ǂthe ǂAlinity m SARS-CoV-2 and cobas 6800 SARS-CoV-2 assays
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: |
2021 |
Tipologija: |
1.01 - Izvirni znanstveni članek |
Organizacija: |
UL MF - Medicinska fakulteta |
UDK: |
616.9 |
COBISS: |
67502851
|
ISSN: |
1525-1578 |
Št. ogledov: |
78 |
Št. prenosov: |
28 |
Ocena: |
0 (0 glasov) |
Metapodatki: |
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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 |