A novel ELISA using a recombinant outer membrane protein, rTp0663, as the antigen for serological diagnosis of syphilis
A novel ELISA using a recombinant outer membrane protein, rTp0663, as the antigen for serological diagnosis of syphilis
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一种使用重组外膜蛋白 rTp0663 作为梅毒血清学诊断抗原的新型 ELISA。
DOI：
10.1016/j.ijid.2015.12.013
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发表时间：
2016-02-01
影响因子：
8.4
通讯作者：
Wu, Yimou
中科院分区：
文献类型：
--
作者：
Xu, Man;Xie, Yafeng;Wu, Yimou
背景：缺乏高度准确诊断的梅毒螺旋体特异性抗原，使得梅毒的诊断具有挑战性。方法：已生产出新诊断蛋白 Tp0663 的可溶性重组版本。通过筛选 3326 个血清样本来评估该蛋白的血清诊断潜力，同时通过快速血浆反应素和梅毒螺旋体颗粒凝集试验进行评估。采用卡帕（kappa）系数比较临床诊断与基于Tp0663的ELISA或ARCHITECT梅毒TP化学发光免疫分析（Abbott GmbH and Co. KG）的一致性。结果：以临床诊断结果为金标准，发现Tp0663的敏感性和特异性为98.83%（95%置信区间（CI））分别为 96.61-99.60%）和 100%（95% CI 99.88-100%）。相比之下，ARCHITECT 梅毒 TP 检测的灵敏度（97.27%，95% CI 94.46-98.67%）和特异性（99.61%，95% CI 99.32-99.78%）较低。特别是 ARCHITECT 梅毒 TP 的假阳性率为 0.39%。此外，ELISA 与金标准完全一致，k 值为 0.99，与 ARCHITECT Syphilis TP (0.96) 相当。 结论：这些结果表明 Tp0663 是一种新型血清诊断候选药物，具有开发梅毒诊断新测试的巨大潜力。 (C) 2015 年作者。由爱思唯尔有限公司代表国际传染病学会出版。
Background: The lack of Treponema pallidum-specific antigens with highly accurate diagnosis makes the diagnosis of syphilis challenging.Methods: A soluble recombinant version of a new diagnostic protein Tp0663 has been produced. The serodiagnostic potential of this protein was assessed by screening 3326 serum samples simultaneously evaluated by rapid plasma reagin and T. pallidum particle agglutination tests. Kappa (kappa) coefficients were used to compare the concordance between clinical diagnosis and the Tp0663-based ELISA or the ARCHITECT Syphilis TP chemiluminescent immunoassay (Abbott GmbH and Co. KG).Results: Using the results of clinical diagnosis as the gold standard, the sensitivity and specificity of Tp0663 were found to be 98.83% (95% confidence interval (CI) 96.61-99.60%) and 100% (95% CI 99.88-100%), respectively. In comparison, the ARCHITECT Syphilis TP assay was found to have a lower sensitivity (97.27%, 95% CI 94.46-98.67%) and specificity (99.61%, 95% CI 99.32-99.78%). In particular, the ARCHITECT Syphilis TP exhibited a false-positive rate of 0.39%. Moreover, the ELISA was in perfect agreement with the gold standard, with a k value of 0.99, comparable to that of ARCHITECT Syphilis TP (0.96).Conclusion: These results identified Tp0663 as a novel serodiagnostic candidate with great potential for developing novel tests for the diagnosis of syphilis. (C) 2015 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.