Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification
Tatsuya Fukumoto, Sumio Iwasaki, Shinichi Fujisawa, Kasumi Hayasaka, Kaori Sato, Satoshi Oguri, Keisuke Taki, Sho Nakakubo, Keisuke Kamada, Yu Yamashita, Satoshi Konno, Mutsumi Nishida, Junichi Sugita, Takanori Teshima
Abstract
Rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical for the diagnosis of coronavirus disease 2019 (COVID-19) and preventing the spread of the virus. A novel detection kit - the 2019 Novel Coronavirus Detection Kit (nCoV-DK) - halves the detection time by eliminating the steps of RNA extraction and purification. We evaluated the concordance between the nCoV-DK and direct PCR. The virus was detected in 53/71 specimens (74.6%) by direct PCR and in 55/71 specimens (77.5%) by nCoV-DK; the overall concordance rate was 94.4%: 95.2% for nasopharyngeal swab, 95.5% for saliva, and 85.7% for sputum. The nCoV-DK test effectively detects SARS-CoV-2 in all types of sample including saliva, while reducing the time required for detection, labor, and the risk of human error.