Evaluating the utility of a two-assay serological algorithm for hepatitis C screening in a low prevalence population

Kai J Rogers; Tracy S Halvorson; Matthew D Krasowski; Anna E Merrill

doi:10.1002/jcla.24887

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Evaluating the utility of a two-assay serological algorithm for hepatitis C screening in a low prevalence population

Journal article

Open access

Peer reviewed

Evaluating the utility of a two-assay serological algorithm for hepatitis C screening in a low prevalence population

Kai J Rogers, Tracy S Halvorson, Matthew D Krasowski and Anna E Merrill

Journal of clinical laboratory analysis, Vol.37(7), e24887

04/2023

DOI: 10.1002/jcla.24887

PMCID: PMC10220299

PMID: 37106580

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Abstract

Screening for hepatitis C virus (HCV) is performed by testing for anti-HCV antibodies, which may yield false-positive results leading to additional testing and other downstream consequences for the patient. We report our experience in a low prevalence population (<0.05%) using a two-assay algorithm aimed at testing specimens with borderline or weak positive anti-HCV reactivity in the screening assay by a second anti-HCV assay prior to confirming positive anti-HCV results with RT-PCR. Retrospective analysis of 58,908 plasma samples was obtained over a 5-year period. Samples were initially tested using the Elecsys Anti-HCV II assay (Roche Diagnostics), with borderline or weakly positive results (defined in our algorithm as a Roche cutoff index of 0.9-19.99) reflexively analyzed using the Architect Anti-HCV assay (Abbott Diagnostics). The Abbott anti-HCV results dictated the final anti-HCV interpretation for reflexed samples. Our testing algorithm resulted in 180 samples requiring second-line testing, with final anti-HCV results interpreted as 9% positive, 87% negative, and 4% indeterminate. The positive predictive value (PPV) of a weakly positive Roche result was 12%, which was significantly lower than the PPV using our two-assay approach (65%). The incorporation of a two-assay serological testing algorithm in a low prevalence population provides a cost-effective method of improving the PPV of HCV screening in specimens with borderline or weakly positive anti-HCV results.

Serology

prevalence

hepatitis C

Details

Title: Subtitle: Evaluating the utility of a two-assay serological algorithm for hepatitis C screening in a low prevalence population
Creators: Kai J Rogers - University of Iowa
Tracy S Halvorson - Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
Matthew D Krasowski - Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
Anna E Merrill - Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
Resource Type: Journal article
Publication Details: Journal of clinical laboratory analysis, Vol.37(7), e24887
DOI: 10.1002/jcla.24887
PMID: 37106580
PMCID: PMC10220299
NLM abbreviation: J Clin Lab Anal
ISSN: 0887-8013
eISSN: 1098-2825
Language: English
Electronic publication date: 04/27/2023
Date published: 04/2023
Academic Unit: Microbiology and Immunology; Pathology; Injury Prevention Research Center
Record Identifier: 9984399499202771

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