梅毒血清学检测方法的准确性评价

Analysis of different results by four sorts of syphilis tests

目的 分析常规梅毒血清学检查在临床应用中敏感性和特异性的差异。方法 36例梅毒确诊患者和372例非梅毒患者来自于皮肤科、妇科和男科，血清同时用RPR法、TPPA法、TRUST法和ELISA法进行检测；另取质控血清和1份阳性血清倍比稀释后用上述方法同时检测。结果 对确诊梅毒样本和对照样本TPPA、ELISA1、ELISA2、TRUST和RPR检测的敏感性分别为：97．2％、91．7％、86．1％、72．2％和66．7％，特异性分别为：100．0％、99．7％、99．2％、93．5％和93．0％。倍比稀释后的质控血清和阳性血清最低含量检出能力依次为：TPPA〉ELISA1〉ELISA2〉TRUST=RPR。结论 病例组成和试剂质量的差异是造成各种试剂灵敏度和特异性文献报道不一的原因。

Objective To analyze the difference of sensitivity and specificity of syphilis serological tests. Methods 36 cases of definitely diagnosed syphilis and 372 cases of non-syphilis from Department of Dermatology, Gynecology and Andrology respectively were simultaneously tested by RPR, TRUST, TPPA and ELISA （forming two manufacturers,ELISA1 and ELISA2 ）, so were the doubly diluted quality control serum and positive serum. Results The sensitivity for the definitely diagnosed syphilis and the control sample was as follows： TPPA 97.2%, ELISA 191.7%, ELISA 286. 1%, TRUST 72.2%, and RPR 66.7%; the specificity： TPPA 100%, ELISA1 99.7%, ELISA2 99.2%, TRUST 93.5%, and RPR 93.0%. The detected capability of tests for the least syphilis antibody in diluted quality control serum and positive serum were arrayed in order as follows, TPPA〉 ELISA1〉ELISA2〉TRUST= RPR. Conclusion Cases source and reagent quality difference contribute to the disagreement of the reagents sensitivity and specificity with what the reference literatures reported.