Performance and quality assurance of genotypic drug-resistance testing for human immunodeficiency virus type 1 in Japan

Jpn J Infect Dis. 2007 May;60(2-3):113-7.

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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiretroviral Therapy, Highly Active*
  • Drug Resistance, Viral / genetics*
  • Genotype
  • HIV Infections / drug therapy
  • HIV Infections / epidemiology
  • HIV Infections / virology
  • HIV Protease / genetics
  • HIV Reverse Transcriptase / genetics
  • HIV-1 / drug effects*
  • HIV-1 / enzymology
  • HIV-1 / genetics*
  • Humans
  • Japan
  • Laboratories / standards*
  • Microbial Sensitivity Tests / methods
  • Microbial Sensitivity Tests / standards*
  • Quality Control
  • RNA, Viral / blood
  • Reproducibility of Results
  • Specimen Handling / methods

Substances

  • RNA, Viral
  • HIV Reverse Transcriptase
  • HIV Protease