Multicenter clinical comparative evaluation of Alinity m HIV-1 assay performance
Authors:
- Braun, Patrick
- Glass, Allison
- Maree, Leana
- Krügel, Maria
- Pacenti, Monia
- Onelia, Francesco
- Gunson, Rory
- Goldstein, Emily
- Martínez-García, Laura
- Galán, Juan-Carlos
- Vilas, Alba
- D’costa, Jodie
- Sameer, Rizmina
- Ehret, Robert
- Knechten, Heribert
- Naeth, Gudrun
- Bouvier-Alias, Magali
- Marlowe, Natalia
- Palm, Michael J.
- Joseph, Ajith M.
- Dhein, Jens
- Reinhardt, Birgit
- Pfeifer, Karin
- Lucic, Danijela
- Obermeier, Martin
Details:
Journal of Clinical Virology, Volume 129, 2020-08-31
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Background Accurate, rapid detection of HIV-1 RNA is critical for early diagnosis, treatment decision making, and long-term management of HIV-1 infection. Objective We evaluated the diagnostic performance of the Alinity m HIV-1 assay, which uses a dual target/dual probe design against highly conserved target regions of the HIV-1 genome and is run on the fully automated Alinity m platform. Study design This was an international, multisite study that compared the diagnostic performance of the Alinity m HIV-1 assay to four commercially available HIV-1 assays routinely used in nine independent clinical laboratories. Alinity m HIV-1 assay precision, detectability, and reproducibility was compared across four study sites. Results The Alinity m HIV-1 assay produced comparable results to currently available HIV-1 assays (correlation coefficient >0.995), with an overall bias of -0.1 to 0.10 Log10 copies/mL. The Alinity m HIV-1 assay and its predecessor m2000 HIV-1 assay demonstrated comparable detection of 16 different HIV-1 subtypes (R2 = 0.956). A high level of agreement (>88 %) between all HIV-1 assays was seen near clinical decision points of 1.7 Log10 copies/mL (50 copies/mL) and 2.0 Log10 copies/mL (200 copies/mL). Alinity m HIV-1 assay precision was 0.08 and 0.21 Log10 copies/mL at VLs of 1000 and 50 copies/mL, respectively, with a high level of detectability (≥97 % hit rate) and reproducibility across sites. Conclusions The Alinity m HIV-1 assay provides comparable diagnostic accuracy to current HIV-1 assays, and when run on the Alinity m system, has the capacity to shorten the time between diagnosis and treatment.