Clinical Evaluation of the cobas SARS-CoV-2 Test and a Diagnostic Platform Switch during 48 Hours in the Midst of the COVID-19 Pandemic.
COVID-19
SARS-CoV-2
cobas
cobas 6800
Journal
Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564
Informations de publication
Date de publication:
26 05 2020
26 05 2020
Historique:
received:
29
03
2020
accepted:
08
04
2020
pubmed:
12
4
2020
medline:
2
6
2020
entrez:
12
4
2020
Statut:
epublish
Résumé
Laboratories are currently witnessing extraordinary demand globally for sampling devices, reagents, consumables, and diagnostic instruments needed for timely diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To meet diagnostic needs as the pandemic grows, the U.S. Food and Drug Administration (FDA) recently granted several commercial SARS-CoV-2 tests Emergency Use Authorization (EUA), but manufacturer-independent evaluation data are scarce. We performed the first manufacturer-independent evaluation of the fully automated sample-to-result two-target test cobas 6800 SARS-CoV-2 (cobas) (Roche Molecular Systems, Branchburg, NJ), which received U.S. FDA EUA on 12 March 2020. The comparator was a standardized 3-h SARS-CoV-2 protocol, consisting of RNA extraction using an automated portable instrument, followed by a two-target reverse transcription real-time PCR (RT-PCR), which our laboratory has routinely used since January 2020 [V. M. Corman, O. Landt, M. Kaiser, R. Molenkamp, et al., Euro Surveill 25(3):pii=2000045, 2020, https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045]. cobas and the comparator showed overall agreement of 98.1% and a kappa value of 0.95 on an in-house validation panel consisting of 217 well-characterized retrospective samples. Immediate prospective head-to-head comparative evaluation followed on 502 samples, and the diagnostic approaches showed overall agreement of 99.6% and a kappa value of 0.98. A good correlation (
Identifiants
pubmed: 32277022
pii: JCM.00599-20
doi: 10.1128/JCM.00599-20
pmc: PMC7269406
pii:
doi:
Types de publication
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2020 Poljak et al.
Références
Nature. 2020 Mar;579(7798):270-273
pubmed: 32015507
Lancet. 2020 Feb 22;395(10224):565-574
pubmed: 32007145
J Clin Virol. 2004 Jan;29(1):13-22
pubmed: 14675864
BMC Infect Dis. 2010 May 11;10:113
pubmed: 20459845
Lancet. 2020 Mar 28;395(10229):1063-1077
pubmed: 32145185
N Engl J Med. 2020 Mar 5;382(10):929-936
pubmed: 32004427
J Clin Microbiol. 2020 Apr 23;58(5):
pubmed: 32132196
Euro Surveill. 2020 Mar;25(11):
pubmed: 32209163
Lancet. 2020 Feb 15;395(10223):497-506
pubmed: 31986264
J Clin Med. 2020 Feb 26;9(3):
pubmed: 32110875
Euro Surveill. 2020 Mar;25(9):
pubmed: 32156329
J Virol Methods. 2011 Nov;177(2):168-73
pubmed: 21843553
Emerg Microbes Infect. 2020 Dec;9(1):747-756
pubmed: 32196430
Nature. 2020 Mar;579(7798):265-269
pubmed: 32015508
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
N Engl J Med. 2020 Feb 20;382(8):727-733
pubmed: 31978945
J Virol Methods. 2013 Aug;191(2):118-21
pubmed: 23583489
J Clin Virol. 2020 Feb 28;125:104305
pubmed: 32143123