title: Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection.
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.
authors: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors: Jungwon
authors: J
authors: Hyun
authors: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors: Dae Hyun
authors: DH
authors: Ko
authors: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
authors: Hee Jung
authors: HJ
authors: Kang
authors: Department of Laboratory Medicine, Inje University College of Medicine, Seoul, Korea.
authors: Dong Hee
authors: DH
authors: Whang
authors: Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea. chayoung@cau.ac.kr.
authors: Young Joo
authors: YJ
authors: Cha
authors: Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea. hskim0901@empas.com.
authors: Hyun Soo
authors: HS
authors: Kim
mesh_terms: D001331:Automation; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay; D015151:Immunoblotting; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic
keywords: Hepatitis C; Hepatitis C antibodies; Immunoassay; Immunoblotting; Immunoenzyme techniques; Real-time polymerase chain reaction