国产新型冠状病毒抗体胶体金法检测试剂盒在低流行区应用的诊断效果评价

Evaluation of Two Different Domestic Colloidal Gold Assay Kit for New Coronavirus Antibody in Low Endemic Areas

目的探讨评价两种不同的国产新型冠状病毒抗体胶体金法检测试剂盒的2019-nCoV免疫球蛋白M抗体(抗-IgM)和免疫球蛋白G抗体(抗-IgG)检测试剂在低流行区北京地区的应用与诊断效果,指导临床合理应用。方法选取新型冠状病毒肺炎(COVID-19)确诊患者29例和非感染筛查人群19411例的血清,采用胶体金免疫层析法,评价国产珠海丽珠及唐山英诺特的2019-nCoV抗体检测试剂盒的的灵敏度、特异度、假阳性率等性能指标。结果英诺特2019-nCoV灵敏度稍高于丽珠2019-nCoV,灵敏度分别为58.62%,55.17%;抗体全阴组的标本采集时间明显小于抗体阳性各组(P<0.05);低流行区两种试剂复合报告抗体假阳性率0.16%,2019-nCoV IgG假阳性率英诺特高于丽珠;同一品牌的2019-nCoV IgM假阳性率显著高于IgG(英诺特χ2=14.75609,P=0.0000;丽珠χ^(2)=27.49262,P=0.0000)。结论2019-nCoV抗体检测快速、简单易操作、特异度高,可作为新冠的快速筛查指标;两种试剂盒的特异度、正确率和阴性预测值较好,出现阳性结果时应用另一种试剂盒进行复测,可减少通报临床的假阳性率;新冠抗体阳性报告的应用与分析应结合流行区及临床综合判断。

Objective To evaluate the application and diagnostic effect of two different domestic New Coronavirus antibody colloid gold detection kit 2019-nCoV immunoglobulin M antibody(anti-IgM)and immunoglobulin G antibody(anti-IgG)detection reagent in Beijing Area of low epidemic area,so as to guide clinical rational application.Methods The total serum were collected form 29 Novel Coronavirus Pneumonia(COVID-19)patients and 19411 non infectious screening cases according to the epidemiological history,clinical manifestations,imaging examinations and nucleic acid test results.The sensitivity,specificity and false positive rate of the 2019-nCoV antibody detection kit LIZHU and INNOTECH made in Zhuhai and Tangshan respectively were evaluated.The detection method was colloidal gold immune layer.The influencing and the reasons were analyzed.Results The sensitivity of Innot 2019 nCov was slightly higher than that of LIZHU 2019 nCov,which were 58.62% and 55.17% respectively.The specimen collection time of the antibody negative group was significantly shorter than that of the antibody positive groups(P<0.05).The false positive rate of two reagents in low epidemic areas was 0.16%,and the false positive rate of 2019-nCoV IgG in INNOTECH was higher than that in LIZHU.The false positive rate of 2019-nCoV IgM in the same brand was significantly higher than that of IgG(Innotech χ^(2)=14.75609,P=0.0000 and LIZHU χ^(2)=27.49262,P=0.0000).Conclusion 2019-nCoV antibody detection is fast,easy to operate,and highly specific,which can be used as a rapid screening indicator for COVID-19.The specificity,accuracy and negative predictive value of the two kits were better.When a positive result appears,another kit is used for retesting,which can reduce the false positive rate of clinical reports.The application and analysis of the positive report of 2019-nCoV antibody should be comprehensive judgment combined with the epidemic areas and clinical.