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Performance and quality assurance of genotypic drug-resistance testing for human immunodeficiency virus type 1 in Japan. 2007
Seiichiro Fujisaki, and
Saeko Fujisaki, and
Shiro Ibe, and
Tsukasa Asagi, and
Toshihiro Itoh, and
Shigeru Yoshida, and
Takao Koike, and
Masayasu Oie, and
Makiko Konda, and
Kenji Sadamasu, and
Mami Nagashima, and
Hiroyuki Gatanaga, and
Masakazu Matsuda, and
Mikio Ueda, and
Aki Masakane, and
Mami Hata, and
Yasushi Mizogami, and
Haruyo Mori, and
Rumi Minami, and
Kiyomi Okada, and
Kanako Watanabe, and
Takuma Shirasaka, and
Shinichi Oka, and
Wataru Sugiura, and
Tsuguhiro Kaneda
National Hospital Organization Nagoya Medical Center, Aichi 460-0001, Japan.
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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