Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification. (September 2020)

• Record Type: Journal Article
• Authors: Fukumoto, Tatsuya; Iwasaki, Sumio; Fujisawa, Shinichi; Hayasaka, Kasumi; Sato, Kaori; Oguri, Satoshi; Taki, Keisuke; Nakakubo, Sho; Kamada, Keisuke; Yamashita, Yu; Konno, Satoshi; Nishida, Mutsumi; Sugita, Junichi; Teshima, Takanori
• Is Part Of: International journal of infectious diseases. Volume 98(2020)
• Page Start: 16
• Page End: 17
• Publication Date: 2020-09
• Subjects: COVID-19 -- SARS-CoV-2 -- PCR -- Saliva; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2020.06.074
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: The 2019 Novel Coronavirus Detection Kit (nCoV-DK) halves the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection time by eliminating RNA extraction and purification. nCoV-DK detects SARS-CoV-2 as effectively as the direct PCR. Saliva is a reliable sample for the detection of SARS-CoV-2 by nCoV-DK. 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.