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<!DOCTYPE html> <html lang="en" dir="ltr" xmlns="http://www.w3.org/1999/xhtml" xmlns:mml="http://www.w3.org/1998/Math/MathML"> <head prefix="og: http://ogp.me/ns# article: http://ogp.me/ns/article# book: http://ogp.me/ns/book#" >  <link rel="dns-prefetch" href="//d33xdlntwy0kbs.cloudfront.net" /> <link rel="dns-prefetch" href="//cdn.jsdelivr.net" /> <link rel="dns-prefetch" href="//www.google.com" /> <link rel="dns-prefetch" href="//scholar.google.com" /> <link rel="dns-prefetch" href="//www.googletagmanager.com" /> <link rel="dns-prefetch" href="//rum-static.pingdom.net" /> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <link rel="shortcut icon" href="https://www.medrxiv.org/sites/default/files/images/favicon.ico" type="image/vnd.microsoft.icon" /> <meta name="viewport" content="width=device-width, initial-scale=1" /> <meta name="type" content="article" /> <meta name="category" content="article" /> <meta name="HW.identifier" content="/medrxiv/early/2024/11/25/2024.11.19.24317541.atom" /> <meta name="HW.pisa" content="medrxiv;2024.11.19.24317541v1" /> <meta name="DC.Format" content="text/html" /> <meta name="DC.Language" content="en" /> <meta name="DC.Title" content="Detection of human IgG antibodies against Mycoplasma genitalium using a recombinant MG075 antigen" /> <meta name="DC.Identifier" content="10.1101/2024.11.19.24317541" /> <meta name="DC.Date" content="2024-11-25" /> <meta name="DC.Publisher" content="Cold Spring Harbor Laboratory Press" /> <meta name="DC.Rights" content="© 2024, Posted by Cold Spring Harbor Laboratory. This pre-print is available under a Creative Commons License (Attribution-NonCommercial-NoDerivs 4.0 International), CC BY-NC-ND 4.0, as described at http://creativecommons.org/licenses/by-nc-nd/4.0/" /> <meta name="DC.AccessRights" content="restricted" /> <meta name="DC.Description" content="Mycoplasma genitalium is a sexually transmitted pathogen, which can cause a range of reproductive tract diseases in both men and women. To disentangle the relationship between M. genitalium infection(s) and subsequent reproductive health complications at the population level, accurate serological tools are needed. The major challenge in developing specific M. genitalium serological tests is the extensive cross-reactivity with the closely related ubiquitous respiratory tract pathogen, M. pneumoniae . In this report, we describe the development of an immunoblot assay based on a recombinant fragment of the M. genitalium MG075 protein present in lipid-associated membrane extracts. A sensitivity of 87.1% was achieved based on testing antibody responses in sera from 101 adults with PCR-confirmed M. genitalium infection. A specificity of 95.2% was obtained through evaluation of sera from 166 children under 15 years of age with and without M. pneumoniae infection, who were unlikely to have been exposed to sexually transmitted M. genitalium . The development of a serological assay capable of accurately distinguishing M. genitalium and M. pneumoniae , will enable a better understanding of associations between M. genitalium and adverse reproductive sequelae. ### Competing Interest Statement JSJ reports grants, personal fees, and non-financial support from Hologic; grants and personal fees from Nabriva, and personal fees from LeoPharma, Abbott, and BioMerieux all outside the submitted work. ### Funding Statement Parts of the present work were funded by an NIH grant to Brandie Taylor (1R01AI143653-01A1) with JSJ as sub-PI, an NIH/NIAID grant to Lisa Manhart (R01 AI61019) with JSJ as subcontractor. Furthermore, this work was supported in part by the grant: Gulf South Sexually Transmitted Infections/Topical Microbicide Cooperative Research Center (NIAID grant no. U19 AI061972) and the Intramural Research Program of the NIH Clinical Center, Bethesda, Maryland, USA. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Mg positive samples were from Louisiana State University, United States of America, where written informed consent was obtained from participants and the study protocol was approved by the Institutional Review Board of the Louisiana State University Health Sciences Center. All Mg positive samples used in the study were fully anonymised (also to research group) and originally collected with consent for further serological work. Sample set 1 Uppsala Research Ethical Committee (journal no. 2010/429) and Sample set 2: Karolinska University Hospital Ethics Committee in Stockholm, Sweden, D.nr: 392/01. The use of fully anonymised Mg negative samples was not subject to ethical review and approval, as this was not required according to the Danish Legislation and Institutional Requirements (Statens Serum Institut). Furthermore, written informed consent was not required for this study in accordance with the National Legislation and the Institutional Requirements. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors" /> <meta name="DC.Contributor" content="Anna Overgaard Kildemoes" /> <meta name="DC.Contributor" content="Olivia Sureya Seierø Rai" /> <meta name="DC.Contributor" content="Elisabeth Probst Lyng Westermann" /> <meta name="DC.Contributor" content="Henrik Frederik Bekkevold Johansen" /> <meta name="DC.Contributor" content="Eva Bjørnelius" /> <meta name="DC.Contributor" content="Carin Anagrius" /> <meta name="DC.Contributor" content="Liang Ma" /> <meta name="DC.Contributor" content="Ida Rosenkrands" /> <meta name="DC.Contributor" content="Jørgen Skov Jensen" /> <meta name="article:published_time" content="2024-11-25" /> <meta name="citation_title" content="Detection of human IgG antibodies against Mycoplasma genitalium using a recombinant MG075 antigen" /> <meta name="citation_abstract" lang="en" content="<p>Mycoplasma genitalium is a sexually transmitted pathogen, which can cause a range of reproductive tract diseases in both men and women. To disentangle the relationship between M. genitalium infection(s) and subsequent reproductive health complications at the population level, accurate serological tools are needed. The major challenge in developing specific M. genitalium serological tests is the extensive cross-reactivity with the closely related ubiquitous respiratory tract pathogen, M. pneumoniae. In this report, we describe the development of an immunoblot assay based on a recombinant fragment of the M. genitalium MG075 protein present in lipid-associated membrane extracts. A sensitivity of 87.1% was achieved based on testing antibody responses in sera from 101 adults with PCR-confirmed M. genitalium infection. A specificity of 95.2% was obtained through evaluation of sera from 166 children under 15 years of age with and without M. pneumoniae infection, who were unlikely to have been exposed to sexually transmitted M. genitalium. The development of a serological assay capable of accurately distinguishing M. genitalium and M. pneumoniae, will enable a better understanding of associations between M. genitalium and adverse reproductive sequelae.</p>" /> <meta name="citation_journal_title" content="medRxiv" /> <meta name="citation_publisher" content="Cold Spring Harbor Laboratory Press" /> <meta name="citation_publication_date" content="2024/01/01" /> <meta name="citation_mjid" content="medrxiv;2024.11.19.24317541v1" /> <meta name="citation_id" content="2024.11.19.24317541v1" /> <meta name="citation_public_url" content="https://www.medrxiv.org/content/10.1101/2024.11.19.24317541v1" /> <meta name="citation_abstract_html_url" content="https://www.medrxiv.org/content/10.1101/2024.11.19.24317541v1.abstract" /> <meta name="citation_full_html_url" content="https://www.medrxiv.org/content/10.1101/2024.11.19.24317541v1.full" /> <meta name="citation_pdf_url" content="https://www.medrxiv.org/content/medrxiv/early/2024/11/25/2024.11.19.24317541.full.pdf" /> <meta name="citation_doi" content="10.1101/2024.11.19.24317541" /> <meta name="citation_num_pages" content="14" /> <meta name="citation_article_type" content="Article" /> <meta name="citation_firstpage" content="2024.11.19.24317541" /> <meta name="citation_author" content="Anna Overgaard Kildemoes" /> <meta name="citation_author_institution" content="Reproductive Microbiology, Department of Bacteria" /> <meta name="citation_author_email" content="jsj@ssi.dk" /> <meta name="citation_author_email" content="tsl374@alumni.ku.dk" /> <meta name="citation_author_orcid" content="http://orcid.org/0000-0001-5150-1153" /> <meta name="citation_author" content="Olivia Sureya Seierø Rai" /> <meta name="citation_author_institution" content="Reproductive Microbiology, Department of Bacteria" /> <meta name="citation_author" content="Elisabeth Probst Lyng Westermann" /> <meta name="citation_author_institution" content="Reproductive Microbiology, Department of Bacteria" /> <meta name="citation_author" content="Henrik Frederik Bekkevold Johansen" /> <meta name="citation_author_institution" content="Reproductive Microbiology, Department of Bacteria" /> <meta name="citation_author" content="Eva Bjørnelius" /> <meta name="citation_author_institution" content="Department of Dermatovenereology, Karolinska University Hospital Huddinge" /> <meta name="citation_author" content="Carin Anagrius" /> <meta name="citation_author_institution" content="Department of Venereology" /> <meta name="citation_author" content="Liang Ma" /> <meta name="citation_author_institution" content="Critical Care Medicine Department, NIH Clinical Center, National Institutes of Health" /> <meta name="citation_author" content="Ida Rosenkrands" /> <meta name="citation_author_institution" content="Infectious Disease Immunology, Center for vaccine research" /> <meta name="citation_author" content="Jørgen Skov Jensen" /> <meta name="citation_author_institution" content="Reproductive Microbiology, Department of Bacteria" /> <meta name="citation_author_email" content="jsj@ssi.dk" /> <meta name="citation_author_email" content="tsl374@alumni.ku.dk" /> <meta name="citation_reference" content="Taylor-Robinson D, Jensen JS. 2011. Mycoplasma genitalium: from Chrysalis to multicolored butterfly. Clin Microbiol Rev 24:498–514." /> <meta name="citation_reference" content="Lis R, Rowhani-Rahbar A, Manhart LE. 2015. Mycoplasma genitalium infection and female reproductive tract disease: a meta-analysis. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America 61:418–426." /> <meta name="citation_reference" content="Tully JG, Taylor-Robinson D, Cole RM, Rose DL. 1981. A newly discovered mycoplasma in the human urogenital tract. Lancet 1:1288–91." /> <meta name="citation_reference" content="Waites KB, Crabb DM, Ratliff AE, Geisler WM, Atkinson TP, Xiao L. 2023. Latest Advances in Laboratory Detection of Mycoplasma genitalium. J Clin Microbiol 61:e0079021." /> <meta name="citation_reference" content="Sonnenberg P, Ison CA, Clifton S, Field N, Tanton C, Soldan K, Beddows S, Alexander S, Khanom R, Saunders P, Copas AJ, Wellings K, Mercer CH, Johnson AM. 2015. 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Sexually Transmitted Diseases 50:e26–e29." /> <meta name="twitter:title" content="Detection of human IgG antibodies against Mycoplasma genitalium using a recombinant MG075 antigen" /> <meta name="twitter:site" content="@medrxivpreprint" /> <meta name="twitter:card" content="summary" /> <meta name="twitter:image" content="https://www.medrxiv.org/sites/default/files/images/medrxiv_logo_homepage7-5-small-test-up.png" /> <meta name="twitter:description" content="Mycoplasma genitalium is a sexually transmitted pathogen, which can cause a range of reproductive tract diseases in both men and women. To disentangle the relationship between M. genitalium infection(s) and subsequent reproductive health complications at the population level, accurate serological tools are needed. The major challenge in developing specific M. genitalium serological tests is the extensive cross-reactivity with the closely related ubiquitous respiratory tract pathogen, M. pneumoniae . In this report, we describe the development of an immunoblot assay based on a recombinant fragment of the M. genitalium MG075 protein present in lipid-associated membrane extracts. A sensitivity of 87.1% was achieved based on testing antibody responses in sera from 101 adults with PCR-confirmed M. genitalium infection. A specificity of 95.2% was obtained through evaluation of sera from 166 children under 15 years of age with and without M. pneumoniae infection, who were unlikely to have been exposed to sexually transmitted M. genitalium . The development of a serological assay capable of accurately distinguishing M. genitalium and M. pneumoniae , will enable a better understanding of associations between M. genitalium and adverse reproductive sequelae. ### Competing Interest Statement JSJ reports grants, personal fees, and non-financial support from Hologic; grants and personal fees from Nabriva, and personal fees from LeoPharma, Abbott, and BioMerieux all outside the submitted work. ### Funding Statement Parts of the present work were funded by an NIH grant to Brandie Taylor (1R01AI143653-01A1) with JSJ as sub-PI, an NIH/NIAID grant to Lisa Manhart (R01 AI61019) with JSJ as subcontractor. Furthermore, this work was supported in part by the grant: Gulf South Sexually Transmitted Infections/Topical Microbicide Cooperative Research Center (NIAID grant no. U19 AI061972) and the Intramural Research Program of the NIH Clinical Center, Bethesda, Maryland, USA. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Mg positive samples were from Louisiana State University, United States of America, where written informed consent was obtained from participants and the study protocol was approved by the Institutional Review Board of the Louisiana State University Health Sciences Center. All Mg positive samples used in the study were fully anonymised (also to research group) and originally collected with consent for further serological work. Sample set 1 Uppsala Research Ethical Committee (journal no. 2010/429) and Sample set 2: Karolinska University Hospital Ethics Committee in Stockholm, Sweden, D.nr: 392/01. The use of fully anonymised Mg negative samples was not subject to ethical review and approval, as this was not required according to the Danish Legislation and Institutional Requirements (Statens Serum Institut). Furthermore, written informed consent was not required for this study in accordance with the National Legislation and the Institutional Requirements. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors" /> <meta name="og-title" property="og:title" content="Detection of human IgG antibodies against Mycoplasma genitalium using a recombinant MG075 antigen" /> <meta name="og-url" property="og:url" content="https://www.medrxiv.org/content/10.1101/2024.11.19.24317541v1" /> <meta name="og-site-name" property="og:site_name" content="medRxiv" /> <meta name="og-description" property="og:description" content="Mycoplasma genitalium is a sexually transmitted pathogen, which can cause a range of reproductive tract diseases in both men and women. To disentangle the relationship between M. genitalium infection(s) and subsequent reproductive health complications at the population level, accurate serological tools are needed. The major challenge in developing specific M. genitalium serological tests is the extensive cross-reactivity with the closely related ubiquitous respiratory tract pathogen, M. pneumoniae . In this report, we describe the development of an immunoblot assay based on a recombinant fragment of the M. genitalium MG075 protein present in lipid-associated membrane extracts. A sensitivity of 87.1% was achieved based on testing antibody responses in sera from 101 adults with PCR-confirmed M. genitalium infection. A specificity of 95.2% was obtained through evaluation of sera from 166 children under 15 years of age with and without M. pneumoniae infection, who were unlikely to have been exposed to sexually transmitted M. genitalium . The development of a serological assay capable of accurately distinguishing M. genitalium and M. pneumoniae , will enable a better understanding of associations between M. genitalium and adverse reproductive sequelae. ### Competing Interest Statement JSJ reports grants, personal fees, and non-financial support from Hologic; grants and personal fees from Nabriva, and personal fees from LeoPharma, Abbott, and BioMerieux all outside the submitted work. ### Funding Statement Parts of the present work were funded by an NIH grant to Brandie Taylor (1R01AI143653-01A1) with JSJ as sub-PI, an NIH/NIAID grant to Lisa Manhart (R01 AI61019) with JSJ as subcontractor. Furthermore, this work was supported in part by the grant: Gulf South Sexually Transmitted Infections/Topical Microbicide Cooperative Research Center (NIAID grant no. U19 AI061972) and the Intramural Research Program of the NIH Clinical Center, Bethesda, Maryland, USA. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Mg positive samples were from Louisiana State University, United States of America, where written informed consent was obtained from participants and the study protocol was approved by the Institutional Review Board of the Louisiana State University Health Sciences Center. All Mg positive samples used in the study were fully anonymised (also to research group) and originally collected with consent for further serological work. Sample set 1 Uppsala Research Ethical Committee (journal no. 2010/429) and Sample set 2: Karolinska University Hospital Ethics Committee in Stockholm, Sweden, D.nr: 392/01. The use of fully anonymised Mg negative samples was not subject to ethical review and approval, as this was not required according to the Danish Legislation and Institutional Requirements (Statens Serum Institut). Furthermore, written informed consent was not required for this study in accordance with the National Legislation and the Institutional Requirements. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. 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class="highwire-article-citation highwire-citation-type-highwire-article node905690" data-node-nid="905690" id="node-905690--21818538079" data-pisa="medrxiv;2024.11.19.24317541v1" data-pisa-master="medrxiv;2024.11.19.24317541" data-apath="/medrxiv/early/2024/11/25/2024.11.19.24317541.atom" data-hw-author-tooltip-instance=""><div class="highwire-cite highwire-cite-highwire-article highwire-citation-medrxiv-article-top clearfix has-author-tooltip" > <h1 class="highwire-cite-title" id="page-title">Detection of human IgG antibodies against <em>Mycoplasma genitalium</em> using a recombinant MG075 antigen</h1> <div class="highwire-cite-authors" ><span class="highwire-citation-authors"><span class="highwire-citation-author first hw-author-orcid-logo-wrapper" data-delta="0"><a href="http://orcid.org/0000-0001-5150-1153" target="_blank" class="hw-author-orcid-logo link-icon-only link-icon"><span class="hw-icon-orcid hw-icon-color-orcid"></span> <span class="title element-invisible">View ORCID Profile</span></a><span class="nlm-given-names">Anna Overgaard</span> <span class="nlm-surname">Kildemoes</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">Olivia Sureya Seierø</span> <span class="nlm-surname">Rai</span></span>, <span class="highwire-citation-author" data-delta="2"><span class="nlm-given-names">Elisabeth Probst Lyng</span> <span class="nlm-surname">Westermann</span></span>, <span class="highwire-citation-author" data-delta="3"><span class="nlm-given-names">Henrik Frederik Bekkevold</span> <span class="nlm-surname">Johansen</span></span>, <span class="highwire-citation-author" data-delta="4"><span class="nlm-given-names">Eva</span> <span class="nlm-surname">Bjørnelius</span></span>, <span class="highwire-citation-author" data-delta="5"><span class="nlm-given-names">Carin</span> <span class="nlm-surname">Anagrius</span></span>, <span class="highwire-citation-author" data-delta="6"><span class="nlm-given-names">Liang</span> <span class="nlm-surname">Ma</span></span>, <span class="highwire-citation-author" data-delta="7"><span class="nlm-given-names">Ida</span> <span class="nlm-surname">Rosenkrands</span></span>, <span class="highwire-citation-author" data-delta="8"><span class="nlm-given-names">Jørgen Skov</span> <span class="nlm-surname">Jensen</span></span></span></div> <div class="highwire-cite-metadata" ><span class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">doi:</span> https://doi.org/10.1101/2024.11.19.24317541 </span></div> </div> <div id="hw-article-author-popups-node-905690--21818538079" style="display: none;"><div class="author-tooltip-0"><div class="author-tooltip-name">Anna Overgaard Kildemoes </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>1</span><span class='nlm-institution'>Reproductive Microbiology, Department of Bacteria</span>, Parasites & Fungi, Statens Serum Institut, Copenhagen, <span class='nlm-country'>Denmark</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Anna%2BOvergaard%2BKildemoes%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Kildemoes%20AO&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link"><a href="/search/author1%3AAnna%2BOvergaard%2BKildemoes%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li><li class="author-orcid-link"><a href="http://orcid.org/0000-0001-5150-1153" target="_blank" class="" data-icon-position="" data-hide-link-title="0">ORCID record for Anna Overgaard Kildemoes</a></li><li class="author-corresp-email-link last"><span>For correspondence: <a href="mailto:jsj@ssi.dk" class="" data-icon-position="" data-hide-link-title="0">jsj@ssi.dk</a> <a href="mailto:tsl374@alumni.ku.dk" class="" data-icon-position="" data-hide-link-title="0">tsl374@alumni.ku.dk</a></span></li></ul></div><div class="author-tooltip-1"><div class="author-tooltip-name">Olivia Sureya Seierø Rai </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>1</span><span class='nlm-institution'>Reproductive Microbiology, Department of Bacteria</span>, Parasites & Fungi, Statens Serum Institut, Copenhagen, <span class='nlm-country'>Denmark</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Olivia%2BSureya%2BSeier%C3%B8%2BRai%2B" target="_blank" class="" 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class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Elisabeth%2BProbst%2BLyng%2BWestermann%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Westermann%20EP&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AElisabeth%2BProbst%2BLyng%2BWestermann%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-3"><div class="author-tooltip-name">Henrik Frederik Bekkevold Johansen </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>1</span><span class='nlm-institution'>Reproductive Microbiology, Department of Bacteria</span>, Parasites & Fungi, Statens Serum Institut, Copenhagen, <span class='nlm-country'>Denmark</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Henrik%2BFrederik%2BBekkevold%2BJohansen%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Johansen%20HF&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AHenrik%2BFrederik%2BBekkevold%2BJohansen%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this 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Serum Institut, Copenhagen, <span class='nlm-country'>Denmark</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=J%C3%B8rgen%2BSkov%2BJensen%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Jensen%20JS&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link"><a href="/search/author1%3AJ%25C3%25B8rgen%2BSkov%2BJensen%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li><li class="author-corresp-email-link last"><span>For correspondence: <a href="mailto:jsj@ssi.dk" class="" data-icon-position="" data-hide-link-title="0">jsj@ssi.dk</a> <a href="mailto:tsl374@alumni.ku.dk" class="" data-icon-position="" data-hide-link-title="0">tsl374@alumni.ku.dk</a></span></li></ul></div></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-panel-tabs pane-panels-ajax-tab-tabs" > <div class="pane-content"> <div class="item-list"><ul class="tabs inline panels-ajax-tab"><li class="first"><a href="/content/10.1101/2024.11.19.24317541v1" class="panels-ajax-tab-tab" data-panel-name="biorxiv_tab_art" data-target-id="highwire_article_tabs" data-entity-context="node:905690" data-trigger="" data-url-enabled="1">Abstract</a><a href="/panels_ajax_tab/biorxiv_tab_art/node:905690/1" rel="nofollow" style="display:none" class="js-crawler-link"></a></li><li><a href="/content/10.1101/2024.11.19.24317541v1.full-text" class="panels-ajax-tab-tab" data-panel-name="article_tab_full_text" data-target-id="highwire_article_tabs" data-entity-context="node:905690" 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data-target-id="highwire_article_tabs" data-entity-context="node:905690" data-trigger="full.pdf+html" data-url-enabled="1"><i class="icon-file-alt"></i> Preview PDF</a><a href="/panels_ajax_tab/biorxiv_tab_pdf/node:905690/1" rel="nofollow" style="display:none" class="js-crawler-link"></a></li></ul></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-panel-tabs-container" > <div class="pane-content"> <div data-panels-ajax-tab-preloaded="biorxiv_tab_art" id="panels-ajax-tab-container-highwire_article_tabs" class="panels-ajax-tab-container"><div class="panels-ajax-tab-loading" style ="display:none"><img class="loading" src="https://www.medrxiv.org/sites/all/modules/contrib/panels_ajax_tab/images/loading.gif" alt="Loading" title="Loading" /></div><div class="panels-ajax-tab-wrap-biorxiv_tab_art"><div class="panel-display panel-1col clearfix" > <div class="panel-panel panel-col"> <div><div class="panel-pane pane-highwire-markup" > <div class="pane-content"> <div class="highwire-markup"><div xmlns="http://www.w3.org/1999/xhtml" data-highwire-cite-ref-tooltip-instance="highwire_reflinks_tooltip" class="content-block-markup" xmlns:xhtml="http://www.w3.org/1999/xhtml"><div class="article abstract-view "><span class="highwire-journal-article-marker-start"></span><div class="section abstract" id="abstract-1"><h2 class="">Abstract</h2><p id="p-2"><em>Mycoplasma genitalium</em> is a sexually transmitted pathogen, which can cause a range of reproductive tract diseases in both men and women. To disentangle the relationship between <em>M. genitalium</em> infection(s) and subsequent reproductive health complications at the population level, accurate serological tools are needed. The major challenge in developing specific <em>M. genitalium</em> serological tests is the extensive cross-reactivity with the closely related ubiquitous respiratory tract pathogen, <em>M. pneumoniae</em>. In this report, we describe the development of an immunoblot assay based on a recombinant fragment of the <em>M. genitalium</em> MG075 protein present in lipid-associated membrane extracts. A sensitivity of 87.1% was achieved based on testing antibody responses in sera from 101 adults with PCR-confirmed <em>M. genitalium</em> infection. A specificity of 95.2% was obtained through evaluation of sera from 166 children under 15 years of age with and without <em>M. pneumoniae</em> infection, who were unlikely to have been exposed to sexually transmitted <em>M. genitalium</em>. The development of a serological assay capable of accurately distinguishing <em>M. genitalium</em> and <em>M. pneumoniae</em>, will enable a better understanding of associations between <em>M. genitalium</em> and adverse reproductive sequelae.</p></div><h3>Competing Interest Statement</h3><p id="p-3">JSJ reports grants, personal fees, and non-financial support from Hologic; grants and personal fees from Nabriva, and personal fees from LeoPharma, Abbott, and BioMerieux all outside the submitted work.</p><h3>Funding Statement</h3><p id="p-4">Parts of the present work were funded by an NIH grant to Brandie Taylor (1R01AI143653-01A1) with JSJ as sub-PI, an NIH/NIAID grant to Lisa Manhart (R01 AI61019) with JSJ as subcontractor. Furthermore, this work was supported in part by the grant: Gulf South Sexually Transmitted Infections/Topical Microbicide Cooperative Research Center (NIAID grant no. U19 AI061972) and the Intramural Research Program of the NIH Clinical Center, Bethesda, Maryland, USA.</p><h3>Author Declarations</h3><p id="p-5">I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.</p><p id="p-6">Yes</p><p id="p-7">The details of the IRB/oversight body that provided approval or exemption for the research described are given below:</p><p id="p-8">Mg positive samples were from Louisiana State University, United States of America, where written informed consent was obtained from participants and the study protocol was approved by the Institutional Review Board of the Louisiana State University Health Sciences Center. All Mg positive samples used in the study were fully anonymised (also to research group) and originally collected with consent for further serological work. Sample set 1 Uppsala Research Ethical Committee (journal no. 2010/429) and Sample set 2: Karolinska University Hospital Ethics Committee in Stockholm, Sweden, D.nr: 392/01. The use of fully anonymised Mg negative samples was not subject to ethical review and approval, as this was not required according to the Danish Legislation and Institutional Requirements (Statens Serum Institut). Furthermore, written informed consent was not required for this study in accordance with the National Legislation and the Institutional Requirements.</p><p id="p-9">I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.</p><p id="p-10">Yes</p><p id="p-11">I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).</p><p id="p-12">Yes</p><p id="p-13">I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.</p><p id="p-14">Yes</p><div class="section data-availability" id="sec-13"><h2 class="">Data Availability</h2><p id="p-32">All data produced in the present study are available upon reasonable request to the authors</p></div><span class="highwire-journal-article-marker-end"></span></div><span class="related-urls"></span></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-biorxiv-copyright" > <div class="pane-content"> <div class="field 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