Evidence map›Paper›PMID 32674118›Full record

ArticleThe journal of applied laboratory medicine2020

Clinical Immunoassay for Human Hepcidin Predicts Iron Deficiency in First-Time Blood Donors.

Patrick Gutschow, Huiling Han, Gordana Olbina, Keith Westerman, Elizabeta Nemeth, Tomas Ganz, Karen Copeland, Mark Westerman, Vaughn Ostland

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The journal of applied laboratory medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Patrick GutschowIntrinsic LifeSciences LLC, La Jolla, CA.
Huiling HanIntrinsic LifeSciences LLC, La Jolla, CA.
Gordana OlbinaIntrinsic LifeSciences LLC, La Jolla, CA.
Keith WestermanIntrinsic LifeSciences LLC, La Jolla, CA.
Elizabeta NemethDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA.
Tomas GanzDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA.
Karen CopelandBoulder Statistics, Steamboat Springs, CO.
Mark WestermanIntrinsic LifeSciences LLC, La Jolla, CA.
Vaughn OstlandIntrinsic LifeSciences LLC, La Jolla, CA.
Intrinsic LifeSciences (United States) · USUniversity of California, Los Angeles · US

Funding

supplemental funding for Phase 2B NIDDK grantR44DK083843 · NIDDK · INTRINSIC LIFESCIENCES, LLC · PI OSTLAND, VAUGHN E · 2011 to 2016
$5.7M
Ferroportin Structure and functionR01DK107309 · NIDDK · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI JORMAKKA, MIKA, MACKENZIE, BRYAN · 2015 to 2019
$3.0M
Iron physiology and pathology in pregnancyR01HD096863 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI NEMETH, ELIZABETA · 2019 to 2023
$2.1M
Novel Point-of-Care Device for Urinary Hepcidin to Detect Iron Deficiency in Children and AdolescentsR44DK135139 · NIDDK · INTRINSIC LIFESCIENCES, LLC · PI OSTLAND, VAUGHN E · 2022 to 2023
$1.7M
Monoclonal Sandwich ELISA for Serum Erythroferrone for Clinical Assessment of Ineffective ErythropoiesisR44DK113841 · NIDDK · INTRINSIC LIFESCIENCES, LLC · PI OSTLAND, VAUGHN E · 2017 to 2018
$1.5M
NICHD NIH HHS R01 HD096863NIDDK NIH HHS R01 DK107309NIDDK NIH HHS R44 DK083843NIDDK NIH HHS R44 DK113841NIDDK NIH HHS R44 DK135139
6 · The paper itself

Abstract

backgroundSerum 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.

methodsA 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.

resultsThe 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%.

conclusionThe clinical measurement of serum hepcidin concentrations was shown to be a potentially useful tool for diagnosing ID.

Indexed as

Anemia, Iron-DeficiencyBlood DonorsHepcidinsFemaleFerritinsHumansImmunoassayMaleFerritinsHepcidinsAnemiaELISAHepcidinIron Deficiency

Identifiers

PMID32674118
PMCPMC7497288
OpenAlexW3018492059

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.