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HelpTest Code Epic LAB2553 Insulin-Like Growth Factor-Binding Protein 3, Serum
Additional Codes
SQ code GFB3M
Mayo code IGFB3
Reporting Name
IGFBP-3, SSpecimen Type
SerumPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Diagnosing growth disorders
Diagnosing adult growth hormone deficiency
Monitoring of recombinant human growth hormone treatment
As a possible adjunct to insulin-like growth factor 1 and growth hormone in the diagnosis and follow-up of acromegaly and gigantism
Necessary Information
Indicate patient's age and sex.
Specimen Required
Patient Preparation: For 12 hours before specimen collection, do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.8 mL
Collection Instructions: Centrifuge promptly and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 14 days | |
| Ambient | 72 hours | ||
| Refrigerated | 72 hours |
Reference Values
1-7 days: ≤0.7 mcg/mL
8-14 days: 0.5-1.4 mcg/mL
15 days-11 months: unavailable
1 year: 0.7-3.6 mcg/mL
2 years: 0.8-3.9 mcg/mL
3 years: 0.9-4.3 mcg/mL
4 years: 1.0-4.7 mcg/mL
5 years: 1.1-5.2 mcg/mL
6 years: 1.3-5.6 mcg/mL
7 years: 1.4-6.1 mcg/mL
8 years: 1.6-6.5 mcg/mL
9 years: 1.8-7.1 mcg/mL
10 years: 2.1-7.7 mcg/mL
11 years: 2.4-8.4 mcg/mL
12 years: 2.7-8.9 mcg/mL
13 years: 3.1-9.5 mcg/mL
14 years: 3.3-10 mcg/mL
15 years: 3.5-10 mcg/mL
16 years: 3.4-9.5 mcg/mL
17 years: 3.2-8.7 mcg/mL
18 years: 3.1-7.9 mcg/mL
19 years: 2.9-7.3 mcg/mL
20 years: 2.9-7.2 mcg/mL
21-25 years: 3.4-7.8 mcg/mL
26-30 years: 3.5-7.6 mcg/mL
31-35 years: 3.5-7.0 mcg/mL
36-40 years: 3.4-6.7 mcg/mL
41-45 years: 3.3-6.6 mcg/mL
46-50 years: 3.3-6.7 mcg/mL
51-55 years: 3.4-6.8 mcg/mL
56-60 years: 3.4-6.9 mcg/mL
61-65 years: 3.2-6.6 mcg/mL
66-70 years: 3.0-6.2 mcg/mL
71-75 years: 2.8-5.7 mcg/mL
76-80 years: 2.5-5.1 mcg/mL
81-85 years: 2.2-4.5 mcg/mL
Tanner Stages:
Males
Stage I: 1.4-5.2 mcg/mL
Stage II: 2.3-6.3 mcg/mL
Stage III: 3.1-8.9 mcg/mL
Stage IV: 3.7-8.7 mcg/mL
Stage V: 2.6-8.6 mcg/mL
Females
Stage I: 1.2-6.4 mcg/mL
Stage II: 2.8-6.9 mcg/mL
Stage III: 3.9-9.4 mcg/mL
Stage IV: 3.3-8.1 mcg/mL
Stage V: 2.7-9.1 mcg/mL
Note: Puberty onset, ie, the transition from Tanner stage I (prepubertal) to Tanner stage II (early pubertal), occurs for girls at a median age of 10.5 (±2) years and for boys at a median age of 11.5 (±2) years. There is evidence that it may occur up to 1 year earlier in girls who are obese and in African American girls. By contrast, for boys there is no definite proven relationship between puberty onset and body weight or ethnic origin. Progression through Tanner stages is variable. Tanner stage V (young adult) should be reached by age 18.
Day(s) Performed
Monday through Saturday
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
83520
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| IGFB3 | IGFBP-3, S | 2483-6 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| IGFB3 | IGFBP-3, S | 2483-6 |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | Reject |
Method Name
Enzyme-Labeled Chemiluminescent Immunometric Assay
Method Description
The Immulite 2000 insulin-like growth factor-binding protein 3 (IGFBP-3) is a solid-phase, enzyme-linked chemiluminescent immunoassay based on murine monoclonal antibodies. The patient sample and alkaline phosphatase-conjugated anti-insulin-like growth factor-binding protein 3 (IGFBP-3) antibodies are simultaneously incubated with an antibody-coated bead. During this time, IGFBP-3 in the sample forms an antibody sandwich complex that binds to the streptavidin on the bead. Unbound enzyme conjugate is then removed by washing, after which substrate is added. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light. The photon output is directly proportional to the concentration of IGFBP-3 in the sample.(Package insert: Immulite 2000 IGFBP-3 PIL2KGB-15. Siemens Healthcare Diagnostics; 03/2018)