Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays.
Betacoronavirus
/ isolation & purification
Bronchoalveolar Lavage Fluid
/ virology
COVID-19
Coronavirus Infections
/ diagnosis
Humans
Molecular Diagnostic Techniques
/ methods
Nasopharynx
/ virology
Pandemics
Pneumonia, Viral
/ diagnosis
RNA, Viral
/ isolation & purification
Reagent Kits, Diagnostic
/ standards
SARS-CoV-2
Sensitivity and Specificity
COVID-19
LOD
SARS-CoV-2
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
16
04
2020
revised:
19
04
2020
accepted:
21
04
2020
pubmed:
4
5
2020
medline:
17
6
2020
entrez:
4
5
2020
Statut:
ppublish
Résumé
In December 2019, a novel coronavirus (SARS-CoV-2) was first isolated from Wuhan city, China and within three months, the global community was challenged with a devastating pandemic. The rapid spread of the virus challenged diagnostic laboratories to rapidly develop molecular diagnostic methods. As SARS CoV-2 assays became available for testing on existing molecular platforms, laboratories devoted unprecedented energy and resources into evaluating the analytical performance of the new tests and in some cases developed their own diagnostic assays under FDA-EUA guidance. This study compares the validation of three different molecular assays at the Johns Hopkins Molecular Virology laboratory: the RealStar® SARS-CoV-2 RT-PCR, ePlex® SARS-CoV-2, and the CDC COVID-19 RT-PCR tests. Overall, our studies indicate a comparable analytical performance of the three assays for the detection of SARS-CoV-2.
Identifiants
pubmed: 32361285
pii: S1386-6532(20)30126-8
doi: 10.1016/j.jcv.2020.104384
pmc: PMC7194987
pii:
doi:
Substances chimiques
RNA, Viral
0
Reagent Kits, Diagnostic
0
Types de publication
Comparative Study
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
104384Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
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