{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T11:49:56Z","timestamp":1767872996439,"version":"3.49.0"},"posted":{"date-parts":[[2026,1,6]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":20,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,1,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>\n                    Neonatal IgM antibodies reflect an in-utero immune response to\n                    <jats:italic>Treponema pallidum<\/jats:italic>\n                    and may offer added diagnostic value. This study evaluated the test performance of treponemal IgM levels measured by the research-use-only (RUO) DPP Syphilis TnT point-of-care (POC) assay for CS risk stratification.\n                  <\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>\n                    Conducted from May 2023 to May 2025, this study tested neonatal serum samples from infants born to mothers with syphilis using the DPP Syphilis TnT RUO POC assay, which reports treponemal and nontreponemal IgM levels as relative light units (RLU). Neonates were classified as\n                    <jats:italic>Confirmed Proven<\/jats:italic>\n                    or\n                    <jats:italic>Highly Probable CS<\/jats:italic>\n                    ,\n                    <jats:italic>Possible CS<\/jats:italic>\n                    , or\n                    <jats:italic>CS Less Likely<\/jats:italic>\n                    per guidelines; 23 neonates without maternal syphilis served as controls. Treponemal IgM levels were compared across categories using nonparametric tests and ordinal logistic regression. Diagnostic performance used prespecified cutoffs, with agreement assessed against neonatal RPR.\n                  <\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>\n                    Twenty-two maternal\u2013neonatal dyads were included. Mean treponemal IgM levels rose with CS severity, peaking in the high-risk group (\n                    <jats:italic>Possible<\/jats:italic>\n                    or\n                    <jats:italic>Confirmed Proven\/Highly Probable<\/jats:italic>\n                    CS: 29.9 \u00b1 20.6 RLU) versus\n                    <jats:italic>CS Less Likely<\/jats:italic>\n                    (17.5 \u00b1 20.8 RLU) and controls (3.5 \u00b1 0.8 RLU; p&lt;0.05). Higher IgM levels independently linked to elevated CS risk (OR 1.10 per 1 RLU; p=0.0025). At \u226510 RLU cutoff, treponemal IgM detected 88.9% of high-risk neonates, with 76% agreement to neonatal RPR.\n                  <\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The DPP Syphilis TnT RUO POC assay\u2019s treponemal IgM levels discriminated CS risk categories effectively and may supplement current algorithms to improve neonatal CS stratification.<\/jats:p>\n                <\/jats:sec>","DOI":"10.64898\/2026.01.05.26343454","type":"posted-content","created":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T01:00:14Z","timestamp":1767747614000},"source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic Potential for IgM Antibody Detection by the DPP Syphilis TnT Assay in Neonates at Risk for Congenital Syphilis"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2803-7329","authenticated-orcid":false,"given":"Irene A.","family":"Stafford","sequence":"first","affiliation":[{"name":"Associate Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Maternal-Fetal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, 77030"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lierni Ugartemendia","family":"Ugalde","sequence":"additional","affiliation":[{"name":"Senior Research Scientist, Goetzl Lab. Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, TX, 77030"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura M.","family":"Goetzl","sequence":"additional","affiliation":[{"name":"Professor, Vice Chair of Research, Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Maternal-Fetal Medicine, The University of Texas Health Science Center at Houston, Houston, TX, 77030"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Analuisa","family":"Mosqueda","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, TX, 77030"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabrina","family":"DaCosta","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, TX, 77030"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dhammika","family":"Gunasekera","sequence":"additional","affiliation":[{"name":"Senior Director of Research and Development (R&D), Chembio Diagnostics, Inc., Medford, NY, 11763"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Rivieccio","sequence":"additional","affiliation":[{"name":"Principal Scientist, Research and Development (R&D), Chembio Diagnostics, Inc., Medford, NY, 11763"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javan","family":"Esfandiari","sequence":"additional","affiliation":[{"name":"President, Chembio Diagnostics, Inc., Medford, NY, 11763"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0200-8255","authenticated-orcid":false,"given":"Konstantin P.","family":"Lyashchenko","sequence":"additional","affiliation":[{"name":"Senior Director of Research and Development (R&D), Chembio Diagnostics, Inc., Medford, NY, 11763"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"54368","reference":[{"key":"2026010801100742000_2026.01.05.26343454v1.1","unstructured":"World Health Organization. Global HIV, Hepatitis and STIs Programmes: Strategic Information. Accessed November 25, 2025.https:\/\/www.who.int\/teams\/global-hiv-hepatitis-and-stis-programmes\/stis\/strategic-information"},{"key":"2026010801100742000_2026.01.05.26343454v1.2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.5009"},{"key":"2026010801100742000_2026.01.05.26343454v1.3","unstructured":"Centers for Disease Control and Prevention. Sexually transmitted infections surveillance, 2024 (provisional). Accessed November 25, 2025.https:\/\/www.cdc.gov\/sti-statistics\/annual\/index.html"},{"key":"2026010801100742000_2026.01.05.26343454v1.4","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.8673"},{"key":"2026010801100742000_2026.01.05.26343454v1.5","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000005642"},{"key":"2026010801100742000_2026.01.05.26343454v1.6","unstructured":"World Health Organization. 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