tetano
Editor, Senior Moderator
Sci Rep
. 2021 Jul 20;11(1):14817.
doi: 10.1038/s41598-021-94196-3.
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
Yoon-Seok Chung[SUP] 1 [/SUP], Nam-Joo Lee[SUP] 2 [/SUP], Sang Hee Woo[SUP] 2 [/SUP], Jeong-Min Kim[SUP] 2 [/SUP], Heui Man Kim[SUP] 2 [/SUP], Hye Jun Jo[SUP] 2 [/SUP], Ye Eun Park[SUP] 3 [/SUP], Myung-Guk Han[SUP] 4 [/SUP]
Affiliations
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.
. 2021 Jul 20;11(1):14817.
doi: 10.1038/s41598-021-94196-3.
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
Yoon-Seok Chung[SUP] 1 [/SUP], Nam-Joo Lee[SUP] 2 [/SUP], Sang Hee Woo[SUP] 2 [/SUP], Jeong-Min Kim[SUP] 2 [/SUP], Heui Man Kim[SUP] 2 [/SUP], Hye Jun Jo[SUP] 2 [/SUP], Ye Eun Park[SUP] 3 [/SUP], Myung-Guk Han[SUP] 4 [/SUP]
Affiliations
- PMID: 34285290
- DOI: 10.1038/s41598-021-94196-3
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.