Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic and Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.
J Clin Microbiol. 2011 Apr;49(4):1313-7. doi: 10.1128/JCM.02555-10. Epub 2011 Feb 23.
The diagnosis of syphilis is challenging and often relies on serologic tests to detect treponemal or nontreponemal antibodies. Recently, the Centers for Disease Control and Prevention and the Association of Public Health Laboratories proposed an update to the syphilis serology testing algorithm, in which serum samples are first tested using a treponema-specific test and positive samples are analyzed with a nontreponemal assay. The goal of this study was to compare the performance of seven treponemal assays (BioPlex 2200 syphilis IgG [Bio-Rad, Hercules, CA], fluorescent treponemal antibody [FTA] assay [Zeus Scientific, Raritan, NJ], Treponema pallidum particle agglutination [TP-PA; Fujirebio Diagnostics, Malvern, PA], Trep-Sure enzyme immunoassay [EIA; Phoenix Biotech, Oakville, Ontario, Canada], Trep-Chek EIA [Phoenix Biotech], Trep-ID EIA [Phoenix Biotech], and Treponema ViraBlot IgG [Viramed Biotech AG, Planegg, Germany]) using serum samples (n = 303) submitted to our reference laboratory. In addition to testing with these 7 assays, all samples were tested by a rapid plasma reagin (RPR) assay and a treponemal IgM Western blot assay (Viramed ViraBlot). Compared to the FTA assay as the gold standard, the evaluated treponemal tests demonstrated comparable levels of performance, with percent agreement ranging from 95.4% (95% confidence interval, 92.3 to 97.3) for the Trep-Sure EIA to 98.4% (96.1 to 99.4) for the Trep-ID EIA. Compared to a "consensus of the test panel" (defined as at least 4 of 7 treponemal tests being in agreement), the percent agreement ranged from 95.7% (92.7 to 97.5) for Trep-Sure to 99.3% (97.5 to 99.9) for Trep-ID. These data may assist clinical laboratories that are considering implementing a treponemal test for screening or confirmatory purposes.
梅毒的诊断具有挑战性，通常依赖血清学检测来检测梅毒螺旋体或非梅毒螺旋体抗体。最近，疾病控制与预防中心和公共卫生实验室协会提出了梅毒血清学检测算法的更新，其中血清样本首先使用梅毒螺旋体特异性检测进行检测，阳性样本用非梅毒螺旋体检测进行分析。本研究的目的是比较七种梅毒螺旋体检测方法（BioPlex 2200 梅毒 IgG [Bio-Rad，赫拉克勒斯，加利福尼亚]、荧光密螺旋体抗体 [FTA] 检测 [Zeus Scientific，Raritan，新泽西]、梅毒螺旋体颗粒凝集 [TP-PA；Fujirebio Diagnostics，马尔文，宾夕法尼亚]、Trep-Sure 酶免疫测定 [EIA；凤凰生物技术，安大略省奥克维尔，加拿大]、Trep-Chek EIA [凤凰生物技术]、Trep-ID EIA [凤凰生物技术]和 Treponema ViraBlot IgG [Viramed Biotech AG，普朗根，德国]）在提交给我们参考实验室的 303 份血清样本中的表现。除了用这 7 种检测方法进行检测外，所有样本均用快速血浆反应素（RPR）检测和梅毒螺旋体 IgM 免疫印迹检测（Viramed ViraBlot）进行检测。与 FTA 检测作为金标准相比，评估的梅毒螺旋体检测方法表现出相当的水平，一致率范围从 Trep-Sure EIA 的 95.4%（95%置信区间，92.3%至 97.3%）到 Trep-ID EIA 的 98.4%（96.1%至 99.4%）。与“测试小组的共识”（定义为至少 7 种梅毒螺旋体检测中有 4 种检测结果一致）相比，Trep-Sure 的一致率范围为 95.7%（92.7%至 97.5%），Trep-ID 的一致率为 99.3%（97.5%至 99.9%）。这些数据可能有助于考虑实施梅毒螺旋体检测用于筛查或确认目的的临床实验室。
