Evidence map›Paper›PMID 15364989›Full record

ArticleJournal of clinical microbiology2004

Evaluation of the core antigen assay as a second-line supplemental test for diagnosis of active hepatitis C virus infection.

Mel Krajden, Rishma Shivji, Kingsley Gunadasa, Annie Mak, Gail McNabb, Michel Friesenhahn, David Hendricks, Lorraine Comanor

Open access · greenAbstract read
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 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Five Years of HCV Dried Blood Spot Testing in At-Risk Populations and the Impact of Reduced Sensitivity on Missed Diagnoses.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Health care costs associated with hepatitis C: a longitudinal cohort study.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2010
    Article
  7. Article
  8. Factors associated with spontaneous clearance of hepatitis C virus among illicit drug users.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2007
    Article
  9. Article
  10. Article
  11. The laboratory diagnosis of hepatitis B virus.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2005
    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

8 authors at 2 institutions in 2 countries.

Mel KrajdenBritish Columbia Center for Disease Control, 655 W. 12th Ave., Vancouver, BC V5Z4R4, Canada. mel.krajden@bccdc.ca
Rishma Shivji
Kingsley Gunadasa
Annie Mak
Gail McNabb
Michel Friesenhahn
David Hendricks
Lorraine Comanor
BC Centre for Disease Control · CABayer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The British Columbia Center for Disease Control laboratory performs approximately 95% of all hepatitis C virus (HCV) antibody tests for the province's 4 million inhabitants. In 2002, the laboratory tested 96,000 specimens for anti-HCV antibodies, of which 4,800 (5%) were seroreactive and required confirmation of active infection. Although HCV RNA assays with a sensitivity of 50 IU/ml or less are recommended for the confirmation of active HCV infection, given the large number of seroreactive specimens tested annually, we evaluated the Ortho trak-C assay (OTCA) as a second-line confirmatory test and determined its limit of detection (LoD). Of 502 specimens from treatment-naïve anti-HCV-positive individuals, 478 had sufficient volumes for evaluation by the OTCA and HCV RNA tests. Core antigen was not detected in 147 of 478 (30.8%) of these specimens, of which 37 of 147 (25.2%) were shown to be viremic by the VERSANT HCV (version 3.0) (branched-DNA) assay and/or the VERSANT HCV qualitative assay. Testing of 144 replicates of a World Health Organization standard dilution series indicated that the LoD of OTCA was approximately 27,000 IU/ml. This LoD is consistent with the inability of OTCA to detect core antigen in clinical specimens with low viral loads. We conclude that OTCA has limited value as a confirmatory test for the diagnosis of active HCV infection because 37 of 367 (10%) of viremic specimens had undetectable core antigen. Qualitative HCV RNA testing remains the present standard for the confirmation of active HCV infection in the diagnostic setting.

Indexed as

CanadaHepacivirusHepatitis CHumansRegression AnalysisRNA, ViralSensitivity and SpecificityViral Core ProteinsViral LoadRNA, ViralViral Core Proteins

Identifiers

PMID15364989
PMCPMC516310
OpenAlexW1991707939

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.