Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays.


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:
24 08 2020
Historique:
received: 17 06 2020
accepted: 09 07 2020
pubmed: 12 7 2020
medline: 9 9 2020
entrez: 12 7 2020
Statut: epublish

Résumé

Analytical sensitivity for SARS-CoV-2 detection is a key performance metric for the evaluation of viral detection assays. We determined analytical limits of detection for seven SARS-CoV-2 assays using serial dilutions of pooled patient material quantified with droplet digital PCR. Limits of detection ranged from ≤10 to 74 copies/ml for commercial high-throughput laboratory analyzers (Roche Cobas, Abbott m2000, and Hologic Panther Fusion) and 167 to 511 copies/ml for sample-to-answer (DiaSorin Simplexa, GenMark ePlex) and point-of-care instruments (Abbott ID NOW). The CDC assay yielded limits of detection ranging from 85 to 499 copies/ml, depending on the extraction method and thermocycler used. These results can help to inform the assay choice for testing approaches to manage the current COVID-19 outbreak.

Identifiants

pubmed: 32651238
pii: JCM.01535-20
doi: 10.1128/JCM.01535-20
pmc: PMC7448668
pii:
doi:

Substances chimiques

RNA, Viral 0

Types de publication

Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2020 American Society for Microbiology.

Références

J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32381643
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32341143
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32327448
Emerg Microbes Infect. 2020 Dec;9(1):1259-1268
pubmed: 32438868
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32332061
N Engl J Med. 2020 Mar 19;382(12):1177-1179
pubmed: 32074444
Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1059-1061
pubmed: 32342252
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32350048
Emerg Infect Dis. 2020 Jul;26(7):
pubmed: 32364890
Clin Microbiol Rev. 2010 Jul;23(3):550-76
pubmed: 20610823

Auteurs

Becky Fung (B)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.

Allan Gopez (A)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, California, USA.

Venice Servellita (V)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, California, USA.

Shaun Arevalo (S)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, California, USA.

Coral Ho (C)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.

Anne Deucher (A)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.

Ed Thornborrow (E)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.

Charles Chiu (C)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, California, USA.

Steve Miller (S)

Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA steve.miller@ucsf.edu.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, California, USA.

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Classifications MeSH