Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

• Published in: Annals of laboratory medicine Vol. 36; no. 6; pp. 550 - 554
• Main Authors: Hyun, Jungwon, Ko, Dae-Hyun, Kang, Hee Jung, Whang, Dong Hee, Cha, Young Joo, Kim, Hyun Soo
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society for Laboratory Medicine 01.11.2016; 대한진단검사의학회
• Subjects: Automation; Hepatitis C - diagnosis; Hepatitis C Antibodies - blood; Humans; Immunoassay; Immunoblotting; Original; Reagent Kits, Diagnostic; Sensitivity and Specificity; 병리학; Immunoenzyme techniques; Immunoassay; Immunoblotting; Hepatitis C antibodies; Hepatitis C; Real-time polymerase chain reaction
• ISSN: 2234-3806; 2234-3814; 2234-3814
• DOI: 10.3343/alm.2016.36.6.550

Anti-hepatitis C virus antibody (anti-HCV) assays are recommended for screening HCV-infected persons. The VIDAS Anti-HCV Assay (bioMérieux, France), based on the enzyme-linked fluorescence test principle, was recently introduced in Korea. We evaluated the clinical performance of the VIDAS assay. One hundred HCV-positive and 1,002 HCV-negative blood samples confirmed by Architect anti-HCV (Abbott Laboratories, USA) and COBAS TaqMan HCV real-time PCR (Roche Diagnostics, USA) or the Procleix Ultrio Plus Assay (Gen-Probe Incorporated, USA) were obtained from the Human Serum Bank (HSB) and tested by VIDAS. In case of discrepant results, we conducted a recombinant immunoblot assay (RIBA). The agreement rates for known HCV-positive and HCV-negative samples between the VIDAS assay and the HSB testing were 100% (95% confidence interval [CI]: 96.4-100%) and 99.5% (95% CI: 98.8-99.8%), respectively. One of the five discrepant samples was positive for Core 2+ and NS3-2 2+ reactivity, two samples were negative, and the other two were indeterminate regarding NS4 2+ reactivity in RIBA. We observed a significant but weak positive correlation between the titers of VIDAS and Architect assays (r=0.315, P<0.001). The VIDAS anti-HCV assay, developed on the VIDAS automated immunoassay platform based on the ready-to-use, single-sample test concept may be useful in small-to-medium-sized laboratories. It showed good agreement with Architect anti-HCV and COBAS PCR assays and is therefore useful for detection of HCV infection. Weakly test-positive (ambiguous) samples require additional testing by another anti-HCV, RIBA, or HCV RNA assay.