KMID : 0381120220440050617
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Genes and Genomics 2022 Volume.44 No. 5 p.617 ~ p.628
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Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR¢â Di20K COVID-19 Detection Kit without viral RNA extraction
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Shin Won-Seok
Lee Cherl-Joon Lee Yong-Moon Choi Young-Bong Mun Se-Young Han Kyu-Dong
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Abstract
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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¢â 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¢â 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.
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KEYWORD
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COVID-19, qRT-PCR, dPCR, Point-of-care testing, POCT
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