A-275 Clinical Evaluation of SMARTCHEK® SARS-CoV-2 Detection Kit and SMARTCHEK® SARS-CoV-2 Fast Detection Kit for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Nasopharyngeal Swabs

Abstract

Abstract Background Rapid and accurate diagnosis of COVID-19 is very important in our daily lives. SMARTCHEK® SARS-CoV-2 Detection Kit (Genesystem, Daejeon, Korea) and SMARTCHEK® SARS-CoV-2 Fast Detection Kit (Genesystem) are rapid PCR kits for SARS-CoV-2 using a microfluidic chip-based PCR method. These two kits can provide results in 40 min and 20 min, respectively, enabling rapid point-of-care diagnostics. In this study, the diagnostic performance of SMARTCHEK® SARS-CoV-2 Detection Kit and SMARTCHEK® SARS-CoV-2 Fast Detection Kit using UF-340 Four-in-One Real-time PCR System (Genesystem) were compared to STANDARD M nCoV Real-Time Detection kit (SD Biosensor, Korea) using CFX96 Dx System (Bio-Rad, USA) in nasopharyngeal swabs. Methods Nasopharyngeal swabs were collected and frozen (at ≤−70°C) using 500ul of the residual samples of 64 patients who underwent COVID-19 PCR at Ajou University Hospital. After thawing, RNA was extracted with TANBead OptiPure Nucleic Acid Auto Plate (Taiwan Advanced Nanotech Inc., Taoyuan, Taiwan) using SLA-E13200 (Taiwan Advanced Nanotech Inc.), and real time PCR was performed according to the manufacturer’s instructions. For correlation evaluation, positive, negative, and overall concordance rates were calculated. Results Among 64 samples, results from STANDARD M nCoV Real-Time Detection kit showed 49 negative (77%) and 15 positive (23%) results. Ct value exceeding 30 was observed in 4 samples (27% of positive samples). The positive, negative, and overall concordance rates of the STANDARD M nCoV Real-Time Detection Kit and SMARTCHEK® SARS-CoV-2 Detection Kit were all 100%. One positive sample with the STANDARD M nCoV Real-Time Detection Kit (Ct value: E gene 34.5, RdRp gene 35.5) was excluded from the analysis because the results could not be determined even after repeated testing with SMARTCHEK® SARS-CoV-2 Detection Kit. The positive, negative, and overall concordance rate of the STANDARD M nCoV Real-Time Detection Kit and SMARTCHEK® SARS-CoV-2 Fast Detection Kit were 87%, 100%, and 97%, respectively. Both of the two discrepant samples had a Ct value close to 35. Conclusion SMARTCHEK® SARS-CoV-2 Detection Kit and SMARTCHEK® SARS-CoV-2 Fast Detection Kit can quickly and accurately diagnose COVID-19 in nasopharyngeal swabs and is especially useful in small to medium-sized laboratories or areas where space or equipment is limited.