Man Xu1, Yafeng Xie1, Chuanhao Jiang1, Yongjian Xiao2, Xingxing Kuang1, Feijun Zhao1, Tiebing Zeng1, Shuangquan Liu3, Mingxing Liang1, Li Li1, Chuan Wang1, Yimou Wu4. 1. 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. 2. 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. 3. Department of Clinical Laboratory, The First Affiliated Hospital of University of South China, Hengyang, China. 4. 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. Electronic address: yimouwu@sina.com.
Abstract
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 (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). 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 κ 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.
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 (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). 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 κ 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.
Authors: Ângelo Antônio Oliveira Silva; Ueriton Dias de Oliveira; Larissa de Carvalho Medrado Vasconcelos; Leonardo Foti; Leonardo Maia Leony; Ramona Tavares Daltro; Amanda Leitolis; Fernanda Washington de Mendonça Lima; Marco Aurélio Krieger; Nilson Ivo Tonin Zanchin; Fred Luciano Neves Santos Journal: PLoS One Date: 2020-06-18 Impact factor: 3.240