Multicenter clinical comparative evaluation of Alinity m HIV-1 assay performance

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 Log(10) copies/mL. The Alinity m HIV-1 assay and its predecessor m2000 HIV-1 assay demonstrated comparable detection of 16 different HIV-1 subtypes (R-2 = 0.956). A high level of agreement (> 88 %) between all HIV-1 assays was seen near clinical decision points of 1.7 Log(10) copies/mL (50 copies/mL) and 2.0 Log(10) copies/mL (200 copies/mL). Alinity m HIV-1 assay precision was 0.08 and 0.21 Log(10) 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.