{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T14:25:35Z","timestamp":1785421535636,"version":"3.56.0"},"reference-count":26,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2025,8,13]]},"abstract":"ABSTRACT<\/jats:title>\n \n \n \n Preliminary experimentation has suggested that a research-use-only real-time transcription-mediated amplification assay for\n Treponema pallidum<\/jats:italic>\n (RUO\n T. pallidum<\/jats:italic>\n TMA) yields instances of\n T. pallidum<\/jats:italic>\n nucleic acid detection that coincide with non-treponemal serology in men who have sex with men (MSM) at increased risk for sexually transmitted infection. To further characterize the specificity of RUO\n T. pallidum<\/jats:italic>\n TMA testing, 3,586 rectal swab specimens reported as \u201cnot detected\u201d by the assay generated a mean endpoint FAM fluorescence of 637.5 units. Introduction of\n Treponema denticola<\/jats:italic>\n ,\n Treponema phagedenis<\/jats:italic>\n , and\n Treponema refringens<\/jats:italic>\n nucleic acid into matrices generated mean endpoint FAM fluorescence ranging from 620.7 to 633.5 units (\n P<\/jats:italic>\n \u2265 0.15 versus control). Introduction of lubricant to a pooled rectal swab matrix did not result in elevated FAM fluorescence (mean endpoint value 628.3 units [95% CI 612.0, 644.6];\n P<\/jats:italic>\n = 0.67). Introduction of talcum powder, urine, seminal fluid, and blood also failed to generate increased FAM fluorescence (\n P<\/jats:italic>\n \u2265 0.20). Analytic sensitivity assessment was measured by serial 10-fold dilution of\n T. pallidum<\/jats:italic>\n whole organism or\n in vitro<\/jats:italic>\n 23S rRNA transcript in specimen transport medium or pooled rectal swab matrix and interrogation by the assay. Probit analysis estimated sensitivity (95% detection) of RUO\n T. pallidum<\/jats:italic>\n TMA at 421\u20135,707\n in vitro<\/jats:italic>\n transcript copies\/mL and 9\u201348\n T. pallidum<\/jats:italic>\n cells\/mL, depending on dilution matrix. These results support RUO\n T. pallidum<\/jats:italic>\n TMA as a highly sensitive method for\n T. pallidum<\/jats:italic>\n detection that is not impacted by potentially cross-reactive organisms or interfering substances and may have adjunctive diagnosis capability for syphilis in MSM.\n <\/jats:p>\n <\/jats:sec>\n \n IMPORTANCE<\/jats:title>\n \n Research-use-only\n Treponema pallidum<\/jats:italic>\n transcription-mediated amplification (RUO\n T. pallidum<\/jats:italic>\n TMA) has the potential to improve laboratory diagnosis of syphilis, particularly in patients at increased risk for sexually transmitted infection. The high analytic sensitivity and lack of cross-reactivity of the assay can facilitate other laboratories exploring the use of the test in a research setting.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1128\/jcm.00388-25","type":"journal-article","created":{"date-parts":[[2025,6,20]],"date-time":"2025-06-20T09:00:35Z","timestamp":1750410035000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Advanced specificity and sensitivity studies relative to a research use only transcription-mediated amplification-based assay for\n Treponema pallidum<\/i>\n RNA detection"],"prefix":"10.1128","volume":"63","author":[{"given":"Trinity","family":"Krueger","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04gr4te78","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Laboratory Science, Marquette University","place":["Milwaukee, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"Kadonsky","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04gr4te78","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Laboratory Science, Marquette University","place":["Milwaukee, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Thelen","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04gr4te78","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Laboratory Science, Marquette University","place":["Milwaukee, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Zapp","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04gr4te78","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Laboratory Science, Marquette University","place":["Milwaukee, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josephine","family":"Moore","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04gr4te78","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Laboratory Science, Marquette University","place":["Milwaukee, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmet","family":"Muslu","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00qzjvm58","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of STD Prevention, Centers for Disease Control and Prevention","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5326-9490","authenticated-orcid":true,"given":"Allan","family":"Pillay","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00qzjvm58","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of STD Prevention, Centers for Disease Control and Prevention","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene A.","family":"Stafford","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, McGovern Medical School at UTHealth","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5359-6643","authenticated-orcid":true,"given":"Erik","family":"Munson","sequence":"additional","affiliation":[{"name":"Wisconsin Clinical Laboratory Network Laboratory Technical Advisory Group","place":["Madison, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6613a1"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid2910.230660"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/ajd.13964"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00112-23"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01363-21"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000001244"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01625-16"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00311-24"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0302785"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.01351-23"},{"key":"e_1_3_3_12_2","first-page":"1199","volume-title":"Manual of clinical microbiology","author":"Se\u00f1a AC","year":"2023","unstructured":"Se\u00f1a AC, Pillay A, Radolf JD. 2023. 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