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
| 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 | 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 (between run, CV) | 4% (98.6 ng/ml); 8% (51.1 ng/ml); 7% (11.8 ng/ml) | 5% (332.1 ng/ml); 3% (150.6 ng/ml); 9% (16.8 ng/ml) |
| Lower Limit of Detection (LLOD) | 1.5 ng/ml | 3.8 ng/ml |
| Analytical Measurement Range (AMR) | 4.0 – 200.0 ng/ml (extended: 4.0 – 800.0 ng/ml) | 9.0 – 315.0 ng/ml (extended: 9.0 – 630.0 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 °C: 3 days; -20 °C: at least 6 months | Room Temp: 24 hours; 2-8 °C: 3 days; -20 °C: 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 | Grossly hemolyzed samples are not recommended for analysis |