Evaluation of the Aptima(®) HIV‐1 Quant Dx assay for HIV‐1 RNA viral load detection and quantitation in plasma of HIV‐1‐infected individuals: A comparison with Abbott RealTime HIV‐1 assay

The Hologic Aptima(®) HIV‐1 Quant Dx assay (Aptima HIV) is a real‐time transcription‐mediated amplification method CE‐approved for use in diagnosis and monitoring of HIV‐1 infection. The analytical performance of this new assay was compared to the FDA‐approved Abbott RealTime HIV‐1 (RealTime). The evaluation was performed using 220 clinical plasma samples, the WHO 3rd HIV‐1 International Standard, and the QCMD HIV‐1 RNA EQA. Concordance on qualitative results, correlation between quantitative results, accuracy, and reproducibility of viral load data were analyzed. The ability to measure HIV‐1 subtypes was assessed on the second WHO International Reference Preparation Panel for HIV‐1 Subtypes. With clinical samples, inter‐assay agreement for qualitative results was high (91.8%) with Cohen's kappa statistic equal to 0.836. For samples with quantitative results in both assays (n = 93), Lin's concordance correlation coefficient was 0.980 (P < 0.0001) and mean differences of measurement, conducted according to Bland–Altman method, was low (0.115 log(10) copies/ml). The Aptima HIV quantified the WHO 3rd HIV‐1 International Standard diluted from 2000 to 31 cp/ml (5,700–88 IU/ml) at expected values with excellent linearity (R(2) > 0.970) and showed higher sensitivity compared to RealTime being able to detect HIV‐1 RNA in 10 out of 10 replicates containing down to 7 cp/ml (20 IU/ml). Reproducibility was very high, even at low HIV‐1 RNA values. The Aptima HIV was able to detect and accurately quantify all the main HIV‐1 subtypes in both reference panels and clinical samples. Besides excellent performance, Aptima HIV shows full automation, ease of use, and improved workflow compared to RealTime. J. Med. Virol. 88:1535–1544, 2016. © 2016 Wiley Periodicals, Inc.