化学发光微粒法检测孕妇抗TP抗体的复检范围探讨  

The investigation on the retesting range of anti-TP antibody detected bychemiluminescence micropartide immunoassay in pregnant women

作　　者：齐结华[1] 张春利 吴守乐[1] 宦宇[1] 陈宇[1] 乐江漫[1] 蔡徐山[1] QI Jiehua;ZHANG Chunli;WU Shoule;HUAN Yu;CHEN Yu;LE Jiangman;CAI Xushan(Department of Clinical Laboratory,Maternal and Child Health Hospital of Jiading District,Shanghai 201821,China)

机构地区：[1]上海市嘉定区妇幼保健院检验科,上海201821

出　　处：《检验医学与临床》2021年第13期1883-1885,1889,共4页Laboratory Medicine and Clinic

基　　金：上海市嘉定区卫生健康委员会资助项目(2017-KY-18)。

摘　　要：目的探讨基于化学发光法(CLIA)初筛抗TP抗体阳性的孕妇标本应用化学发光微粒法(CMIA)检测的复检范围。方法选取经科美Chemclin CLIA系统筛查抗TP抗体S/CO≥1.0的548例孕妇血清标本,采用CMIA检测548例孕妇血清标本的抗TP抗体,同时用免疫印迹法(WB)进行确认,以WB检测结果为标准,采用受试者工作特征(ROC)曲线评价CMIA检测孕妇抗TP抗体的性能。结果CMIA检出孕妇抗TP抗体的S/CO≥1.0的标本490例,经WB确认,阳性483例,不确定2例,阴性5例,根据ROC曲线,约登指数最大时(0.979),抗TP抗体S/CO为2.31,灵敏度为97.9%,特异度为100.0%;CMIA检出孕妇抗TP抗体的S/CO<1.0的标本58例,经WB确认,阳性11例,不确定9例,阴性38例,根据ROC曲线,约登指数最大时(0.921),抗TP抗体S/CO为0.22,灵敏度为100.0%,特异度为92.1%。结论根据ROC曲线计算的最佳截断值,CMIA检测孕妇抗TP抗体的复检范围S/CO设定为0.22~2.31,S/CO在此范围的孕妇标本须采用WB确认,以确保结果的准确性。Objective To investigate the retesting range of anti-Treponema pallidum(TP)antibody sample detected by chemiluminescence micropartide immunoassay(CMIA)in pregnant women which were positive screened by Chemiluminescence(CLIA).Methods A total of 548 serum samples of pregnant women with anti-TP antibody S/CO≥1.0 screened by the Chemclin CLIA system were selected.Anti-TP antibody was detected in 548 pregnant women′s serum samples by CMIA,which was confirmed by Western blotting(WB).The results of WB were used as standard,the performance of CMIA was evaluated by receiver operating characteristic(ROC)curve in pregnant women.Results There were 490 samples with S/CO≥1.0,and confirmed by WB,483 samples were positive,2 samples were indeterminate,and 5 samples were negative.According to the ROC curve,the S/CO of anti-TP antibody was 2.31,the sensitivity was 97.9%,and the specificity was 100.0%while the Youden index was the largest(0.979).There were 58 samples with S/CO<1.0,and confirmed by WB,11 samples were positive,9 samples were indeterminate and 38 samples were negative.According to the ROC curve,the S/CO of anti-TP antibody was 0.22,the sensitivity was 100.0%,and the specificity was 92.1%while the Youden index was the largest(0.921).Conclusion According to the best cut-off value calculated by ROC curve,the S/CO of the retesting range for CMIA to detect anti-TP antibodies in pregnant women is 0.22-2.31,and the sample must be confirmed by WB when the S/CO is within this range to ensure the accuracy of the result.

关 键 词：抗梅毒螺旋体抗体 化学发光微粒法 复检范围 孕妇 

分 类 号：R446.6[医药卫生—诊断学]