Evaluation of the automated fluorescent immunoassay system anti-hepatitis C virus assay for the detection of hepatitis C virus infection

Abstract

Introduction: Hepatitis C has emerged as a fatal epidemic in the country in the past two decades. One of the major risk factors remains unsafe blood transfusions. Aims and Objectives: The present study evaluated the performance of a newly developed automated fluorescent immunoassay system (AFIAS anti-hepatitis C virus [HCV] assay) in comparison with the Architect anti-HCV assay for the detection of anti-HCV antibodies in the blood donor samples. Methodology: This cross-sectional study was conducted in the Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad. About 3–5 ml blood was collected from 282 blood donors and was processed for the detection of anti-HCV by the Architect anti-HCV assay and AFIAS anti-HCV assay during the period January–October 2016. All those samples which were indeterminate by the Architect anti-HCV assay (with 1–5 value in the signal-to-cutoff) were further examined by the AFIAS anti-HCV assay. Architect anti-HCV assay was considered as gold standard. We compared the results of individual specimen; discrepant results specimens were further tested by third-party test, the Elecsys anti-HCV II assay on Cobas e411 by Roche. Sensitivity (level of detection [LOD]) of the AFIAS anti-HCV assay with 10 widely used rapid immune-chromatographic diagnostic tests (RIDTs) for anti-HCV was evaluated. We assessed the imprecision of the AFIAS anti-HCV assay. To measure the variation of the intra-assays (within days), 12 replicate tests were performed with known concentrations of anti-HCV. Results: The results obtained by the AFIAS anti-HCV assay showed similarity with those obtained by the Architect anti-HCV assay when tested with 282 blood specimens. When examining the results of an individual specimen by these two assays, 126 and 151 specimens showed identical positive and negative results, respectively; overall identity was 98.23%. Only five specimens showed comparatively different results. In comparison to RIDT, the AFIAS anti-HCV assay is 20–40 times more sensitive. Conclusion: The AFIAS anti-HCV assay will be useful in small-to-medium-sized laboratories for testing ready to use single sample test. It showed good agreement with the Architect anti-HCV assay and is useful for the detection of HCV infection. It is a superior alternative for low-sensitive RIDT anti-HCV assay.