3种梅毒血清学诊断试验的临床应用评价

Clinical evaluation and treatment optimization for three different syphilis serum diagnostic methods

目的通过比较3种梅毒血清学检测方法的敏感性、特异性,选择简单、快速、敏感性高和特异性强的检测方法。提高对梅毒(特别是妊娠期隐性梅毒)的早期诊治,控制梅毒传播。方法采用甲苯胺红不加热血清反应素试验(TRUST),梅毒螺旋体特异性抗体明胶凝集试验(TPPA),梅毒螺旋体抗体诊断试剂盒(胶体金法)3种方法检测218例血清标本,TPPA法和胶体金法检测40例质控标本。结果TRUST、TPPA、胶体金法对95例梅毒血清标本和123例非梅毒血清标本对照组的敏感性分别为78.9%、97.9%、88.4%,特异性分别为84.6%、98.4%、96.7%。TPPA法的敏感性明显高于TRUST法和胶体金法,差异有统计学意义(P<0.05);胶体金法对2NCU梅毒确认抗体室内质控和低浓度室间质评标本均不能检出,其敏感性明显低于TPPA法,差异有统计学意义(P<0.05);TPPA法的特异性明显高于TRUST法,差异有统计学意义(P<0.05),TPPA法特异性高于胶体金法,差异有统计学意义(P<0.05)。结论TPPA法有极高的敏感性和特异性,可作为梅毒血清抗体检测的确证方法;胶体金法简便快速,较适用于临床急诊标本检测;TRUST法适用于梅毒疗程观察和疗效判断,有助于判断梅毒复发及再感染,采用TPPA和TRUST联合检测,既可提高梅毒检出的阳性率,减少漏诊和误诊;又可作为病程观察和疗效判断的指标,以便梅毒患者能得出及时有效的诊治,对有效控制妊娠期梅毒和胎传梅毒的发生及梅毒传播都具有较大的临床价值。

Objective To improve the accuracy for diagnosing syphilis in early stage and to optimize clinical existing methods by comparing three different syphilis serum diagnostic methods in the directions of sensitivity and specificity. Methods We tested 218 different patient specimens with Toluidine Red Unheated Serum Test （TRUST）,Treponema Pallidum Particle Agglutination（TPPA） and Diagnostic Kit for Antibody to Treponema Pallidum（Colloidal Gold） respectively. The other 40 quality control specimens were examined by using TPPA and Colloidal Gold. Results There were 218 specimens which contained 95 disease specimens and 123 normal specimens. We used both sensitivity and specificity to evaluate the performances of TRUST,TPPA and Colloidal Gold. Their sensitivity were 78. 9% ,97.9% ,88. 4% respectively and specificity were 84.6% ,98.4% ,96.7%. The sensitivity of TPPA was significantly higher than that of TRUST and Colloidal Gold with a p-value smaller than 0. 05. Colloidal Gold could not detect 2NCU syphilis serum antibody quality control specimens and quality evaluate with low chroma specimens. Its specificity significantly was smaller than TPPA with a p-value smaller than 0. 05. Specificity of TPPA was significantly higher than TRUST with a p-value smaller than 0.05 and higher than Colloidal Gold but without a pvalue smaller than 0.05. Conclusion Because of high sensitivity and specificity,TPPA can use as a golden-standard for syphilis serum antibody screening. Colloidal Gold is suitable for testing patient in emergency for its convenient and celerity. TRUST could be used to evaluate the performance of drugs during treatment period and improve judgment of recrudescence and reinfection of the syphilis. Combining both TPPA and TRUST, doctors can increase the positive rate of the syphilis and reducing rate of missed diagnosis and misdiagnosis. It also could be used as standard for evaluating performance of clinical treatment and contribute to prevent syphilis spreading via pregnancy and embryo pathways.