化学发光免疫分析法检测孕妇抗TP抗体阳性判断值探讨  

Investigation on the positive cut off value of anti-TP antibody in pregnant women by chemiluminescence immunoassay

作　　者：蔡徐山[1] 齐结华[1] 陈宇[1] 王东江[1] 吴守乐[1] 

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》2015年第12期1190-1192,共3页Laboratory Medicine

摘　　要：目的建立适合孕妇的抗梅毒螺旋体(TP)抗体化学发光免疫分析法(CLIA)阳性判断值。方法用科美东雅Chemclin CLIA系统检测13 974例孕妇血清抗TP抗体,对抗TP抗体筛查试验呈阳性反应[信号/临界值(S/CO)比值≥1.0]的样本,用免疫印迹法(WB)分析确认。采用受试者工作特征(ROC)曲线评价CLIA的检测性能。结果 Chemclin CLIA系统检出抗TP抗体S/CO比值≥1.0的样本152例,初筛呈阳性反应的样本比率为1.09%;初筛呈阳性反应样本经WB确认,阳性119例,不确定7例,阴性26例,初筛呈阳性反应样本中假阳性率为17.11%。根据ROC曲线,约登指数最大时,抗TP抗体S/CO比值为3.32;Chemclin CLIA系统抗TP抗体筛查试验阳性预测值≥95%的S/CO比值为3.25。结论为既降低抗TP抗体筛查试验假阳性率,又减少须进行补充确证试验的样本数,各实验室应建立针对不同人群和检测系统(试剂)合适的界值,以确定筛查试验阳性样本需进行确证试验的S/CO比值范围。Objective To establish a reasonable positive cut off value of anti-treponema pallidum（ TP） antibody in pregnant women by chemiluminescence immunoassay（ CLIA）. Methods A total of 13 974 serum samples from pregnant women for anti-TP antibody were collected. All the samples were determined by Kemei Dongya Chemclin CLIA system. The positive samples [signal-to-cut off（ S / CO） ratio≥1. 0] were further verified by western blotting（ WB）.The performance was evaluated by receiver operating characteristic（ ROC） curve. Results The 152 samples of S / CO ratio≥1. 0 were determined by Chemclin CLIA system. The screening positive reaction rate was 1. 09%. The results verified by WB for the screening positive samples showed that 119 samples were positive,7 samples were indeterminate,and 26 samples were negative. The false positive rate of screening positive reaction samples was 17. 11%. The ROC curve indicated that the S / CO ratio for anti-TP antibody was 3. 32 when Youden index reached maximum. The S / CO ratio was 3. 25,when positive predictive value was ≥95% of Chemclin CLIA system. Conclusions In order to both reduce the false positive rate of anti-TP antibody screening and minimize the number of samples to be further determined by confirmation assay,each laboratory should set up a suitable S / CO ratio for different populations and determination systems（ reagents） and determine the S / CO ratio scope to be further determined by confirmation assay.

关 键 词：抗梅毒螺旋体抗体 化学发光免疫分析法 确证试验 阳性判断值 孕妇 

分 类 号：R446.61[医药卫生—诊断学]