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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
ID
Kogoj, Rok
(
Avtor
),
ID
Kmetič, Petra
(
Avtor
),
ID
Oštrbenk Valenčak, Anja
(
Avtor
),
ID
Fujs Komloš, Kristina
(
Avtor
),
ID
Seme, Katja
(
Avtor
),
ID
Sagadin, Martin
(
Avtor
),
ID
Korva, Miša
(
Avtor
),
ID
Poljak, Mario
(
Avtor
)
PDF - Predstavitvena datoteka,
prenos
(411,54 KB)
MD5: CD9821C51DDA5D168974CEBBD1A64CD4
URL - Izvorni URL, za dostop obiščite
https://www.sciencedirect.com/science/article/pii/S1525157821001252
Galerija slik
Izvleček
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
Število ogledov:
1364
Število prenosov:
97
Metapodatki:
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Objavi na:
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
Projekti
Financer:
Drugi - Drug financer ali več financerjev
Program financ.:
University of Ljubljana, Faculty of Medicine, Institute of Microbiology and Immunology
Financer:
ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
Številka projekta:
P3-0083
Naslov:
Odnosi parazitskega obstajanja
Financer:
ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
Številka projekta:
V3-2034
Naslov:
Epidemiologija, diagnostika, zdravljenje in preprečevanje COVID-19
Financer:
EC - European Commission
Program financ.:
H2020
Številka projekta:
871029
Naslov:
European Virus Archive GLOBAL
Akronim:
EVA-GLOBAL
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