Int J Infect Dis . Efficacy of a Novel SARS-CoV-2 Detection Kit Without RNA Extraction and Purification

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Int J Infect Dis


. 2020 Jun 26;S1201-9712(20)30509-9.
doi: 10.1016/j.ijid.2020.06.074. Online ahead of print.
Efficacy of a Novel SARS-CoV-2 Detection Kit Without RNA Extraction and Purification

Tatsuya Fukumoto ¹ , Sumio Iwasaki ¹ , Shinichi Fujisawa ¹ , Kasumi Hayasaka ¹ , Kaori Sato ¹ , Satoshi Oguri ¹ , Keisuke Taki ¹ , Sho Nakakubo ² , Keisuke Kamada ² , Yu Yamashita ² , Satoshi Konno ² , Mutsumi Nishida ¹ , Junichi Sugita ¹ , Takanori Teshima ³


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• PMID: 32599282
• DOI: 10.1016/j.ijid.2020.06.074

Abstract

Rapid detection of SARS-CoV-2 is critical for the diagnosis of coronavirus disease 2019 (COVID-19) and preventing the spread of the virus. A novel "2019 Novel Coronavirus Detection Kit (nCoV-DK)" halves detection time by eliminating the steps of RNA extraction and purification. We evaluated concordance between the nCoV-DK and direct PCR. The virus was detected in 53/71 (74.6%) and 55/71 (77.5%) by the direct PCR and nCoV-DK, respectively, with overall concordance rate of 94.4%: 95.2% in nasopharyngeal swab, 95.5% in saliva, and 85.7% in sputum. The nCoV-DK effectively detects SARS-CoV-2 in all types of the samples including saliva, while reducing time required for detection, labor, and risk of human error.

Keywords: COVID-19; PCR; SARS-CoV-2; Saliva.