Intrinsic Erythroferrone IDx™ Test Specifications
PLEASE NOTE: Presently the Intrinsic Erythroferrone IDx™ Test does not have a CPT code and is not covered by insurance. Thus the cost of the Intrinsic Erythroferrone IDx Test will be billed directly to the patient or institution.
Methodology – The Intrinsic Erythroferrone IDx Test is a double monoclonal antibody based sandwich ELISA, performed in a 96 microwell plate. The test is performed at IntrinsicDx, our CLIA certified and CAP accredited clinical laboratory.
Performance Characteristics
| Matrix | Serum |
|---|---|
| Specificity | Human Erythroferrone |
| Cross Reactivity | No Cross-reactivity observed with erythroferrone from other species (mouse) or structurally similar peptides |
| Accuracy | Slope = 2.09 R = 0.99 |
| Intra-Assay Precision (CV) | 7% (0.87 ng/ml); 3% (4.10 ng/ml); 4% (7.93 ng/ml) |
| Between Day Precision (CV) | 19% (0.87 ng/ml); 9% (4.10 ng/ml); 7% (7.93 ng/ml) |
| Lower Limit of Detection (LLOD) | 0.08 ng/ml |
| Analytical Measurement Range (AMR) | 0.25 - 90.00 ng/ml (extended: 0.25 – 180.00 ng/ml) |
| Erythroferrone Stability | -80°C: 1 year. 4°C: 72 hours. Room Temperature: 24 hours. |
| Erythroferrone Freeze Thaw Stability | Stable to 4 freeze thaw cycles |
| Matrix Interference | Interference observed from EDTA and Li-Heparin |