syphilis.

    Science.gov (United States)

    Nakku-Joloba, Edith; Kiragga, Agnes; Mbazira, Joshua Kimeze; Kambugu, Fred; Jett-Goheen, Mary; Ratanshi, Rosalind Parkes; Gaydos, Charlotte; Manabe, Yukari C

    2016-10-01

    A diagnostic performance study comparing the only Food and Drug Administration-approved, point-of-care (POC) treponemal test (Syphilis Health Check) and the World Health Organization pre-qualified SD Bioline POC treponemal test against a treponemal hemagglutination test (TPHA) and a sequential algorithm of nontreponemal rapid plasma reagin and TPHA found both POC tests had >85% sensitivity compared with the TPHA and >85% sensitivity and >95% specificity compared with the rapid plasma reagin and TPHA standards. PMID:27631356

  20. Dynamic MR imaging and stress testing in glenohumeral instability: comparison with normal shoulders and clinical/surgical findings.

    Science.gov (United States)

    Hodge, D K; Beaulieu, C F; Thabit, G H; Gold, G E; Bergman, A G; Butts, R K; Dillingham, M F; Herfkens, R J

    2001-05-01

    Our objectives were to test the hypotheses that: 1) during shoulder motion, glenohumeral alignment differs between asymptomatic shoulders and those with symptomatic instability; 2) during magnetic resonance (MR)-monitored physical exam or stress testing, glenohumeral alignment differs between asymptomatic shoulders and those with instability; and 3) glenohumeral translation during MR stress testing correlates with findings of shoulder instability by clinical exam and exam under anesthesia (EUA). Using an open-configuration 0.5 T MR imaging (MRI) system, we studied symptomatic shoulders in 11 subjects and compared them to their contralateral asymptomatic shoulders. Each shoulder was studied during abduction/adduction and internal/external rotation to determine the humeral head position on the glenoid. An examiner also performed the MR stress test on each shoulder by applying manual force on the humeral head during imaging. All shoulders were assigned an instability grade from the MR stress test, and this grade was correlated with: 1) clinical exam grade assigned during preoperative assessment by an orthopedic surgeon and 2) intraoperative instability grade by EUA immediately preceding arthroscopy. With dynamic abduction and internal/external rotation, the humeral head remained centered on the glenoid in 9 of 11 shoulders, but in two subjects there were dramatic demonstrations of subluxation. With stress testing, a trend toward more joint laxity was demonstrated in symptomatic than in asymptomatic joints (P = 0.11). MR grading of instability correlated directly with clinical grading in six cases and underestimated the degree of instability relative to clinical exam in the other cases. MR instability grading systematically underestimated instability compared with EUA in 7 of the 10 cases that underwent surgical repair. We concluded that dynamic MR evaluation of glenohumeral alignment did not demonstrate abnormalities in symptomatic shoulders in 8 of 10 patients

  1. d-dimer testing as an adjunct to ultrasonography in patients with clinically suspected deep vein thrombosis: prospective cohort study

    Science.gov (United States)

    Bernardi, Enrico; Prandoni, Paolo; Lensing, Anthonie W A; Agnelli, Giancarlo; Guazzaloca, Giuliana; Scannapieco, Gianluigi; Piovella, Franco; Verlato, Fabio; Tomasi, Cristina; Moia, Marco; Scarano, Luigi; Girolami, Antonio

    1998-01-01

    Objective To investigate the efficacy of using a rapid plasma d-dimer test as an adjunct to compression ultrasound for diagnosing clinically suspected deep vein thrombosis. Design d-dimer concentrations were determined in all patients with a normal ultrasonogram at presentation. Repeat ultrasonography was performed 1 week later only in patients with abnormal d-dimer test results. Main outcome measure Patients with normal ultrasonograms were not treated with anticoagulants and were followed for 3 months for thromboembolic complications. Setting University research and affiliated centres. Subjects 946 patients with clinically suspected deep vein thrombosis. Results Ultrasonograms were abnormal at presentation in 260 (27.5%) patients. Of the remaining 686 patients tested for d-dimer, 88 (12.8%) had abnormal concentrations. During follow up venous thromboembolic complications occurred in one of the 598 patients who were not treated with anticoagulants and who had an initial normal ultrasonogram and d-dimer concentration, whereas thromboembolic complications occurred in two of the 83 untreated patients who had abnormal d-dimer concentrations but a normal repeat ultrasonogram. The cumulative incidence of venous thromboembolic complications during follow up was 0.4% (95% confidence interval 0% to 0.9%). The rapid plasma d-dimer test used as an adjunct to compression ultrasonography resulted in a reduction in the mean number of repeat ultrasound examinations and additional hospital visits from 0.7 to 0.1 per patient. Conclusions Testing for d-dimer as an adjunct to a normal baseline ultrasound examination decreased the number of subsequent ultrasound examinations considerably without any increased risk of venous thromboembolic complications in patients not receiving anticoagulants. The use of ultrasound and testing for d-dimer enabled treatment decisions to be made at the time of presentation in most patients. Key messagesPatients with clinically suspected deep vein

  2. Development of computer tablet software for clinical quantification of lateral knee compartment translation during the pivot shift test.

    Science.gov (United States)

    Muller, Bart; Hofbauer, Marcus; Rahnemai-Azar, Amir Ata; Wolf, Megan; Araki, Daisuke; Hoshino, Yuichi; Araujo, Paulo; Debski, Richard E; Irrgang, James J; Fu, Freddie H; Musahl, Volker

    2016-01-01

    The pivot shift test is a commonly used clinical examination by orthopedic surgeons to evaluate knee function following injury. However, the test can only be graded subjectively by the examiner. Therefore, the purpose of this study is to develop software for a computer tablet to quantify anterior translation of the lateral knee compartment during the pivot shift test. Based on the simple image analysis method, software for a computer tablet was developed with the following primary design constraint - the software should be easy to use in a clinical setting and it should not slow down an outpatient visit. Translation of the lateral compartment of the intact knee was 2.0 ± 0.2 mm and for the anterior cruciate ligament-deficient knee was 8.9 ± 0.9 mm (p software provides reliable, objective, and quantitative data on translation of the lateral knee compartment during the pivot shift test and meets the design constraints posed by the clinical setting.

  3. Using pathology-specific laboratory profiles in Clinical Pathology to reduce inappropriate test requesting: two completed audit cycles

    Directory of Open Access Journals (Sweden)

    Baricchi Roberto

    2012-07-01

    Full Text Available Abstract Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy, it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs in the trial district (Castelnovo nè Monti tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1 the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p  Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the prescriptive compliance of most of the GPs involved. The presence of the clinical pathologist is seen as an added value.

  4. Barriers to hospital-based clinical adoption of point-of-care testing (POCT): A systematic narrative review.

    Science.gov (United States)

    Quinn, Alistair D; Dixon, Dorian; Meenan, Brian J

    2016-01-01

    Recent advances in areas such as biomarker discovery and microfluidic device fabrication have allowed clinical testing to be moved ever closer to the site of patient care. The development of a range of point-of-care testing (POCT) devices that seek to provide the clinician with diagnostic test results more rapidly offer the opportunity to enhance the quality of care for the individual patient and the population at large. However, there are indications that, notwithstanding advances in the technologies that underpin the utility of POCT, their clinical uptake and utilization is less than might be expected. Moreover, the nature and relative importance of the barriers identified as being impediments to their more widespread adoption are not well understood. This article reports the findings from a systematic narrative review of published literature sources over the period 2000 to January 2014 to identify and categorize the various barriers to adoption of POCT devices within the clinical environment. Data from a total of six electronic bibliographic databases were accessed and these searches were supplemented by scrutinizing the reference lists within the key articles identified. A set of 49 key articles were assessed in detail and from these four specific categories of barrier to adoption of POCT were identified. Identification and categorization of these barriers, along with an assessment of their significance to clinical practice, is seen as necessary for developing real solutions to ensure appropriate and effective POCT uptake. The most prevalent categories were those associated with the economics of adoption and quality assurance and regulatory issues, each which were reflected in 65% of the literature articles reviewed. Device performance and data management issues were cited in 51% of the publications. Staff and operational issues were found within 35% of articles. The most significant barriers identified concerned higher cost per test of POCT in comparison to

  5. Computational enzyme design

    Science.gov (United States)

    Bolon, Daniel N.

    2002-08-01

    developed within the scope of protein design that require core polar residues to largely satisfy their hydrogen bonding potential. Using this polar strategy to design the core of thioredoxin resulted in a protein that was thermodynamically stabilized relative to both the wt protein and a protein designed without core polar residues.The enzyme design procedures presented here may serve as a platform to develop more detailed methods. It is hoped that the development and experimental testing of more detailed methods will continue to improve our understanding of enzyme mechanism and lead to the long-term goal of designing highly efficient enzymes.

  6. The testing of Sanocrysin: science, profit, and innovation in clinical trial design, 1926-31.

    Science.gov (United States)

    Gabriel, Joseph M

    2014-10-01

    This article provides a detailed analysis of the origins and significance of the 1926 clinical trial of Sanocrysin, a gold compound thought at the time to be useful in the treatment of tuberculosis. This experiment is generally considered to be the first clinical trial in the United States that used a formal system of randomization to divide research subjects into treatment and nontreatment groups; it was probably also the first clinical trial in the United States to use placebo shams in a nontreatment control group to overcome the problem of what researchers at the time called "psychic influence." As such, it was an extremely important moment in the history of clinical trial design. Yet, as I argue, the Sanocrysin experiment also needs to be understood in terms of both the regulatory environment at the time and the commercial interests of Parke, Davis & Company, the pharmaceutical manufacturer that was intent on introducing the drug. Although some historians argue that therapeutic reformers in the twentieth century used experimental science to rein in the commercial forces of the market, this article suggests that, at least in this case, the promotion of rigorous clinical science and the pursuit of corporate profit were deeply intertwined.

  7. A Simple Step Test to Estimate Cardio-Respiratory Fitness Levels of Rheumatoid Arthritis Patients in a Clinical Setting

    Directory of Open Access Journals (Sweden)

    Jennifer K. Cooney

    2013-01-01

    Full Text Available Purpose. Exercise tests represent an important clinical tool to evaluate cardio-respiratory fitness and to predict future adverse cardiovascular events. However, use of such tests in patients with rheumatoid arthritis (RA is relatively uncommon despite well-established evidence that low exercise capacity and high CVD mortality are features of this disease. Therefore, this study examined the validity and reliability of a sub-maximal step test for use in RA patients. Methods. Thirty patients (24 females (mean ± SD age 53±10 years performed a sub-maximal step test on two occasions to estimate the criterion measure of cardio-respiratory fitness (V.O2max. A further maximal cycling test provided a direct fitness measurement (V.O2 peak. Pearson correlation coefficient, intraclass correlation coefficient (ICC, Bland and Altman plots, and 95% limits of agreement (LOA were used to determine the validity and reliability of the sub-maximal test. Results. Estimated V.O2max correlated well with directly measured V.O2 peak (r=0.79, LoA ±5.7 mL·kg−1·min−1. Test-retest reproducibility for estimated V.O2max was excellent (ICC=0.97, LoA ±2.2 mL·kg−1·min−1. Conclusion. The sub-maximal step test studied here represents a valid and reproducible method to estimate cardio-respiratory fitness in RA patients. This test may be useful for the assessment and management of CVD risk in a clinical setting.

  8. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues.

    Science.gov (United States)

    Gekas, Jean; Langlois, Sylvie; Ravitsky, Vardit; Audibert, François; van den Berg, David Gradus; Haidar, Hazar; Rousseau, François

    2016-01-01

    Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening) was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women. PMID:26893576

  9. ERα/E2 signaling suppresses the expression of steroidogenic enzyme genes via cross-talk with orphan nuclear receptor Nur77 in the testes.

    Science.gov (United States)

    Lee, Seung-Yon; Park, Eunsook; Kim, Seung-Chang; Ahn, Ryun-Sup; Ko, CheMyong; Lee, Keesook

    2012-10-15

    Estrogen receptor alpha (ERα) has been reported to affect steroidogenesis in testicular Leydig cells, but its molecular mechanism remains unclear. Here, we investigate the effect of estrogen and ERα on Nur77, a major transcription factor that regulates the expression of steroidogenic enzyme genes. In MA-10 Leydig cells, estradiol (E2) treatment, and interestingly ERα overexpression, suppressed the cAMP-induced and Nur77-activated promoter activity of steroidogenic enzyme genes via the suppression of Nur77 transactivation. ERα physically interacted with Nur77 and inhibited its DNA binding activity. In addition, ERα/E2 signaling decreased Nur77 protein levels. Consistent with the above results, the testicular testosterone level was higher in Leydig cell-specific ERα knock-out mice (ERα(flox/flox)Cyp17iCre) than in wild-type mice (ERα(flox/flox)). Taken together, these results suggest that ERα/E2 signaling controls the Nur77-mediated expression of steroidogenic enzyme genes in Leydig cells. These findings may provide a mechanistic explanation for the local regulation of testicular steroidogenesis by estrogenic compounds and ERα.

  10. Enzyme detection by microfluidics

    DEFF Research Database (Denmark)

    2013-01-01

    Microfluidic-implemented methods of detecting an enzyme, in particular a DNA-modifying enzyme, are provided, as well as methods for detecting a cell, or a microorganism expressing said enzyme. The enzyme is detected by providing a nucleic acid substrate, which is specifically targeted...... by that enzyme...

  11. Reliability, construct and discriminative validity of clinical testing in subjects with and without chronic neck pain

    DEFF Research Database (Denmark)

    Jørgensen, René; Ris Hansen, Inge; Falla, Deborah;

    2014-01-01

    -retest reliability in people with and without chronic neck pain. Moreover, construct and between-group discriminative validity of the tests were examined. METHODS: Twenty-one participants with chronic neck pain and 21 asymptomatic participants were included. Intra- and inter-reliability were evaluated for the Cranio......-Cervical Flexion Test (CCFT), Range of Movement (ROM), Joint Position Error (JPE), Gaze Stability (GS), Smooth Pursuit Neck Torsion Test (SPNTT), and neuromuscular control of the Deep Cervical Extensors (DCE). Test-retest reliability was assessed for Postural Control (SWAY) and Pressure Pain Threshold (PPT) over......-reliability for GS and SPNTT showed kappa ranging from 0.66 to 0.92, and 0.57 to 0.78 (prevalence adjusted), respectively. For the test-retest study, ICC was 0.83 to 0.89 for PPT and 0.39 to 0.79 for SWAY. Construct validity was satisfactory for all tests, except JPE. Significant between group discriminative...

  12. Human papillomavirus testing by self-sampling: assessment of accuracy in an unsupervised clinical setting

    Science.gov (United States)

    Szarewski, Anne; Cadman, Louise; Mallett, Susan; Austin, Janet; Londesborough, Philip; Waller, Jo; Wardle, Jane; Altman, Douglas G; Cuzick, Jack

    2007-01-01

    Objectives: To compare the performance and acceptability of unsupervised self-sampling with clinician sampling for high-risk human papillomavirus (HPV) types for the first time in a UK screening setting. Setting: Nine hundred and twenty women, from two demographically different centres, attending for routine cervical smear testing Methods: Women performed an unsupervised HPV self-test. Immediately afterwards, a doctor or nurse took an HPV test and cervical smear. Women with an abnormality on any test were offered colposcopy. Results: Twenty-one high-grade and 39 low-grade cervical intraepithelial neoplasias (CINs) were detected. The sensitivity for high-grade disease (CIN2+) for the self HPV test was 81% (95% confidence interval [CI] 60–92), clinician HPV test 100% (95% CI 85–100), cytology 81% (95% CI 60–92). The sensitivity of both HPV tests to detect high- and low-grade cervical neoplasia was much higher than that of cytology (self-test 77% [95%CI 65–86], clinician test 80% [95% CI 68–88], cytology 48% [95% CI 36–61]). For both high-grade alone, and high and low grades together, the specificity was significantly higher for cytology (greater than 95%) than either HPV test (between 82% and 87%). The self-test proved highly acceptable to women and they reported that the instructions were easy to understand irrespective of educational level. Conclusions: Our results suggest that it would be reasonable to offer HPV self-testing to women who are reluctant to attend for cervical smears. This approach should now be directly evaluated among women who have been non-attenders in a cervical screening programme. PMID:17362570

  13. Clinical utility of PKD2 mutation testing in a polycystic kidney disease cohort attending a specialist nephrology out-patient clinic

    Directory of Open Access Journals (Sweden)

    Robinson Caroline

    2012-08-01

    Full Text Available Abstract Background ADPKD affects approximately 1:1000 of the worldwide population. It is caused by mutations in two genes, PKD1 and PKD2. Although allelic variation has some influence on disease severity, genic effects are strong, with PKD2 mutations predicting later onset of ESRF by up to 20 years. We therefore screened a cohort of ADPKD patients attending a nephrology out-patient clinic for PKD2 mutations, to identify factors that can be used to offer targeted gene testing and to provide patients with improved prognostic information. Methods 142 consecutive individuals presenting to a hospital nephrology out-patient service with a diagnosis of ADPKD and CKD stage 4 or less were screened for mutations in PKD2, following clinical evaluation and provision of a detailed family history (FH. Results PKD2 mutations were identified in one fifth of cases. 12% of non-PKD2 patients progressed to ESRF during this study whilst none with a PKD2 mutation did (median 38.5 months of follow-up, range 16–88 months, p PKD2 vs. PKD2, 54 yrs vs. 65 yrs; p PKD2 mutations were identified in patients with a FH of ESRF occurring before age 50 yrs, whereas a PKD2 mutation was predicted by a positive FH without ESRF. Conclusions PKD2 testing has a clinically significant detection rate in the pre-ESRF population. It did not accurately distinguish those individuals with milder renal disease defined by stage of CKD but did identify a group less likely to progress to ESRF. When used with detailed FH, it offers useful prognostic information for individuals and their families. It can therefore be offered to all but those whose relatives have developed ESRF before age 50.

  14. Enhancing medical-surgical nursing practice: using practice tests and clinical examples to promote active learning and program evaluation.

    Science.gov (United States)

    DuHamel, Martha B; Hirnle, Constance; Karvonen, Colleen; Sayre, Cindy; Wyant, Sheryl; Colobong Smith, Nancy; Keener, Sheila; Barrett, Shannon; Whitney, Joanne D

    2011-10-01

    In a 14-week medical-surgical nursing review course, two teaching strategies are used to promote active learning and assess the transfer of knowledge to nursing practice. Practice tests and clinical examples provide opportunities for participants to engage in self-assessment and reflective learning and enhance their nursing knowledge, skills, and practice. These strategies also contribute to program evaluation and are adaptable to a variety of course formats, including traditional classroom, web conference, and online self-study.

  15. Predictive validity of the UK clinical aptitude test in the final years of medical school: a prospective cohort study

    OpenAIRE

    Husbands, Adrian; Mathieson, Alistair; Dowell, Jonathan; Cleland, Jennifer; MacKenzie, Rhoda

    2014-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was designed to address issues identified with traditional methods of selection. This study aims to examine the predictive validity of the UKCAT and compare this to traditional selection methods in the senior years of medical school. This was a follow-up study of two cohorts of students from two medical schools who had previously taken part in a study examining the predictive validity of the UKCAT in first year. Methods The sample consisted of ...

  16. PIGE - Resonance profiling applied to a clinical test of flouride varnishes

    Science.gov (United States)

    Zschau, H. E.; Plier, F.; Otto, G.; Wyrwich, C.; Treide, A.

    1992-03-01

    A clinical in-vivo experiment had been carried out to compare two caries preventing fluorine varnishes. The fluorine depth profiles in the near surface region of tooth enamel were measured using the 935 keV resonance of the nuclear reaction 19F( p, p' γ) 19F. The results can be understood by studying the flourine anamnese of the patients.

  17. The value of clinical tests in acute full-thickness tears of the supraspinatus tendon

    DEFF Research Database (Denmark)

    Bak, Klaus; Sørensen, Anne Kathrine Belling; Jørgensen, Uffe Viegh;

    2010-01-01

    Early repair of rotator cuff tears leads to superior results. To detect symptomatic full-thickness tears of the supraspinatus tendon at an early stage, we conducted a prospective study to evaluate the value of clinical examination with and without subacromial lidocaine within the first weeks after...

  18. Engineering Cellulase Enzymes for Bioenergy

    Science.gov (United States)

    Atreya, Meera Elizabeth

    methods. Protein engineering targets to improve cellulases include reducing enzyme inhibition, improving inter-enzyme synergy, and increasing enzyme thermotolerance. Ameliorating enzyme inhibition could improve catalytic activity and thus the speed of conversion from biomass to fermentable sugars. Improved enzyme synergy could reduce the enzyme loading required to achieve equivalent biomass conversion. Finally, thermostable enzymes could enable more biomass to be processed at a time, due to high temperatures decreasing the viscosity of biomass slurries. A high-temperature enzyme saccharification reaction could also decrease the risk of contamination in the resulting concentrated sugar solution. Throughout my PhD, I have explored research projects broadly across all of these topics, with the most success in addressing the issue of enzyme inhibition. Cellulase enzyme Cel7A is the most abundant cellulase employed by natural systems for cellulose hydrolysis. Cellobiohydrolase enzymes like Cel7A break down cellulose into cellobiose (two glucose molecules). Unfortunately, upon cleavage, this product molecule interferes with continued hydrolysis activity of Cel7A; the strong binding of cellobiose in the active site can obstruct the enzyme from processing down the cellulase chain. This phenomenon, known as product inhibition, is a bottleneck to efficient biomass breakdown. Using insights from computational protein modeling studies, I experimentally generated and tested mutant Cel7A enzymes for improved tolerance to cellobiose. Indeed, this strategy yielded Cel7A enzymes exhibiting reduced product inhibition, including some mutants completely impervious to cellobiose. The improvements in tolerance to cellobiose, however, resulted in an overall reduction of enzyme activity for the mutants tested. Nevertheless, my findings substantiated computational reports with experimental evidence and pinpointed an amino acid residue in the Cel7A product binding site that is of interest for

  19. Clinical usefulness of dual-label Schilling test for pancreatic exocrine function

    International Nuclear Information System (INIS)

    The usefulness of the pancreatic dual-label Schilling test as an indirect test of pancreatic exocrine function was evaluated. This dual-label Schilling test was based on the difference of absorption for [58Co]cobalamin bound to hog R protein and [57Co]cobalamin bound to intrinsic factor. In this study, the test was performed in 7 normal subjects, 5 patients with pancreatectomy, 12 patients with chronic pancreatitis, 10 patients with suspicion of chronic pancreatitis, and 13 patients without chronic pancreatitis. The normal lower limit (mean -2 SD) of excretion ratio for [58Co]/[57Co] in 24-h urine was 0.68. Of the 26 patients on whom endoscopic retrograde pancreatography was performed, none of the 9 patients with normal pancreatogram, 4 of the 9 patients with mild to moderate pancreatitic changes in pancreatogram, and 7 of the 8 patients with advanced pancreatitic changes in pancreatogram showed a positive value lower than the ratio of 0.68 in this test. In 28 patients examined with the direct test of pancreatic secretory capacity, 2 of the 13 patients with normal function, 6 of the 9 patients with mild dysfunction, and 5 of the 6 patients with definite dysfunction were positive in this test. The results of the pancreatic dual-label Schilling test significantly correlated with those of a direct test of pancreatic secretory capacity and the findings of pancreatitic changes in pancreatogram (p less than 0.01, chi 2 test). The ratio for [58Co]/[57Co] correlated (r = 0.73) with the maximal bicarbonate concentration in duodenal juice of the direct test of pancreatic secretory capacity. The impairment of bicarbonate output by the pancreas may adversely affect the transfer of cobalamin from R protein to intrinsic factor

  20. Couple experiences of provider-initiated couple HIV testing in an antenatal clinic in Lusaka, Zambia: lessons for policy and practice

    OpenAIRE

    Musheke, M.; Bond, V.; Merten, S

    2013-01-01

    Background: Couple HIV testing has been recognized as critical to increase uptake of HIV testing, facilitate disclosure of HIV status to marital partner, improve access to treatment, care and support, and promote safe sex. The Zambia national protocol on integrated prevention of mother-to-child transmission of HIV (PMTCT) allows for the provision of couple testing in antenatal clinics. This paper examines couple experiences of provider-initiated couple HIV testing at a public antenatal clinic...

  1. Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations

    Science.gov (United States)

    Brown, Richard F.; Bylund, Carma L.; Li, Yuelin; Edgerson, Shawna; Butow, Phyllis

    2012-01-01

    Objective A Question Prompt List (QPL) is a proven, simple intervention to aid patients to be active participants in consultations with their physicians by asking questions. We aimed to further develop and test the efficacy of a targeted QPL for clinical trials (QPL-CT). Methods Breast, Lung and Genitourinary cancer patients who were facing a discussion about a therapeutic clinical trial completed short pre- and post-consultation questionnaires and used the QPL-CT in their discussions with their oncologists. Results: 30 participants were recruited from 6 oncologists All QPL-CT questions were selected by at least one-third of participants. Participants mostly wanted and asked questions about personal trial benefit. Oncologists provided information about personal benefit to varying degrees, thus patients did not ask some questions. Patients were still left with some unasked and unanswered questions. Conclusion The QPL-CT has potential as a simple, inexpensive intervention to aid such communication. Further investigation is needed to demonstrate the efficacy of the QPL-CT in improving cancer patient outcomes. Practice Implications These preliminary finding suggest that important areas of clinical trials are overlooked in clinical consultations. The QPL-CT may be an effective method to encourage oncologists to endorse patient question asking about clinical trials and prompt patient questions. PMID:22390854

  2. Clinical patch test data evaluated by multivariate analysis. Danish Contact Dermatitis Group

    DEFF Research Database (Denmark)

    Christophersen, J; Menné, T; Tanghøj, P;

    1989-01-01

    patch tested with the standard series of the International Contact Dermatitis Research Group (ICDRG) by members of the Danish Contact Dermatitis Group (DCDG) over a period of 6 months. For the 8 test allergens most often found positive (nickel, fragrance-mix, cobalt, chromate, balsam of Peru, carba...

  3. Test Anxiety: Theory, Assessment, and Treatment. The Series in Clinical and Community Psychology.

    Science.gov (United States)

    Spielberger, Charles D., Ed.; Vagg, Peter R., Ed.

    It is not surprising that a broad array of treatment programs have been developed to reduce test anxiety, since the consequences can be serious. The contributions in this volume review and evaluate the theory of test anxiety, its measurement, its manifestations, and possible treatments and their outcomes. The following chapters are included: (1)…

  4. Genetic testing of children for predisposition to mood disorders: anticipating the clinical issues.

    Science.gov (United States)

    Erickson, Jessica A; Kuzmich, Lili; Ormond, Kelly E; Gordon, Erynn; Christman, Michael F; Cho, Mildred K; Levinson, Douglas F

    2014-08-01

    Large-scale sequencing information may provide a basis for genetic tests for predisposition to common disorders. In this study, participants in the Coriell Personalized Medicine Collaborative (N = 53) with a personal and/or family history of Major Depressive Disorder or Bipolar Disorder were interviewed based on the Health Belief Model around hypothetical intention to test one's children for probability of developing a mood disorder. Most participants (87 %) were interested in a hypothetical test for children that had high ("90 %") positive predictive value, while 51 % of participants remained interested in a modestly predictive test ("20 %"). Interest was driven by beliefs about effects of test results on parenting behaviors and on discrimination. Most participants favored testing before adolescence (64 %), and were reluctant to share results with asymptomatic children before adulthood. Participants anticipated both positive and negative effects of testing on parental treatment and on children's self-esteem. Further investigation will determine whether these findings will generalize to other complex disorders for which early intervention is possible but not clearly demonstrated to improve outcomes. More information is also needed about the effects of childhood genetic testing and sharing of results on parent-child relationships, and about the role of the child in the decision-making process. PMID:24651919

  5. Value of ovarian reserve testing before IVF: a clinical decision analysis

    NARCIS (Netherlands)

    B.W. Mol; T.E.M. Verhagen; D.J. Hendriks; J.A. Collins; A. Coomarasamy; B.C. Opmeer; F.J. Broekmans

    2006-01-01

    BACKGROUND: To assess the value of testing for ovarian reserve prior to a first cycle IVF incorporating patient and doctor valuation of mismatches between test results and treatment outcome. METHODS: A decision model was developed for couples who were considering participation in an IVF programme. T

  6. The Assessment of Basic Learning Abilities Test for Persons with Intellectual Disability: A Valuable Clinical Tool

    Science.gov (United States)

    Vause, Tricia; Yu, C. T.; Martin, Garry L.

    2007-01-01

    The Assessment of Basic Learning Abilities (ABLA) test requires a tester to attempt to teach to a person, using standard prompting and reinforcement procedures, six tasks that are hierarchically ordered in difficulty. Performance on the test provides valuable information for teachers and rehabilitation workers to match the difficulty of training…

  7. European recommendations for the clinical use of HIV drug resistance testing: 2011 update

    DEFF Research Database (Denmark)

    Vandamme, Anne-Mieke; Camacho, Ricardo J; Ceccherini-Silberstein, Francesca;

    2011-01-01

    , and other drug targets (integrase and envelope) if such drugs were part of the failing regimen; (iii) consider testing for CCR5 tropism at virologic failure or when a change of therapy has to be made in absence of detectable viral load, and in the latter case test DNA or last detectable plasma RNA; (iv...

  8. Total pregnancy-associated plasma protein A--a first trimester maternal serum marker for Down's syndrome: clinical and technical assessment of a poly-monoclonal enzyme immunoassay.

    Science.gov (United States)

    Christiansen, M; Jaliashvili, I

    2003-01-01

    Pregnancy-associated plasma protein A (PAPP-A) is a maternal serum marker of fetal chromosomal disease and a risk marker for adverse outcome. PAPP-A in the circulation exists both as a 2:2 complex (PAPP-A/proMBP) with the proform of eosinophil major basic protein (proMBP) and as dimeric PAPP-A. Non-PAPP-A containing proMBP complexes constitute the bulk of proMBP in maternal serum. We developed and characterized a sandwich enzyme immunoassay for PAPP-A using a polyclonal rabbit anti-PAPP-A/proMBP antibody (SSI 6823) and a monoclonal murine anti-PAPP-A/proMBP antibody (HYB 234-3), reactive with the PAPP-A part of PAPP-A/proMBP. The assay range was 2 mIU/L-500 mIU/L, intra- and inter-assay coefficients of variation Mr 669 kDa, in gel filtration and bound to a heparin column. Serum concentrations of PAPP-A were determined in gestational weeks 5-13 in 167 pregnant women with normal fetuses and 39 women with Down's syndrome (DS) fetuses. The median PAPP-A MoM (multiples of the median in normal controls) in DS pregnancies was 0.30 (quartile range: 0.17-0.54). The PAPP-A logMoMs in DS pregnancies were normally distributed with a mean of -0.5927 and SD of 0.3639. When simulating the performance of PAPP-A and age as markers for DS in population screening a detection rate (DR) of 62% was found for a screen positive rate (SPR) of 5%. Together with beta-HCG and nuchal translucency, two other first trimester markers for fetal DS, a DR 90% could be obtained for an SPR of 5%. PMID:14594321

  9. The Effect of Inhalation of Essential Oils of Polianthes Tuberosa on Test Anxiety in Students: A Clinical Trial

    Science.gov (United States)

    Ghorat, Fereshteh; Shahrestani, Shamim; Tagabadi, Zahra; Bazghandi, Monir

    2016-01-01

    Background: Based on Iranian traditional medicine, the root cause of anxiety is due to the heart and brain diseases. The use of aromatic substances is one of the basic treatments for the heart and brain diseases in Iranian traditional medicine. Concerning the prevalence of test anxiety among students, this study was conducted to determine the effect of inhalation of essential oils of Polianthes tuberosa on test anxiety among students of Farzanegan high school in Sabzevar during 2015. Methods: This was a randomized clinical trial, in which 54 students with eligibility criteria were randomly divided into the intervention and control groups. In the pre-test stage, demographic data and Sarason anxiety questionnaires were filled by all students (7th grade). Then, in the intervention stage, students of the intervention group inhaled Tuberose oil using handkerchiefs smeared with Tuberose oil for 15-20 minutes during the exam. The control group received placebo with the same method. At the end of the exam, test anxiety questionnaire was filled by the two groups again. The collected data were analyzed by the statistical tests (i.e. χ2, paired t-test and independent sample t-test) using SPSS 18. Results: Independent t-test showed a significant difference in the mean scores of test anxiety after intervention between the two groups of study and control (Paromatherapy with essential oil of Polianthes tuberosa was effective in reducing test anxiety among students. It is recommended to conduct educational programs concerning this method in schools to decrease the test anxiety of students. PMID:26722140

  10. Clinical Performance of Aspergillus PCR for Testing Serum and Plasma: a Study by the European Aspergillus PCR Initiative.

    Science.gov (United States)

    White, P Lewis; Barnes, Rosemary A; Springer, Jan; Klingspor, Lena; Cuenca-Estrella, Manuel; Morton, C Oliver; Lagrou, Katrien; Bretagne, Stéphane; Melchers, Willem J G; Mengoli, Carlo; Donnelly, J Peter; Heinz, Werner J; Loeffler, Juergen

    2015-09-01

    Aspergillus PCR testing of serum provides technical simplicity but with potentially reduced sensitivity compared to whole-blood testing. With diseases for which screening to exclude disease represents an optimal strategy, sensitivity is paramount. The associated analytical study confirmed that DNA concentrations were greater in plasma than those in serum. The aim of the current investigation was to confirm analytical findings by comparing the performance of Aspergillus PCR testing of plasma and serum in the clinical setting. Standardized Aspergillus PCR was performed on plasma and serum samples concurrently obtained from hematology patients in a multicenter retrospective anonymous case-control study, with cases diagnosed according to European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) consensus definitions (19 proven/probable cases and 42 controls). Clinical performance and clinical utility (time to positivity) were calculated for both kinds of samples. The sensitivity and specificity for Aspergillus PCR when testing serum were 68.4% and 76.2%, respectively, and for plasma, they were 94.7% and 83.3%, respectively. Eighty-five percent of serum and plasma PCR results were concordant. On average, plasma PCR was positive 16.8 days before diagnosis and was the earliest indicator of infection in 13 cases, combined with other biomarkers in five cases. On average, serum PCR was positive 10.8 days before diagnosis and was the earliest indicator of infection in six cases, combined with other biomarkers in three cases. These results confirm the analytical finding that the sensitivity of Aspergillus PCR using plasma is superior to that using serum. PCR positivity occurs earlier when testing plasma and provides sufficient sensitivity for the screening of invasive aspergillosis while maintaining methodological simplicity.

  11. The importance of pre-clinical animal testing in interventional cardiology.

    Science.gov (United States)

    Suzuki, Yoriyasu; Yeung, Alan C; Ikeno, Fumiaki

    2008-11-01

    The treatment of cardiovascular disease has changed dramatically over the past 2 decades, allowing patients to live longer and better quality lives. The introduction of new therapies has contributed much to this success. Nowhere has this been more evident than in interventional cardiology, where percutaneous cardiovascular intervention has evolved in the past 2 decades from a quirky experimental procedure to a therapeutic cornerstone for patients with symptomatic cardiovascular disease. The development of these technologies from the earliest stages requires preclinical experiments using animal models. Once introduced into the clinical arena, an understanding of therapeutic mechanisms of these devices can be ascertained through comparisons of animal model research findings with clinical pathological specimens. This review provides an overview of the emerging role, results of preclinical studies and development, and evaluation of animal models for percutaneous cardiovascular intervention technologies for patients with symptomatic cardiovascular disease. PMID:19142381

  12. From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals.

    Science.gov (United States)

    Gunn, G R; Sealey, D C F; Jamali, F; Meibohm, B; Ghosh, S; Shankar, G

    2016-05-01

    Unlike conventional chemical drugs where immunogenicity typically does not occur, the development of anti-drug antibodies following treatment with biologics has led to concerns about their impact on clinical safety and efficacy. Hence the elucidation of the immunogenicity of biologics is required for drug approval by health regulatory authorities worldwide. Published ADA 'incidence' rates can vary greatly between same-class products and different patient populations. Such differences are due to disparate bioanalytical methods and interpretation approaches, as well as a plethora of product-specific and patient-specific factors that are not fully understood. Therefore, the incidence of ADA and their association with clinical consequences cannot be generalized across products. In this context, the intent of this review article is to discuss the complex nature of ADA and key nuances of the methodologies used for immunogenicity assessments, and to dispel some fallacies and myths.

  13. CT densitovolumetry in children with obliterative bronchiolitis: correlation with clinical scores and pulmonary function test results* , **

    OpenAIRE

    Mocelin, Helena; Bueno, Gilberto; Irion, Klaus; Marchiori, Edson; Sarria, Edgar; Watte, Guilherme; Hochhegger, Bruno

    2013-01-01

    OBJECTIVE: To determine whether air trapping (expressed as the percentage of air trapping relative to total lung volume [AT%]) correlates with clinical and functional parameters in children with obliterative bronchiolitis (OB). METHODS: CT scans of 19 children with OB were post-processed for AT% quantification with the use of a fixed threshold of −950 HU (AT%950) and of thresholds selected with the aid of density masks (AT%DM). Patients were divided into three groups by AT% severity. We exami...

  14. Genetic testing for young-onset colorectal cancer: case report and evidence-based clinical guidelines

    OpenAIRE

    Zhou, Yaolin; Boardman, Lisa A; Miller, Robert C.

    2010-01-01

    Background Young-onset colorectal cancer is clinicopathologically different from older-onset colorectal cancer and tends to occur in patients with hereditary germline conditions such as Lynch syndrome and familial adenomatous polyposis. Case report. We describe the case of a 44-year-old man with a paternal history of colon polyps, a personal 2-year history of hematochezia, and a diagnosis of rectal cancer. Further clinical evaluation of the patient at our institution determined the cancer to ...

  15. Clinical relevance of positive patch test reactions to the 26 EU-labelled fragrances

    OpenAIRE

    van Oosten, Eleonoor J; Schuttelaar, Marie-Louise A; Coenraads, Pieter Jan

    2009-01-01

    BACKGROUND: Fragrance mix I (FM I) and fragrance mix II (FM II) in the European baseline series are used as screening tools for fragrance contact allergy. In 2005 the European Union (EU) required labelling of 26 fragrances when present in cosmetic products. INCI nomenclature is obligatory for such labelling. OBJECTIVES: To describe frequencies of contact allergy to these 26 fragrance substances, and to evaluate clinical relevance of these positive reactions. METHODS: Three hundred and twenty ...

  16. Hypersensitivity reactions to metallic implants-diagnostic algorithm and suggested patch test series for clinical use

    DEFF Research Database (Denmark)

    Schalock, Peter C; Menné, Torkil; Johansen, Jeanne D;

    2011-01-01

    algorithm to guide the selection of screening allergen series for patch testing is provided. At a minimum, an extended baseline screening series and metal screening is necessary. Static and dynamic orthopaedic implants, intravascular stent devices, implanted defibrillators and dental and gynaecological......Cutaneous and systemic hypersensitivity reactions to implanted metals are challenging to evaluate and treat. Although they are uncommon, they do exist, and require appropriate and complete evaluation. This review summarizes the evidence regarding evaluation tools, especially patch and lymphocyte...... transformation tests, for hypersensitivity reactions to implanted metal devices. Patch test evaluation is the gold standard for metal hypersensitivity, although the results may be subjective. Regarding pre-implant testing, those patients with a reported history of metal dermatitis should be evaluated by patch...

  17. Isolation, Identification, and In Vitro Antifungal Susceptibility Testing of Dermatophytes from Clinical Samples at Sohag University Hospital in Egypt

    Science.gov (United States)

    Shalaby, Mona Fattouh Mohamed; El-din, Asmaa Nasr; El-Hamd, Mohammed Abu

    2016-01-01

    Aim The objective of this study was to isolate, identify, and explore the in-vitro antifungal susceptibility pattern of dermatophytes isolated from clinically suspected cases of dermatophytosis (tinea infections) attending the Dermatology Outpatient Clinic. Methods This study was conducted at Sohag University Hospital from December 2014 to December 2015. Clinical samples (e.g., skin scrapings and hair stumps) were collected under aseptic precautions. The identification of dermatophytes was performed through microscopic examination using 10% potassium hydroxide (KOH) with 40% dimethyl sulphoxide (DMSO) mounts and culture on Sabouraud dextrose agar (SDA) and on Dermasel agar base media, both supplemented with chloramphenicol and cycloheximide. All dermatophytes isolates were subjected to antifungal susceptibility testing using the agar-based disk diffusion (ABDD) method against Clotrimazole, Miconazole, Fluconazole, and Griseofulvin. Data were analyzed via SPSS 16, using Chi square and a screening test (cross-tabulation method). Results A total of 110 patients of dermatophytosis were studied. The patients were clinically diagnosed and mycologically confirmed as having tinea capitis (49), tinea corporis (30), tinea pedis (16), tinea cruris (9), or tinea barbae (6). The dermatophytes isolates belonged to 4 species: Microsporum canis 58 (52.7%), Microsporum gypseum 23 (20.9%), Trichophyton mentagrophytes 18 (16.4%), and Microsporum audouinii 11 (10%). The most effective antifungal drugs tested were Clotrimazole, followed by Miconazole (95.5% and 84.5% of isolates were susceptible, respectively). Conclusion Every patient with a tinea infection should be properly studied for a mycological examination and should be treated accordingly. Dermasel agar is more useful as an identification medium in the isolation of dermatophytes. The ABDD method appears to be a simple, cost-effective, and promising method for the evaluation of antifungal susceptibility of dermatophytes. PMID

  18. High-resolution CT in patients with chronic airflow obstruction: correlation with clinical diagnosis and pulmonary function test

    International Nuclear Information System (INIS)

    To determine the utility of HRCT in the diagnosis of chronic airflow obstruction and to correlate the morphologic abnormalities revealed by this modality with functional impairment in patients with chronic airflow obstruction. This study involved 80 patients with chronic airflow obstruction who underwent HRCT and a pulmonary function test. Final clinical diagnosis in these patients was determined by a chest physician on the basis of clinical features, bronchoscopy, pulmonary function test, and HRCT. In order to diagnose and determine the extent of areas of decreased attenuation revealed by HRCT (the CT score), the findings of HRCT were retrospectively reviewed by two radiologists, who reached a consensus. Clinical and HRCT diagnoses were then compared, and the rate of agreement between them was calculated. The relationship between the extent of areas of decreased attenuation revealed by HRCT and by FEV1/FVC was evaluated using Correl's account and Student's unpaired t-test. The agreement rate between clinical and HRCT diagnoses was 77.5% (62/80). The rates for bronchiectasis (88.9%, 24/27), emphysema (93.9%, 31/33), and bronchiolitis obliterans (100%, 6/6) were considerably higher than those for chronic bronchitis and bronchial asthma. The correlation rate between CT score and FEV1/FVC was significant in bronchiectasis (p less than 0.05; r: -0.76) and bronchiolitis obliterans (p less than 0.01; r: -0.66), but not in cases involving emphysema, bronchial asthma, or chronic bronchitis (p greater than 0.05). HRCT is valuable in the diagnosis and prediction of physiologic impairment in patients with bronchiectasis and bronchiolitis obliterans, but has limited value in those with emphysema, chronic bronchitis or asthma. (author)

  19. High-resolution CT in patients with chronic airflow obstruction: correlation with clinical diagnosis and pulmonary function test

    Energy Technology Data Exchange (ETDEWEB)

    Hong, Ki Taek; Kang, Eun Young; Rhee, Ji Yong; Kim, Jin Hyung; Choi, Jung Ah; Cho, Jae Yoen; Oh, Yu Whan; Suh, Won Hyuck [College of Medicine, Korea University, Seoul (Korea, Republic of)

    2000-06-01

    To determine the utility of HRCT in the diagnosis of chronic airflow obstruction and to correlate the morphologic abnormalities revealed by this modality with functional impairment in patients with chronic airflow obstruction. This study involved 80 patients with chronic airflow obstruction who underwent HRCT and a pulmonary function test. Final clinical diagnosis in these patients was determined by a chest physician on the basis of clinical features, bronchoscopy, pulmonary function test, and HRCT. In order to diagnose and determine the extent of areas of decreased attenuation revealed by HRCT (the CT score), the findings of HRCT were retrospectively reviewed by two radiologists, who reached a consensus. Clinical and HRCT diagnoses were then compared, and the rate of agreement between them was calculated. The relationship between the extent of areas of decreased attenuation revealed by HRCT and by FEV1/FVC was evaluated using Correl's account and Student's unpaired t-test. The agreement rate between clinical and HRCT diagnoses was 77.5% (62/80). The rates for bronchiectasis (88.9%, 24/27), emphysema (93.9%, 31/33), and bronchiolitis obliterans (100%, 6/6) were considerably higher than those for chronic bronchitis and bronchial asthma. The correlation rate between CT score and FEV1/FVC was significant in bronchiectasis (p less than 0.05; r: -0.76) and bronchiolitis obliterans (p less than 0.01; r: -0.66), but not in cases involving emphysema, bronchial asthma, or chronic bronchitis (p greater than 0.05). HRCT is valuable in the diagnosis and prediction of physiologic impairment in patients with bronchiectasis and bronchiolitis obliterans, but has limited value in those with emphysema, chronic bronchitis or asthma. (author)

  20. Handgrip strength test as a complementary tool in monitoring asthma in daily clinical practice in children.

    OpenAIRE

    2014-01-01

    The aim of this study was to demonstrate that handgrip strength test can discriminate the presence/absence of asthma and between intermittent and moderate persistent asthma in children. 140 children (70 healthy and 70 with asthma) completed the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and performed the handgrip strength test. Forty-eight hours later, subjects performed spirometry. The results showed Handgrip strength was significantly lower (p