Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis
Objective To discover novel serodiagnostic candidates for the serological diagnosis of syphilis. Methods 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...
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| Veröffentlicht in: | Journal of clinical laboratory analysis 2022-09, Vol.36 (9), p.e24635-n/a |
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| creator | Chen, Dejun Wang, Siqian He, Yuxing Fu, Yue Zhao, Feijun Zhou, Xiuping Yin, Haoquan Wan, Jia Huang, Yunting Wu, Yimou Cao, Longgu Zeng, Tiebing |
| description | Objective
To discover novel serodiagnostic candidates for the serological diagnosis of syphilis.
Methods
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.
Results
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.
Conclusion
The recombinant T. pallidum protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.
SDS‐PAGE analysis of the expression and purification of recombinant proteins. (A, B) Tp0100 (22 kDa); (C, D) Tp1016 (39 kDa). M: molecular mass markers; N:noninduced; I: induced with IPTG; P: purification. Western blotting identification of recombinant proteins Tp0100 and Tp1016 with sera from normal rabbits (1), sera from uninfected human (2), anti‐Hismonoclonal antibody (3), sera from T. pallidum‐infected rabbits (4), and sera frompatients with secondary syphilis (5). |
| doi_str_mv | 10.1002/jcla.24635 |
| format | Article |
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To discover novel serodiagnostic candidates for the serological diagnosis of syphilis.
Methods
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.
Results
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.
Conclusion
The recombinant T. pallidum protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.
SDS‐PAGE analysis of the expression and purification of recombinant proteins. (A, B) Tp0100 (22 kDa); (C, D) Tp1016 (39 kDa). M: molecular mass markers; N:noninduced; I: induced with IPTG; P: purification. Western blotting identification of recombinant proteins Tp0100 and Tp1016 with sera from normal rabbits (1), sera from uninfected human (2), anti‐Hismonoclonal antibody (3), sera from T. pallidum‐infected rabbits (4), and sera frompatients with secondary syphilis (5).</description><identifier>ISSN: 0887-8013</identifier><identifier>EISSN: 1098-2825</identifier><identifier>DOI: 10.1002/jcla.24635</identifier><identifier>PMID: 35908795</identifier><language>eng</language><publisher>New York: John Wiley & Sons, Inc</publisher><subject>Antibodies ; Antigens ; Automation ; Bacterial infections ; Diagnosis ; Disease control ; ELISA ; Enzymes ; Hepatitis B ; Immunoassay ; Immunoglobulin G ; Infections ; Laboratories ; Leptospirosis ; Lyme disease ; Medical research ; Patients ; Proteins ; Rabbits ; recombinant protein ; Rheumatoid arthritis ; Sensitivity analysis ; serodiagnosis ; Serological tests ; Serology ; Syphilis ; Systemic lupus erythematosus ; Tp0100 ; Tp1016 ; Treponema pallidum ; Western blotting</subject><ispartof>Journal of clinical laboratory analysis, 2022-09, Vol.36 (9), p.e24635-n/a</ispartof><rights>2022 The Authors. published by Wiley Periodicals LLC.</rights><rights>2022. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3555-de3d82a6843aa0f358b293c3f823222ce2e74a89a07456efcdfe8d86b0cb4bd23</citedby><cites>FETCH-LOGICAL-c3555-de3d82a6843aa0f358b293c3f823222ce2e74a89a07456efcdfe8d86b0cb4bd23</cites><orcidid>0000-0001-9542-6896 ; 0000-0002-4075-1613</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459255/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459255/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1411,11541,27901,27902,45550,45551,46027,46451,53766,53768</link.rule.ids></links><search><creatorcontrib>Chen, Dejun</creatorcontrib><creatorcontrib>Wang, Siqian</creatorcontrib><creatorcontrib>He, Yuxing</creatorcontrib><creatorcontrib>Fu, Yue</creatorcontrib><creatorcontrib>Zhao, Feijun</creatorcontrib><creatorcontrib>Zhou, Xiuping</creatorcontrib><creatorcontrib>Yin, Haoquan</creatorcontrib><creatorcontrib>Wan, Jia</creatorcontrib><creatorcontrib>Huang, Yunting</creatorcontrib><creatorcontrib>Wu, Yimou</creatorcontrib><creatorcontrib>Cao, Longgu</creatorcontrib><creatorcontrib>Zeng, Tiebing</creatorcontrib><title>Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis</title><title>Journal of clinical laboratory analysis</title><description>Objective
To discover novel serodiagnostic candidates for the serological diagnosis of syphilis.
Methods
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.
Results
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.
Conclusion
The recombinant T. pallidum protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.
SDS‐PAGE analysis of the expression and purification of recombinant proteins. (A, B) Tp0100 (22 kDa); (C, D) Tp1016 (39 kDa). M: molecular mass markers; N:noninduced; I: induced with IPTG; P: purification. Western blotting identification of recombinant proteins Tp0100 and Tp1016 with sera from normal rabbits (1), sera from uninfected human (2), anti‐Hismonoclonal antibody (3), sera from T. pallidum‐infected rabbits (4), and sera frompatients with secondary syphilis (5).</description><subject>Antibodies</subject><subject>Antigens</subject><subject>Automation</subject><subject>Bacterial infections</subject><subject>Diagnosis</subject><subject>Disease control</subject><subject>ELISA</subject><subject>Enzymes</subject><subject>Hepatitis B</subject><subject>Immunoassay</subject><subject>Immunoglobulin G</subject><subject>Infections</subject><subject>Laboratories</subject><subject>Leptospirosis</subject><subject>Lyme disease</subject><subject>Medical research</subject><subject>Patients</subject><subject>Proteins</subject><subject>Rabbits</subject><subject>recombinant protein</subject><subject>Rheumatoid arthritis</subject><subject>Sensitivity analysis</subject><subject>serodiagnosis</subject><subject>Serological tests</subject><subject>Serology</subject><subject>Syphilis</subject><subject>Systemic lupus erythematosus</subject><subject>Tp0100</subject><subject>Tp1016</subject><subject>Treponema pallidum</subject><subject>Western blotting</subject><issn>0887-8013</issn><issn>1098-2825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kUGLFDEQhYMo7uzqxV_Q4EWEXitJJ51chGHQ1WVgL7PnkE5Xz2ZId9pkW5l_b8ZZBD3soUg98uVVikfIOwrXFIB9Orhgr1kjuXhBVhS0qpli4iVZgVJtrYDyC3KZ8wEAlKbyNbngQoNqtViReZ0z5jzi9FjFoUro4tj5yRZZyu9xytVuhjKn6L60FKg8kbuEc5xwtNVsQ_D9MlZDTFXGFEPce2dD1Xu7n2L2-cTn4_zgg89vyKvBhoxvn84rcv_1y27zrd7e3XzfrLe140KIukfeK2alari1MHChOqa544NinDHmkGHbWKUttI2QOLh-QNUr2YHrmq5n_Ip8PvvOSzdi78qCyQYzJz_adDTRevPvzeQfzD7-NLoRmglRDD48GaT4Y8H8aEafHYZgJ4xLNkzqFrSkoi3o-__QQ1zSVNYzrKVUKiqAF-rjmXIp5pxw-PsZCuYUpDkFaf4EWWB6hn_5gMdnSHO72a7Pb34DNFSf3Q</recordid><startdate>202209</startdate><enddate>202209</enddate><creator>Chen, Dejun</creator><creator>Wang, Siqian</creator><creator>He, Yuxing</creator><creator>Fu, Yue</creator><creator>Zhao, Feijun</creator><creator>Zhou, Xiuping</creator><creator>Yin, Haoquan</creator><creator>Wan, Jia</creator><creator>Huang, Yunting</creator><creator>Wu, Yimou</creator><creator>Cao, Longgu</creator><creator>Zeng, Tiebing</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M7P</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PIMPY</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-9542-6896</orcidid><orcidid>https://orcid.org/0000-0002-4075-1613</orcidid></search><sort><creationdate>202209</creationdate><title>Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis</title><author>Chen, Dejun ; Wang, Siqian ; He, Yuxing ; Fu, Yue ; Zhao, Feijun ; Zhou, Xiuping ; Yin, Haoquan ; Wan, Jia ; Huang, Yunting ; Wu, Yimou ; Cao, Longgu ; Zeng, Tiebing</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3555-de3d82a6843aa0f358b293c3f823222ce2e74a89a07456efcdfe8d86b0cb4bd23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Antibodies</topic><topic>Antigens</topic><topic>Automation</topic><topic>Bacterial infections</topic><topic>Diagnosis</topic><topic>Disease control</topic><topic>ELISA</topic><topic>Enzymes</topic><topic>Hepatitis B</topic><topic>Immunoassay</topic><topic>Immunoglobulin G</topic><topic>Infections</topic><topic>Laboratories</topic><topic>Leptospirosis</topic><topic>Lyme disease</topic><topic>Medical research</topic><topic>Patients</topic><topic>Proteins</topic><topic>Rabbits</topic><topic>recombinant protein</topic><topic>Rheumatoid arthritis</topic><topic>Sensitivity analysis</topic><topic>serodiagnosis</topic><topic>Serological tests</topic><topic>Serology</topic><topic>Syphilis</topic><topic>Systemic lupus erythematosus</topic><topic>Tp0100</topic><topic>Tp1016</topic><topic>Treponema pallidum</topic><topic>Western blotting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Dejun</creatorcontrib><creatorcontrib>Wang, Siqian</creatorcontrib><creatorcontrib>He, Yuxing</creatorcontrib><creatorcontrib>Fu, Yue</creatorcontrib><creatorcontrib>Zhao, Feijun</creatorcontrib><creatorcontrib>Zhou, Xiuping</creatorcontrib><creatorcontrib>Yin, Haoquan</creatorcontrib><creatorcontrib>Wan, Jia</creatorcontrib><creatorcontrib>Huang, Yunting</creatorcontrib><creatorcontrib>Wu, Yimou</creatorcontrib><creatorcontrib>Cao, Longgu</creatorcontrib><creatorcontrib>Zeng, Tiebing</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central 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Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Applied & Life Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical laboratory analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Dejun</au><au>Wang, Siqian</au><au>He, Yuxing</au><au>Fu, Yue</au><au>Zhao, Feijun</au><au>Zhou, Xiuping</au><au>Yin, Haoquan</au><au>Wan, Jia</au><au>Huang, Yunting</au><au>Wu, Yimou</au><au>Cao, Longgu</au><au>Zeng, Tiebing</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis</atitle><jtitle>Journal of clinical laboratory analysis</jtitle><date>2022-09</date><risdate>2022</risdate><volume>36</volume><issue>9</issue><spage>e24635</spage><epage>n/a</epage><pages>e24635-n/a</pages><issn>0887-8013</issn><eissn>1098-2825</eissn><abstract>Objective
To discover novel serodiagnostic candidates for the serological diagnosis of syphilis.
Methods
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.
Results
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.
Conclusion
The recombinant T. pallidum protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.
SDS‐PAGE analysis of the expression and purification of recombinant proteins. (A, B) Tp0100 (22 kDa); (C, D) Tp1016 (39 kDa). M: molecular mass markers; N:noninduced; I: induced with IPTG; P: purification. Western blotting identification of recombinant proteins Tp0100 and Tp1016 with sera from normal rabbits (1), sera from uninfected human (2), anti‐Hismonoclonal antibody (3), sera from T. pallidum‐infected rabbits (4), and sera frompatients with secondary syphilis (5).</abstract><cop>New York</cop><pub>John Wiley & Sons, Inc</pub><pmid>35908795</pmid><doi>10.1002/jcla.24635</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-9542-6896</orcidid><orcidid>https://orcid.org/0000-0002-4075-1613</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical laboratory analysis, 2022-09, Vol.36 (9), p.e24635-n/a |
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| source | Wiley Online Library Open Access; DOAJ Directory of Open Access Journals; Wiley Online Library Journals Frontfile Complete; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Antibodies Antigens Automation Bacterial infections Diagnosis Disease control ELISA Enzymes Hepatitis B Immunoassay Immunoglobulin G Infections Laboratories Leptospirosis Lyme disease Medical research Patients Proteins Rabbits recombinant protein Rheumatoid arthritis Sensitivity analysis serodiagnosis Serological tests Serology Syphilis Systemic lupus erythematosus Tp0100 Tp1016 Treponema pallidum Western blotting |
| title | Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis |
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