Ann Lab Med.  2016 Nov;36(6):550-554. 10.3343/alm.2016.36.6.550.

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

• Hyun J
• Ko DH
• Kang HJ
• Whang DH
• Cha YJ
• Kim HS

• KMID: 2373593
• DOI: http://doi.org/10.3343/alm.2016.36.6.550

Abstract

BACKGROUND
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.
METHODS
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).
RESULTS
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).
CONCLUSIONS
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.

Keyword

Hepatitis C; Hepatitis C antibodies; Immunoassay; Immunoenzyme techniques; Immunoblotting; Real-time polymerase chain reaction

MeSH Terms

Automation
Hepatitis C/*diagnosis
Hepatitis C Antibodies/*blood
Humans
*Immunoassay
Immunoblotting
Reagent Kits, Diagnostic
Sensitivity and Specificity
Hepatitis C Antibodies
Reagent Kits, Diagnostic

Figure

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  Fig. 1 Correlation between the titers of test-positive samples (n=100) detected by the VIDAS and Architect anti-HCV assays.Abbreviations: HCV, hepatitis C virus; S/CO, signal-to-cut-off.

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