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Test Code IGFPN Insulin-Like Growth Factor 1 and Insulin-Like Growth Factor Binding Protein 3 Growth Panel, Serum


Necessary Information


Necessary Information

Indicate patient's age and sex.



Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: 2 Plastic vials

Specimen Volume: 1.6 mL Serum

Collection Instructions: Centrifuge and aliquot serum into 2 plastic vials, each containing 0.8 mL of serum.


Useful For

Evaluation of growth disorders

 

Evaluation of growth hormone deficiency or excess in children and adults

 

Monitoring of recombinant human growth hormone treatment

 

Follow-up of individuals with acromegaly and gigantism

Profile Information

Test ID Reporting Name Available Separately Always Performed
IGF1S Insulin-Like Growth Factor 1, S Yes Yes
IGFB3 IGFBP-3, S Yes Yes

Method Name

IGF1S: Chemiluminescence

IGFB3: Enzyme-Labeled Chemiluminescent Immunometric Assay

Reporting Name

IGF-1, IGFBP-3 Growth Panel

Specimen Type

Serum

Specimen Minimum Volume

Serum: 0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 14 days
  Ambient  72 hours
  Refrigerated  72 hours

Reference Values

INSULIN-LIKE GROWTH FACTOR 1

Male:

<1 year: 27.0-157.0 ng/mL

1 year: 29.7-166.8 ng/mL

2 years: 33.9-183.9 ng/mL

3 years: 39.0-204.5 ng/mL

4 years: 44.3-225.0 ng/mL

5 years: 50.0-245.5 ng/mL

6 years: 56.2-267.1 ng/mL

7 years: 63.4-291.9  ng/mL

8 years: 72.4-323.1 ng/mL

9 years: 83.6-361.6 ng/mL

10 years: 96.9-406.6 ng/mL

11 years: 111.6-454.4 ng/mL

12 years: 126.1-498.7 ng/mL

13 years: 138.6-532.5 ng/mL

14 years: 147.5-551.2 ng/mL

15 years: 152.2-553.5 ng/mL

16 years: 152.9-541.8 ng/mL

17 years: 150.6-520.6 ng/mL

18 years: 146.2-493.6 ng/mL

19 years: 140.2-462.7 ng/mL

20 years: 133.1-430.0 ng/mL

21-25 years: 115.2-354.8 ng/mL

26-30 years: 97.9-281.6 ng/mL

31-35 years: 88.3- 246.0 ng/mL

36-40 years: 83.4-232.7 ng/mL

41-45 years: 74.9-216.4 ng/mL

46-50 years: 66.9-205.1 ng/mL

51-55 years: 60.6-200.3 ng/mL

56-60 years: 54.3-194.2 ng/mL

61-65 years: 48.8-187.7 ng/mL

66-70 years: 46.5-191.9 ng/mL

71-75 years: 40.9-179.2 ng/mL

76-80 years: 37.1-172.0 ng/mL

81-85 years: 33.8-165.4 ng/mL

86-90 years: 32.2-166.1 ng/mL

 

Females:

<1 year: 17.9-125.6 ng/mL

1 year: 19.5-132.3 ng/mL

2 years: 22.2-145.4 ng/mL

3 years: 25.9-164.2 ng/mL

4 years: 30.7-187.8 ng/mL

5 years: 36.2-214.4 ng/mL

6 years: 42.0-240.4 ng/mL

7 years: 48.6-269.6 ng/mL

8 years: 56.9-305.3 ng/mL

9 years: 67.2-349.4 ng/mL

10 years: 79.5-400.3 ng/mL

11 years: 92.6-452.6 ng/mL

12 years: 105.3- 499.1 ng/mL

13 years: 115.9-533.4 ng/mL

14 years: 123.4-552.0 ng/mL

15 years: 127.4-554.2 ng/mL

16 years: 127.9-541.5 ng/mL

17 years: 125.3-517.3 ng/mL

18 years: 120.5-485.8 ng/mL

19 years: 114.4-450.8 ng/mL

20 years: 107.8-416.0 ng/mL

21-25 years: 92.9-342.0 ng/mL

26-30 years: 78.4-270.0 ng/mL

31-35 years: 73.1-243.0 ng/mL

36-40 years: 69.0-227.0 ng/mL

41-45 years: 61.5-204.4 ng/mL

46-50 years: 56.8-194.5 ng/mL

51-55 years: 53.0-189.6 ng/mL

56-60 years: 45.6-172.4 ng/mL

61-65 years: 42.2-169.0 ng/mL

66-70 years: 38.3-162.5 ng/mL

71-75 years: 36.6-164.7 ng/mL

76-80 years: 34.7-164.8 ng/mL

81-85 years: 34.4-172.4 ng/mL

86-90 years: 33.6-177.8 ng/mL

 

Tanner stage reference intervals:

Males:

I : 81.3-255.3 ng/mL

II: 106.2-432.3 ng/mL

III: 244.9-511.4 ng/mL

IV: 222.6-577.7 ng/mL

V: 227.4-517.8 ng/mL

Females:

I: 85.9-323.0 ng/mL

II: 117.5-451.3 ng/mL

III: 258.3-528.5 ng/mL

IV: 224.2-585.8 ng/mL

V: 188.2-511.6 ng/mL

Tanner Stage reference source: Bindlingmaier M, Friedrich N, Emeny RT,et al. Reference intervals for insulin-like growth factor-1 (IGF-1) from birth to senescence: results from a multicenter study using a new automated chemiluminescence IGF-I immunoassay conforming to recent international recommendations. J Clin Endocrinol Metab. 2014;99(5):1712-1721

 

Note: Puberty onset (transition from Tanner stage I to Tanner stage II) occurs for boys at a median age of 11.5 (±2) years and for girls at a median age of 10.5 (±2) years. There is evidence that it may occur up to 1 year earlier in obese girls and in African American girls. 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.

 

INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3

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 (transition from Tanner stage I to Tanner stage II) occurs for boys at a median age of 11.5 (±2) years and for girls at a median age of 10.5 (±2) years. There is evidence that it may occur up to 1 year earlier in obese girls 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

Both insulin-like growth factor 1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3) measurements can be used to assess growth hormone (GH) excess or deficiency. However, for all applications, IGF-1 measurement has generally been shown to have superior diagnostic sensitivity and specificity and should be used as the primary test. In particular, in the diagnosis and follow-up of acromegaly and gigantism, IGFBP-3 measurement adds little, if anything, to IGF-1 testing. The combination of IGF-1 and IGFBP-3 measurements appears superior to determining either analyte alone in the diagnosis of GH deficiency and resistance and in the monitoring of recombinant human GH (rhGH) therapy.

 

Insulin-like growth factor 1 and IGFBP-3 levels below the 2.5th percentile for age are consistent with GH deficiency or severe GH 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 may also be low and can 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 a pediatric or adult 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. In both diagnosis and follow-up, IGF-1 levels correlate better with clinical disease activity than IGFBP-3 levels.

 

After transsphenoidal removal of pituitary tumors in patients with acromegaly, IGF-1 concentration starts to decrease and returns to normal levels in most patients postoperatively by the fourth day.(1)

 

Individuals with anorexia or malnutrition have low values of IGF-1. IGF-1 is a more sensitive indicator than prealbumin, retinol-binding protein, or transferrin for monitoring nutritional repletion.

 

Clinical Reference

1. Bidlingmaier M, Friedrich N, Emeny RT, et al. Reference intervals for insulin-like growth factor-1 (IGF-1) from birth to senescence: results from a multicenter study using a new automated chemiluminescence IGF-1 immunoassay conforming to recent international recommendations. J Clin Endocrinol Metab. 2014; 99(5): 1712-1721

2. Yuen KCJ, Biller BMK, Radovick S, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of growth hormone deficiency in adults and patients transitioning from pediatric to adult care. Endocr Pract. 2019;25(11):1191-1232

3. Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86(6):361-397

4. Molitch ME, Clemmons DR, Malozowski S, et al. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587-1609

5. Kannan S, Kennedy L. Diagnosis of acromegaly: State of the art. Expert Opin Med Diagn. 2013;7(5):443-453

6. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: An endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951

7. Melmed S, Colao A, Barkan A, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009;94(5):1509-1517

8.Tzanela M. Dynamic tests and basal values for defining active acromegaly. Neuroendocrinology. 2006;83(3-4):200-204

9. Clemmons DR, Bidlingmaier M. IGF-I assay methods and biologic variability: evaluation of acromegaly treatment response. Eur J Endocrinol. 2024;191(1):R1-R8. doi:10.1093/ejendo/lvae065

10. 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

11.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

12. 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

13. Monzavi R, Cohen P. IGFs and IGFBPs: Role in health and disease. Best Pract Res Clin Endocrinol Metab. 2002;16(3):433-447

14. 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

15. 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

16. 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

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

84305

LOINC Code Information

Test ID Test Order Name Order LOINC Value
IGFPN IGF-1, IGFBP-3 Growth Panel In Process

 

Result ID Test Result Name Result LOINC Value
IGFB3 IGFBP-3, S 2483-6
IGF1C Insulin-Like Growth Factor 1, S 2484-4
IGF1Z Z-score 73561-3
IGFZ1 Z-score 73561-3