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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.


Secondary ID

623574

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

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

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus Reject

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.

 

Method Description

Insulin-Like Growth Factor 1:

Insulin-like growth factor 1 (IGF-1) testing is performed using the IDS iSYS instrument. The assay is based on chemiluminescence technology. Ten microliters of patient sample are incubated with an acidic solution to dissociate IGF-I from the binding proteins. A portion of this, along with neutralization buffer is incubated with a biotinylated anti-IGF-I monoclonal antibody and an acridinium labelled anti-IGF-I monoclonal antibody. Streptavidin-labelled magnetic particles are then added. The magnetic particles are captured using a magnet, and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of IGF-I in the original sample.(Package insert: IDS-iSYS Insulin-like Growth Factor-I (IGF-I). Immunodiagnostic Systems Inc. IS-3900PLv13. 3/15/2025)

 

Insulin-Like Growth Factor-Binding Protein 3:

The Immulite 2000 insulin-like growth factor-binding protein 3 (IGFBP-3) assay is a solid-phase, enzyme-linked chemiluminescent immunoassay based on murine monoclonal antibodies. The patient sample and alkaline phosphatase-conjugated anti- 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)

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Specimen Retention Time

2 weeks

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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