Multicenter Clinical Comparative Evaluation of Alinity m HIV-1 Assay Performance

Abstract 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 20 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.