Journal of clinical microbiology 2017 04 19() pii 10.1128/JCM.00078-17
The analytical performance of the VERIS HIV-1 Assay for use on the new, fully automated Beckman Coulter DxN VERIS Molecular Diagnostics System(¥) was evaluated at 10 European Virology laboratories. Precision, analytical sensitivity, performance with negative samples, linearity, and performance with HIV-1 Groups/Subtypes were evaluated. Precision for the 1 mL assay showed an SD of 0.14 log10 cp/mL or less and CV ≤6.1% for each level tested. The 0.175 mL assay showed an SD of 0.17 log10 cp/mL or less and CV ≤5.2% for each level tested. Analytical sensitivity determined by probit analysis, was determined to be 19.3 cp/mL for the 1 mL assay and 126 cp/mL for the 0.175 mL assay. Performance with 1,357 negative samples demonstrated 99.2% not detected. Linearity using patient samples was shown from 1.54 – 6.93 log10 cp/mL. The assay performed well, detecting and showing linearity with all HIV-1 genotypes tested. The VERIS HIV-1 Assay demonstrated comparable analytical performance to currently marked HIV-1 assays.