一期梅毒实验室诊断差异性研究

目的通过梅毒螺旋体初筛试验、确认试验和鉴别诊断试验，探讨一期梅毒实验室诊断差异性，最大限度减少漏诊与误诊，为深入研发新型早期梅毒诊断试剂奠定基础。方法依据2000年中国卫生部防疫司颁布的性病诊断标准，临床筛选一期梅毒患者86例（研究组）和非梅毒患者100例（对照组），对患者血清进行甲苯胺红不加热血清试验（TRUST）初筛和梅毒螺旋体明胶颗粒凝集试验（TPPA）确认。筛选临床体征、TRUST法和TPPA法三者结果有差异的患者进一步鉴别诊断，鉴别诊断主要应用荧光定量PCR（FQ-PCR）法、免疫PCR法与自身抗体检测等试验。结果初筛TRUST法灵敏度和特异性分别为62．8％、93．0％；确认TPPA法灵敏度与特异性分别为66．3％、100％。TRUST法和TPPA法两者结果差异占12．8％；临床体征诊断、TRUST法和TPPA法三者结果差异占41．9％。TPPA法与TRUST法两者均阴性的一期梅毒患者中，FQ-PCR阳性率达88．0％，免疫PCR阳性率占40．0％。TPPA法阳性、TRUST法阴性的一期梅毒患者免疫PCR法与TPPA法结果一致；TPPA法阴性、TRUST法阳性11例患者中结核抗体阳性2例，类风湿因子阳性3例与抗Sm抗体结果阳性6例。结论一期梅毒患者实验室诊断结果差异性较大，漏诊与误诊的比例较高，有待研发新型的诊断试剂和提高诊断水平。

Study on variability of laboratory diagnosis in primary syphilis

Objective To investigate the variability of laboratory diagnosis of primary syphilis by preliminary screening, confirmatory test and differential diagnosis and to diminish missed diagnosis with primary syphilis.Methods Each of two serological tests including TRUST and TPPA was employed to detect the serum antibodies against treponema pallidum in 86 patients with primary syphilis and normal control 100 patients respectively.FQ-PCR,Immun-PCR and autoantibody test were employed to diagnosis variability in all imcompatibility. And the diagnostic value was compared among TRUST,TPPA,FQ-PCR, Immun-PCR and autoantibody test.Results There was a significant difference in the detection result among TRUST,TPPA,FQ-PCR and Immun-PCR method.The sensitivity and specificity were 62.8% and 93.0% for TRUST and 66.3% and 100% for TPPA.The variability was 12.8% between TRUST and TPPA and 41.9% among clinical diagnosis,TRUST and TPPA.The variability of patients with negative TPPA and TRUST were 88.0% by FQ-PCR and 40.0% by Immun-PCR.The Immun-PCR and TPPA results were compatible for patients with positive TPPA and negative TRUST results while there were 11 patients with other diseases having results of positive TRUST and negative TPPA. Conclusion There were significant difference and higher misdiagnosis in the detection results of primary syphilis among TRUST,TPPA,FQ-PCR and Immun-PCR method.We expect new diagnosis reagent for primary syphilis with higher sensitivity,specificity and accuracy in the future.