{"doi":"10.1093/jalm/jfaa038","title":"Clinical Immunoassay for Human Hepcidin Predicts Iron Deficiency in First-Time Blood Donors","abstract":"BACKGROUND: 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. METHODS: 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 = 292) were analyzed for hepcidin, ferritin, transferrin, and serum iron. Logistic regression served to determine the utility of hepcidin as a predictor of ID. RESULTS: The C-ELISA was specific for human hepcidin and had a low limit of quantitation (4.0 ng/mL). The hepcidin concentration measured with the monoclonal C-ELISA was strongly correlated with a previously established, extensively tested polyclonal C-ELISA (Blood 2008;112:4292-7) (r = 0.95, P < 0.001). The area under the receiver operating characteristic curve for hepcidin as a predictor of ID, defined by 3 ferritin concentration thresholds, was >0.9. For predicting ID defined by ferritin <15 ng/mL, hepcidin <10 ng/mL yielded sensitivity of 93.1% and specificity of 85.5%, whereas the same hepcidin cutoff for ferritin <30 ng/mL yielded sensitivity of 67.6% and specificity of 91.7%. CONCLUSION: The clinical measurement of serum hepcidin concentrations was shown to be a potentially useful tool for diagnosing ID.","journal":"The Journal of Applied Laboratory Medicine","year":2020,"id":70956,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":18,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9574,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":375643,"name":"Huiling Han","orcid":null,"position":1,"is_corresponding":false},{"id":375644,"name":"Gordana Olbina","orcid":null,"position":2,"is_corresponding":false},{"id":375645,"name":"Keith Westerman","orcid":null,"position":3,"is_corresponding":false},{"id":374946,"name":"Elizabeta Nemeth","orcid":"0000-0002-3477-2397","position":4,"is_corresponding":false},{"id":374947,"name":"Tomas Ganz","orcid":"0000-0002-2830-5469","position":5,"is_corresponding":false},{"id":374948,"name":"Karen Copeland","orcid":"0000-0002-6455-3283","position":6,"is_corresponding":false},{"id":375646,"name":"Mark Westerman","orcid":null,"position":7,"is_corresponding":false},{"id":375647,"name":"Vaughn Ostland","orcid":null,"position":8,"is_corresponding":false},{"id":375642,"name":"Patrick Gutschow","orcid":null,"position":0,"is_corresponding":true}],"reference_count":40,"raw_metadata":null,"created_at":"2026-07-18T21:43:32.585486Z","pmid":"32674118","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}