新型冠状病毒抗原检测胶体金法与核酸检测实时荧光RT-PCR方法比较

Comparative analysis of colloidal gold method for SARS-CoV-2 antigen detection and Real-Time RT-PCR test

目的 对比分析新型冠状病毒抗原检测胶体金法与核酸检测实时荧光RT-PCR方法的检测结果,验证抗原检测胶体金法能否快速辅助诊断新型冠状病毒感染。方法 从河南省疾病预防控制中心生物资源库挑选2021年7-8月收集的新冠阳性和新冠阴性鼻拭子各60份,口咽拭子各30份,所有样本用实时荧光RT-PCR方法检测新冠核酸ORF1ab和N基因,用抗原检测胶体金法检测抗原,选择13份阳性样本进行10倍和100倍稀释,两种方法检测,分析胶体金法与核酸检测RT-PCR法检测结果的阳性和阴性一致率,进行统计学Kappa分析。结果 180份样本抗原检测胶体金法与核酸检测RT-PCR法的阳性符合率为98.89%,阴性符合率为100.00%,Kappa=0.989,13个样本10倍和100稀释后胶体金法阳性符合率分别为100%、84.61%。结论 新型冠状病毒抗原检测胶体金法可作为早期辅助确诊新型冠状病毒感染的快速方法。

Objective To analyze the results between colloidal gold method for SARS-CoV-2 and realtime RT-PCR test and to verify whether colloidal gold method for SARS-CoV-2 can be used as a rapid auxiliary diagnosis of COVID-19 infection.Methods Positive and negative SARS-CoV-2 samples(60 nasal swabs and30 pharyngeal swabs,respectively)were collected from the biological resource bank of Henan Center for Disease Control and Prevention from July to August,2021.All samples were detected by RT-PCR for ORF1ab and N gene and colloidal gold method for SARS-CoV-2 antigen.Thirteen positive samples were selected for 10 multiples and100 multiples dilution and tested by two methods.The positive and negative consistency was analyzed by Kappa analysis.Results The positive and negative coincidence rates of colloidal gold method was 98.89% and 100.00%respectively(Kappa =0.989).The positive coincidence rates of gold standard method after 10 multiples and 100multiples dilution was 100%,84.61% respectively.Conclusion Colloidal gold method for antigen detection can be used as an early auxiliary diagnosis method for SARS-CoV-2.