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新型冠状病毒2019-nCoV核酸检测试剂盒(荧光RT-RAA法)完成三家临床评估
发布时间:2020-06-12 15:02:35         阅读量:3746         来源:未知        

中国疾病预防中心病毒病预防控制所  和  江苏奇天基因生物科技有限公司 联合研制的新型冠状病毒( 2019-nCoV )核酸等温扩增快速检测试剂盒分别在浙江大学医学院附属第一医院( 92 例临床标本),浙江省疾病预防控制中心( 104 例临床标本)和江苏省疾病预防控制中心( 100 例标本)完成了临床评估。标本在提取核酸后,使用本试剂盒检测新型冠状病毒核酸 8-15 分钟 出检测结果 。经分别与药监局批准的商业化定量 PCR 试剂盒平行比较,试剂盒的阳性符合率 100% ,阴性符合率 100% 总符合率 100% ,具有等效性。该试剂盒被上述评价单位推荐用于临床 2019-nCoV 的定性检测,鉴别 2019-nCoV 疑似感染的病人。该试剂盒适宜于在地市级实验室使用。目前该试剂盒正在申报药监局批准文号。 




疾控中心病毒病预防控制所研发团队于2020年4月,在《 Clinical Microbiology and Infection 发表了相关文章: 标题为:《 A multiple center clinical evaluation of an ultra-fast single-tube assay for SARS-CoV-2 RNA 》。摘要内容如下:

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 15minutesat39ı 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.


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