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.
NETL
NSTL
维普
万方数据
