title: 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.
abstract: 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 log10  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.
authors: Laboratory of Virology, National Institute for Infectious Diseases "Lazzaro Spallanzani,", Rome, Italy.
authors: Alessandra
authors: A
authors: Amendola
authors: Laboratory of Virology, National Institute for Infectious Diseases "Lazzaro Spallanzani,", Rome, Italy.
authors: Maria
authors: M
authors: Pisciotta
authors: Laboratory of Virology, National Institute for Infectious Diseases "Lazzaro Spallanzani,", Rome, Italy.
authors: Loredana
authors: L
authors: Aleo
authors: Laboratory of Virology, National Institute for Infectious Diseases "Lazzaro Spallanzani,", Rome, Italy.
authors: Valeria
authors: V
authors: Ferraioli
authors: Department of Epidemiology, National Institute for Infectious Diseases "Lazzaro Spallanzani,", Rome, Italy.
authors: Claudio
authors: C
authors: Angeletti
authors: Laboratory of Virology, National Institute for Infectious Diseases "Lazzaro Spallanzani,", Rome, Italy.
authors: Maria Rosaria
authors: MR
authors: Capobianchi
mesh_terms: D001331:Automation; D015658:HIV Infections / Q000175:diagnosis / Q000821:virology*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification / Q000502:physiology*; D006801:Humans; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Aptima HIV-1 Quant Dx assay; HIV-1 RNA quantitation; WHO 3rd HIV-1 International Standard; WHO International Reference Panel for HIV-1 Subtypes; viral load