Intrinsic Hepcidin IDx Test Information

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

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

Performance Characteristics

Test Parameter	Serum or Li-Heparin Plasma	K2-EDTA Plasma
Specificity	Human hepcidin-25	Human hepcidin-25
Cross Reactivity	No cross-reactivity observed with hepcidin from other species (rat, mouse) or structurally similar peptides.
Accuracy (vs 2nd generation polyclonal assay)	Slope  = 1.06;   R = 0.95	Slope = 1.03;  R = 0.95
Precision (within run, CV)	98.6 ng/ml = 4% 51.1 ng/ml = 5% 11.8 ng/ml = 7%	152.6 ng/ml = 5% 51.4 ng/ml = 4% 18.4 ng/ml = 9%
Precision (between run, CV)	98.6 ng/ml = 4% 51.1 ng/ml = 8% 11.8 ng/ml = 7%	332.1 ng/ml = 5% 150.6 ng/ml = 3% 16.8 ng/ml = 9%
Precision (between day, CV)	98.6 ng/ml = 4% 51.5 ng/ml = 5% 11.8 ng/ml = 7%	135.5 ng/ml = 10% 47.6 ng/ml = 12% 14.2 ng/ml = 17%
Lower Limit of Detection  (LLOD)	1.5 ng/ml	3.8 ng/ml
Lower Limit of Quantitation (LLOQ)	4.0 ng/ml	9.0 ng/ml
Analytical Measurement Range (AMR)	4.0  – 200.0 ng/ml	9.0 – 315.0 ng/ml
Hepcidin Reference Range (5-95%)	Female:  4.4 – 47.3 ng/ml Male:  6.7 – 85.6 ng/ml	Female: 9.7 – 38.3 ng/ml Male: 9.4 – 40.5 ng/ml
Hepcidin Stability	Room Temp: 24 hours 2-8 oC: 7 days -20 oC: at least 6 months	Room Temp: 24 hours 2-8 oC: 3 days -20 oC: at least 6 months
Hepcidin Freeze Thaw Stability	Stable to 4 freeze thaw cycles	Stable to 4 freeze thaw cycles
Hemolysis Interference	Grossly hemolyzed samples are not recommended for analysis

Clinical Significance

The Intrinsic Hepcidin IDx^TM Test is a quantitative assay that aids in management of iron-restricted disorders, such as iron deficiency anemia, anemia of inflammation, and iron-refractory iron deficiency anemia (IRIDA). Hepcidin also aids in the management of iron overload disorders, such as hereditary hemochromatosis, and iron-loading anemias.

Specimen Type – Prefer: Human serum or Lithium-heparin plasma.    Acceptable: K2-EDTA Plasma

Minimum Volume – 0.5 ml for adult patients or 0.25 ml for pediatric patients

Storage – If shipped same day, store at 2-8^oC prior to shipment.  If unable to ship same day, store at -20^oC.

Turnaround Time – 25 business days