Fujisaki Seiichiro, Fujisaki Saeko, Ibe Shiro, Asagi Tsukasa, Itoh Toshihiro, Yoshida Shigeru, Koike Takao, Oie Masayasu, Konda Makiko, Sadamasu Kenji, Nagashima Mami, Gatanaga Hiroyuki, Matsuda Masakazu, Ueda Mikio, Masakane Aki, Hata Mami, Mizogami Yasushi, Mori Haruyo, Minami Rumi, Okada Kiyomi, Watanabe Kanako, Shirasaka Takuma, Oka Shinichi, Sugiura Wataru, Kaneda Tsuguhiro
National Hospital Organization Nagoya Medical Center, Aichi 460-0001, Japan.
Jpn J Infect Dis. 2007 May;60(2-3):113-7.
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.
高效抗逆转录病毒疗法（HAART）可抑制1型人类免疫缺陷病毒（HIV-1）复制，并将血浆中的HIV-1水平降低至检测不到的水平以下。然而，当HAART期间出现耐药病毒时，HAART就会失效。监测病毒中的耐药突变对于选择能够有效抑制此类HIV-1变体的新药或疗法至关重要。日本的大多数实验室都使用内部方案进行检测。然而，这些检测的质量从未得到评估。我们在日本15个实验室评估HIV-1基因型耐药性检测准确性和可靠性的研究表明，质量非常高（准确率97.3%）。这些错误虽然罕见，但都是由人为错误、电泳图谱不佳以及使用不适当的引物导致的。在此，我们提出故障排除程序，以提高日本检测的准确性和可靠性。
