Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody

Abstract

Rapid diagnostic tests (RDTs) can serve as good alternatives to standard serological assays for hepatitis C virus (HCV) detection in limited resource settings. Aim of this study was to evaluate performance of three Indian manufactured RDTs with chemiluminescent microparticle immunoassay (CLIA) for screening of HCV infection with further evaluation using HCV RNA. Serum samples tested for anti-HCV by CLIA (Architect i1000SR, Abbott Diagnostics, IL, USA) were retrieved from − 80 °C and retested for anti-HCV by three RDTs: Alere Trueline (SD Bioline; Haryana, India) (RDT 1), Benesphera HCV Rapid card test (Avantor Performance Materials India Limited; Uttarakhand, India) (RDT 2), AccuTest HCV (Accurex Biomedical Pvt. Ltd.; Mumbai, India) (RDT 3). HCV RNA results were obtained from hospital information system and anti-HCV reactive but RNA negative cases without treatment were considered as either ‘false positives’ or ‘spontaneous clearance of HCV RNA’. Among 86 samples, 75 (87.2%), 49 (57%), 58 (67.4%) and 51 (59.3%) were reactive by CLIA, RDT1, RDT2 and RDT3, respectively. Taking CLIA as reference standard, RDT 1, 2 and 3 demonstrated sensitivity of 65.30%, 77.33% and 68% respectively. Specificity of all three RDTs was 100% with sensitivity of 97.6–100% above signal/cut-off ratio (S/Co) of 6 by CLIA and 88–100% in all HCV RNA positive cases. Sensitivity of RDTs increased from 65.30–77.33 to 72–82.4% when RNA negative/anti-HCV reactive results were considered as non-reactive. The three RDTs have acceptable sensitivity and specificity in anti-HCV detection especially in RNA positive patients that would require treatment for HCV.