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

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.

• Jezik: Angleški jezik
• Ključne besede: SARS-CoV2, molecular analyzer, Abbott's Alinity m
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: MF - Medicinska fakulteta
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2021
• Št. strani: Str. 920-928
• Številčenje: Vol. 23, no. 8
• PID: 20.500.12556/RUL-138709
• UDK: 616.9
• ISSN pri članku: 1525-1578
• DOI: 10.1016/j.jmoldx.2021.05.003
• COBISS.SI-ID: 67502851
• Datum objave v RUL: 10.08.2022

Gradivo je del revije

• Naslov: Journal of molecular diagnostics
• Skrajšan naslov: J. mol. diagn.
• Založnik: Association for Molecular Pathology, American Society for Investigative Pathology, Elsevier
• ISSN: 1525-1578
• COBISS.SI-ID: 2150420

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: SARS-CoV2, molekularni analizator, Abbott, Alinity m