Li Hua, Liu Zhe, He Yue, Qi Yingjie, Chen Jie, Ma Yuanyuan, Liu Fujia, Lai Kaisheng, Zhang Yong, Jiang Liu, Wang Xiangdong, Ge Junbo
Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Shanghai Xuhui District Central Hospital & Zhongshan-xuhui Hospital, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Medicine, BestNovo (Beijing) Medical Technology Co., Ltd, Beijing, China.
Clin Transl Med. 2020 Jun;10(2):e90. doi: 10.1002/ctm2.90. Epub 2020 Jun 5.
The pandemic of novel coronavirus disease 2019 (COVID-19) seriously threatened the public health all over the world. A colloidal gold immunochromatography assay for IgM/IgG antibodies against the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 protein was established to assess its rapid diagnostic value. We first designed and manufactured all contents of the test cassette of SARS-CoV-2 rapid test kit: the colloidal gold-labeled mouse-antihuman lgM/lgG antibody, the recombinant SARS-CoV-2 antigen, the nitrocellulose membrane control line, and specimen diluents. Furthermore, reverse transcription-polymerase chain reaction (RT-PCR) assay, colloidal gold immunochromatography assay, serological validation of cross reaction with other common viruses, and clinical validation were performed. The kit was finally evaluated by 75 serum/plasma samples of SARS-CoV-2 infection cases and 139 healthy samples as control, with the result of that the sensitivity, specificity, and accuracy for IgM were 90.67%, 97.84%, and 95.33%, whereas for IgG were 69.33%, 99.28%, and 88.79%, respectively; the combination of IgM and IgG could improve the value: 92.00%, 97.12%, and 95.33%, respectively. Therefore, the rapid detection kit has high sensitivity and specificity, especially for IgM&IgG, showing a critical value in clinical application and epidemic control of COVID-19.
2019年新型冠状病毒病（COVID-19）大流行严重威胁着全球公众健康。为评估其快速诊断价值，建立了一种针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）S1蛋白受体结合域的IgM/IgG抗体胶体金免疫层析检测方法。我们首先设计并制作了SARS-CoV-2快速检测试剂盒检测卡的所有内容物：胶体金标记的鼠抗人IgM/IgG抗体、重组SARS-CoV-2抗原、硝酸纤维素膜质控线和样本稀释液。此外，还进行了逆转录-聚合酶链反应（RT-PCR）检测、胶体金免疫层析检测、与其他常见病毒交叉反应的血清学验证以及临床验证。该试剂盒最终以75份SARS-CoV-2感染病例的血清/血浆样本和139份健康样本作为对照进行评估，结果显示，IgM的敏感性、特异性和准确性分别为90.67%、97.84%和95.33%，而IgG的分别为69.33%、99.28%和88.79%；IgM和IgG联合使用可提高检测价值，分别为92.00%、97.12%和95.33%。因此，该快速检测试剂盒具有较高的敏感性和特异性，尤其是对IgM和IgG，在COVID-19的临床应用和疫情防控中显示出重要价值。
