基于微量中和试验的社区健康人群新型冠状病毒中和抗体高通量检测方法评价-东南大学学报医学版

基于微量中和试验的社区健康人群新型冠状病毒中和抗体高通量检测方法评价

作者：张诗晗¹ 田华² 姜娜³ 王笑辰² 黄昊頔² 李楚楚² 孔筱筱² 董晨² 周璐² 彭杰夫² 郭喜玲² 金辉¹ 朱立国²

单位：1. 东南大学公共卫生学院流行病与卫生统计学系环境医学工程教育部重点实验室, 江苏南京 210009;
2. 江苏省疾病预防控制中心急性传染病防制所, 江苏南京 210009;
3. 建邺区疾病预防控制中心免疫计划科, 江苏南京 210031

关键词：微量中和试验社区健康人群中和抗体高通量

分类号：R183.3; R-33

出版年·卷·期（页码）：2023·42·第三期（439-445）

摘要：

目的: 以微量中和试验为金标准,评价胶体金法和酶联免疫吸附法这两种高通量检测方法的检测能力。方法: 以江苏省南京市某社区招募的250名健康成年人为研究对象,采集血样开展中和抗体水平分析,用微量中和试验、胶体金法和酶联免疫吸附法分别对血样进行测试,评价这两种高通量中和抗体检测方法的灵敏度、特异度及与金标准的相关系数等。结果: 当金标准的判定界值取为1∶4时(<4为阴性),胶体金法的灵敏度为97.50%,特异度为98.82%,正确指数为0.963,与金标准之间的Kappa值为0.963 2;酶联免疫吸附法的灵敏度为95.00%,特异度为100.00%,正确指数为0.950,Kappa值为0.962 7。这两种方法相对于微量中和试验的相关系数为0.963。结论: 建立的新型冠状病毒中和抗体高通量检测方法具有科学性和可行性。

Objective: To evaluate the detection capability of two high-throughput assays, colloidal gold and enzyme-linked immunosorbent assay, based on a micro-neutralisation test as the gold standard. Methods: Blood samples were collected from 250 healthy adults recruited from a community in Nanjing, Jiangsu Province for neutralizing antibody level analysis. The blood samples were tested by micro-neutralization test, colloidal gold method and enzyme-linked immunosorbent assay were used to evaluate the sensitivity, specificity and correlation coefficient with the gold standard of these two high-throughput neutralizing antibody assays. Results: The sensitivity of the colloidal gold method was 97.50%, the specificity was 98.82%, the Youden's index was 0.963 and the Kappa value between the gold standard and the ELISA was 0.963 2. The sensitivity of the ELISA was 95.00%, the specificity was 100.00%, the Youden's index was 0.950 and the Kappa value was 0.962 7. The correlation coefficient on these two methods relative to the micro-neutralisation test was 0.963. Conclusion: The high-throughput methods for the detection of SARS-CoV-2 neutralizing antibodies are scientific and feasible.

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