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目的探讨分析快速血浆反应素环状卡片试验(RPR)、梅毒螺旋体颗粒凝集试验(TPPA)和化学发光法(CIA)在梅毒血清学诊断中的应用价值。方法使用RPR、TPPA和CIA法同时对3 268例门诊患者、1 700例住院患者以及2 230例体检中心患者进行筛查。CIA阳性检出标本随后以RPR进行筛查,如果二者结果不一致则以TPPA再次检测。结果根据流行病学史、临床表现以及实验室检查等结果进行确诊,参照WS273-2007中华人民共和国卫生行业梅毒诊断标准,在7 198例患者中筛查出576例临床确诊的梅毒(其中,一期梅毒血清168例,二期梅毒血清306例,潜伏期梅毒102例)。RPR、TPPA和CIA阳性检出率(灵敏度)分别为81.94%(472/576)、98.96%(570/576)、96.53%(556/576),RPR、TPPA和CIA特异度分别为99.82%、100.0%、99.98%。CIA联合TPPA检测灵敏度及特异度均为100%,CIA与TPPA的κ值为0.986。结论 TPPA的血清诊断价值优于RPR和CIA,灵敏度和特异度均较高。尽管CIA的梅毒阳性检出率略低于TPPA,但鉴于CIA的简便、快速、准确、自动化以及抗原制备容易等优点,CIA有望成为TPPA的一种替代性梅毒血清诊断实验。如果联合使用CIA和TPPA,可减少梅毒的误诊、漏诊,进一步提高梅毒诊断的准确性。
Objective To investigate the value of rapid plasma homokinin cyclic card test (RPR), syphilis spirochete particle agglutination test (TPPA) and chemiluminescence (CIA) in serological diagnosis of syphilis. Methods RPR, TPPA and CIA were used to screen 3 268 outpatients, 1,700 inpatients and 2,230 physical examination centers simultaneously. CIA-positive specimens were subsequently screened by RPR, and if the results were inconsistent, they were retested with TPPA. According to the results of epidemiological history, clinical manifestations and laboratory tests, the results were confirmed. According to the WS273-2007 diagnostic criteria of syphilis in the health sector in the People’s Republic of China, 576 clinically diagnosed syphilis were screened out in 7 198 patients 168 cases of syphilis serum, secondary syphilis serum of 306 cases, 102 cases of latent syphilis). The positive rates of RPR, TPPA and CIA were 81.94% (472/576), 98.96% (570/576) and 96.53% (556/576) respectively. The specificity of RPR, TPPA and CIA were 99.82% 100.0%, 99.98%. Sensitivity and specificity of CIA in combination with TPPA were 100%, and κ values of CIA and TPPA were 0.986. Conclusion The serum diagnostic value of TPPA is better than RPR and CIA, and the sensitivity and specificity are higher. Although the positive detection rate of syphilis in CIA is slightly lower than that of TPPA, CIA is expected to become an alternative TPP serology test in view of the advantages of simple, rapid, accurate, automated and antigen-preparation of CIA. If the combination of CIA and TPPA, can reduce the misdiagnosis, misdiagnosis of syphilis, and further improve the accuracy of syphilis diagnosis.