Evaluation of LIAISON Treponema Screen, a novel recombinant antigen-based chemiluminescence immunoassay for laboratory diagnosis of syphilis.

Clinical and diagnostic laboratory immunology Pub Date : 2005-10-01 DOI:10.1128/CDLI.12.10.1231-1234.2005

Antonella Marangoni, Vittorio Sambri, Silvia Accardo, Francesca Cavrini, Antonietta D'Antuono, Alessandra Moroni, Elisa Storni, Roberto Cevenini

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Abstract

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).

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评估用于梅毒实验室诊断的新型重组抗原化学发光免疫测定 LIAISON Treponema Screen。

本研究的目的是评估新型自动化学发光免疫分析仪（CLIA）LIAISON Treponema Screen（意大利萨卢吉亚 DiaSorin 公司）的诊断性能，并与快速血浆试剂（RPR）和目前使用的下列三联试剂（血凝试验（TPHA）、免疫酶测定（EIA）和免疫印迹（WB））进行比较。首先，对 2,494 份献血者血清、131 份临床和血清学特征梅毒血清以及 96 份从患有潜在干扰疾病或病症的受试者处获得的样本进行了回顾性研究。此外，还进行了一项前瞻性研究，对提交给意大利博洛尼亚圣奥索拉医院微生物实验室用于梅毒常规筛查的 1800 份未选择样本进行了检测。不出所料，RPR 是特异性最低的方法，尤其是在检测潜在交叉反应血清时。相反，所有的三螺旋体检测都被证明具有很高的特异性（99.9%），其灵敏度如下：100%（WB）、99.9%（WB）、99.9%（WB）、99.9%（WB）、99.9%（WB）：100%（WB）、99.2%（CLIA）、95.4%（EIA）和 94.7%（TPHA）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Clinical and diagnostic laboratory immunology

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