一种新型冠状病毒抗原检测试剂性能分析和临床评价

      Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance

      • 摘要: 目的 快速筛查包括无症状在内的新型冠状病毒(COVID-19)感染者。方法 使用胶体金免疫层析技术建立一种抗原快速检测试剂,进行分析性能评估,验证其临床应用。结果 该检测试剂的最低检出限为9.75×102 TCID50/mL;测试29种常见呼吸道病原体高浓度样本均无交叉反应和干扰。临床样本测试,诊断灵敏度为98.56%,特异性为99.00%,总符合率为98.85%;一致性检验Kappa值为0.974 5;对不同Ct值阳性样本分层分析,每个层级内符合率均大于95%。结论 该试剂检测性能优异,检测速度快,操作便携,可作为现有核酸检测法的补充手段,用于新型冠状病毒的早期筛查。

         

        Abstract: Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.

         

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