Intrinsic Hepcidin IDx™ Test Specifications

PLEASE NOTE: Presently the Intrinsic Hepcidin IDx™ Test does not have a CPT code and is not covered by insurance. Thus the cost of the Intrinsic Hepcidin IDx Test will be billed directly to the patient or institution. We are working to have the cost of the Intrinsic Hepcidin IDx Test covered by all major insurance providers.

Methodology – The Intrinsic Hepcidin IDx Test is a monoclonal antibody-based quantitative competitive ELISA, performed in a 96 microwell plate. The test is performed at IntrinsicDx, our CLIA certified and CAP accredited clinical laboratory. Performance Characteristics

Performance Characteristics

Test ParameterSerum or Li-Heparin PlasmaK2-EDTA Plasma
SpecificiyHuman hepcidin-25Human hepcidin-25
Cross ReacitivityNo Cross-reactivity observed with hepcidin from other species (rat, mouse) or structurally similar peptides

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Accuracy (vs 2nd generation polyclonal assay)Slope - 1.06 R = 0.95Slope - 1.03 R = 0.95
Prevision (between run, CV)98.6 ng/ml = 4% 511 ng/ml = 8% 11.8 ng/ml = 7%332.1 ng/ml = 5% 150.6 ng/ml = 3% 16.8 ng/ml = 9%
Lower Limit of Detection (LLOD)1.5 ng/ml3.8 ng/ml
Analytical Measurement Range (AMR)4.0 - 200.0 ng/ml9.0 - 315.0 ng/ml
Hepcidin Reference Range (5-95%)Female: 4.4 - 47.3 ng/ml Male: 6.7 - 85.6 ng/mlFemale: 9.7 - 38.3 ng/mt Male: 9.4 - 40.5 ng/mt
Hepcidin StabilityRoom Temp: 24 hours 2-8 °C: 7 days -20 °C: at least 6 monthsRoom Temp: 24 hours 2-8 °C: 3 days -20 °C: at least 6 months
Hepcidin Freeze Thaw StabilityStable to 4 freeze thaw cyclesStable to 4 freeze thaw cycles
Hemolysis InterferenceGrossly hemolyzed samples are not recommended for analysis