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J Clin Virol. 2017 Jul;92:75-82. doi: 10.1016/j.jcv.2017.05.003. Epub 2017 May 11.

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.

Author information

1
Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany.
2
Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12) Madrid, Spain.
3
Clinical Chemistry and Microbiology Laboratories, Niguarda Ca' Granda Hospital, Milan, Italy.
4
Virology Department, Hôpital Pellegrin, CHU, Bordeaux, France.
5
Virology Department, Labor Berlin - Charité Vivantes GmbH, Berlin, Germany.
6
Department of Virology, Federative Institute of Biology, CHU, Toulouse, France.
7
Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy.
8
Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain.
9
Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
10
Laboratory Medicine Building, North Lane, Northern General Hospital, Sheffield, United Kingdom.
11
Beckman Coulter, Immunotech, 130 Ave Lattre de Tassigny, Marseille 13009, France.
12
Beckman Coulter, Immunotech, 130 Ave Lattre de Tassigny, Marseille 13009, France. Electronic address: dwrhodes@beckman.com.

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

PMID:
28599228
DOI:
10.1016/j.jcv.2017.05.003
[Indexed for MEDLINE]

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