ǂthe ǂAlinity m SARS-CoV-2 and cobas 6800 SARS-CoV-2 assays
Rok Kogoj (Avtor), Petra Kmetič (Avtor), Anja Oštrbenk (Avtor), Kristina Fujs Komloš (Avtor), Katja Seme (Avtor), Martin Sagadin (Avtor), Miša Korva (Avtor), Mario Poljak (Avtor)

Povzetek

Abbott's Alinity m is a recently launched fully integrated, automated molecular analyzer allowing continuous loading of samples and sample-to-result molecular detection of several microorganisms. Manufacturer-independent clinical evaluation of Alinity m SARS-CoV-2 (Alinity) against cobas 6800 SARS-CoV-2 (cobas) as a standard comparator was performed on 2,157 consecutive nasopharyngeal swabs. Valid initial results of Alinity and cobas were obtained from 2,129/2,157 (98.7%) and 2,157/2,157 (100%) samples, respectively. Overall percent agreement of 98.3% (2,092/2,129; 95%CI:97.6-98.7%), positive percent agreement of 100.0% (961/961; 95%CI:99.6-100.0%), negative percent agreement of 96.8% (1,131/1,168; 95%CI:95.7-97.7%), and a high kappa value of 0.965 (95%CI:0.954-0.976) were observed on 2,129 samples with valid results for both assays. There were 37 discordant results and based on discordant analyses, including previous and/or follow-up PCR results, 22 could be considered Alinity analytically true positive with high probability. Due to the lack of additional information and inability of repeated/further testing, the status of the remaining 15 discordant samples remains unresolved. Comparative real-life throughput of both analyzers assessed while testing 564 samples in parallel across two 8-hour shifts and comparative turnaround time assessment measured while processing in parallel the first 94 routine samples received in the laboratory each working day for 5 consecutive days showed similar real-life performance of both analyzers with certain differences, which has potential importance in some laboratory settings.

Ključne besede

SARS-CoV2;molecular analyzer;Abbott's Alinity M;

Podatki

Jezik: Angleški jezik
Leto izida:
Tipologija: 1.01 - Izvirni znanstveni članek
Organizacija: UL MF - Medicinska fakulteta
UDK: 616.9
COBISS: 67502851 Povezava se bo odprla v novem oknu
ISSN: 1525-1578
Št. ogledov: 78
Št. prenosov: 28
Ocena: 0 (0 glasov)
Metapodatki: JSON JSON-RDF JSON-LD TURTLE N-TRIPLES XML RDFA MICRODATA DC-XML DC-RDF RDF

Ostali podatki

Sekundarni jezik: Slovenski jezik
Sekundarne ključne besede: SARS-CoV2;molekularni analizator;Abbott's Alinity M;
Vrsta dela (COBISS): Članek v reviji
Strani: str. 920-928
Letnik: ǂVol. ǂ23
Zvezek: ǂiss. ǂ8
Čas izdaje: 2021
DOI: 10.1016/j.jmoldx.2021.05.003
ID: 16137647