A European multicientre study on the comparison of HIV-1 viral loads between VERIS HIV-1 Assay and Roche COBAS® TAQMAN® HIV-1 test, Abbott RealTime HIV-1 Assay, and Siemens VERSANT HIV-1 Assay

Abstract

Background: Viral load monitoring is essential for patients under treatment for HIV. Beckman Coulter has developed the VERIS HIV-1 Assay for use on the novel, automated DxN VERIS Molecular Diagnostics System.^¥ OBJECTIVES: Evaluation of the clinical performance of the new quantitative VERIS HIV-1 Assay at multiple EU laboratories.

Study design: Method comparison with the VERIS HIV-1 Assay was performed with 415 specimens at 5 sites tested with COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 Test, v2.0, 169 specimens at 3 sites tested with RealTime HIV-1 Assay, and 202 specimens from 2 sites tested with VERSANT HIV-1 Assay. Patient monitoring sample results from 4 sites were also compared.

Results: Bland-Altman analysis showed the average bias between VERIS HIV-1 Assay and COBAS HIV-1 Test, RealTime HIV-1 Assay, and VERSANT HIV-1 Assay to be 0.28, 0.39, and 0.61 log₁₀ cp/mL, respectively. Bias at low end levels below 1000cp/mL showed predicted bias to be <0.3 log₁₀ cp/mL for VERIS HIV-1 Assay versus COBAS HIV-1 Test and RealTime HIV-1 Assay, and <0.5 log₁₀cp/mL versus VERSANT HIV-1 Assay. Analysis on 174 specimens tested with the 0.175mL volume VERIS HIV-1 Assay and COBAS HIV-1 Test showed average bias of 0.39 log₁₀cp/mL. Patient monitoring results using VERIS HIV-1 Assay demonstrated similar viral load trends over time to all comparators.

Conclusions: The VERIS HIV-1 Assay for use on the DxN VERIS System demonstrated comparable clinical performance to COBAS^® HIV-1 Test, RealTime HIV-1 Assay, and VERSANT HIV-1 Assay.

Keywords: COBAS(®) TaqMan(®) HIV-1 test; HIV-1 RNA quantification; RealTime HIV-1 assay; VERIS HIV-1 assay; VERSANT HIV-1 assay.