title: Performance and quality assurance of genotypic drug-resistance testing for human immunodeficiency virus type 1 in Japan.
abstract: 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.
authors.affiliation: National Hospital Organization Nagoya Medical Center, Aichi 460-0001, Japan.
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Fujisaki
authors.forename: Saeko
authors.initials: S
authors.lastname: Fujisaki
authors.forename: Shiro
authors.initials: S
authors.lastname: Ibe
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Asagi
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Itoh
authors.forename: Shigeru
authors.initials: S
authors.lastname: Yoshida
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
authors.forename: Masayasu
authors.initials: M
authors.lastname: Oie
authors.forename: Makiko
authors.initials: M
authors.lastname: Konda
authors.forename: Kenji
authors.initials: K
authors.lastname: Sadamasu
authors.forename: Mami
authors.initials: M
authors.lastname: Nagashima
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Gatanaga
authors.forename: Masakazu
authors.initials: M
authors.lastname: Matsuda
authors.forename: Mikio
authors.initials: M
authors.lastname: Ueda
authors.forename: Aki
authors.initials: A
authors.lastname: Masakane
authors.forename: Mami
authors.initials: M
authors.lastname: Hata
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Mizogami
authors.forename: Haruyo
authors.initials: H
authors.lastname: Mori
authors.forename: Rumi
authors.initials: R
authors.lastname: Minami
authors.forename: Kiyomi
authors.initials: K
authors.lastname: Okada
authors.forename: Kanako
authors.initials: K
authors.lastname: Watanabe
authors.forename: Takuma
authors.initials: T
authors.lastname: Shirasaka
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
authors.forename: Wataru
authors.initials: W
authors.lastname: Sugiura
authors.forename: Tsuguhiro
authors.initials: T
authors.lastname: Kaneda
mesh_terms: 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
chemical_list: D012367:RNA, Viral; D054303:HIV Reverse Transcriptase; D016333:HIV Protease