TY - JOUR
T1 - 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
AU - Adams, Phillip
AU - Vancutsem, Ellen
AU - Nicolaizeau, Cyrielle
AU - Servais, Jean Yves
AU - Piérard, Denis
AU - François, Jean Hugues
AU - Schneider, Tanja
AU - Paxinos, Ellen E.
AU - Marins, Ed G.
AU - Canchola, Jesse A.
AU - Seguin-Devaux, Carole
N1 - Funding Information:
Funding for this study including support for third-party writing assistance for this manuscript to Data First Consulting (Belmont, CA, USA) was provided by Roche Molecular Systems, Inc. (Pleasanton, CA, USA) .
Publisher Copyright:
© 2019
PY - 2019/5
Y1 - 2019/5
N2 - 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.
AB - 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.
KW - Antiretroviral therapy
KW - HIV-1
KW - Real-time PCR
KW - Viral load
UR - http://www.scopus.com/inward/record.url?scp=85064159452&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/30991164
U2 - 10.1016/j.jcv.2019.03.008
DO - 10.1016/j.jcv.2019.03.008
M3 - Article
C2 - 30991164
AN - SCOPUS:85064159452
SN - 1386-6532
VL - 114
SP - 43
EP - 49
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
ER -