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HelpTest Code IGFB3 Insulin-Like Growth Factor-Binding Protein 3, Serum
Reporting Name
IGFBP-3, SUseful 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
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumNecessary 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 |
Interpretation
For all applications, insulin-like growth factor 1 (IGF-1) measurement has generally been shown to have superior diagnostic sensitivity and specificity compared with insulin-like growth factor-binding protein 3 (IGFBP-3). IGFBP-3 testing should, therefore, usually be combined with IGF-1 testing. The combination of IGF-1 and IGFBP-3 measurements appears superior to determining either analyte alone in the diagnosis of growth hormone (GH) deficiency and resistance and in the monitoring of recombinant human GH therapy. By contrast, in the diagnosis and follow-up of acromegaly and gigantism, IGFBP-3 measurement adds little if anything to IGF-1 testing.
IGF-1 and IGFBP-3 levels below the 2.5th percentile for age are consistent with GH deficiency or severe resistance, but patients with incomplete GH deficiency or mild-to-moderate GH resistance may have levels within the reference range. In GH deficiency, GH levels are also low and show suboptimal responses in stimulation tests (eg, exercise, clonidine, arginine, ghrelin, growth hormone-releasing hormone, insulin-induced hypoglycemia), while in severe GH resistance, GH levels are substantially elevated. However, dynamic GH testing is not always necessary for diagnosis. If it is undertaken, it should be performed and interpreted in endocrine testing centers under the supervision of an endocrinologist.
The aim of both pediatric and adult GH replacement therapy is to achieve IGF-1 and IGFBP-3 levels within the reference range, ideally within the middle to upper third. Higher levels are rarely associated with any further therapeutic gains but could potentially lead to long-term problems of GH excess.
Elevated IGF-1 and IGFBP-3 levels support the diagnosis of acromegaly or gigantism in individuals with appropriate symptoms or signs. In successfully treated patients, both levels should be within the normal range, ideally within the lower third. In both diagnosis and follow-up, IGF-1 levels correlate better with clinical disease activity than IGFBP-3 levels.
Clinical Reference
1. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays. Clin Chem. 1988;34(1):27-33
2. Wetterau L, Cohen P. Role of insulin-like growth factor monitoring in optimizing growth hormone therapy. J Ped Endocrinol Metab. 2000;13 Suppl 6:1371-1376
3. Granada ML, Murillo J, Lucas A, et al. Diagnostic efficiency of serum IGF-1, IGF-binding protein-3 (IGFBP-3), IGF/IGFBP-3 molar ratio and urinary GH measurements in the diagnosis of adult GH deficiency: importance of an appropriate reference population. Eur J Endocrinol. 2000;142(3):243-253
4. Parama C, Fluiters E, de la Fuente J, Andrade A, Garcia-Mayor RV. Monitoring of treatment success in patients with acromegaly: the value of serum insulin-like growth factor binding protein-3 and serum leptin measurements in comparison to plasma insulin-like growth factor 1 determination. Metabolism. 2001;50(9):1117-1121
5. Monzavi R, Cohen P. IGFs and IGFBPs: role in health and disease. Best Pract Res Clin Endocrinol Metab. 2002;16(3):433-447
6. Boquete HR, Sobrado PGV, Fideleff HL, et al: Evaluation of diagnostic accuracy of insulin-like growth factor (IGF)-1 and IGF-binding protein-3 in growth hormone-deficient children and adults using ROC plot analysis. J Endocrinol Metab. 2003;88(10):4702-4708
7. Shen Y, Zhang J, Zhao Y, Yan Y, Liu Y, Cai J. Diagnostic value of serum IGF-1 and IGFBP-3 in growth hormone deficiency: a systematic review with meta-analysis. Eur J Pediatr. 2015;174(4):419-427
8. Inoue-Lima TH, Vasques GA, Nakaguma M, et al. A Bayesian Approach to Diagnose Growth Hormone Deficiency in Children: Insulin-Like Growth Factor Type 1 Is Valuable for Screening and IGF-Binding Protein Type 3 for Confirmation. Horm Res Paediatr. 2020;93(3):197-205
Report Available
1 to 3 daysMethod Name
Enzyme-Labeled Chemiluminescent Immunometric Assay