{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T21:48:31Z","timestamp":1788558511334,"version":"build-2803163510"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2020,4,24]],"date-time":"2020-04-24T00:00:00Z","timestamp":1587686400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","award":["R44DK083843"],"award-info":[{"award-number":["R44DK083843"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Serum markers currently used as indicators of iron status have clinical limitations. Hepcidin, a key regulator of iron homeostasis, is reduced in iron deficiency (ID) and increased in iron overload. We describe the first CLIA-validated immunoassay with excellent accuracy and precision to quantify human serum hepcidin. Its diagnostic utility for detecting ID in first-time blood donors was demonstrated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A monoclonal competitive ELISA (C-ELISA) was developed for the quantitation of human hepcidin and validated according to CLIA guidelines. Sera from nonanemic first-time blood donors (n\u2009=\u2009292) were analyzed for hepcidin, ferritin, transferrin, and serum iron. Logistic regression served to determine the utility of hepcidin as a predictor of ID.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The C-ELISA was specific for human hepcidin and had a low limit of quantitation (4.0\u2009ng\/mL). The hepcidin concentration measured with the monoclonal C-ELISA was strongly correlated with a previously established, extensively tested polyclonal C-ELISA (Blood 2008;112:4292\u20137) (r\u2009=\u20090.95, P\u2009&amp;lt;\u20090.001). The area under the receiver operating characteristic curve for hepcidin as a predictor of ID, defined by 3 ferritin concentration thresholds, was &amp;gt;0.9. For predicting ID defined by ferritin &amp;lt;15\u2009ng\/mL, hepcidin &amp;lt;10\u2009ng\/mL yielded sensitivity of 93.1% and specificity of 85.5%, whereas the same hepcidin cutoff for ferritin &amp;lt;30\u2009ng\/mL yielded sensitivity of 67.6% and specificity of 91.7%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The clinical measurement of serum hepcidin concentrations was shown to be a potentially useful tool for diagnosing ID.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jalm\/jfaa038","type":"journal-article","created":{"date-parts":[[2020,2,19]],"date-time":"2020-02-19T04:29:20Z","timestamp":1582086560000},"page":"943-953","source":"Crossref","is-referenced-by-count":15,"title":["Clinical Immunoassay for Human Hepcidin Predicts Iron Deficiency in First-Time Blood Donors"],"prefix":"10.1093","volume":"5","author":[{"given":"Patrick","family":"Gutschow","sequence":"first","affiliation":[{"name":"Intrinsic LifeSciences LLC, La Jolla, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huiling","family":"Han","sequence":"additional","affiliation":[{"name":"Intrinsic LifeSciences LLC, La Jolla, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordana","family":"Olbina","sequence":"additional","affiliation":[{"name":"Intrinsic LifeSciences LLC, La Jolla, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Westerman","sequence":"additional","affiliation":[{"name":"Intrinsic LifeSciences LLC, La Jolla, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeta","family":"Nemeth","sequence":"additional","affiliation":[{"name":"Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomas","family":"Ganz","sequence":"additional","affiliation":[{"name":"Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Copeland","sequence":"additional","affiliation":[{"name":"Boulder Statistics, Steamboat Springs, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Westerman","sequence":"additional","affiliation":[{"name":"Intrinsic LifeSciences LLC, La Jolla, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vaughn","family":"Ostland","sequence":"additional","affiliation":[{"name":"Intrinsic LifeSciences LLC, La Jolla, 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