Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School, University of South China, Hengyang, China.
Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study, University of South China, Hengyang, China.
J Clin Lab Anal. 2022 Sep;36(9):e24635. doi: 10.1002/jcla.24635. Epub 2022 Jul 31.
To discover novel serodiagnostic candidates for the serological diagnosis of syphilis.
Two recombinant Treponema pallidum proteins Tp0100 and Tp1016 were expressed, purified, and identified by Western Blotting. A total of 600 clinical serum samples were tested with the Tp0100-based ELISA, the Tp1016-based ELISA, and the commercial LICA Syphilis TP kit (ChIVD, Beijing, China). The sensitivities were determined by testing 340 samples from individuals with clinically diagnosed primary, secondary, latent, and tertiary syphilis. The specificities were determined by screening 260 samples from healthy controls and individuals with potentially cross-reactive infections, including leptospirosis, Lyme disease, hepatitis B, tuberculosis, rheumatoid arthritis, systemic lupus erythematosus. Kappa (κ) values were applied to compare the agreement between clinical syphilis diagnosis and the Tp0100-based ELISA, the Tp1016-based ELISA, or the LICA Syphilis TP test.
Using clinical syphilis diagnosis as the gold standard, Tp0100 exhibited an overall sensitivity of 95.6% and specificity of 98.1% for testing IgG antibody while Tp1016 demonstrated only an overall sensitivity of 75.0% and specificity of 79.6%. In contrast, the LICA Syphilis TP test revealed an overall sensitivity of 97.6% and specificity of 96.2%. In addition, the overall percent agreement and corresponding κ values were 96.7% (95% CI 95.6%-97.8%) and 0.93 for the Tp0100-based ELISA, 77.0% (95% CI 74.3%-79.7%) and 0.54 for the Tp1016-based ELISA, and 97.0% (95% CI 96.0%-98.0%) and 0.94 for the LICA Syphilis TP test, respectively.
The recombinant T. pallidum protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.
发现用于梅毒血清学诊断的新型血清学诊断候选物。
表达和纯化重组梅毒螺旋体蛋白 Tp0100 和 Tp1016，并通过 Western Blotting 进行鉴定。用 Tp0100 为基础的 ELISA、Tp1016 为基础的 ELISA 和商业 LICA 梅毒 TP 试剂盒（北京中检维康生物技术有限公司）检测 600 例临床血清样本。通过检测 340 例临床诊断为原发性、二期、潜伏性和三期梅毒的个体样本来确定敏感性。通过筛选 260 例来自健康对照者和可能具有交叉反应性感染的个体（包括钩端螺旋体病、莱姆病、乙型肝炎、结核病、类风湿关节炎、系统性红斑狼疮）的样本来确定特异性。应用 Kappa（κ）值比较 Tp0100 为基础的 ELISA、Tp1016 为基础的 ELISA 或 LICA 梅毒 TP 试验与临床梅毒诊断的一致性。
以临床梅毒诊断为金标准，Tp0100 检测 IgG 抗体的总敏感性为 95.6%，特异性为 98.1%，而 Tp1016 仅显示总敏感性为 75.0%，特异性为 79.6%。相比之下，LICA 梅毒 TP 试验的总敏感性为 97.6%，特异性为 96.2%。此外，基于 Tp0100 的 ELISA 的总一致性百分比和相应的κ值分别为 96.7%（95%CI 95.6%-97.8%）和 0.93，基于 Tp1016 的 ELISA 为 77.0%（95%CI 74.3%-79.7%）和 0.54，LICA 梅毒 TP 试验为 97.0%（95%CI 96.0%-98.0%）和 0.94。
重组梅毒螺旋体蛋白 Tp0100 作为梅毒血清学检测的新型诊断抗原具有一定的应用前景。
