Performance characteristics of the Abbott Alinity m SARS-CoV-2 assay.

Autor: Perchetti GA; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States., Pepper G; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States., Shrestha L; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States., LaTurner K; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States., Yae Kim D; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States., Huang ML; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States., Jerome KR; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States., Greninger AL; Department of Laboratory Medicine and Pathology, Virology Division, University of Washington, Seattle, WA, United States; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States. Electronic address: agrening@uw.edu.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2021 Jul; Vol. 140, pp. 104869. Date of Electronic Publication: 2021 May 14.
DOI: 10.1016/j.jcv.2021.104869
Abstrakt: Mass molecular diagnostic testing for the SARS-CoV-2 pandemic has drawn on laboratory developed tests, commercial assays, and fully-automated platforms to accommodate widespread demand. The Alinity m instrument by Abbott is capable of detecting several clinically relevant pathogens and has recently received FDA emergency use authorization for SARS-CoV-2 molecular testing. The Alinity m performs automatic sample preparation, RT-PCR assembly, amplification, detection, and result calculation in under two hours. Here, we validate the performance characteristics of the Alinity m SARS-CoV-2 assay in comparison with the Roche cobas 6800 and Hologic Panther Fusion platforms. Across 178 positive and 195 negative nasopharyngeal swab specimens (C T range 14.30-38.84), the Alinity m detected one additional positive specimen that was found to be negative on the Roche cobas 6800 (PPA 100%, NPA 99.5%). Across a separate set of 30 positive and 174 negative nasopharyngeal swab specimens (C T range 14.1-38.5), the Alinity m had 100% positive and negative agreement with the Hologic Panther Fusion. Using SeraCare SARS-CoV-2 RNA standards, the assay limit of detection was verified to be two-fold more sensitive than the parameters stated by the SARS-CoV-2 AMP kit package insert, at 50 virus copies/mL. Assay specificity was 100% over 20 specimens positive for other respiratory viruses and intraday precision was 100% concordant with <2% CV. These data illst u illustrate the Abbott Alinity m system's high concordance with reference assays and analyti high analytical for SARS-CoV-2 molecular detection.
(Copyright © 2021. Published by Elsevier B.V.)
Databáze: MEDLINE
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