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Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction

BACKGROUND: Since COVID-19 was declared the pandemic by the WHO, it has continued to spread. There is a need for rapid, efficient, and accurate diagnostic kits and techniques to control its spread. OBJECTIVE: The diagnostic capability of the qRT-PCR-based Real-Q 2019-nCoV Detection Kit and dPCR-base...

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Autores principales: Shin, Wonseok, Lee, Cherl-Joon, Lee, Yong-Moon, Choi, Young-Bong, Mun, Seyoung, Han, Kyudong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Nature Singapore 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8965542/
https://www.ncbi.nlm.nih.gov/pubmed/35353341
http://dx.doi.org/10.1007/s13258-022-01242-z
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author Shin, Wonseok
Lee, Cherl-Joon
Lee, Yong-Moon
Choi, Young-Bong
Mun, Seyoung
Han, Kyudong
author_facet Shin, Wonseok
Lee, Cherl-Joon
Lee, Yong-Moon
Choi, Young-Bong
Mun, Seyoung
Han, Kyudong
author_sort Shin, Wonseok
collection PubMed
description BACKGROUND: Since COVID-19 was declared the pandemic by the WHO, it has continued to spread. There is a need for rapid, efficient, and accurate diagnostic kits and techniques to control its spread. OBJECTIVE: The diagnostic capability of the qRT-PCR-based Real-Q 2019-nCoV Detection Kit and dPCR-based Dr. PCR™ Di20K COVID-19 Detection Kit was compared and evaluated. METHODS: Diagnostic tests for COVID-19 were performed using two different COVID-19 kits and 301 individual specimens with confirmed COVID-19 positive/negative at the government-accredited medical institution. Assessment of diagnostic capability was measured through diagnostic sensitivity, specificity, Cohen’s Kappa coefficient, and dilutional linearity tests. RESULTS: The COVID-19 diagnostic test results using two kits and 301 individual specimens perfectly matched the pre-diagnosis results of the medical institution. In addition, the measurement results of diagnostic sensitivity and specificity were “1”, indicating high diagnostic capability. Cohen’s Kappa coefficient value is “1”, which means that the diagnosis concordance between the two kits is “Almost Perfect”. As a result of dilutional linearity tests to evaluate their detection capability, both kits were measured with very high detection reliability. CONCLUSION: Here, we propose that the dPCR-based Dr. PCR™ Di20K COVID-19 Detection Kit has the advantages of the dPCR method reported in the previous study and is suitable for point-of-care testing (POCT) by overcoming the limitations of space, test time, cross-over contamination, and biosafety due to omitting RNA extraction process. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13258-022-01242-z.
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spelling pubmed-89655422022-03-30 Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction Shin, Wonseok Lee, Cherl-Joon Lee, Yong-Moon Choi, Young-Bong Mun, Seyoung Han, Kyudong Genes Genomics Research Article BACKGROUND: Since COVID-19 was declared the pandemic by the WHO, it has continued to spread. There is a need for rapid, efficient, and accurate diagnostic kits and techniques to control its spread. OBJECTIVE: The diagnostic capability of the qRT-PCR-based Real-Q 2019-nCoV Detection Kit and dPCR-based Dr. PCR™ Di20K COVID-19 Detection Kit was compared and evaluated. METHODS: Diagnostic tests for COVID-19 were performed using two different COVID-19 kits and 301 individual specimens with confirmed COVID-19 positive/negative at the government-accredited medical institution. Assessment of diagnostic capability was measured through diagnostic sensitivity, specificity, Cohen’s Kappa coefficient, and dilutional linearity tests. RESULTS: The COVID-19 diagnostic test results using two kits and 301 individual specimens perfectly matched the pre-diagnosis results of the medical institution. In addition, the measurement results of diagnostic sensitivity and specificity were “1”, indicating high diagnostic capability. Cohen’s Kappa coefficient value is “1”, which means that the diagnosis concordance between the two kits is “Almost Perfect”. As a result of dilutional linearity tests to evaluate their detection capability, both kits were measured with very high detection reliability. CONCLUSION: Here, we propose that the dPCR-based Dr. PCR™ Di20K COVID-19 Detection Kit has the advantages of the dPCR method reported in the previous study and is suitable for point-of-care testing (POCT) by overcoming the limitations of space, test time, cross-over contamination, and biosafety due to omitting RNA extraction process. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13258-022-01242-z. Springer Nature Singapore 2022-03-30 2022 /pmc/articles/PMC8965542/ /pubmed/35353341 http://dx.doi.org/10.1007/s13258-022-01242-z Text en © The Author(s) under exclusive licence to The Genetics Society of Korea 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Research Article
Shin, Wonseok
Lee, Cherl-Joon
Lee, Yong-Moon
Choi, Young-Bong
Mun, Seyoung
Han, Kyudong
Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction
title Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction
title_full Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction
title_fullStr Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction
title_full_unstemmed Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction
title_short Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction
title_sort rapid identification of sars-cov-2 in the point-of-care using digital pcr-based dr. pcr™ di20k covid-19 detection kit without viral rna extraction
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8965542/
https://www.ncbi.nlm.nih.gov/pubmed/35353341
http://dx.doi.org/10.1007/s13258-022-01242-z
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