{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T21:09:33Z","timestamp":1777928973207,"version":"3.51.4"},"reference-count":13,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T00:00:00Z","timestamp":1678752000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Beckman Coulter, Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Med Screen"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Unconjugated estriol (uE3) is used as a marker for fetal aneuploidy in maternal serum screening tests. The goal of this study was to examine the validity of a new immunoassay for uE3 that uses a monoclonal antibody (m-uE3) rather than the more commonly used polyclonal antibody (p-uE3).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Assays were performed in the Special Chemistry laboratory at Women and Infants Hospital of Rhode Island.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Residual fresh ( n\u2009=\u2009100) and frozen ( n\u2009=\u2009533) second trimester serum samples from routine clinical care were tested using p-uE3 and\/or m-uE3 assays. Assay results were compared between methods using Bland\u2013Altman plots. A median equation was developed for m-uE3 results. Down syndrome risks were compared between the two assays in a case\u2013control sample set (21 cases each matched with five controls for the completed week of gestation, duration of freezer storage and race).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Log-transformed serum uE3 levels were highly correlated between the assays ( r\u2009=\u20090.93, p\u2009&lt;\u20090.001), with the m-uE3 assay levels yielding, on average, 23% higher (standard deviation of differences in log uE3 concentrations\u2009=\u20090.07) results. Assay and gestation-based median equations were calculated and used to convert m-uE3 concentrations to multiples of the median (MoM). The m-uE3 MoM values fit a log Gaussian distribution well with a log standard deviation of 0.11. Down syndrome risk results were not significantly different between assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The m-uE3 assay, with results expressed in MoMs, is suitable for screening and as a monoclonal-based assay offers the advantage of a predictable and indefinite supply of antibody to perform the assay.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09691413231160109","type":"journal-article","created":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T03:50:55Z","timestamp":1678765855000},"page":"120-124","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Validation of a monoclonal unconjugated estriol antibody for use in prenatal maternal serum screening"],"prefix":"10.1177","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9440-3411","authenticated-orcid":false,"given":"Geralyn M","family":"Lambert-Messerlian","sequence":"first","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Women and Infants Hospital and the Alpert Medical School at Brown University, Providence, RI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3088-8616","authenticated-orcid":false,"given":"Jonathan P","family":"Bestwick","sequence":"additional","affiliation":[{"name":"Centre for Prevention, Detection and Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1676-5908","authenticated-orcid":false,"given":"Nicholas J","family":"Wald","sequence":"additional","affiliation":[{"name":"Institute of Health Informatics, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,3,14]]},"reference":[{"key":"bibr1-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa043693"},{"key":"bibr2-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1177\/096914130301000202"},{"key":"bibr3-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199908123410701"},{"key":"bibr4-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1097\/OGX.0000000000000342"},{"key":"bibr5-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1177\/096914139700400402"},{"key":"bibr6-09691413231160109","first-page":"639","volume":"30","author":"Hausknecht RU","year":"1967","journal-title":"Obstet Gynecol"},{"key":"bibr7-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-8628(19990212)82:4<355::AID-AJMG16>3.0.CO;2-4"},{"key":"bibr8-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1002\/pd.1699"},{"key":"bibr9-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1097\/01.GIM.0000167808.96439.F3"},{"key":"bibr10-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9378(81)90664-5"},{"key":"bibr11-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0223(199808)18:8<842::AID-PD339>3.0.CO;2-G"},{"key":"bibr12-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9120(97)00095-7"},{"key":"bibr13-09691413231160109","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(86)90837-8"}],"container-title":["Journal of Medical Screening"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09691413231160109","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/09691413231160109","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09691413231160109","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T23:25:39Z","timestamp":1777677939000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/09691413231160109"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,14]]},"references-count":13,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,9]]}},"alternative-id":["10.1177\/09691413231160109"],"URL":"https:\/\/doi.org\/10.1177\/09691413231160109","relation":{},"ISSN":["0969-1413","1475-5793"],"issn-type":[{"value":"0969-1413","type":"print"},{"value":"1475-5793","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,14]]}}}