Sex Hormone Binding Globulin in Human Serum and Plasma with Roche e801

Detection of Sex Hormone Binding Globulin in Human Serum and Plasma with Roche e801

Test Name: This immunoassay is for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma.
Method Name: In the Elecsys SHBG assay, a sex hormone binding globulin specific antibody labeled with a ruthenium complex is used to determine the sex hormone binding globulin concentration.
Results: Technical Range: 0.8-200 nmol/L
Reportable Range: 0.908-180 nmol/L
Reference Ranges: CHILDREN
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
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
≥18 years: 13.3-89.5 nmol/L
18-46 years: 18.2-135.5 nmol/L
47-91 years, post-menopausal: 16.8-125.2 nmol/L
Clinical Significance: Sex hormone binding globulin (SHBG) is the blood transport protein for testosterone and estradiol. It is a large glycoprotein with a molecular weight of about 95 kDa and exists as a homodimer composed of two identical subunits. Each subunit contains two disulfide bridges. Planar C18 and C19 steroids with a 17α hydroxyl group bind particularly well, whereas C19 17 ketosteroids such as dehydroepiandrosterone (DHEA) and androstendione do not bind so easily. SHBG has a high binding affinity to dihydrotestosterone (DHT), medium affinity to testosterone and estradiol, and only a low affinity to estrone, DHEA, androstendione, and estriol. SHBG binds reversibly to sexual steroids. Albumin, which exists in far higher concentrations than SHBG, also binds sexual steroids – although with a clearly lower binding affinity (e.g. about 100 times lower for testosterone). SHBG has a half-life of about 7 days and is produced mainly by the liver. Its synthesis and secretion are regulated by estrogen. SHBG serum concentrations depend on the extent, duration, and the kind of estrogen applied, and how regulation takes place. Androgens and gestagens with androgenic residual action have the opposite effect.

In the serum SHBG mainly takes over the transportation of steroids and the reduction/regulation of the effect of androgen. Decreased SHBG serum levels are associated with conditions where elevated androgen levels are present or where the effect of androgen on its target organs is excessive. This explains the gender related differences seen between men and women, especially during puberty.

Measurement of SHBG can be an important indicator of an excessive/chronic androgenic action where androgen levels are normal, but where clinical symptoms would seem to indicate androgen in excess. SHBG is a useful supplementary parameter in the determination of androgen where a relatively high concentration of free androgen (e.g. testosterone) is suspected.

Elevated SHBG levels can be seen in elderly men and are often found in patients with hyperthyroidism and cirrhosis of the liver. SHBG levels also increase when oral contraceptives or antiepileptic drugs are taken. Pregnant women have markedly higher SHBG serum concentrations due to their increased estrogen production. Decreased SHBG concentrations are often seen with hypothyroidism, polycystic ovarian syndrome (PCOS), obesity, hirsutism, elevated androgen levels, alopecia, and acromegaly. The Elecsys SHBG assay employs two monoclonal antibodies specifically directed against human SHBG.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum Plasma: Li-heparin and K2-EDTA plasma
Do not use fluoride plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    12 months at -20°C
7 days at 2-8°C
5 days at 20-25 °C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.