ArticleJournal of clinical microbiology2003
Multicenter evaluation of the VERSANT HCV RNA qualitative assay for detection of hepatitis C virus RNA.
Article in Journal of clinical microbiology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 42 citations in OpenAlex.
- Recombinase polymerase amplification as a promising tool in hepatitis C virus diagnosis.World journal of hepatology · 2014Review
- Advances in the Diagnosis and Monitoring of Hepatitis C Virus Infection.Gastroenterology research · 2013Review
- Performance evaluation of the new Roche cobas AmpliPrep/cobas TaqMan HCV test, version 2.0, for detection and quantification of hepatitis C virus RNA.Journal of clinical microbiology · 2013Article
- Direct quantitative analysis of HCV RNA by atomic force microscopy without labeling or amplification.Nucleic acids research · 2012Article
- Introduction of an automated system for the diagnosis and quantification of hepatitis B and hepatitis C viruses.The open virology journal · 2012Article
- Reduction of insulin resistance with effective clearance of hepatitis C infection: results from the HALT-C trial.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2010Article
- Performance of the Abbott real-time PCR assay using m2000sp and m2000rt for hepatitis C virus RNA quantification.Journal of clinical microbiology · 2009Article
- Interpretation of positive transcription-mediated amplification test results from polymerase chain reaction-negative samples obtained after treatment of chronic hepatitis C.Hepatology (Baltimore, Md.) · 2008Article
- Comparison of performance characteristics of three real-time reverse transcription-PCR test systems for detection and quantification of hepatitis C virus.Journal of clinical microbiology · 2007Article
- Transcription-mediated amplification linked to line probe assay as a routine tool for HCV typing in clinical laboratories.Journal of clinical laboratory analysis · 2007Article
- Hepatitis C infection in dialysis patients: a link to poor clinical outcome?International urology and nephrology · 2007Review
- Comparison of qualitative (COBAS AMPLICOR HCV 2.0 versus VERSANT HCV RNA) and quantitative (COBAS AMPLICOR HCV monitor 2.0 versus VERSANT HCV RNA 3.0) assays for hepatitis C virus (HCV) RNA detection and quantification: impact on diagnosis and treatment of HCV infections.Journal of clinical microbiology · 2005Article
- Evaluation of the COBAS TaqMan HCV test with automated sample processing using the MagNA pure LC instrument.Journal of clinical microbiology · 2005Article
- Evaluation of the core antigen assay as a second-line supplemental test for diagnosis of active hepatitis C virus infection.Journal of clinical microbiology · 2004Article
- Increased sensitivity of the Roche COBAS AMPLICOR HCV test, version 2.0, using modified extraction techniques.The Journal of molecular diagnostics : JMD · 2004Article
- PCR-based diagnostics for infectious diseases: uses, limitations, and future applications in acute-care settings.The Lancet. Infectious diseases · 2004Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We report the results of a multicenter evaluation of a new assay for the detection of hepatitis C virus (HCV) RNA in human serum or plasma based on transcription-mediated amplification (HCV TMA). Analysis of combined data obtained from 15 independent sites, including 4 sites in the United States and 11 in Europe, by using preproduction kits showed a limit of detection of 9.8 IU/ml and an overall mean specificity of 97.9%. In addition, assay runs and samples were valid consistently (97.8% of assay runs and 98.0% of specimen results). Of the 15 sites that participated in the multicenter evaluation, 2 subsequently carried out additional performance studies with production kits in support of the assay's registration in France. Comparison of the findings from these two sites during the multicenter evaluation and during the registration studies showed an overall improvement in assay performance. A statistically significant (P < 0.001) improvement was achieved for both specificity and specimen validity in the registration studies, which were 99.4 and 98.1%, respectively. Combined data from the two sites showed a lower limit of detection of approximately 2.4 IU/ml and an improved assay validity of 100%, although the sample size was too small to show statistical significance at the 0.05 level. In summary, the performance characteristics of HCV TMA indicate that this assay is a reliable tool for the detection of HCV RNA in serum or plasma. Improvement in assay performance has been demonstrated with refinement of assay reagents, instrumentation, and operator experience.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.