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.
J Clin Virol
; 114: 43-49, 2019 05.
Article
em En
| MEDLINE
| ID: mdl-30991164
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 log10) 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 (R2 ≥ 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 log10 or 0.01 log10, 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Kit de Reagentes para Diagnóstico
/
Infecções por HIV
/
Carga Viral
/
Técnicas de Amplificação de Ácido Nucleico
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Evaluation_studies
Limite:
Humans
Idioma:
En
Revista:
J Clin Virol
Assunto da revista:
VIROLOGIA
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Luxemburgo