Sensitivity and specificity of rapid diagnostic tests for hepatitis C virus with or without HIV coinfection: a multicentre laboratory evaluation study.

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 three laboratories using archived plasma samples from four countries (Nigeria, Georgia, Cambodia, Belgium). HCV status was determined using three 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, 1,710 samples met inclusion criteria. In HIV uninfected samples (n=384), the majority of RDTs had sensitivity ≥98% in one 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 one RDT reached >95%. The majority of HIV infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Inter-reader variability, lot-to-lot variability and rate of invalid runs were low for all RDTs (<2%). CONCLUSION HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status.