Test Catalog

Test Id : SHBG1

Sex Hormone-Binding Globulin, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis and follow-up of women with symptoms or signs of androgen excess (eg, polycystic ovarian syndrome and idiopathic hirsutism)

 

An adjunct in monitoring sex-steroid and antiandrogen therapy

 

An adjunct in the diagnosis of disorders of puberty

 

An adjunct in the diagnosis and follow-up of anorexia nervosa

 

An adjunct in the diagnosis of thyrotoxicosis (tissue marker of thyroid hormone excess)

 

A possible adjunct in diagnosis and follow-up of insulin resistance and cardiovascular and type 2 diabetes risk assessment, particularly in women

Highlights

Sex hormone-binding globulin (SHBG) is a major carrier protein for sex steroids in the blood.

 

Determination of SHBG concentrations is useful in the investigation of cases of suspected androgen excess such as polycystic ovarian syndrome or idiopathic hirsutism.

 

SHBG concentration measurements may be useful in the evaluation of infertility, disorders of puberty, thyrotoxicosis, and in the monitoring of sex-steroid and anti-androgen therapies.

Method Name
A short description of the method used to perform the test

Immunoenzymatic Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Sex Hormone-Binding Globulin, S

Aliases
Lists additional common names for a test, as an aid in searching

Sex Steroid Binding Protein (SBP)

SHBG

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 90 days
Ambient 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis and follow-up of women with symptoms or signs of androgen excess (eg, polycystic ovarian syndrome and idiopathic hirsutism)

 

An adjunct in monitoring sex-steroid and antiandrogen therapy

 

An adjunct in the diagnosis of disorders of puberty

 

An adjunct in the diagnosis and follow-up of anorexia nervosa

 

An adjunct in the diagnosis of thyrotoxicosis (tissue marker of thyroid hormone excess)

 

A possible adjunct in diagnosis and follow-up of insulin resistance and cardiovascular and type 2 diabetes risk assessment, particularly in women

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Sex hormone-binding globulin (SHBG), a 95 KDa homodimer, is the blood transport protein for testosterone and estradiol. SHBG is mainly produced in the liver and has a half-life of approximately seven days. SHBG binds reversibly to sex steroids. SHBG has a relatively high binding affinity to dihydrotestosterone (DHT), medium affinity to testosterone and estradiol, and exhibits a low affinity to estrone, dehydroepiandrosterone (DHEA), androstenedione, and estriol. Albumin, which exists at physiologically higher concentrations than SHBG, also binds to sex steroids although with a much lower binding affinity (eg, about 100 times lower for testosterone).

 

Decreased SHBG serum concentrations are associated with conditions in which elevated androgen concentrations are present or the effect of androgen on its target organs is excessive. Because of the high binding affinity of SHBG to DHT, as compared to estradiol, SHBG has profound effects on the balance between bioavailable androgens and estrogens. Increased SHBG concentrations may be associated with symptoms and signs of hypogonadism in men, while decreased concentrations can result in androgenization in women. SHBG is also regulated by insulin, and a low SHBG concentration often indicates insulin resistance and, consequently, may be a predictor of type 2 diabetes.

 

Endogenous or exogenous thyroid hormones or estrogens increase SHBG concentrations. In men, there is also an age-related gradual rise, possibly secondary to the mild age-related fall in testosterone production. This process can result in bioavailable testosterone concentrations that are much lower than would be expected based on total testosterone measurements alone.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

CHILDREN

Males

Tanner Stages

Mean Age

Reference Interval (nmol/L)

Stage I

10.4

17-135

Stage II

11.1

21-114

Stage III

12.7

12-138

Stage IV

14.5

7.7-67

Stage V

14.2

3.9-40

Females

Tanner Stages

Mean Age

Reference Interval (nmol/L)

Stage I

10.5

16-182

Stage II

10.9

24-121

Stage III

12.5

18-87

Stage IV

14

7.7-108

Stage V

14.9

10-79

 

ADULTS          

Males

> or =18 years: 13.3-89.5 nmol/L

Females

18-46 years: 18.2-135.5 nmol/L

47-91 years, post-menopausal: 16.8-125.2 nmol/L

Interpretation
Provides information to assist in interpretation of the test results

Many conditions of mild-to-moderate androgen excess in women, particularly polycystic ovarian syndrome, are associated with low sex hormone-binding globulin (SHBG) concentrations. A defect in SHBG production could lead to bioavailable androgen excess, in turn causing insulin resistance that depresses SHBG concentrations further. There are rare cases of SHBG variants that follow this pattern. SHBG concentrations are typically very low in these individuals. However, in most patients, SHBG concentrations are mildly depressed or even within the lower part of the reference interval. In these patients, the primary problem may be androgen overproduction, insulin resistance, or both.

 

Adult SHBG concentrations in adolescent males with signs of precocious puberty support that the condition is testosterone driven, rather than representing premature adrenarche.

 

Therapies/behavior alterations that potentially increase SHBG concentrations include reducers of bioactivity of androgens (eg, androgen receptor antagonists, alpha-reductase inhibitors) or reduction of insulin resistance (eg, weight loss, metformin, peroxisome proliferator-activated receptor [PPAR] gamma agonists). Clinical assays may not be available for many therapeutic synthetic androgens and estrogens (eg, ethinyl-estradiol). In those instances, increasing SHBG concentrations may be associated with anti-androgen or estrogen therapy, while SHBG reduction can be associated with androgen treatment.

 

Patients with anorexia nervosa have high SHBG concentrations. With successful treatment, concentrations start to fall as nutritional status improves. Normalization of SHBG precedes, and may be predictive of, future normalization of reproductive function.

 

Thyrotoxicosis increases SHBG concentrations. In situations when assessment of true functional thyroid status may be difficult (eg, patients receiving amiodarone treatment, individuals with thyroid hormone transport-protein abnormalities, patients with suspected thyroid hormone resistance or suspected inappropriate thyroid-stimulating hormone [TSH] secretion such as a TSH-secreting pituitary adenoma), elevated SHBG concentrations suggests tissue thyrotoxicosis, while a normal level indicates euthyroidism or near-euthyroidism. 

 

SHBG is also produced by placental tissue and therefore values will be elevated during pregnancy. Reference ranges for pregnant females have not been established in our institution.

 

In patients with known insulin resistance, "metabolic syndrome," or high risk of type 2 diabetes (eg, women with a history of gestational diabetes), low SHBG concentrations may predict progressive insulin resistance, cardiovascular complications, and progression to type 2 diabetes. An increase in SHBG concentrations may indicate successful therapeutic intervention.

 

A genetic variant of SHBG (Asp327>Asn) introduces an additional glycosylation site in 10% to 20% of the population, resulting in significantly slower degradation. These individuals tend to have higher SHBG concentrations for any given level of other factors influencing SHBG.

 

In laboratories without access to bioavailable testosterone or equilibrium dialysis-based "true" free testosterone assays, sex hormone-binding globulin measurement is crucial in cases when assessment of the free testosterone fraction (free androgen index or calculated free testosterone) is required. At Mayo Clinic Laboratories, both bioavailable testosterone (TTBS / Testosterone, Total and Bioavailable, Serum) and free testosterone (TGRP / Testosterone, Total and Free, Serum) measurements are available. Free testosterone (TGRP) is measured by equilibrium dialysis, obviating the need for sex hormone-binding globulin measurements to calculate free androgen fractions.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

In rare cases, interference due to extremely high titers of antibodies to analyte-specific reagents (human antimouse or heterophile antibodies) can occur. The laboratory should be alerted if the result does not correlate with the clinical presentation.

 

For patients presenting with cirrhosis or sub-clinical thyroid conditions, carefully evaluate results as these conditions can potentially cause erroneous sex hormone-binding globulin (SHBG) results.

 

SHBG results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Konforte D, Shea JL, Kyriakopoulou L, et al:, Complex biological pattern of fertility hormones in children and adolescents: A study of healthy children from the CALIPER cohort and establishment of pediatric reference interval. Clin Chem. 2013;59(8):1215–1227

2. Pugeat M, Plotton I, de la Perriere, Raverot G, Dechaud H, Raverot V:( Management of endocrine disease hyperandrogenic states in women: Pitfalls in laboratory diagnosis. Eur J Endocrinol. 2018;178(4):141-154

3. Jarecki P, Herman WA, Pawliczak E, Lacka K:Can low SHBG serum concentration be a good early marker of male hypogonadism in metabolic syndrome? Diabetes Metab Syndr Obes. 2019;12:2181-2191.

4. Calzada M, Lopez N, Noguera JA, et al: AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynecol. 2019;39(8):1130-1136

5. Tchernof A, Despres JP: Sex steroid hormone, sex hormone-binding globulin, and obesity in men and women. Horm Metab Res. 2000;32:526-536

6. Kahn SM, Hryb DJ, Nakhle AM, Romas NA, Rosner W: Sex hormone-binding globulin is synthesized in target cells. J Endocrinol. 2002;175:113-120

7. Hammond GL: Access of reproductive steroids to target tissues. Obstet Gynecol Clin North Am. 2002;29:411-423

8. Elmlinger MW, Kuhnel W, Ranke MB: Reference ranges for serum concentrations of lutropin (LH), follitropin (FSH), estradiol (E2), prolactin, progesterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), cortisol and ferritin in neonates, children, and young adults. Clin Chem Lab Med. 2002;40(11):1151-1160

Method Description
Describes how the test is performed and provides a method-specific reference

The Access SHBG assay is a sequential 2-step immunoenzymatic (sandwich) assay. Patient sample is added to a reaction vessel along with paramagnetic particles coated with monoclonal anti-sex hormone-binding globulin (SHBG) antibody and saline buffer with proteins. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A second monoclonal anti-SHBG antibody conjugated to alkaline phosphatase is added to the reaction vessel. After the second incubation in the reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of SHBG in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.(Instruction manual: Access SHBG Sex Hormone-Binding Globulin, A48617. Beckman Coulter, Inc; 04/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

84270

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports