Clinical performance 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 saliva

초록

Background-Aim Saliva is a good alternative to the nasopharyngeal swab because it is non-invasive and does not require separate collection personnel. SMARTCHEK SARS-CoV-2 Detection Kit (Genesystem, 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 minutes and 20 minutes, respectively, enabling rapid point-of-care diagnostics. This study compared 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) to the STANDARD M nCoV Real-Time Detection kit (SD Biosensor, Korea) using CFX96 Dx System (Bio-Rad Laboratories, Inc., USA) in saliva. Methods Saliva was collected in a sterile specimen cup after obtaining consent from subjects who were scheduled to perform a COVID-19 PCR within 24 hours or had already performed it within 24 hours. RNA was extracted by SLA-E13200 (Taiwan Advanced Nanotech Inc., Taiwan). Real-time PCR was performed according to each manufacturer’s guidelines. The STANDARD M nCoV Real-Time Detection kit after RNA extraction by SLA-E13200 was tested as the control method. The positive, negative, and overall concordance rates were calculated for evaluation of correlation with the control method. Results Among 90 samples, the control method identified 66 negative and 24 positive samples, four of which showed Ct values exceeding 30. When RNA was extracted with SLA-E13200, the positive, negative, and overall concordance rates of SMARTCHEK SARS-CoV-2 Detection Kit and SMARTCHEK SARS-CoV-2 Fast Detection Kit were 100 %, 100 %, 100 %, and 96 %, 100 %, 98 %, respectively. Conclusions SMARTCHEK SARS-CoV-2 Detection Kit and SMARTCHEK SARS-CoV-2 Fast Detection Kit can quickly and accurately diagnose COVID-19 in saliva after RNA extraction with SLA-E13200, and may be useful especially in small to medium-sized laboratories lacking in space or equipment.