PLEASE NOTE: Presently the Intrinsic Hepcidin IDxTM Test does not have a CPT code and is not covered by insurance. Thus the cost of the Intrinsic Hepcidin IDxTM Test will be billed directly to the patient or institution. We are working to have the cost of the Intrinsic Hepcidin IDxTM Test covered by all major insurance providers.
Methodology – The Intrinsic Hepcidin IDxTM Test is a monoclonal antibody-based quantitative competitive ELISA, performed in a 96 microwell plate. The test is performed at IntrinsicDxTM, 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 |
9.6 ng/ml |
| Analytical Measurement Range (AMR) |
4 – 200 ng/ml |
9 – 317 ng/ml |
| Hepcidin Reference Range (5-95% CI) |
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: 7 days |
Room Temp: 24 hours 2-8 oC: 3 days -20 oC: to be determined |
| 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 IDxTM 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 2-8oC prior to shipment. If unable to ship same day, store at -20oC.
Turnaround Time – 10 business days
