Evidence map›Paper›PMID 20107102›Full record

ArticleJournal of clinical microbiology2010

Analytical performance characteristics and clinical utility of a novel assay for total hepatitis C virus core antigen quantification.

R S Ross, S Viazov, S Salloum, P Hilgard, G Gerken, M Roggendorf

Abstract readComparative StudyEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical microbiology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Laboratory Diagnosis and Monitoring of Viral Hepatitis.Gastroenterology clinics of North America · 2019
    Review
  7. Article
  8. Article
  9. Approaches for simplified HCV diagnostic algorithms.Journal of the International AIDS Society · 2018
    Review
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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

6 authors.

R S RossInstitute of Virology, National Reference Centre for Hepatitis C, Essen University Hospital, University of Duisburg-Essen, Essen, Germany. stefan.ross@uni-due.de
S Viazov
S Salloum
P Hilgard
G Gerken
M Roggendorf

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The detection and quantification of hepatitis C virus (HCV) core antigen in serum or plasma by the use of different assay formats have previously been shown to represent useful markers of viral replication. In the present study, the intrinsic performance characteristics and the potential clinical utility of a novel assay for the quantification of total HCV core antigen were comprehensively assessed by using clinical serum samples and specimens contained in various evaluation panels. The Architect HCV Ag assay showed a specificity of 100%. The intra- and interassay coefficients of variation ranged from 3.6 to 8.0% and from 4.7 to 9.5%, respectively. Except for HCV genotype 2 isolates, the analytical sensitivity was always less than 10 fmol core antigen/liter, corresponding to approximately 500 to 3,000 IU of HCV RNA/ml. Linearity was guaranteed throughout the dynamic range (10 to 20,000 fmol/liter). When seroconversion panels were tested, the assay was not inferior to HCV RNA detection and reduced the preseroconversion period by 4 to 16 days. The results obtained by core antigen and HCV RNA quantification for 385 clinical specimens were correlated by regression analysis (r = 0.857), but the calculated conversion equation differed significantly from the line of identity. Monitoring of viral kinetics by use of either core antigen or RNA concentrations in 38 HCV-infected patients undergoing antiviral combination therapy resulted in very similarly shaped curves in all cases. Finally, the Architect HCV Ag assay was also shown to enable high-throughput screening of in vitro HCV RNA replication. With these results taken together, the Architect HCV Ag assay proved to be a specific, reproducible, highly sensitive, and clinically applicable test format which will find its future place in the context of virological HCV diagnostics.

Indexed as

Antigens, ViralFemaleHepacivirusHepatitis CHumansImmunoassayMaleMiddle AgedReproducibility of ResultsRNA, ViralSensitivity and SpecificityViral Core ProteinsAntigens, Viralnucleocapsid protein, Hepatitis C virusRNA, ViralViral Core Proteins

Identifiers

PMID20107102
PMCPMC2849592

What OpenQuestion holds

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Registered trials

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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.