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: | Ed G. Marins, Cyrielle Nicolaizeau, Phillip Adams, Ellen E. Paxinos, Ellen Vancutsem, Carole Seguin-Devaux, Denis Pierard, Jesse A. Canchola, Tanja Schneider, Jean-Yves Servais, Jean-Hugues François |
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| Přispěvatelé: | Microbiology and Infection Control, Clinical Biology, Supporting clinical sciences |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
030106 microbiology Human immunodeficiency virus (HIV) HIV Infections medicine.disease_cause Sensitivity and Specificity Plasma viral load 03 medical and health sciences 0302 clinical medicine Limit of Detection Virology medicine Humans In patient 030212 general & internal medicine Detection limit medicine.diagnostic_test business.industry Nucleic acid test Reproducibility of Results virus diseases Viral Load Antiretroviral therapy Treatment efficacy Infectious Diseases HIV-1 RNA Viral Reagent Kits Diagnostic business Viral load Nucleic Acid Amplification Techniques |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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