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

Phillip Adams, Ellen Vancutsem, Cyrielle Nicolaizeau, Jean Yves Servais, Denis Piérard, Jean Hugues François, Tanja Schneider, Ellen E. Paxinos, Ed G. Marins, Jesse A. Canchola, Carole Seguin-Devaux*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)43-49
Number of pages7
JournalJournal of Clinical Virology
Volume114
DOIs
Publication statusPublished - May 2019

Keywords

  • Antiretroviral therapy
  • HIV-1
  • Real-time PCR
  • Viral load

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