Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load.

Autor: Adams P; Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg., Vancutsem E; AIDS Reference Laboratory, Dept. Microbiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium., Nicolaizeau C; Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg., Servais JY; Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg., Piérard D; AIDS Reference Laboratory, Dept. Microbiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium., François JH; Molecular Biology Laboratory, Centre Hospitalier de Luxembourg, Luxembourg., Schneider T; Roche Diagnostics Ltd, Rotkreuz, Switzerland., Paxinos EE; Roche Molecular Systems, Pleasanton, CA, USA., Marins EG; Roche Molecular Systems, Pleasanton, CA, USA., Canchola JA; Roche Molecular Systems, Pleasanton, CA, USA., Seguin-Devaux C; Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg. Electronic address: carole.devaux@lih.lu.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2019 May; Vol. 114, pp. 43-49. Date of Electronic Publication: 2019 Mar 16.
DOI: 10.1016/j.jcv.2019.03.008
Abstrakt: Background and Objectives: Measurement of HIV-1 viral load (VL) is necessary to monitor treatment efficacy in patients receiving antiretroviral therapy. We evaluated the performance of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system ("cobas 4800 HIV-1").
Methods: Limit of detection, linearity, accuracy, precision, and specificity of cobas 4800 HIV-1, COBAS® AmpliPrep/COBAS® Taqman® HIV-1 version 2.0 (CAP/CTM HIV-1 v2) and Abbott RealTime HIV-1 were determined in one or two out of three sites.
Results: The limit of detection of the cobas 4800 HIV-1 for 400 μL and 200 μL input volumes was 14.2 copies/mL (95% CI: 12.5-16.6 copies/mL) and 43.9 copies/mL (37.7-52.7 copies/mL), respectively. Cobas 4800 HIV-1 demonstrated 100% specificity, and results were linear for all analyzed group M HIV-1 subtypes. Precision was high (SD < 0.19 log 10 ) across all measured ranges, reagent lots and input volumes. Correlation between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was high (R 2 ≥ 0.95). Agreement between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 was 96.5% (95.0%-97.7%) at a threshold of 50 copies/mL, and 97.2% (95.8%-98.3%) at 200 copies/mL. Agreement between cobas 4800 HIV-1 and RealTime HIV-1 was 96.6% (93.4%-98.5%) at 50 copies/mL, and 97.0% (94.0%-98.8%) at 200 copies/mL. The mean difference between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was -0.10 log 10 or 0.01 log 10 , respectively.
Conclusions: The cobas 4800 HIV-1 test is highly sensitive, accurate and correlated well with other assays, including agreement around clinically relevant thresholds, indicating minimal overall VL quantification differences between tested platforms.
(Copyright © 2019. Published by Elsevier B.V.)
Databáze: MEDLINE
Externí odkaz: