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

Abstract 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...

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Autores principales:	Yoon-Seok Chung, Nam-Joo Lee, Sang Hee Woo, Jeong-Min Kim, Heui Man Kim, Hye Jun Jo, Ye Eun Park, Myung-Guk Han
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/4ea30b3a7a0248d6950595262d139fc6
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spelling	oai:doaj.org-article:4ea30b3a7a0248d6950595262d139fc62021-12-02T17:55:03ZValidation of real-time RT-PCR for detection of SARS-CoV-2 in the early stages of the COVID-19 outbreak in the Republic of Korea10.1038/s41598-021-94196-32045-2322https://doaj.org/article/4ea30b3a7a0248d6950595262d139fc62021-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-94196-3https://doaj.org/toc/2045-2322Abstract 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.Yoon-Seok ChungNam-Joo LeeSang Hee WooJeong-Min KimHeui Man KimHye Jun JoYe Eun ParkMyung-Guk HanNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Yoon-Seok Chung Nam-Joo Lee Sang Hee Woo Jeong-Min Kim Heui Man Kim Hye Jun Jo Ye Eun Park Myung-Guk Han 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
description	Abstract 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.
format	article
author	Yoon-Seok Chung Nam-Joo Lee Sang Hee Woo Jeong-Min Kim Heui Man Kim Hye Jun Jo Ye Eun Park Myung-Guk Han
author_facet	Yoon-Seok Chung Nam-Joo Lee Sang Hee Woo Jeong-Min Kim Heui Man Kim Hye Jun Jo Ye Eun Park Myung-Guk Han
author_sort	Yoon-Seok Chung
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/4ea30b3a7a0248d6950595262d139fc6
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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

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