Intact Fibroblast Growth Factor 23, Serum
Order Code
IFG23
Test Summary
Diagnosing and monitoring tumor induced osteomalacia. Diagnosing X-linked hypophosphatemia or autosomal dominant hypophosphatemia rickets. Diagnosing familial tumoral calcinosis with hyperphosphatemia.
Aliases
FGF23, Fibroblast Growth Factor 23
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.5 mL serum from (SST) serum separator tube
Minimum Volume
0.25 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Transport Tube
Transport Temperature
Refrigerated
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 14 days
Frozen: 90 days
Limitations
Fibroblast growth factor 23 (FGF23) concentrations must be interpreted in conjunction with serum phosphate (phosphorus) measurements, as FGF23 will be elevated in other conditions that cause hyperphosphatemia in vivo. These include chronic kidney disease; severe catabolic states (eg, severe systemic illness, uncontrolled type I diabetes mellitus, and severe starvation); vitamin D toxicity; intravenous phosphate treatment and very high phosphate diets; advanced malignancy in particular with tumor lysis; crush or other significant muscle injury or destruction; fractures; and some endocrine disorders, in particular hypoparathyroidism and acromegaly. With the exception of kidney failure, FGF23 measurements will not contribute to diagnosis or patient management in these situations. Do not interpret FGF23 concentrations as absolute evidence of the presence or the absence of tumor induced osteomalacia (TIO). Some patients with TIO may have FGF23 levels within the reference interval. It is thought that tumors in these individuals may be secreting different, and yet unidentified, phosphatonins. Therefore, if the clinical picture and general osteomalacia laboratory workup strongly suggest that the patient has TIO, a normal intact FGF23 level should not discourage tumor search or removal. In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation Patients receiving burosumab therapy may have prolonged elevations of intact FGF23 in serum following monoclonal antibody administration. Measurement of intact FGF23 is not recommended on these patients. Serum phosphate, alkaline phosphatase, and 1,25(OH)2D measurements should be considered for monitoring response to therapy. |
Other Acceptable Specimens
N/A
Unacceptable Specimens
- Gross hemolysis
- Gross lipemia
Order Code
IFG23
EPIC (Premier) Code
Includes
Intact Fibroblast Growth Factor 23
CPT Code
83520
Billing Code
CPT Statement
Methodology
Chemiluminescence-Based Quantitative Sandwich Immunoassay
FDA Status
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration
Physician Attestation of Informed Consent
N/A
Testing Laboratory
3050 Superior Drive NW
Rochester MN, 55901
Department
Reference Range
Pediatric (<18 yrs): < or = 52 pg/mL
Adults (> or = 18 yrs): < or = 59 pg/mL
Setup Schedule / Expected Turnaround Time
Tuesday, Thursday; Report available: 2 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.5 mL serum from (SST) serum separator tube
Minimum Volume
0.25 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Transport Tube
Transport Temperature
Refrigerated
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 14 days
Frozen: 90 days
Limitations
Fibroblast growth factor 23 (FGF23) concentrations must be interpreted in conjunction with serum phosphate (phosphorus) measurements, as FGF23 will be elevated in other conditions that cause hyperphosphatemia in vivo. These include chronic kidney disease; severe catabolic states (eg, severe systemic illness, uncontrolled type I diabetes mellitus, and severe starvation); vitamin D toxicity; intravenous phosphate treatment and very high phosphate diets; advanced malignancy in particular with tumor lysis; crush or other significant muscle injury or destruction; fractures; and some endocrine disorders, in particular hypoparathyroidism and acromegaly. With the exception of kidney failure, FGF23 measurements will not contribute to diagnosis or patient management in these situations. Do not interpret FGF23 concentrations as absolute evidence of the presence or the absence of tumor induced osteomalacia (TIO). Some patients with TIO may have FGF23 levels within the reference interval. It is thought that tumors in these individuals may be secreting different, and yet unidentified, phosphatonins. Therefore, if the clinical picture and general osteomalacia laboratory workup strongly suggest that the patient has TIO, a normal intact FGF23 level should not discourage tumor search or removal. In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation Patients receiving burosumab therapy may have prolonged elevations of intact FGF23 in serum following monoclonal antibody administration. Measurement of intact FGF23 is not recommended on these patients. Serum phosphate, alkaline phosphatase, and 1,25(OH)2D measurements should be considered for monitoring response to therapy. |
Other Acceptable Specimens
N/A
Unacceptable Specimens
- Gross hemolysis
- Gross lipemia
Result Information
Methodology
Chemiluminescence-Based Quantitative Sandwich Immunoassay
Testing Laboratory
Reference Range
Pediatric (<18 yrs): < or = 52 pg/mL
Adults (> or = 18 yrs): < or = 59 pg/mL
Setup Schedule / Expected Turnaround Time
Tuesday, Thursday; Report available: 2 days