{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T14:09:16Z","timestamp":1782137356718,"version":"3.54.5"},"reference-count":39,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,7,31]],"date-time":"2022-07-31T00:00:00Z","timestamp":1659225600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100019310","name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study","doi-asserted-by":"publisher","award":["2015\u2010351"],"award-info":[{"award-number":["2015\u2010351"]}],"id":[{"id":"10.13039\/501100019310","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81273322"],"award-info":[{"award-number":["81273322"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To discover novel serodiagnostic candidates for the serological diagnosis of syphilis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Two recombinant <jats:italic>Treponema pallidum<\/jats:italic> proteins Tp0100 and Tp1016 were expressed, purified, and identified by Western Blotting. A total of 600 clinical serum samples were tested with the Tp0100\u2010based ELISA, the Tp1016\u2010based 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\u2010reactive infections, including leptospirosis, Lyme disease, hepatitis B, tuberculosis, rheumatoid arthritis, systemic lupus erythematosus. Kappa (<jats:italic>\u03ba<\/jats:italic>) values were applied to compare the agreement between clinical syphilis diagnosis and the Tp0100\u2010based ELISA, the Tp1016\u2010based ELISA, or the LICA Syphilis TP test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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 <jats:italic>\u03ba<\/jats:italic> values were 96.7% (95% CI 95.6%\u201397.8%) and 0.93 for the Tp0100\u2010based ELISA, 77.0% (95% CI 74.3%\u201379.7%) and 0.54 for the Tp1016\u2010based ELISA, and 97.0% (95% CI 96.0%\u201398.0%) and 0.94 for the LICA Syphilis TP test, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The recombinant <jats:italic>T. pallidum<\/jats:italic> protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24635","type":"journal-article","created":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:29:15Z","timestamp":1659313755000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Assessment of recombinant antigens Tp0100 and Tp1016 of <i>Treponema pallidum<\/i> for serological diagnosis of syphilis"],"prefix":"10.1002","volume":"36","author":[{"given":"Dejun","family":"Chen","sequence":"first","affiliation":[{"name":"Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School University of South China  Hengyang China"},{"name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siqian","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical laboratory of the First Pepole's Hospital of Changde City  Changde China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuxing","family":"He","sequence":"additional","affiliation":[{"name":"Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School University of South China  Hengyang China"},{"name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yue","family":"Fu","sequence":"additional","affiliation":[{"name":"Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School University of South China  Hengyang China"},{"name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9542-6896","authenticated-orcid":false,"given":"Feijun","family":"Zhao","sequence":"additional","affiliation":[{"name":"Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School University of South China  Hengyang China"},{"name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiuping","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Changsha Health Vocational College  Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haoquan","family":"Yin","sequence":"additional","affiliation":[{"name":"Department of Clinical Medical Undergraduates, Hengyang Medical School University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Wan","sequence":"additional","affiliation":[{"name":"Department of Clinical Medical Undergraduates, Hengyang Medical School University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunting","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Clinical Medical Undergraduates, Hengyang Medical School University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yimou","family":"Wu","sequence":"additional","affiliation":[{"name":"Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School University of South China  Hengyang China"},{"name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Longgu","family":"Cao","sequence":"additional","affiliation":[{"name":"College of Medical Imaging Laboratory and Rehabilitation Xiangnan University  Chenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4075-1613","authenticated-orcid":false,"given":"Tiebing","family":"Zeng","sequence":"additional","affiliation":[{"name":"Institution of Pathogenic Biology and Hunan Provincial Key Laboratory for Special Pathogens Prevention and Control, Hengyang Medical School University of South China  Hengyang China"},{"name":"Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study University of South China  Hengyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,7,31]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI57173"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/14760584.2016.1203262"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0143304"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.olq.0000261456.09797.1b"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.143"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrmicro.2016.141"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2017.73"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.19.1.29-49.2006"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.8.1.1"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/CVI.00681-14"},{"issue":"3","key":"e_1_2_8_12_1","first-page":"158","article-title":"Serological diagnosis of syphilis. PHLS syphilis serology working group","volume":"3","author":"Egglestone SI","year":"2000","journal-title":"Commun Dis Public Health"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1258\/ijsa.2008.008510"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.06347-11"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir528"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.5114\/pdia.2013.37029"},{"issue":"5","key":"e_1_2_8_17_1","first-page":"133","article-title":"Discordant results from reverse sequence syphilis screening\u2014five laboratories, United States, 2006\u20132010","volume":"60","year":"2011","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir524"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.41.8.3668-3674.2003"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1128\/iai.65.10.4179-4189.1997"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/iai.55.5.1106-1115.1987"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.73.7.4445-4450.2005"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.44.3.888-891.2006"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780471729259.mc12a01s7"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.23275"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jis459"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0074319"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.281.5375.375"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1258\/0956462981922034"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.27.1.152-157.1989"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0234043"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1128\/CVI.00122-13"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2015.10.005"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2015.12.013"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/lam.12554"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1469-0691.2001.00232.x"},{"issue":"5","key":"e_1_2_8_37_1","first-page":"523","article-title":"Evaluation of a new recombinant antigen\u2010based Virotech treponema pallidum screen ELISA for diagnosis of syphilis","volume":"59","author":"Busse C","year":"2013","journal-title":"Clin Lab"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2014.01.041"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.00834-10"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1155\/2017\/1436080"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24635","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.24635","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24635","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T03:07:08Z","timestamp":1692673628000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.24635"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,31]]},"references-count":39,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2022,9]]}},"alternative-id":["10.1002\/jcla.24635"],"URL":"https:\/\/doi.org\/10.1002\/jcla.24635","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,31]]},"assertion":[{"value":"2022-03-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e24635"}}