梅毒螺旋体特异性抗体试验方法探讨及临床应用价值评估  

An Evaluation of Treponema Pallidum Specific Antibody Test Method and Its Clinical Application Value

作　　者：金晶[1] 潘玥[1] 边春红 聂秀娟 JIN Jing;PAN Yue;BIAN Chunhong;NIE Xiujuan(Beijing Haidian Hospital,Beijing 100090,China)

机构地区：[1]北京市海淀医院,北京100090

出　　处：《标记免疫分析与临床》2021年第1期27-31,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的分析化学发光微粒子免疫法(CMIA)检测梅毒螺旋体特异性抗体的性能价值,探讨其在临床应用的意义。方法回顾性分析北京市海淀医院2019年3月至2020年7月所有采用CMIA法进行梅毒螺旋体特异性抗体检测的标本61051例,阳性标本采用梅毒螺旋体明胶颗粒凝集试验(TPPA)进行确证,分析其相关性。结果61051例患者中CMIA法阳性标本852例,阳性率为1.40%,TPPA法阳性确认663例,阳性符合率为77.82%,假阳性率为0.31%。梅毒特异性抗体阳性符合率男性高于女性,差异有统计学意义(χ^(2)=9.42,P=0.002)。>60岁老年组CMIA法阳性预测值最低,与其他年龄组比较,差异有统计学意义(χ^(2)=7.27,P=0.007),容易引起梅毒误诊。科室以皮肤科患者CMIA法阳性预测值最高。TPPA结果阳性符合率随着S/CO升高而升高,当S/CO≥10时,符合率达到100%。以TPPA法作为确证试验,对CMIA法检测梅毒特异性抗体的S/CO值进行ROC曲线分析得到最佳诊断截断值为3.61。结论CMIA法简便易行,适用于大批量标本的梅毒筛查,TPPA法则更客观反映真实的梅毒阳性情况。对于CMIA法检测梅毒特异性抗体阳性的标本,尤其是S/CO<3.61的标本,有必要进行TPPA复检,联合检测以提高检测结果的准确性,排除假阳性,避免误诊漏诊。Objective To analyze the performance value of chemiluminescent microparticle immunoassay(CMIA)in the detection of Treponema pallidum specific antibody,and to explore its clinical significance.Methods From March,2019 to July,2020,61051 cases of Treponema pallidum specific antibody were collected from Haidian Hospital of Beijing.The positive samples were confirmed by TPPA,and the correlation was analyzed.Results Among 61051 patients,852 cases were positive by CMIA method,with the positive rate of 1.40%,and 663 cases were confirmed by TPPA method,with the positive coincidence rate of 77.82%,while the false positive rate was 0.31%.The positive coincidence rate of syphilis specific antibody in male patients was higher than that in female patients(χ^(2)=9.42,P=0.002).Compared with other age groups,the positive predictive value of the elderly group was the lowest,and the difference was statistically significant(χ^(2)=7.27,P=0.007).The positive predictive value of dermatology patients was the highest.The positive coincidence rate of TPPA results increased with the increase of S/CO.When S/CO≥10,the coincidence rate reached 100%.Using TPPA method as confirmatory test,ROC curve analysis was conducted on S/CO value of syphilis specific antibody detected by CMIA method,and the best diagnostic cut-off value was 3.61.Conclusion CMIA method is simple and easy to operate,and is suitable for syphilis screening in a large number of samples,while TPPA method is more objective to reflect the real syphilis positive situation.Combined detection of these two methods can improve the accuracy of the test results,eliminate false positive and avoid misdiagnosis,especially for S/CO<3.61 positive samples.

关 键 词：梅毒螺旋体特异性抗体 化学发光微粒子免疫分析法 梅毒螺旋体明胶颗粒凝集试验 

分 类 号：R377.1[医药卫生—病原生物学]