Can Hepatitis C Virus Antigen Testing Replace Ribonucleic Acid Polymearse Chain Reaction Analysis for Detecting Hepatitis C Virus? A Systematic Review.

Harun Khan,Andrew Hill,Janice Main,Ashley Brown,Graham Cooke

doi:10.1093/ofid/ofw252

Harun Khan, Andrew Hill + Show 3 more

Open Access

https://doi.org/10.1093/ofid/ofw252

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Abstract

The complexity and cost of current diagnostics for hepatitis C virus (HCV) may act as a prevention to the scale-up of treatment in the developing world. Currently, ribonucleic acid (RNA)-polymerase chain reaction tests are the gold standard. However, there is potential for the use of simpler and cheaper antigen tests to confirm HCV infection in different clinical settings. We evaluated the sensitivity and specificity of antigen assays. This was compared with the reference-standard RNA assays. A subanalysis also assessed Architect core antigen test, which is the only commercially available antigen test on the market. In 24 datasets, evaluating HCV-antigen assays in 8136 samples, the percentage of HCV-antigen positive, HCV-RNA negative was 0.57%. The percentage HCV-antigen negative, HCV-RNA positive was 3.52%. There is strong evidence that antigen detection performs as well as RNA-based assays for HCV management. The use of antigen tests could improve access to HCV care in underresourced healthcare settings.

Highlights

Treatments for hepatitis C virus (HCV) are becoming simpler and more effective, the complexity and high cost of current diagnostics have the potential to act as obstacles to the scale-up of treatment in resource-poor settings [1], even with the advent of treatments with pangenotypic activity
Anti-HCV tests are typically used to screen for exposure to virus with a more complex and expensive ribonucleic acid (RNA) amplification test (HCV-RNA polymerase chain reaction [PCR]) to confirm viremia and stratify treatment decisions
There is strong evidence for the replacement of RNA tests with antigen tests for HCV diagnosis and for the assessment of treatment response

Summary

Introduction

Treatments for hepatitis C virus (HCV) are becoming simpler and more effective, the complexity and high cost of current diagnostics have the potential to act as obstacles to the scale-up of treatment in resource-poor settings [1], even with the advent of treatments with pangenotypic activity. Anti-HCV tests are typically used to screen for exposure to virus with a more complex and expensive ribonucleic acid (RNA) amplification test (HCV-RNA polymerase chain reaction [PCR]) to confirm viremia and stratify treatment decisions. There remains an unmet need for a cheap, simple test to differentiate those with ongoing viral replication (who require treatment) from those who have previously been exposed but have spontaneously cleared the virus [1] and to confirm successful eradication after antiviral therapy. One test (Abbott Architect HCV core antigen [cAg] assay) is already commercially available. A subanalysis assessed the sensitivity and specificity of the Abbott Architect cAg

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