国产新型冠状病毒(2019-nCoV)抗原检测试剂盒的性能比较

A Comparative Study of the Performance of Domestic Novel Coronavirus(2019 nCoV)Antigen Detection Kits

目的探讨不同国产新型冠状病毒(2019-nCoV)抗原检测试剂盒的阳性符合率、阴性符合率及最低检测限的差异。方法为准确衡量产品的性能,选择具有代表性的16个国产新型冠状病毒(2019-nCoV)抗原检测试剂盒,分别检测国家参考品中的阳性参考品、阴性参考品和最低检测限参考品,得出阳性符合率、阴性符合率和最低检测限并分析结果。结果16个新冠抗原检测试剂盒的阳性符合率和阴性符合率均为100%;16个新冠抗原检测试剂盒的最低检测限结果呈梯度分布。结论新型冠状病毒(2019-nCoV)抗原检测试剂盒的检测方法学及原材料不同影响试剂盒最低检测限检测结果。

Objective To evaluate differences in the positive rate,negative rate and limit of detection of different types of China's severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)antigen detection kits.Methods 16 representative China’s SARS-CoV-2 antigen detection kits were selected and tested for positive reference,negative reference and limit of detection reference in the reference products,and the positive rate,negative rate and limit of detection were derived and analyzed.Results Among 16 selected kits,all positive rates reached 100%,while all negative rates reached 100%,and limit of detection were distributed in a gradient.Conclusion The detection methodology and raw materials of SARS-CoV-2 antigen detection kits are different which can influence the results of limit of detection.