Marangoni Antonella, Sambri Vittorio, Accardo Silvia, Cavrini Francesca, D'Antuono Antonietta, Moroni Alessandra, Storni Elisa, Cevenini Roberto
Microbiology Section, DMCSS, University of Bologna, Bologna, Italy.
Clin Diagn Lab Immunol. 2005 Oct;12(10):1231-4. doi: 10.1128/CDLI.12.10.1231-1234.2005.
The purpose of this study was to evaluate the diagnostic performance of LIAISON Treponema Screen (DiaSorin, Saluggia, Italy), a new automated chemiluminescence immunoassay (CLIA), in comparison with that of rapid plasma reagin (RPR) and the following currently used treponemal tests: hemagglutination test (TPHA), immunoenzymatic assay (EIA), and Western blot (WB). First, a retrospective study was performed with a panel of 2,494 blood donor sera, a panel of 131 clinical and serologically characterized syphilitic sera, and 96 samples obtained from subjects with potentially interfering diseases or conditions. A prospective study was also performed by testing 1,800 unselected samples submitted to the Microbiology Laboratory of the St. Orsola Hospital in Bologna, Italy, for routine screening for syphilis. As expected, RPR was the least specific method, especially when potentially cross-reacting sera were tested. On the contrary, all of the treponemal tests proved to be very specific (99.9%) and they performed with the following sensitivities: 100% (WB), 99.2% (CLIA), 95.4% (EIA), and 94.7% (TPHA).
本研究的目的是评估新型自动化化学发光免疫分析（CLIA）——LIAISON梅毒螺旋体筛查试验（DiaSorin公司，意大利萨卢贾）与快速血浆反应素（RPR）以及以下目前使用的梅毒螺旋体检测方法相比的诊断性能：血凝试验（TPHA）、免疫酶测定（EIA）和免疫印迹法（WB）。首先，对一组2494份献血者血清、一组131份经临床和血清学特征鉴定的梅毒血清以及从患有潜在干扰性疾病或状况的受试者中获取的96份样本进行了回顾性研究。还通过检测提交至意大利博洛尼亚圣奥索拉医院微生物实验室进行梅毒常规筛查的1800份未挑选样本进行了前瞻性研究。正如预期的那样，RPR是特异性最低的方法，尤其是在检测可能发生交叉反应的血清时。相反，所有梅毒螺旋体检测方法都被证明具有很高的特异性（99.9%），其敏感性如下：100%（WB）、99.2%（CLIA）、95.4%（EIA）和94.7%（TPHA）。
