SHBG ELISA Kit (Sex Hormone Binding Globulin)

INTENDED USE

Human SHBG ELISA kit is a reliable quantitative procedure for measuring sex hormone binding globulin (SHBG) in human serum or plasma. This assay has a minimum sensitivity detection limit of 0.23 nmol/l.

BACKGROUND

Sex hormone binding globulin (SHBG) is a B-globulin which has a molecular weight of 86 kDa/mol and it has the ability to bind specifically to steroid hormones. It is thought to be predominately synthesised in the hepatocytes, this production is regulated by thyroid hormones, androgen/estrogen balance, insulin and dietary factors. One of the major function is the involvement in the transport of sex steroids within the plasma and its concentrations can be a vital factor in regulating the distribution between protein-bound or free states available.

In general, the determination of SHBG can allow the possibility to calculate the free fraction of many other steroid hormones which is based on the total concentration measured in serum. It must be also remembered that the metabolic activity of any steroid is only represented by the free hormone fraction which represents under 5% of the total amount present. The measurement its levels have been helpful in evaluating mild disorders of androgen metabolism and can allow the identification of women with hirsutism that may respond to estrogen therapy. Testosterone/SHBG-ratios have been found to correlate well with both the calculated and measured values for free testosterone and this can be vital in aiding the discrimination between patients with normal from those with excessive androgen activity individuals.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

• Microtiterwells: Wells coated with anti SHBG antibody (monoclonal).
• Standard 0-6: Concentrations 0, 4, 16, 32, 65, 130, 260 nmol/l. The standards are calibrated against the following reference material: WHO International Standard (08/266).
• Control Low And Control High: Containing human SHBG.
• Assay Buffer.
• Enzyme Conjugate: Consisting of antibody conjugated with horseradish peroxidase (HRP).
• Substrate Solution: Tetramethylbenzidine (TMB).
• Stop Solution.
• Wash Solution: (40x Concentrated).

SENSITIVITY

The minimum sensitivity detection limit of sex hormone binding globulin (SHBG) using current SHBG ELISA kit was approximately 0.23 nmol/l. The dynamic range for this assay is 4.0 – 300.0 nmol/l.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 0.408 ng/mL ‒ 260.0 nmol/L.
– Specificity (Cross Reactivity): SHBG (100%), Corticoid binding globulin (< 0.2%), Thyroxin binding globulin (< 0.04%).
– Analytical Sensitivity: 0.23 nmol/L
– Intra-Assay Variability: 2.3 – 4.8%
– Inter-Assay Variability: 5.2 – 6.3%
– Inter-Lot Variability: 8.1 – 11.7%
– Recovery: 88.3 – 99.8%
– Linearity: 93.8 – 101.6%
– Drug Interferences: None
– Interfering Substances: None
– High-dose-Hook Effect:  No hook effect detected up to 11350 nmol/L of SHBG.

REFERENCES

1. Novel insights in SHBG regulation and clinical implications. Trends Endocrinol Metab. (2015) 26 (7): 376-83. Review. Simó R., et al.
2. Sex hormone binding globulin and insulin resistance. Clin Endocrinol (Oxf). (2013) 78 (3): 321-9. Review. Wallace I.R., et al.
3. The biomarker sex hormone-binding globulin – from established applications to emerging trends in clinical medicine. Best Pract Res Clin Endocrinol Metab. (2015) 29 (5): 749-60. Review. Thaler M.A., et al.

ADDITIONAL INFORMATION

• Full Name: SHBG ELISA Kit (Sex Hormone Binding Globulin)
• Reactivity: Human
• Sample Type: Serum, Plasma
• Sensitivity: 0.23 nmol/l

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