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Validation of the INNO-LIA Syphilis Kit as a Confirmatory Assay for Treponema pallidum Antibodies

机译:验证INNO-LIA梅毒试剂盒作为梅毒螺旋体抗体验证性检测的方法

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摘要

The commercially available diagnostic tests for syphilis are mostly based on the use of extracted antigens of Treponema pallidum. Pronounced cross-reactivities with other spirochete antigens are often reported. The aim of this study was to validate a novel multiparametric assay (the assay performed with the kit) INNO-LIA Syphilis for the confirmation of syphilis antibodies in a set of 840 documented human serum samples. All serum samples were previously tested at the French World Health Organization reference center for venereal diseases (Institute Alfred Fournier, Paris, France), with a consensus result provided for each sample. The study was conducted in two phases, with each phase involving a validation set (500 well-documented serum samples) and an exploratory set (340 serum samples) of serum samples, respectively. By measuring the sensitivity and specificity, we compared the result of the new assay with the consensus result on the basis of the results of a variable number of classical serological methods and clinical information when available. A sensitivity of 99.6% (95% confidence internal [CI], 98.5 to 99.9%) and a specificity of 99.5% (95% CI, 98.1 to 99.9%) were found for the new line immunoassay. Six of seven samples with indeterminate results by classical serology tested positive with the INNO-LIA Syphilis kit. This single multiparametric assay provides reliable confirmatory diagnostic information that must currently be obtained by the performance and interpretation of results of a combination of serological assays.
机译:梅毒的市售诊断测试主要基于使用梅毒螺旋体提取的抗原。经常报告与其他螺旋体抗原具有明显的交叉反应性。这项研究的目的是验证一种新颖的多参数测定(使用试剂盒进行的测定)INNO-LIA Syphilis,用于确认一组840个已记录的人类血清样品中的梅毒抗体。之前,所有血清样本均在法国世界卫生组织性病咨询中心(法国巴黎的阿尔弗雷德·富尼耶研究所)进行了测试,并为每个样本提供了一致的结果。该研究分两个阶段进行,每个阶段分别涉及一个验证组(500个有据可查的血清样品)和一个探索性组(340个血清样品)。通过测量敏感性和特异性,我们根据大量经典血清学方法和临床信息(如果有)的结果,将新测定的结果与共识结果进行了比较。对于新品系免疫测定,发现灵敏度为99.6%(内部可信度[CI]为95%,为98.5至99.9%),特异性为99.5%(95%CI,为98.1至99.9%)。用INNO-LIA Syphilis试剂盒测得的经典血清学结果不确定的七个样本中有六个样本呈阳性。这种单一的多参数测定提供了可靠的确认性诊断信息,目前必须通过执行和解释血清学测定组合的结果来获得这些信息。

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