一种无需RNA提取和纯化的新型SARS-CoV-2检测试剂盒的效能
Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification.
作者信息
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
机构信息
Division of Laboratory and Transfusion Medicine, Hokkaido University Hospital, Sapporo, Japan.
Department of Respiratory Medicine, Hokkaido University Faculty of Medicine, Sapporo, Japan.
出版信息
Int J Infect Dis. 2020 Sep;98:16-17. doi: 10.1016/j.ijid.2020.06.074. Epub 2020 Jun 26.
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.
快速检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）对于2019冠状病毒病（COVID-19）的诊断和防止病毒传播至关重要。一种新型检测试剂盒——2019新型冠状病毒检测试剂盒（nCoV-DK）——通过省去RNA提取和纯化步骤，将检测时间减半。我们评估了nCoV-DK与直接PCR之间的一致性。直接PCR在71份标本中的53份（74.6%）检测到病毒，nCoV-DK在71份标本中的55份（77.5%）检测到病毒；总体一致性率为94.4%：鼻咽拭子为95.2%，唾液为95.5%，痰液为85.7%。nCoV-DK检测能有效检测包括唾液在内的所有类型样本中的SARS-CoV-2，同时减少了检测所需时间、人力以及人为误差风险。
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