Jpn. J. Infect. Dis., 55, 33-36, 2002

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Report

Re-Evaluation of HCV Ab Detection Kits Approved for Marketing in Japan

Committee for Evaluation of In Vitro Diagnostic Devices,
National Institute of Infectious Diseases*

INTRODUCTION
As of 2001, the Japanese Ministry of Health and Welfare (Ministry of Health, Labour and Welfare at present; MHLW) has approved approximately 30 diagnostic kits for detection of antibodies against various epitopes of HCV (Hepatitis C virus) in clinical settings. All of them are commercially available in Japan. In order to provide medical personnel with up-to-date information on each kit's characteristics, such as its sensitivity and specificity, in order to enable them to choose appropriate HCV Ab (antibody) detection kits, National Institute of Infectious Diseases (NIID), according to the guidance of the MHLW, has re-evaluated the diagnostic kits provided by manufacturers/distributors. The present reports are the results of the re-evaluation of HCV Ab detection kits.

*Corresponding author: Toshiaki Mizuochi, Department of Bacterial and Blood Products, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan. Tel: +81-3-5285-1111 ext. 2324, Fax: +81-3-5285-1150, E-mail: miz@nih.go.jp

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