Jpn. J. Infect. Dis., 60 (2-3), 113-117, 2007
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Performance and Quality Assurance of Genotypic Drug-Resistance Testing for Human Immunodeficiency Virus Type 1 in Japan
Seiichiro Fujisaki, Saeko Fujisaki, Shiro Ibe, Tsukasa Asagi1, Toshihiro Itoh1, Shigeru Yoshida2, Takao Koike3, Masayasu Oie4, Makiko Kondo5, Kenji Sadamasu6, Mami Nagashima6, Hiroyuki Gatanaga7, Masakazu Matsuda8, Mikio Ueda9, Aki Masakane10, Mami Hata11, Yasushi Mizogami12, Haruyo Mori13, Rumi Minami14, Kiyomi Okada15, Kanako Watanabe16, Takuma Shirasaka12, Shinichi Oka7, Wataru Sugiura8 and Tsuguhiro Kaneda*
National Hospital Organization Nagoya Medical Center, Aichi 460-0001; 1Sendai Medical Center, Miyagi 983-8520; 2Department of Health Sciences, Hokkaido University School of Medicine, Hokkaido 060-0812; 3Department of Medicine II, Hokkaido University School of Medicine, Hokkaido 060-8638; 4Department of Virology, Niigata University Graduate School of Medical and Dental Sciences, Niigata 951-8510; 5Division of Microbiology, Kanagawa Prefectural Institute of Public Health, Kanagawa 253-0087; 6Division of Virology, Department of Microbiology, Tokyo Metropolitan Institute of Public Health, Tokyo 169-0073; 7AIDS Clinical Center, International Medical Center of Japan, Tokyo 162-8655; 8AIDS Research Center, National Institute of Infectious Diseases, Tokyo 208-0011; 9Hematology Immunology, Ishikawa Prefectural Central Hospital; 10Ishikawa Prefectural Central Hospital (Japanese Foundation for AIDS Prevention), Ishikawa 920-8530; 11Department of Microbiology, Aichi Prefectural Institute of Public Health, Nagoya 462-8576; 12AIDS Medical Center, National Hospital Organization Osaka National Hospital, Osaka 540-0006; 13Division of Virology, Osaka Prefectural Institute of Public Health, Osaka 537-0025; 14Division of Immunology and Infectious Disease, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center, Fukuoka 810-8563; 15KITASATO-OTSUKA Biomedical Assay Laboratories Co., Ltd., Kanagawa 228-8555; and 16Section of Virus, Niigata Prefectural Institute of Public Health and Environmental Sciences, Niigata 950-2144, Japan
(Received November 27, 2006. Accepted January 23, 2007)
*Corresponding author: Mailing address: Clinical Research Center, National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001. Japan. Tel: +81-52-951-1111 ext. 3320, Fax: +81-52-955-1878，E-mail: firstname.lastname@example.org
SUMMARY: Highly active antiretroviral therapy (HAART) can suppress human immunodeficiency virus type 1 (HIV-1) replication and plasma HIV-1 to below detectable levels. However, HAART becomes ineffective when drug-resistant viruses emerge during HAART. Monitoring drug-resistance mutations in viruses is necessary for selecting new drugs or therapies effective at inhibiting such HIV-1 variants. Most laboratories in Japan perform the tests using in-house protocols. However, the quality of these tests has never been assessed. Our study assessing the accuracy and reliability of HIV-1 genotypic drug-resistance testing in 15 laboratories in Japan revealed that the quality was very high (97.3% accurate). The errors, though rare, were caused by human errors, poor electropherograms, and the use of inadequate primers. Here, we propose troubleshooting procedures to improve testing accuracy and reliability in Japan.
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