摘要：目的  评价ELISA检测梅毒螺旋体（TP）抗体的分析性能，探讨未知诊断的定性实验的性能评价方法。方法  参照临床实验室标准化协会(CLSI)发布的EP12-A2文件对ELISA法测定TP的临界值±20%范围的重复性进行分析，并与TP明胶凝集试验（TPPA）结果进行一致性比较。结果  +20%浓度临界值检测阳性率为≥95%，CV为14.8%；－20%浓度临界值检测阴性率为≥95%，CV为19.6%；两种方法的一致程度百分比为99.6%，一致程度95%可信区间为98.8%～99.6%。结论  TP-ELISA法检测TP抗体临界值±20%浓度范围之外标本，可得到可靠的检测结果。TP-ELISA法与TPPA法结果一致性好，可代替其作为TP诊断试验。

Abstract: Objective To evaluate the performance of treponema pallidum （TP） antibody detected by ELISA. Methods According to the CLSI document EP12-A2, the reproducibility of TP antibody measurement within the range of ±20% cut off by ELISA was analyzed, and the concordance was compared with TP particle agglutination assay (TPPA). Results The samples with +20% concentrations from the cut-off point yielded positive rate ≥95%. The coefficient of variation (CV) was 14.8%. The yielded negative rate was ≥95% in samples with -20% concentrations from the cut-off point. The CV was 19.6%. The comparison of the two analysis assay was showed that the concordance was 99.6%. The 95% confidence interval was 98.8%~99.6%. Conclusion The reliable results could be acquired by ELISA when it utilized in the detection of TP antibody with the concentration away from the range of   ±20% cut off. The ELISA could replace TPPA for the treponema pallidum antibody detection.