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新聞新發展新型冠狀病毒2019-nCoV核酸檢測試劑盒（熒光RT-RAA法）完成三家臨床評估
2020-06-12 10:33:06
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中國疾病預防中心病毒病預防控制所 和 江蘇奇天基因生物科技有限公司 聯合研制的新型冠狀病毒（ 2019-nCoV ）核酸等溫擴增快速檢測試劑盒分別在浙江大學醫學院附屬第一醫院（ 92 例臨床標本），浙江省疾病預防控制中心（ 104 例臨床標本）和江蘇省疾病預防控制中心（ 100 例標本）完成了臨床評估。標本在提取核酸后，使用本試劑盒檢測新型冠狀病毒核酸 8-15 分鐘 出檢測結果 。經分別與藥監局批準的商業化定量 PCR 試劑盒平行比較，試劑盒的陽性符合率 100% ，陰性符合率 100% ， 總符合率 100% ，具有等效性。該試劑盒被上述評價單位推薦用于臨床 2019-nCoV 的定性檢測，鑒別 2019-nCoV 疑似感染的病人。該試劑盒適宜于在地市級實驗室使用。目前該試劑盒正在申報藥監局批準文號。
疾控中心病毒病預防控制所研發團隊于2020年4月，在《 Clinical Microbiology and Infection 》 上 發表了相關文章： 標題為：《 A multiple center clinical evaluation of an ultra-fast single-tube assay for SARS-CoV-2 RNA 》。摘要內容如下：
Abstract
Objectives: To evaluate the performance of an ultra-fast single-tube nucleic acid isothermal amplification detection assay for SARS-CoV-2 RNA using clinical samples from 44 multiple centers.
Methods: A reverse transcription recombinase-aided amplification (RT-RAA) assay for SARS-CoV-2 was conducted within 15minutesat39? with portable instruments after addition of extracted RNA. The clinical performance of RT-RAA assay was evaluated using 947 clinical samples from five institutions in four regions of China, and the approved commercial real-time fluorescent RT-PCR (qRT-PCR) kits were used for parallel detection. The sensitivity and specificity of RT-RAA were compared and analyzed.
Results: The RT-RAA test results of 926 samples were consistent with those of qRT-PCR (330 were positive, 596 were negative) and 21 were inconsistent. The sensitivity and specificity of RT-RAA was 97.63% [330/338, 95% confidence interval (CI): 95.21 to 98.90] and 97.87% (596/609, 95% CI: 96.28 to 98.81), respectively. The positive predictive value (PPV) and negative predictive value (NPV) were 96.21% (330/343, 95% CI: 93.45 to 97.88), and 98.68% (596/604, 95% CI: 97.30 to 99.38), respectively. The total coincidence rate was 97.78% (926/947, 95% CI: 96.80 to 98.70) and the Kappa was 0.952 (P <0.05).
Conclusion: With comparable sensitivity and specificity to the commercial qRT-PCR kits, RT-RAA assay for SARS-CoV-2 exhibited distinctive advantages of simplicity and rapidity in terms of operation and turn-around time.
