KMID : 0381120210430111277
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Genes and Genomics 2021 Volume.43 No. 11 p.1277 ~ p.1288
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Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19
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Lee Cherl-Joon
Shin Won-Seok Mun Se-Young Yu Min-Jae Choi Young-Bong Kim Dong-Hee Han Kyu-Dong
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Abstract
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Background: Coronavirus disease of 2019 (COVID-19) is well known as a fatal disease, first discovered at Wuhan in China, ranging from mild to death, such as shortness of breath and fever. Early diagnosis of COVID-19 is a crucial point in preventing global prevalence.
Objective: We aimed to evaluate the diagnostic competency and efficiency with the Allplex¢â 2019-nCoV Assay kit and the Dr. PCR 20 K COVID-19 Detection kit, designed based on the qRT-PCR and dPCR technologies, respectively.
Methods: A total of 30 negative and 20 COVID-19 positive specimens were assigned to the diagnostic test by using different COVID-19 diagnosis kits. Diagnostic accuracy was measured by statistical testing with sensitivity, specificity, and co-efficiency calculations.
Results: Comparing both diagnostic kits, we confirmed that the diagnostic results of 30 negative and 20 positive cases were the same pre-diagnostic results. The diagnostic statistics test results were perfectly matched with value (1). Cohen¡¯s Kappa coefficient was demonstrated that the given kits in two different ways were ¡°almost perfect¡± with value (1). In evaluating the detection capability, the dilutional linearity experiments substantiate that the Dr. PCR 20 K COVID-19 Detection kit could detect SARS-CoV-2 viral load at a concentration ten times lower than that of the Allplex¢â 2019-nCoV Assay kit.
Conclusions: In this study, we propose that the dPCR diagnosis using LOAA dPCR could be a powerful method for COVID-19 point-of-care tests requiring immediate diagnosis in a limited time and space through the advantages of relatively low sample concentration and small equipment size compared to conventional qRT-PCR.
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KEYWORD
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Coronavirus disease of 2019, Severe Acute Respiratory Syndrome Coronavirus 2, quantitative real-time PCR, Digital PCR
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