一种新型严重急性呼吸综合征冠状病毒2实时逆转录聚合酶链反应诊断试剂盒的多中心临床评估
A multiple-center clinical evaluation of a new real-time reverse transcriptase PCR diagnostic kit for SARS-CoV-2.
作者信息
Guo Jing-Jing, Yu Yan-Hua, Ma Xue-Ying, Liu Ya-Nan, Fang Qian, Qu Pei, Guo Jie, Lou Jin-Li, Wang Ya-Jie
机构信息
Department of Clinical Laboratory, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Department of Clinical Laboratory, Beijing Youan Hospital, Capital Medical University, Beijing, China.
出版信息
Future Virol. 2020 Oct. doi: 10.2217/fvl-2020-0299.
The outbreak of severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has had serious repercussions worldwide. This study was aimed to evaluate the accuracy of a new kit for detection of SARS-CoV-2 compared with similar detection kit. A total of 500 subjects were included and tested with both the new test and control kits. Clinical diagnosis results were taken as the reference standard. Compared with clinical diagnosis, the sensitivity of the test kit was 82.64%, specificity was 98.45% and total coincidence rate was 90.80%. The total coincidence rate, sensitivity and specificity between control kit and clinical diagnosis were 89.20%, 78.10% and 99.61%, respectively. The new kit was comparable to the similar detection kit for detection of SARS-CoV-2 in sensitivity, specificity and total coincidence rate.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的爆发在全球范围内造成了严重影响。本研究旨在评估一种新型SARS-CoV-2检测试剂盒与类似检测试剂盒相比的准确性。共纳入500名受试者，使用新型检测试剂盒和对照试剂盒进行检测。以临床诊断结果作为参考标准。与临床诊断相比，检测试剂盒的灵敏度为82.64%，特异性为98.45%，总符合率为90.80%。对照试剂盒与临床诊断之间的总符合率、灵敏度和特异性分别为89.20%、78.10%和99.61%。新型试剂盒在检测SARS-CoV-2的灵敏度、特异性和总符合率方面与类似检测试剂盒相当。
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