口腔液在新型冠状病毒感染抗体流行病学调查中的应用评价

Evaluation of using oral fluid in epidemiological investigation of antibody among SARS-CoV-2 infection

目的 探索无创、安全、便捷的新型生物样本口腔液在新型冠状病毒感染(以下简称新冠病毒感染)血清流行病学调查中的应用价值。方法 从北京市大兴区随机抽样选取505名社区人员,同时采集血清和口腔液样本,血清样本新冠病毒IgG抗体检测采用国家药品监督管理局批准的商品化试剂盒;口腔液样本新冠病毒IgG抗体检测采用北京市疾病预防控制中心建立的口腔液新冠病毒IgG抗体磁微粒化学发光法;运用Spearman相关分析,比较两种样本的新冠病毒抗体检测结果。结果 以血清抗体检测结果为对照,口腔液检测新冠病毒抗体灵敏度为94.1%,特异度为92.9%,符合率为94.1%,阳性预测值为99.8%,阴性预测值为31.0%,约登指数为87.0%,相关系数为0.754(P<0.001)。结论 口腔液和血清检测新冠病毒抗体结果具有很好的符合性,并且其无创、安全、便捷,受试者依从性好,可用于开展大规模人群抗体水平调查和监测。

Objective To explore the value of applying oral fluid as a new in the non-invasive,safe and convenient biological sample in the sero-epidemiological survey for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection.Methods Five hundred and five persons in the communities in Daxing district of Beijing were selected randomly.Serum samples and oral fluid samples were collected at the same time.The anti-SARS-CoV-2 IgG antibody in serum samples was detected using a commercial kit approved by the National Medical Products Administration.The anti-SARS-CoV-2 IgG antibody in oral fluid samples was detected by Magnetism particulate immuno chemistry luminescence method by Beijing Center for Disease Prevention and Control.The Spearman correlation analysis was used to compare the result of anti-SARS-CoV-2 antibodies using the two specimens.Results Using serum antibody test result as reference,the sensitivity,specificity,agreement rate,positive predictive value and negative predictive value of anti-SARS-CoV-2 antibody detection using oral fluid were 94.1%,92.9%,94.1%,99.8%and 31.0%,respectively.The Youden index was 87.0%and the correlation coefficient was 0.754(P<0.001).Conclusions The result of SARS-CoV-2 antibody detections using oral fluid samples were in good agreement with result of serum samples.The method was non-invasive,safe,convenient with good compliance of the subjects and can be used in large-scale population study and surveillance.