Validation of real-time RT-PCR for detection of SARS-CoV-2 in the early stages of the COVID-19 outbreak in the Republic of Korea.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
20 07 2021
20 07 2021
Historique:
received:
12
02
2021
accepted:
22
06
2021
entrez:
21
7
2021
pubmed:
22
7
2021
medline:
30
7
2021
Statut:
epublish
Résumé
A real-time reverse transcription polymerase chain reaction (RT-qPCR) assay that does not require Emergency Use Authorization (EUA) reagents was tested and validated for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the early stages of the outbreak of coronavirus disease 2019 (COVID-19) in the Republic of Korea. Early diagnosis of COVID-19 enables timely treatment and the implementation of public health measures. We validated the sensitivity, specificity, precision, linearity, accuracy, and robustness of the RT-qPCR assay for SARS-CoV-2 detection and compared its performance with that of several EUA-approved kits. Our RT-qPCR assay was highly specific for SARS-CoV-2 as demonstrated by not amplifying 13 other viruses that cause respiratory diseases. The assay showed high linearity using a viral isolate from a patient with known COVID-19 as well as plasmids containing target SARS-CoV-2 genes as templates. The assay showed good repeatability and reproducibility with a coefficient of variation of 3%, and a SARS-CoV-2 limit of detection of 1 PFU/mL. The RT-qPCR-based assay is highly effective and can facilitate the early diagnosis of COVID-19 without the use of EUA-approved kits or reagents in the Republic of Korea.
Identifiants
pubmed: 34285290
doi: 10.1038/s41598-021-94196-3
pii: 10.1038/s41598-021-94196-3
pmc: PMC8292370
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
14817Subventions
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Organisme : This work was supported by Korea Centers for Disease Control and Prevention .
ID : [grant number 4800-4837-301]
Informations de copyright
© 2021. The Author(s).
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