| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5668180 | Journal of Clinical Virology | 2017 | 8 Pages |
â¢Extraction/amplification for HIV-1 RNA quantitation are integrated in one instrument.â¢Method comparison of HIV-1 viral load results demonstrated low bias below 1000 cp/mL.â¢Patient results over time showed similar profiles and trending between methods.â¢Differing definitions of virologic failure level may cause confusion with patient management.â¢Care should be taken when changing systems as variability exists in assay results.
BackgroundViral 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.Â¥ObjectivesEvaluation of the clinical performance of the new quantitative VERIS HIV-1 Assay at multiple EU laboratories.Study designMethod 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.ResultsBland-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 1000Â cp/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 log10Â cp/mL versus VERSANT HIV-1 Assay. Analysis on 174 specimens tested with the 0.175Â mL volume VERIS HIV-1 Assay and COBAS HIV-1 Test showed average bias of 0.39 log10Â cp/mL. Patient monitoring results using VERIS HIV-1 Assay demonstrated similar viral load trends over time to all comparators.ConclusionsThe 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.
