Evidence map›Paper›PMID 14766817›Full record

ArticleJournal of clinical microbiology2004

Multicenter evaluation of the performance characteristics of the bayer VERSANT HCV RNA 3.0 assay (bDNA).

Tarek Elbeik, Johan Surtihadi, Mark Destree, Jed Gorlin, Mark Holodniy, Saeed A Jortani, Ken Kuramoto, Valerie Ng, Roland Valdes, Alexandra Valsamakis and 1 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical microbiology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 93 citations in OpenAlex.

  1. Trial
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  4. Amplification chemistries in clinical virology.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2019
    Review
  5. Article
  6. Alternative Watson-Crick Synthetic Genetic Systems.Cold Spring Harbor perspectives in biology · 2016
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
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  13. Article
  14. Expanded genetic alphabets in the polymerase chain reaction.Angewandte Chemie (International ed. in English) · 2010
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

Tarek ElbeikDepartment of Laboratory Medicine, University of California, San Francisco 94110, USA. elbeik@itsa.ucsf.edu
Johan Surtihadi
Mark Destree
Jed Gorlin
Mark Holodniy
Saeed A Jortani
Ken Kuramoto
Valerie Ng
Roland Valdes
Alexandra Valsamakis
Norah A Terrault
Memorial Blood Centers · USSan Francisco General Hospital · USUniversity of Louisville · USBayer (Germany) · DEJohns Hopkins University · USStanford University · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this multicenter evaluation, the VERSANT HCV RNA 3.0 Assay (bDNA) (Bayer Diagnostics, Tarrytown, N.Y.) was shown to have excellent reproducibility, linearity, and analytical sensitivity across specimen collection matrices (serum, EDTA, ACD-A), and hepatitis C virus (HCV) genotypes 1 to 6. The VERSANT HCV bDNA Assay has a reportable range of 615 to 7690000 (7.69 x 10(6)) IU/ml. The total coefficient of variation (CV) ranged from 32.4% at 615 IU/ml to 17% at 6.8 x 10(6) IU/ml. The assay was linear across the reportable range. Analytical specificity of 98.8% was determined by testing 999 specimens from volunteer blood donors. Evaluation of HCV genotypes using RNA transcripts of representative clones of 1a, 1b, 2a, 2b, 2c, 3a, 4a, 5a, and 6a and patient specimens showed that the largest difference between genotype 1, upon which the assay is standardized, and non-1 genotypes was within 1.5-fold. Testing of potentially interfering endogenous substances and exogenous substances and conditions found no interference in HCV-positive or HCV-negative specimens except for unconjugated bilirubin at concentrations of >or=20 mg/dl and protein at concentrations of >or=9 g/dl. Biological variability was estimated from 29 clinically stable individuals not on HCV therapy who were tested weekly over an 8-week period. The combined estimate of total (biologic plus assay) variability was 0.15 log(10) standard deviation (CV, 36.1%), a fold change of 2.6. Thus, the observed fold change between any two consecutive HCV RNA measures is expected to be less than 2.6-fold (equivalent to 0.41 log(10) IU/ml) 95% of the time in clinically stable individuals.

Indexed as

Branched DNA Signal Amplification AssayHepacivirusHepatitis CHumansReagent Kits, DiagnosticReproducibility of ResultsRNA, ViralSensitivity and SpecificitySpecimen HandlingReagent Kits, DiagnosticRNA, Viral

Identifiers

PMID14766817
PMCPMC344448
OpenAlexW2100531374

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.