Real-life head-to-head comparison of performance of two high-throughput automated assays for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs : the Alinity m and cobas 6800 SARS-CoV-2 assays

Kogoj, Rok (author), Kmetič, Petra (author), Oštrbenk Valenčak, Anja (author), Fujs Komloš, Kristina (author), Seme, Katja (author), Sagadin, Martin (author), Korva, Miša (author), Poljak, Mario (author)

The Alinity m (Abbott Molecular, Des Plaines, IL) automated molecular analyzer allows continuous loading of samples and sample-to-result molecular detection of several microorganisms. The detection of SARS-CoV-2 by the Alinity m was compared with that of the cobas 6800 (Roche Molecular Systems, Branchburg, NJ; standard comparator) in a manufacturer-independent clinical evaluation on 2157 consecutive nasopharyngeal swab samples. Valid initial results on Alinity m and cobas 6800 were obtained from 2129 (98.7%) and 2157 (100%) samples, respectively. The overall percent agreement (95% CI) was 98.3% (2092/2129 [97.6%–98.7%]); positive percent agreement, 100% (961/961 [99.6%–100%]); negative percent agreement, 96.8% (1131/1168 [95.7%–97.7%]); and high κ value, 0.965 (0.954–0.976). There were 37 discordant results on Alinity m and, based on discordant analyses, including previous and/or follow-up PCR results, 22 could be considered analytically true positive with high probability. Due to a lack of additional information and an inability to perform repeated/further testing, the status of the remaining 15 discordant results remained unresolved. The throughput of the two analyzers was compared using testing on 564 samples in parallel across two 8-hour shifts in clinical practice. The turnaround times were compared using processing of 94 routine samples in parallel on each working day for 5 consecutive days. The two analyzers showed similar performance, with certain differences that have potential importance in some laboratory settings.

• Language: English
• Keywords: SARS-CoV2, molecular analyzer, Abbott's Alinity m
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2021
• Number of pages: Str. 920-928
• Numbering: Vol. 23, no. 8
• PID: 20.500.12556/RUL-138709
• UDC: 616.9
• ISSN on article: 1525-1578
• DOI: 10.1016/j.jmoldx.2021.05.003
• COBISS.SI-ID: 67502851
• Publication date in RUL: 10.08.2022

Record is a part of a journal

• Title: Journal of molecular diagnostics
• Shortened title: J. mol. diagn.
• Publisher: Association for Molecular Pathology, American Society for Investigative Pathology, Elsevier
• ISSN: 1525-1578
• COBISS.SI-ID: 2150420

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: SARS-CoV2, molekularni analizator, Abbott, Alinity m