Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load

•The cobas 4800 HIV-1 viral load test is highly sensitive, precise and accurate.•Results from cobas 4800 HIV-1 and two other commercial tests were highly correlated.•High levels of agreement between the 3 tests were obtained at 50 and 200 copies/ml.•Automated platforms like cobas 4800 HIV-1 enable the global scale-up of viral load. Measurement of HIV-1 viral load (VL) is necessary to monitor treatment efficacy in patients receiving antiretroviral therapy. We evaluated the performance of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system (“cobas 4800 HIV-1”). Limit of detection, linearity, accuracy, precision, and specificity of cobas 4800 HIV-1, COBAS® AmpliPrep/COBAS® Taqman® HIV-1 version 2.0 (CAP/CTM HIV-1 v2) and Abbott RealTime HIV-1 were determined in one or two out of three sites. The limit of detection of the cobas 4800 HIV-1 for 400 μL and 200 μL input volumes was 14.2 copies/mL (95% CI: 12.5–16.6 copies/mL) and 43.9 copies/mL (37.7–52.7 copies/mL), respectively. Cobas 4800 HIV-1 demonstrated 100% specificity, and results were linear for all analyzed group M HIV-1 subtypes. Precision was high (SD