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≥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抗体的临界值±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。
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% concen- trations 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% coincidence 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.
出处
《标记免疫分析与临床》
CAS
2013年第6期455-457,共3页
Labeled Immunoassays and Clinical Medicine
