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

J Kress, M Vermeulen, M Chudy, A Reissinger, K-M Hanschmann, A Saville, C M Nübling

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 2020 Nov

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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. Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.

Citation

J Kress, M Vermeulen, M Chudy, A Reissinger, K-M Hanschmann, A Saville, C M Nübling. Reliability of CE-marked NATs for HIV-1 subtype C detection and quantitation. Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 2020 Nov;132:104649