{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T20:46:35Z","timestamp":1777927595353,"version":"3.51.4"},"reference-count":19,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"German Federal Ministry of Health","award":["1369-370"],"award-info":[{"award-number":["1369-370"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Int J STD AIDS"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Syphilis can cause significant clinical complications in adults and severe harm to fetuses and newborns through vertical transmission if it remains undiagnosed and untreated. With syphilis being on the rise in many countries, it causes a high and increasing burden of disease worldwide. Due to its high sensitivity and specificity, the TPPA (Treponema pallidum particle agglutination test) is considered the gold standard in serological syphilis diagnostic. However, the production of TPPA by the world\u2019s only manufacturer has stopped which has generated major gaps in diagnostic capabilities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Four polyvalent screening tests from Abbott, Roche, Diasorin and Euroimmun were evaluated on the base of negative, borderline and positive samples to develop an alternative diagnostic procedure of the highest possible quality. Additionally, alternative diagnostic threshold values of the test systems were evaluated for further optimization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 1768 samples from different patient populations were analyzed. When performed according to the manufacturer\u2019s instructions, most tests achieved a high specificity. However, the sensitivity of the screening tests was not fully satisfactory, particularly in the early stages of infection, where sensitivity remained relatively low.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>By lowering threshold values, the sensitivity could be significantly increased allowing for some of the evaluated assays to reach a test quality comparable to the TPPA, which is particularly relevant for samples from patients with higher risk of acquiring STIs. Moreover, the results of the polyvalent screening assays could also be used to monitor treatment success and detect possible re-infections.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09564624251400579","type":"journal-article","created":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T09:45:16Z","timestamp":1763977516000},"page":"383-389","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["The end of the gold standard in syphilis diagnostics - A comparison of alternative screening test methods"],"prefix":"10.1177","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-4214-6730","authenticated-orcid":false,"given":"Juliane","family":"Fazio","sequence":"first","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie-Christin","family":"H\u00f6ppner","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristin Maria","family":"Meyer-Schlinkmann","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Guttmann","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim Laura","family":"Sch\u00f6n","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Nei\u00dfe","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Jansen","sequence":"additional","affiliation":[{"name":"Robert Koch Institut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans-Jochen","family":"Hagedorn","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dieter","family":"M\u00fcnstermann","sequence":"additional","affiliation":[{"name":"MVZ Labor Krone GmbH"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,11,24]]},"reference":[{"key":"e_1_3_5_2_2","volume-title":"ECDC. Annual Epidemiological Report for 2023","author":"European Centre for Disease Prevention and Control. Syphilis","year":"2025","unstructured":"European Centre for Disease Prevention and Control. Syphilis. ECDC. Annual Epidemiological Report for 2023. ECDC, 2025."},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7246e1"},{"key":"e_1_3_5_4_2","first-page":"3","article-title":"Syphilis in Deutschland in den Jahren 2020-2022","volume":"8","author":"Jansen K","year":"2024","unstructured":"Jansen K, Bremer V. Syphilis in Deutschland in den Jahren 2020-2022. Epidemiol Bull 2024; 8: 3\u201324.","journal-title":"Epidemiol Bull"},{"key":"e_1_3_5_5_2","volume-title":"MIQ 16 Qualit\u00e4tsstandards in der mikrobiologischen-infektiologischen Diagnostik","author":"Hagedorn H","year":"2012","unstructured":"Hagedorn H, Brockmeyer N, Hunfeld K, et al. MIQ 16 Qualit\u00e4tsstandards in der mikrobiologischen-infektiologischen Diagnostik. Urban & Fischer Verlag \/ Elsevier GmbH, 2012."},{"key":"e_1_3_5_6_2","volume-title":"Diagnostik und Therapie der Syphilis","author":"STI-Gesellschaft D","unstructured":"STI-Gesellschaft D (ed). Diagnostik und Therapie der Syphilis, Retrieved from 2021, June 11. https:\/\/register.awmf.org\/assets\/guidelines\/059-002l_S2k_Diagnostik_Therapie_Syphilis_2021_06.pdf"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.16946"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2020-054923"},{"key":"e_1_3_5_9_2","unstructured":"Guttmann S Fazio J Gunkel T et al. Comparative performance measurement of agglutination assays for antibody detection against Treponema pallidum. In: 74th annual conference of the German Society for hygiene and microbiology [DGHM] 2022."},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy558"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1086\/655832"},{"key":"e_1_3_5_12_2","unstructured":"Abbott GmbH (package insert). Alinity i Syphilis TP reagent kit 2020."},{"key":"e_1_3_5_13_2","unstructured":"Hagedorn H-J Meyer-Schlinkmann KM Fazio J et al. Screening in the context of syphilis diagnostics: threshold ranges for automated syphilis immunoassays. In: 74th annual conference of the German society for hygiene and microbiology [DGHM] 2022."},{"key":"e_1_3_5_14_2","volume-title":"Anti-Treponema-pallidum-Screen-ELISA (IgG\/IgM)","author":"Euroimmun AG","year":"2022","unstructured":"Euroimmun AG (package insert). Anti-Treponema-pallidum-Screen-ELISA (IgG\/IgM), 2022."},{"key":"e_1_3_5_15_2","unstructured":"Roche Diagnostics (package insert) Elecsys Syphilis V 1.0 2021."},{"key":"e_1_3_5_16_2","unstructured":"Diasorin SPA (package insert). Liasion treponema screen 2019."},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00112-23"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00551-24"},{"key":"e_1_3_5_19_2","volume-title":"Passiver Teilchenagglutinationstest f\u00fcr den Nachweis von Antik\u00f6rpern gegen Treponema pallidum","author":"Fujirebio Inc","year":"2023","unstructured":"Fujirebio Inc. Passiver Teilchenagglutinationstest f\u00fcr den Nachweis von Antik\u00f6rpern gegen Treponema pallidum. 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