{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:28:55Z","timestamp":1787563735729,"version":"build-2736575974"},"reference-count":20,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-079080"],"award-info":[{"award-number":["INV-079080"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD108201"],"award-info":[{"award-number":["R01HD108201"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2026,5,13]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Neonatal IgM antibodies reflect an\n                      <jats:italic toggle=\"yes\">in utero<\/jats:italic>\n                      immune response to\n                      <jats:italic toggle=\"yes\">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) Dual Path Platform (DPP) Syphilis TnT point-of-care (POC) assay for congenital syphilis (CS) risk stratification. 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 toggle=\"yes\">confirmed proven or highly probable CS<\/jats:italic>\n                      ,\n                      <jats:italic toggle=\"yes\">possible CS<\/jats:italic>\n                      , or\n                      <jats:italic toggle=\"yes\">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 rapid plasma reagin (RPR). Twenty-two maternal-neonatal dyads were included. Mean treponemal IgM levels rose with CS severity, peaking in the high-risk group (\n                      <jats:italic toggle=\"yes\">possible<\/jats:italic>\n                      or\n                      <jats:italic toggle=\"yes\">confirmed proven\/highly probable<\/jats:italic>\n                      CS: 29.9 \u00b1 20.6 RLU) versus\n                      <jats:italic toggle=\"yes\">CS less likely<\/jats:italic>\n                      (17.5 \u00b1 20.8 RLU) and controls (3.5 \u00b1 0.8 RLU;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.05). Higher IgM levels independently linked to elevated CS risk (OR 1.10 per 1 RLU;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.0025). At \u226510 RLU cutoff, treponemal IgM detected 88.9% of high-risk neonates, with 76% agreement to neonatal RPR. 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.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>\n                        Congenital syphilis (CS) continues to rise in the United States and globally, yet diagnosis at birth remains difficult because no single laboratory test definitively confirms infection in newborns. Clinical decisions often rely on maternal history and indirect serologic comparisons, which can result in both missed cases and unnecessary treatment of low-risk infants. IgM antibodies are produced by the fetus in response to infection\n                        <jats:italic toggle=\"yes\">in utero<\/jats:italic>\n                        and therefore represent a biologically meaningful marker of congenital infection. This study evaluates the diagnostic potential of the Dual Path Platform Syphilis TnT research-use-only point-of-care assay to detect treponemal IgM in at-risk neonates. We demonstrate that IgM levels increase across\n                        <jats:italic toggle=\"yes\">CS less likely<\/jats:italic>\n                        ,\n                        <jats:italic toggle=\"yes\">possible CS<\/jats:italic>\n                        , and\n                        <jats:italic toggle=\"yes\">confirmed proven or highly probable CS<\/jats:italic>\n                        categories and are independently associated with disease risk. These findings provide early evidence that neonatal IgM testing may improve risk stratification and support more precise clinical decision-making in CS management.\n                      <\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01903-25","type":"journal-article","created":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T13:41:48Z","timestamp":1776692508000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":2,"title":["Diagnostic potential for IgM antibody detection by the DPP Syphilis TnT assay in neonates at risk for congenital syphilis"],"prefix":"10.1128","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2803-7329","authenticated-orcid":true,"given":"Irene A.","family":"Stafford","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03gds6c39","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lierni","family":"Ugartemendia Ugalde","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03gds6c39","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura M.","family":"Goetzl","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03gds6c39","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Analuisa","family":"Mosqueda","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03gds6c39","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"DaCosta","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03gds6c39","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhammika","family":"Gunasekera","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/009k2za57","id-type":"ROR","asserted-by":"publisher"}],"name":"Chembio Diagnostics, Inc.","place":["Medford, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Rivieccio","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/009k2za57","id-type":"ROR","asserted-by":"publisher"}],"name":"Chembio Diagnostics, Inc.","place":["Medford, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javan","family":"Esfandiari","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/009k2za57","id-type":"ROR","asserted-by":"publisher"}],"name":"Chembio Diagnostics, Inc.","place":["Medford, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0200-8255","authenticated-orcid":true,"given":"Konstantin P.","family":"Lyashchenko","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/009k2za57","id-type":"ROR","asserted-by":"publisher"}],"name":"Chembio Diagnostics, Inc.","place":["Medford, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","unstructured":"World Health Organization. 2025. 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American Academy of Pediatrics, Elk Grove Village, Illinois."},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000002209"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/157.5.903"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.1992.02160220057022"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00551-24"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01903-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01903-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T13:02:30Z","timestamp":1779973350000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.01903-25"}},"subtitle":[],"editor":[{"given":"Erik","family":"Munson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,5,13]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5,13]]}},"alternative-id":["10.1128\/jcm.01903-25"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01903-25","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,13]]},"assertion":[{"value":"2025-12-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-20","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01903-25"}}