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FerriScan® Product Specifications
Sensitivity and Specificity
The FerriScan analysis has the highest sensitivity and specificity for predicting LIC measured from biopsy over the entire LIC range encountered in clinical practice.
| LIC Threshold1 | Clinical Relevance2 | Sensitivity %3 | Specificity %3 |
|---|---|---|---|
| 1.8 | Upper 95% of normal |
94% (86-97) |
100% (88-100) |
| 3.2 | Suggested lower limit of optimal range for LICs for chelation therapy in transfusional iron loading |
94% (85-98) |
100% (91-100) |
| 7.0 | Suggested upper limit of optimal range for LICs for transfusional loading and threshold for increased risk of iron-induced complications |
89% (79-95) |
96% (86-99) |
| 15 | Threshold for greatly increased risk for cardiac disease and early death in patients with transfusional iron overload |
85% (70-94) |
92% (83-96) |
1 LIC Threshold measured in (mg Fe/g dw).
2 Clinical Relevance taken from Olivieri and Brittenham, Blood 1997; 89:739-61.
3 *St. Pierre T.G., Clark P.R., Chua-anusorn W., Fleming A.J., Jeffrey G.P., Olynyk J.K., Pootrakul P., Robins E., Lindeman R. (2005) Noninvasive measurement and imaging of liver iron concentrations using proton magnetic resonance. Blood 105: 855-861.
Technical Specifications
Technology
SDPA (Spin Density Projection Assisted) R2-MRI.
FerriScan calibration
Confounding factors
Evaluation
Longitudinal monitoring capability
Patient age groups
Results generated
Data acquisition time
10 minutes
Breathhold requirements
Contrast agents
Slices
Data transfer and report delivery system
GDPR compliant secure portal system Scanner compatibility
Compatible on 1.5T and 3T machines, including 
,
, General Electrics and 
others.
Software requirements
Hardware requirements
Saline bag (imaged alongside every patient)
MRI scanner validation
With FerriScan Phantom Pack Quality assured certification
Clearances
FDA 510(k) cleared• 
• 
• ARTG included