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Journal of Clinical Microbiology, December 2008, p. 3919-3923, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.01603-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection{triangledown}

Sinyoung Kim, Jeong-Ho Kim, Seoyoung Yoon, Youn-Hee Park, and Hyon-Suk Kim*

Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea

Received 18 August 2008/ Returned for modification 13 September 2008/ Accepted 11 October 2008

Various automated chemiluminescence immunoassay (CLIA) analyzers for the detection of antibodies to hepatitis C virus (HCV) are now commercially available in clinical laboratories and are replacing conventional enzyme immunoassays. We investigated the performance of four anti-HCV CLIAs (the Architect Anti-HCV assay on the Architect i2000 system, the Vitros Anti-HCV assay on the Vitros ECiQ Immunodiagnostic System, the Access HCV Ab PLUS assay on the UniCel DxI 800 analyzer, and the newly developed Elecsys Anti-HCV assay on the Cobas e 411 analyzer). The total percent coefficient of variation values of imprecision were 3.5 to 5.7% with positive control materials and 7.2 to 10.2% with negative control materials. The agreement between the results of the Elecsys, Architect, Vitros, and Access CLIAs ranged from 94.5 to 98.1%. The clinical sensitivity of all CLIAs was 100%. Each CLIA showed excellent reproducibility and clinical sensitivity. The Elecsys, Architect, Vitros, and Access CLIAs showed clinical specificities of 98.2, 98.8, 96.5, and 98.2%.

* Corresponding author. Mailing address: Department of Laboratory Medicine, Yonsei University College of Medicine, 134-Sinchon-dong, Seodaemun-gu, CPO Box 8044, Seoul, Korea. Phone: (82) 2-2228-2443. Fax: (82) 2-313-0956. E-mail: kimhs54{at}yuhs.ac

{triangledown} Published ahead of print on 22 October 2008.

Journal of Clinical Microbiology, December 2008, p. 3919-3923, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.01603-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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