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Test Code LAB0255604 Insulin-Like Growth Factor-Binding Protein 3, Serum

Additional Codes

Mayo Test ID
IGFB3

Performing 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

Method Name

Enzyme-Labeled Chemiluminescent Immunometric Assay

Reporting Name

IGFBP-3, S

Specimen Type

Serum


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

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus Reject

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.

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.

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Specimen Retention Time

2 weeks

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