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A European Multicentre Study on the Analytical Performance of the VERIS HIV-1 Assay.

A European Multicentre Study on the Analytical Performance of the VERIS HIV-1 Assay.
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Braun P, Delgado R, Drago M, Fanti D, Fleury H, Hofmann J, Izopet J, Kalus U, Lombardi A, Marcos M, Mileto D, Sauné K, O'Shea S, Pérez-Rivilla A, Ramble J, Trimoulet P, Vila J, Whittaker D, Artus A, Rhodes D,


Braun P, Delgado R, Drago M, Fanti D, Fleury H, Hofmann J, Izopet J, Kalus U, Lombardi A, Marcos M, Mileto D, Sauné K, O'Shea S, Pérez-Rivilla A, Ramble J, Trimoulet P, Vila J, Whittaker D, Artus A, Rhodes D, (click to view)

Braun P, Delgado R, Drago M, Fanti D, Fleury H, Hofmann J, Izopet J, Kalus U, Lombardi A, Marcos M, Mileto D, Sauné K, O'Shea S, Pérez-Rivilla A, Ramble J, Trimoulet P, Vila J, Whittaker D, Artus A, Rhodes D,

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Journal of clinical microbiology 2017 04 19() pii 10.1128/JCM.00078-17

Abstract

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.

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