Performance and quality assurance of genotypic drug-resistance testing for human immunodeficiency virus type 1 in 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.
Fujisaki
Seiichiro
S
National Hospital Organization Nagoya Medical Center, Aichi 460-0001, Japan.
Fujisaki
Saeko
S
Ibe
Shiro
S
Asagi
Tsukasa
T
Itoh
Toshihiro
T
Yoshida
Shigeru
S
Koike
Takao
T
Oie
Masayasu
M
Konda
Makiko
M
Sadamasu
Kenji
K
Nagashima
Mami
M
Gatanaga
Hiroyuki
H
Matsuda
Masakazu
M
Ueda
Mikio
M
Masakane
Aki
A
Hata
Mami
M
Mizogami
Yasushi
Y
Mori
Haruyo
H
Minami
Rumi
R
Okada
Kiyomi
K
Watanabe
Kanako
K
Shirasaka
Takuma
T
Oka
Shinichi
S
Sugiura
Wataru
W
Kaneda
Tsuguhiro
T
D023241:Antiretroviral Therapy, Highly Active; D024882:Drug Resistance, Viral / Q000235:genetics*; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D016333:HIV Protease / Q000235:genetics; D054303:HIV Reverse Transcriptase / Q000235:genetics; D015497:HIV-1 / Q000187:drug effects* / Q000201:enzymology / Q000235:genetics*; D006801:Humans; D007564:Japan; D007753:Laboratories / Q000592:standards*; D008826:Microbial Sensitivity Tests / Q000379:methods / Q000592:standards*; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000379:methods
D012367:RNA, Viral; D054303:HIV Reverse Transcriptase; D016333:HIV Protease