梅毒重组抗原酶联免疫吸附试验与快速血浆反应素试验的比较研究

Sensitivity and specificity of ELISA based on recombinant Treponema pallidum antigen and rapid plasma reagin test in diagnosis of syphilis:a comparative study

目的比较传统的快速血浆反应素试验(RPR)与重组梅毒螺旋体抗原为基础的梅毒快速试验的敏感性和特异性。方法选择249例性传播疾病中心门诊患者,签署知情同意书后采集其静脉血,取血清进行梅毒螺旋体血球凝集试验(TPHA)、RPR 试验和重组抗原的酶联免疫吸附试验并对结果进行比较。结果以 TPHA 结果为标准,重组抗原的酶联免疫吸附试验血清敏感性为100%,特异性为98.4%。RPR 试验血清敏感性为65.1%,特异性为98.4%。结论以重组梅毒螺旋体抗原为基础的试验方法与 RPR 试验相比,具有更高的敏感性。

Objective To compare the sensitivity and specificity between ELISA based on the recombinant Treponema pallidum （Tp） antigen and rapid plasma reagin （RPR） test diagnosis of syphilis. Methods Peripheral blood samples were collected from 249 patients, 177 males and 72 females, aged 34. Abbott Determine Syphilis TP test （ELISA based on the recombinant Tp antigen）, RPR test, and Trepenema pallidum haemagglutination assay （TPHA） were conducted with TPHA used as the gold standard. Results The serum sensitivity and specificity of Abbott Determine Syphilis TP test were 100% and 98.4% respectively. The serum sensitivity and specificity of RPR test were 65. 1% and 98.4% respectively. Conclusion The sensitivity of the rapid ELISA based on recombinant Tp antigen is significantly higher than that of RPR test.