Test Directory

Test Code
FGF23
Test Name
Fibroblast Growth Factor 23
CPT Codes
83520
Expected Turnaround Time
2 - 8 days
Clinical Utility
  • Diagnosing and monitoring tumor induced osteomalacia
  • Diagnosing X-linked hypophosphatemia or autosomal dominant hypophosphatemic rickets
  • Diagnosing familial tumoral calcinosis with hyperphosphatemia
Specimen and Container Info

Specimen Type: Serum

Preferred Collection Container: Gold Top, Serum Separator

Alternate Collection Container: Red Top, Plain

Desired Specimen Volume: 0.5 mL

Collection Instructions
  1. Collect a gold top, serum separator tube via venipuncture.
Processing and Submission Instructions
  1. Separate serum from cells.
  2. Transfer 0.5 mL of serum to a clear aliquot tube (screw cap)
Patient Preparation

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.

Transport Instructions

Transport to the laboratory refrigerated. 

Stability Requirements

Refrigerated

14 days

Frozen

90 days
Causes for Rejection
  • Gross hemolysis
  • Gross lipemia
Methodology
Chemiluminescence-Based Quantitative Sandwich Immunoassay
Reference Intervals

 See patient report.

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.

Alternate Names
  • FGF23
  • Intact-FGF23
  • Autosomal Dominant Hypophosphatemic Rickets
  • Familial Tumoral Calcinosis with Hyperphosphatemia
  • Fibroblast Growth Factor 23
  • Oncogenic Osteomalacia
  • Phosphatonin
  • X-linked Hypophosphatemia
Reference Lab
Mayo Clinic Laboratories
Testing Schedule
Routine, 1 time per week