Reliability of CE-marked NATs for HIV-1 subtype C detection and quantitation

J Clin Virol. 2020 Nov:132:104649. doi: 10.1016/j.jcv.2020.104649. Epub 2020 Sep 23.

Abstract

We compared seven CE-marked HIV-1 RNA nucleic acid amplification technology (NAT) based assays for their detection efficiency and quantitation concordance in regard to HIV-1 subtype C. We used 398 plasma samples from South African repeat blood donors identified as HIV positive at occasion of routine screening NAT performed mainly during the years 2010-2013, with most plasma samples reflecting recent HIV-1 infections. All HIV-1 subtype C specimens were detected, independent of mono- or dual-target assay design. In the same time period new variants of HIV-1 subtype B had been identified which were missed by some mono-target assays, a finding which was not corroborated for subtype C in our study. A high level of concordance of HIV-1 subtype C quantitation was determined for the HIV-1 NATs, showing successful standardization in this diagnostic field.

Keywords: Dual-target NAT; HIV-1 RNA quantitation; HIV-1 subtype C; Mono-target NAT; NAT assays.

MeSH terms

  • Blood Donors
  • HIV Infections* / diagnosis
  • HIV-1* / genetics
  • Humans
  • Nucleic Acid Amplification Techniques
  • RNA, Viral / genetics
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • RNA, Viral