{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T04:06:51Z","timestamp":1771042011361,"version":"3.50.1"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2018,7,1]],"date-time":"2018-07-01T00:00:00Z","timestamp":1530403200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The Elecsys\u00ae syphilis immunoassay is an automated, qualitative immunoassay that uses a double-antigen sandwich format to detect antibodies to Treponema pallidum in human serum and plasma. We aimed to validate performance of the immunoassay in various populations at risk for syphilis infection in the US and Argentina.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Samples were obtained for a number of study cohorts, including participants from routine syphilis testing at high or low risk for syphilis, HIV-positive patients, pregnant women, and patients in various stages of syphilis infection. The primary objective was to validate the Elecsys syphilis immunoassay by comparing it with a composite testing algorithm using US Food and Drug Administration (FDA)-approved tests, including the predicate IMMULITE 2000 syphilis screening assay, the rapid plasma reagin, and the T. pallidum particle agglutination assay.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Complete algorithm testing was performed on all 2660 collected samples. Acceptable precision was demonstrated in all samples. Comparison of the Elecsys syphilis immunoassay with the final syphilis status for all samples yielded a diagnostic sensitivity of 99.5% (95% CI, 98.21\u201399.94) and a diagnostic specificity of 99.2% (95% CI, 98.69\u201399.49). Overall, the lower limit of the 95% CIs for sensitivity and specificity met the expected performance of \u226595%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This is the first study that confirms the high sensitivity and specificity of the Elecsys syphilis immunoassay in US and Argentinian cohorts and highlights the assay's usefulness as an alternative to current tests for the diagnosis of syphilis infection in a broad range of participant cohorts.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1373\/jalm.2017.024943","type":"journal-article","created":{"date-parts":[[2018,7,23]],"date-time":"2018-07-23T23:05:25Z","timestamp":1532387125000},"page":"89-99","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the Elecsys Syphilis Immunoassay for Detection of Syphilis in Populations at Risk of Disease in the US and Argentina"],"prefix":"10.1093","volume":"3","author":[{"given":"Robert H","family":"Christenson","sequence":"first","affiliation":[{"name":"Department of Pathology, University of Maryland School of Medicine, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marvin","family":"Lessig","sequence":"additional","affiliation":[{"name":"Nationwide Laboratory Services, Plantation, FL"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabrielle","family":"Miles","sequence":"additional","affiliation":[{"name":"Global Medical and Scientific Affairs CPS, Roche Diagnostics Operations, Indianapolis, IN"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silke","family":"Luebcke","sequence":"additional","affiliation":[{"name":"R&D, Roche Diagnostics GmbH, Penzberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Stillions","sequence":"additional","affiliation":[{"name":"Global Medical and Scientific Affairs CPS, Roche Diagnostics Operations, Indianapolis, IN"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prentiss","family":"Jones","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2018,7,1]]},"reference":[{"key":"2022020118355775900_B1","doi-asserted-by":"crossref","first-page":"e1001396","DOI":"10.1371\/journal.pmed.1001396","article-title":"Global estimates of syphilis in pregnancy and associated adverse outcomes: analysis of multinational antenatal surveillance data","volume":"10","author":"Newman","year":"2013","journal-title":"PLoS Med"},{"key":"2022020118355775900_B2","doi-asserted-by":"crossref","first-page":"e102203","DOI":"10.1371\/journal.pone.0102203","article-title":"Reported estimates of adverse pregnancy outcomes among women with and without syphilis: a systematic review and meta-analysis","volume":"9","author":"Qin","year":"2014","journal-title":"PLoS One"},{"key":"2022020118355775900_B3","unstructured":"World Health Organization. WHO guidelines for the treatment of Treponema pallidum (syphilis). 2016. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK384904 (Accessed January 2017)."},{"key":"2022020118355775900_B4","doi-asserted-by":"crossref","first-page":"e525","DOI":"10.1016\/S2214-109X(16)30135-8","article-title":"Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modelling study","volume":"4","author":"Wijesooriya","year":"2016","journal-title":"Lancet Glob Health"},{"key":"2022020118355775900_B5","doi-asserted-by":"crossref","first-page":"1905","DOI":"10.1001\/jama.2014.13259","article-title":"Treatment of syphilis: a systematic review","volume":"312","author":"Clement","year":"2014","journal-title":"JAMA"},{"key":"2022020118355775900_B6","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1002\/path.1903","article-title":"The pathogenesis of syphilis: the Great Mimicker, revisited","volume":"208","author":"Peeling","year":"2006","journal-title":"J Pathol"},{"key":"2022020118355775900_B7","doi-asserted-by":"crossref","first-page":"744","DOI":"10.1038\/nrmicro.2016.141","article-title":"Treponema pallidum, the syphilis spirochete: making a living as a stealth pathogen","volume":"14","author":"Radolf","year":"2016","journal-title":"Nat Rev Microbiol"},{"key":"2022020118355775900_B8","unstructured":"Centers for Disease Control and Prevention. 2015 sexually transmitted diseases treatment guidelines. Syphilis. https:\/\/www.cdc.gov\/std\/tg2015\/syphilis.htm (Accessed June 2017)."},{"key":"2022020118355775900_B9","first-page":"1","article-title":"Sexually transmitted diseases treatment guidelines, 2010","volume":"59","author":"Workowski","year":"2010","journal-title":"MMWR Recomm Rep"},{"key":"2022020118355775900_B10","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1097\/QCO.0b013e32834e9a3c","article-title":"Which algorithm should be used to screen for syphilis?","volume":"25","author":"Binnicker","year":"2012","journal-title":"Curr Opin Infect Dis"},{"key":"2022020118355775900_B11","doi-asserted-by":"crossref","first-page":"300","DOI":"10.1258\/ijsa.2008.008510","article-title":"IUSTI: 2008 European guidelines on the management of syphilis","volume":"20","author":"French","year":"2009","journal-title":"Int J STD AIDS"},{"key":"2022020118355775900_B12","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1128\/CVI.00505-14","article-title":"Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum","volume":"22","author":"Enders","year":"2015","journal-title":"Clin Vaccine Immunol"},{"key":"2022020118355775900_B13","doi-asserted-by":"crossref","first-page":"2330","DOI":"10.1128\/JCM.02544-15","article-title":"Evaluation of Elecsys syphilis assay for routine and blood screening and detection of early infection","volume":"54","author":"Kremastinou","year":"2016","journal-title":"J Clin Microbiol"},{"key":"2022020118355775900_B14","article-title":"Evaluation of precision performance of quantitative measurement methods; approved guideline \u2013 second edition","author":"Clinical and Laboratory Standards Institute"},{"key":"2022020118355775900_B15","first-page":"402","article-title":"Primary and secondary syphilis \u2013 United States, 2005\u20132013","volume":"63","author":"Patton","year":"2014","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2022020118355775900_B16","unstructured":"Everything about syphilis and syphilis testing (2015). https:\/\/www.stdcheck.com\/blog\/everything-about-syphilis-and-syphilis-testing\/ (Accessed November 2017)."},{"key":"2022020118355775900_B17","doi-asserted-by":"crossref","first-page":"S53","DOI":"10.1097\/01.aids.0000304697.39637.4c","article-title":"Risk factors of HIV infection and prevalence of co-infections among men who have sex with men in Beijing","volume":"21","author":"Zhang","year":"2007","journal-title":"China. AIDS"},{"key":"2022020118355775900_B18","doi-asserted-by":"crossref","first-page":"728","DOI":"10.1086\/527379","article-title":"Prevalence and correlates of HIV infection among female sex workers in 2 Mexico-US border cities","volume":"197","author":"Patterson","year":"2008","journal-title":"J Infect Dis"},{"key":"2022020118355775900_B19","doi-asserted-by":"crossref","first-page":"1654","DOI":"10.1086\/522008","article-title":"Detection of acute and established HIV infections in sexually transmitted disease clinics in Guangxi. China: implications for screening and prevention of HIV infection","volume":"196","author":"Chen","year":"2007","journal-title":"J Infect Dis"},{"key":"2022020118355775900_B20","doi-asserted-by":"crossref","first-page":"294","DOI":"10.1097\/COH.0b013e32832c1881","article-title":"Herpes simplex virus type 2 and syphilis infections with HIV: an evolving synergy in transmission and prevention","volume":"4","author":"Tobian","year":"2009","journal-title":"Curr Opin HIV AIDS"},{"key":"2022020118355775900_B21","unstructured":"United States Census Bureau (2016) https:\/\/www.census.gov\/quickfacts\/fact\/table\/US\/PST045216 (Accessed November 2017)."},{"key":"2022020118355775900_B22","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1016\/j.diagmicrobio.2016.12.003","article-title":"Analytical and clinical comparison of Elecsys syphilis (Roche\u00ae) - ARCHITECT syphilis TP and reformulated ARCHITECT syphilis TP (Abbott\u00ae) assay","volume":"87","author":"De Keukeleire","year":"2017","journal-title":"Diagn Microbiol Infect Dis"}],"container-title":["The Journal of Applied Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/3\/1\/89\/42353736\/3_3_1_89.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/3\/1\/89\/42353736\/3_3_1_89.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,1]],"date-time":"2022-02-01T18:53:55Z","timestamp":1643741635000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jalm\/article\/3\/1\/89\/5581313"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,7,1]]},"references-count":22,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2018,7,1]]},"published-print":{"date-parts":[[2018,7,1]]}},"URL":"https:\/\/doi.org\/10.1373\/jalm.2017.024943","relation":{},"ISSN":["2475-7241"],"issn-type":[{"value":"2475-7241","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2018,7,1]]},"published":{"date-parts":[[2018,7,1]]}}}