Jpn. J. Infect. Dis., 54, 201-207, 2001

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Report

Re-Evaluation of HBsAg Detection Kits Approved for Marketing in Japan

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

INTRODUCTION
Approximately 1% of the Japanese population are estimated to be HBV (hepatitis B virus)-carriers. Rapid as well as accurate diagnosis of HB is extremely important from the viewpoint not only of medical treatment but also that of public health. Detection of HBsAg (hepatitis B virus surface antigen) in patient specimens has been widely used for diagnosis of HBV infection. In Japan, more than 40 different HBsAg detection kits approved by the Ministry of Health and Welfare (Ministry of Health, Labour and Welfare [MHLW], at present) have been commercially available for clinical use during the past two decades. It has become apparent that there are significant differences in sensitivity among the HBsAg kits currently on the market, mainly due to technical improvements made during the last 20 years. Under these circumstances, in order to provide medical personnel with up to date information on characteristics such as sensitivity and specificity, and to enable proper use of HBsAg detection kits, the National Institute of Infectious Diseases (NIID) has been requested to re-evaluate kits by various manufacturers/distributors according to the guidelines of MHLW. The present report aims at establishing an outline and results of the re-evaluation of HBsAg detection kits for release to the public.

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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