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目的研究如何对化学发光酶免疫分析法梅毒抗体检测(TP-CLEIA)筛查梅毒特异性抗体为阳性的检测结果进行正确的解读。方法对100例使用TP-CLEIA筛查阳性的标本,在用免疫印迹法梅毒抗体检测(TP-WB)确认的同时,采用梅毒螺旋体血球凝集试验(TPHA)、微粒子化学发光法梅毒抗体检测(TP-CMIA)及ELISA法梅毒抗体检测(TP-ELISA)同时测定,对试验结果作了进一步分析。结果 (1)以TP-WB法为准,TP-CLEIA法筛查为阳性的标本中,真阳性的比例为48.0%。(2)受试者工作特征曲线(ROC曲线)分析显示,最佳临界值为25.92,此时的阳性预测值为97.7%,阴性预测值89.5%,此时具有最大的ROC曲线下面积;当TP-CLEIA法S/CO<7.84时,经梅毒确认试验被证实为阴性的概率为100.0%;当S/CO>49.77时,梅毒确认试验被证实为阴性的概率为100.0%。(3)对以TP-CLEIA法筛查为阳性,再用TP-CMIA复核为阳性的标本中,其真阳性的比例为81.3%,而无漏检的情况发生。结论 TP-CLEIA作为梅毒的筛查方法,存在较高的筛查假阳性率,尤其是S/CO水平较低时。对TP-CLEIA法筛查为阳性的标本,TP-CMIA法是较为理想的复核方法。
Objective To study how to interpret the detection results of positive results of TP-CLEIA screening of syphilis-specific antibodies by using chemiluminescence enzyme immunoassay. Methods 100 TP-CLEIA positive specimens were screened for TP-WB by TP-WB and TP (superscript +) by chemiluminescence immunoassay (TP -CMIA) and ELISA syphilis antibody test (TP-ELISA) were simultaneously measured, the test results were further analyzed. Results (1) TP-WB method prevalence, TP-CLEIA method for screening positive samples, the true positive ratio was 48.0%. (2) The receiver operating characteristic curve (ROC curve) analysis showed that the best cut-off value was 25.92, the positive predictive value was 97.7% and the negative predictive value was 89.5%, and the area under the ROC curve was the largest. TP-CLEIA S / CO <7.84, confirmed by the syphilis test was negative for the probability of 100.0%; when the S / CO> 49.77, the probability of confirmed syphilis confirmed the test was negative 100.0%. (3) True-positive rate was 81.3% in the specimens screened by TP-CLEIA method and re-checked by TP-CMIA, but no missed inspection occurred. Conclusion TP-CLEIA, as a screening method for syphilis, has a high screening false positive rate, especially at low S / CO levels. TP-CLEIA method screening for positive specimens, TP-CMIA method is the ideal method of review.