Hopkins, Mark, Hau, Sarah, Tiernan, Caroline, Papadimitropoulos, Athanasios 
ORCID: 0000-0001-9822-4931, Chawla, Anu, Beloukas, Apostolos ORCID: 0000-0001-5639-0528 and Geretti, Anna Maria ORCID: 0000-0002-3670-6588
(2015)
Comparative performance of the new Aptima HIV-1 Quant Dx assay with three commercial PCR-based HIV-1 RNA quantitation assays.
JOURNAL OF CLINICAL VIROLOGY, 69.
pp. 56-62.
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Abstract
<h4>Background</h4>Quantitative measurement of HIV-1 RNA levels in plasma ('viral load') plays a central role in clinical management. The choice of assay platform can influence results and treatment decisions.<h4>Objective</h4>To compare the analytical performance of the new TMA-based Hologic Aptima(®) HIV-1 Quant Dx assay with that of three PCR-based assays: Abbott RealTime HIV-1, Qiagen Artus(®) HI Virus-1 QS-RGQ, and Roche CAP/CTM HIV-1 Test v2.<h4>Study design</h4>Assay performance was evaluated using Acrometrix HIV-1 RNA Standard panels; the 3rd WHO HIV-1 RNA International Standard (12-500 copies/ml; 6 dilutions; 9 replicates); and plasma samples from 191 HIV-positive patients.<h4>Results</h4>Aptima showed high (>0.99) precision, accuracy and concordance with the Acrometrix Standards across a wide dynamic range (2.0-6.7 log10copies/ml). Variance caused up to 2.1 (Aptima), 1.7 (RealTime), 7.5 (Artus), and 1.9 (CAP/CTM) fold changes in the International Standard quantifications at 50-500 copies/ml. HIV-1 RNA detection rates in plasma samples were 141/191 (74%), 119/191 (62%), 108/191 (57%), and 145/191 (76%) for Aptima, RealTime, Artus and CAP/CTM, respectively. For categorising samples either side of 50 copies/ml, Aptima had excellent agreement with RealTime (kappa 0.92; 95% CI 0.87-0.98); lowest agreement was with Artus (kappa 0.79; 95%CI 0.70-0.88). Aptima quantifications were mean 0.12 and 0.06 log10copies/ml higher compared with RealTime and CAP/CTM, respectively, and 0.05 log10copies/ml lower compared with Artus. Limits of agreement were narrowest when comparing Aptima to RealTime.<h4>Conclusions</h4>The new Aptima HIV assay is sensitive, precise, and accurate. HIV assays exhibit discordance at low HIV-1 RNA copy numbers.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HIV-1 quantitation, Viral load, Aptima HIV-1 Quant Dx assay, Analytical performance, TMA |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 14 Oct 2015 13:50 |
| Last Modified: | 15 Dec 2022 11:40 |
| DOI: | 10.1016/j.jcv.2015.05.020 |
| Publisher's Statement : | © 2015 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/2031620 |
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