Xu Man, Xie Yafeng, Jiang Chuanhao, Xiao Yongjian, Kuang Xingxing, Zhao Feijun, Zeng Tiebing, Liu Shuangquan, Liang Mingxing, Li Li, Wang Chuan, Wu Yimou
Institution of Pathogenic Biology, Medical College, University of South China, Hengyang 421001, China; Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study, University of South China, Hengyang, China; Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, University of South China, Hengyang, China.
Institution of Pathogenic Biology, Medical College, University of South China, Hengyang 421001, China; Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study, University of South China, Hengyang, China; Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, University of South China, Hengyang, China; Department of Clinical Laboratory, The Second Affiliated Hospital of University of South China, Hengyang, China.
Int J Infect Dis. 2016 Feb;43:51-57. doi: 10.1016/j.ijid.2015.12.013. Epub 2015 Dec 31.
The lack of Treponema pallidum-specific antigens with highly accurate diagnosis makes the diagnosis of syphilis challenging.
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 (κ) 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).
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 κ value of 0.99, comparable to that of ARCHITECT Syphilis TP (0.96).
These results identified Tp0663 as a novel serodiagnostic candidate with great potential for developing novel tests for the diagnosis of syphilis.
缺乏具有高度准确诊断能力的梅毒螺旋体特异性抗原使得梅毒的诊断具有挑战性。
已制备出一种新的诊断蛋白Tp0663的可溶性重组形式。通过筛选3326份血清样本评估该蛋白的血清学诊断潜力，这些样本同时通过快速血浆反应素试验和梅毒螺旋体颗粒凝集试验进行评估。使用kappa（κ）系数比较临床诊断与基于Tp0663的酶联免疫吸附测定（ELISA）或ARCHITECT梅毒螺旋体化学发光免疫测定（雅培有限公司）之间的一致性。
以临床诊断结果作为金标准，发现Tp0663的敏感性和特异性分别为98.83%（95%置信区间（CI）96.61 - 99.60%）和100%（95%CI 99.88 - 100%）。相比之下，发现ARCHITECT梅毒螺旋体检测的敏感性（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梅毒螺旋体检测的假阳性率为0.39%。此外，ELISA与金标准完全一致，κ值为0.99，与ARCHITECT梅毒螺旋体检测的κ值（0.96）相当。
这些结果确定Tp0663是一种新型血清学诊断候选物，在开发梅毒诊断新检测方法方面具有巨大潜力。
