{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:56:53Z","timestamp":1753869413065,"version":"3.41.2"},"reference-count":12,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,3,12]],"date-time":"2019-03-12T00:00:00Z","timestamp":1552348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>We evaluated the recently FDA cleared BioPlex 2200 Syphilis Total Screen and automated rapid plasma reagin (RPR) assay for the detection of total (IgG\/IgM) treponemal and non\u2010treponemal antibodies in the reverse syphilis algorithm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Prospectively submitted samples (n\u00a0=\u00a0885) were assayed by both the IgG\/IgM BioPlex Syphilis Screen and the original IgG BioPlex Syphilis Screen. The IgG screen reactive samples were reflexed to traditional RPR, and IgG\/IgM screen reactive samples were reflexed to the automated RPR. Nonreactive RPR samples were tested by the <jats:italic>Treponemal Pallidum<\/jats:italic> Particle Agglutination test (TP\u2010PA). Additional samples were collected (n\u00a0=\u00a0404 total samples) to directly compare the automated and traditional RPR assays with each other.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The sensitivity and specificity of the IgG\/IgM screen with automated RPR was 95.6% (95% confidence interval [CI] 87.0\u201099.1) and 99.6% (CI 99.2\u201099.8) while the sensitivity and specificity of the BioPlex IgG screen with traditional RPR was 97.8% (CI 89.1\u201099.9) and 99.3% (CI 98.8\u201099.4). The sensitivity and specificity of the BioPlex RPR compared with traditional RPR was 95.8% (CI 93.9\u201097.0) and 94.1% (CI 89.4\u201091.1) and 95.3% (CI 92.6\u201097.1). The mean of the titer differences between the BioPlex RPR and the traditional RPR was 1.0\u00a0\u00b1\u00a00.9\u00a0SD titers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The addition of the detection of treponemal IgM antibodies to the IgG\/IgM screen did not significantly affect the sensitivity and specificity compared to the original IgG screen. However, the addition of the comparable BioPlex RPR assay to the instrumentation significantly reduces the overall labor of syphilis screening and confirmation.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.22878","type":"journal-article","created":{"date-parts":[[2019,3,12]],"date-time":"2019-03-12T20:03:41Z","timestamp":1552421021000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Evaluation of the BioPlex 2200 syphilis total screen (IgG\/IgM) with reflex to an automated rapid plasma reagin test"],"prefix":"10.1002","volume":"33","author":[{"given":"Angela R.","family":"Rourk","sequence":"first","affiliation":[{"name":"Department of Pathology and Laboratory Medicine Medical University of South Carolina Charleston South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4311-7714","authenticated-orcid":false,"given":"Christine M.","family":"Litwin","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine Medical University of South Carolina Charleston South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,3,12]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0028-1142018"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.8.1.1"},{"key":"e_1_2_6_4_1","first-page":"133","article-title":"Discordant results from reverse sequence syphilis screening\u2013five laboratories, United States, 2006\u20102010","volume":"60","author":"Centers for Disease Control and Prevention","year":"2011","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1086\/655832"},{"key":"e_1_2_6_6_1","unstructured":"South Carolina\u20102015 State Health Profile.http:\/\/www.cdc.gov\/nchhstp\/stateprofiles\/pdf\/south_carolina_profile.pdf. Accessed April 2 2016."},{"key":"e_1_2_6_7_1","article-title":"Performance of treponemal tests for the diagnosis of syphilis","author":"Park IU","year":"2018","journal-title":"Clin Infect Dis"},{"key":"e_1_2_6_8_1","unstructured":"Bio\u2010Rad.BioPlex 2200 Syphilis Total & RPR package insert H CA;2017."},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqw182"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00966-17"},{"volume-title":"Statistical methods for rates and proportions","year":"1981","author":"Fleiss JF","key":"e_1_2_6_11_1"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/095646249500600404"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01487-18"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcla.22878","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.22878","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.22878","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.22878","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T18:37:48Z","timestamp":1694371068000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.22878"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3,12]]},"references-count":12,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2019,6]]}},"alternative-id":["10.1002\/jcla.22878"],"URL":"https:\/\/doi.org\/10.1002\/jcla.22878","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"type":"print","value":"0887-8013"},{"type":"electronic","value":"1098-2825"}],"subject":[],"published":{"date-parts":[[2019,3,12]]},"assertion":[{"value":"2019-01-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-02-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-03-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e22878"}}