Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19

다국어 초록 (Multilingual Abstract)

Background Coronavirus disease of 2019 (COVID-19) is well known as a fatal disease, frst 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 efciency with the Allplex™ 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, specifcity, and co-efciency calculations.
Results Comparing both diagnostic kits, we confrmed 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 coefcient was demonstrated that the given kits in two diferent 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™ 2019-nCoV Assay kit.
Conclusions In this study, we propose that the dPCR diagnosis using LOAA dPCR could be a powerful method for COVID19 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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