Dataset Information

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.

ABSTRACT:

Background

Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies.

Methods

Two lots of 13 RDTs were evaluated at 3 laboratories using archived plasma samples from 4 countries (Nigeria, Georgia, Cambodia, and Belgium). HCV status was determined using 3 reference tests according to a composite algorithm. Sensitivity and specificity were evaluated in HIV-infected and HIV-uninfected populations. Operational characteristics were also assessed.

Results

In total, 1710 samples met inclusion criteria. In HIV-uninfected samples (n = 384), the majority of RDTs had sensitivity ≥98% in 1 or both lots and most RDTs had specificity ≥99%. In HIV-infected samples (n = 264), specificity remained high but sensitivity was markedly lower than in HIV-uninfected samples; only 1 RDT reached >95%. The majority of HIV-infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Interreader variability, lot-to-lot variability, and rate of invalid runs were low for all RDTs (<2%).

Conclusions

HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status.

Clinical trials registration

NCT04033887.

SUBMITTER: Vetter BN

PROVIDER: S-EPMC9417120 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.

Vetter Beatrice N BN Reipold Elena Ivanova EI Ongarello Stefano S Audu Rosemary R Ige Fehintola A FA Alkhazashvili Maia M Chitadze Nazibrola N Vanroye Fien F De Weggheleire Anja A An Sokkab S Fransen Katrien K

The Journal of infectious diseases 20220801 3

<h4>Background</h4>Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies.<h4>Methods</h4>Two lots of 13 RDTs were evaluated at 3 laboratories using archived plasma samples from 4 countries (Nigeria, Georgia, Cambodia, and Belgium). HCV status was determined using 3 refer ...[more]

PMID: 32614451

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Dataset Information

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.

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