Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type.
COVID-19
Ct value
Molecular diagnostics
Nasal swab
Nasopharyngeal swab
SARS-CoV-2
Journal
Diagnostic microbiology and infectious disease
ISSN: 1879-0070
Titre abrégé: Diagn Microbiol Infect Dis
Pays: United States
ID NLM: 8305899
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
08
06
2020
revised:
26
08
2020
accepted:
29
08
2020
pubmed:
28
9
2020
medline:
19
12
2020
entrez:
27
9
2020
Statut:
ppublish
Résumé
The COVID-19 pandemic in the United States created a unique situation where multiple molecular SARS-CoV-2 diagnostic assays rapidly received Emergency Use Authorization by the FDA and were validated by laboratories and utilized clinically, all within a period of a few weeks. We compared the performance of four of these assays that were evaluated for use at our institution: Abbott RealTime m2000 SARS-CoV-2 Assay, DiaSorin Simplexa COVID-19 Direct, Cepheid Xpert Xpress SARS-CoV-2, and Abbott ID NOW COVID-19. Nasopharyngeal and nasal specimens were collected from 88 ED and hospital-admitted patients and tested by the four methods in parallel to compare performance. ID NOW performance stood out as significantly worse than the other 3 assays despite demonstrating comparable analytic sensitivity. Further study determined that the use of a nasal swab compared to a nylon flocked nasopharyngeal swab, as well as use in a population chronically vs. acutely positive for SARS-CoV-2, were substantial factors.
Identifiants
pubmed: 32980807
pii: S0732-8893(20)30577-0
doi: 10.1016/j.diagmicrobio.2020.115200
pmc: PMC7470790
pii:
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115200Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
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