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• W3018492059 abstract "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 &lt; 0.001). The area under the receiver operating characteristic curve for hepcidin as a predictor of ID, defined by 3 ferritin concentration thresholds, was &gt;0.9. For predicting ID defined by ferritin &lt;15 ng/mL, hepcidin &lt;10 ng/mL yielded sensitivity of 93.1% and specificity of 85.5%, whereas the same hepcidin cutoff for ferritin &lt;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." @default.
• W3018492059 created "2020-05-01" @default.
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• W3018492059 date "2020-04-24" @default.
• W3018492059 modified "2023-10-16" @default.
• W3018492059 title "Clinical Immunoassay for Human Hepcidin Predicts Iron Deficiency in First-Time Blood Donors" @default.
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• W3018492059 doi "https://doi.org/10.1093/jalm/jfaa038" @default.
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