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Performance evaluation of the Vitros anti-hepatitis C virus antibody assay for use in clinical laboratories.

Authors
 Yongjung Park  ;  Yoonmi Seok  ;  Jonghyeon Choi  ;  Hyon-Suk Kim 
Citation
 CLINICAL BIOCHEMISTRY, Vol.45(1-2) : 175-177, 2012 
Journal Title
 CLINICAL BIOCHEMISTRY 
ISSN
 0009-9120 
Issue Date
2012
MeSH
Clinical Laboratory Techniques/standards ; Female ; Hemolysis ; Hepacivirus/metabolism ; Hepatitis C Antibodies/blood* ; Hepatitis C Antibodies/immunology ; Humans ; Immunoblotting/methods ; Male ; Polymerase Chain Reaction ; Pregnancy ; RNA, Viral/genetics ; RNA, Viral/metabolism ; Reproducibility of Results ; Sensitivity and Specificity
Keywords
Anti-HCV antibody ; Hepatitis C virus ; Vitros anti-HCV ; Elecsys anti-HCV ; Architect anti-HCV
Abstract
OBJECTIVES: We evaluated the performance of Vitros anti-HCV assay. DESIGN AND METHODS: Precision performance was assessed for 20 days. A total of 1011 sera were tested for anti-HCV with Vitros and Elecsys assays. Specimens positive for any of the two assays were retested with Architect assay. Discrepant results were evaluated with recombinant immunoblot assay (RIBA) and HCV RNA quantification. RESULTS: Total imprecision of Vitros assay was 11.6% and 3.3% CV for negative and positive QC. Among the 1011 sera, 17 showed discrepant results between the three assays. Six were positive and three negative for RIBA. HCV RNA was not detected from all discrepant cases. Sensitivity and specificity were 99.5% and 99.5% for the Vitros, and 100.0% and 99.9% for the Elecsys assay. CONCLUSIONS: Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in clinical laboratories, but retesting of weak positive results may be necessary.
Full Text
http://www.sciencedirect.com/science/article/pii/S0009912011027068
DOI
22093968
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hyon Suk(김현숙) ORCID logo https://orcid.org/0000-0001-5662-7740
Park, Yong Jung(박용정)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/90004
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