Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2.
Betacoronavirus
/ genetics
COVID-19
COVID-19 Testing
COVID-19 Vaccines
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Humans
Molecular Diagnostic Techniques
/ methods
Pandemics
Pneumonia, Viral
/ diagnosis
Reagent Kits, Diagnostic
/ standards
SARS-CoV-2
Sensitivity and Specificity
COVID-19
Clinical virology
Molecular diagnostics
SARS-CoV-2
Journal
Journal of virological methods
ISSN: 1879-0984
Titre abrégé: J Virol Methods
Pays: Netherlands
ID NLM: 8005839
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
05
06
2020
revised:
18
08
2020
accepted:
08
09
2020
pubmed:
14
9
2020
medline:
21
10
2020
entrez:
13
9
2020
Statut:
ppublish
Résumé
The global COVID-19 pandemic has led to the rapid development of tests for detection of SARS-CoV-2. Studies are required to assess the relative performance of different assays. Here, we compared the performance of two commercial assays, the cobas® SARS-CoV-2 (Roche Diagnostics) and Xpert® Xpress SARS-CoV-2 (Cepheid®) tests, and a laboratory developed RT-PCR test adapted for use on the Hologic® Panther Fusion® (Hologic®) instrument as well as Bio-Rad and QIAGEN real-time PCR detection systems. Performance characteristics for each test were determined by testing clinical specimens and reference material. All assays detect the pan-Sarbecovirus E (envelope structural protein) gene plus a SARS-CoV-2-specific target. The limit of detection for the E gene target varied from ∼2 copies/reaction to >30 copies/reaction. Due to assay-specific differences in sample processing and nucleic acid extraction, the overall analytical sensitivity ranged from 24 copies/mL specimen to 574 copies/mL specimen. Despite these differences, there was 100 % agreement between the commercial and laboratory developed tests. No false-negative or false-positive SARS-CoV-2 results were observed and there was no cross-reactivity with common respiratory viruses, including endemic coronaviruses.
Identifiants
pubmed: 32920028
pii: S0166-0934(20)30222-6
doi: 10.1016/j.jviromet.2020.113970
pmc: PMC7482591
pii:
doi:
Substances chimiques
COVID-19 Vaccines
0
Covid-19 aAPC vaccine
0
Reagent Kits, Diagnostic
0
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
113970Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
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