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Serum Hepcidin Immunoassay - Laboratory to Marketplace

NCT03310736 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 494

Last updated 2019-06-18

No results posted yet for this study

Summary

This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in adolescents and young adults. This test is considered non-significant risk.

Conditions

  • Anemia, Iron Deficiency

Interventions

DIAGNOSTIC_TEST

Intrinsic Hepcidin IDx™ Test

ILS scientists developed the bioanalytical method for quantitation of human serum hepcidin using a Beckman FX automated liquid handling platform. The method uses a competitive ELISA format that has a proprietary sensitive and specific monoclonal antibody to hepcidin that captures native hepcidin in a sample. During the reaction a competition between a synthetic, bioactive, biotinylated hepcidin tracer and native hepcidin occurs. Bound biotinylated tracer is detected with a streptavidin-HRP conjugate and TMB substrate. Quantitation is based on an eight-point standard curve using validated, synthetic hepcidin calibrators. The standard curve and the hepcidin concentrations of patients samples are calculated using 4-parameter logistic curve fitting (Prism; Graphpad, Inc., La Jolla, CA). Serum hepcidin concentrations are expressed in ng/ml serum.

Sponsors & Collaborators

Principal Investigators

  • Matthew M Heeney, MD · Physician

  • Lydia A Shrier, MD, MPH · Physician

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-12-31
Completion
2019-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03310736 on ClinicalTrials.gov