Free 17 Beta Estradiol Saliva ELISA Kit

INTENDED USE

Human free 17 beta estradiol saliva ELISA kit is an accurate in vitro quantitative method for detecting free 17β estradiol (17 beta estradiol, 17b-diol, 17beta estradiol) in human saliva samples. This assay has a minimum sensitivity detection limit of 0.06 pg/ml.

BACKGROUND

17-beta estradiol is present in both males and females and it is one natural estrogen in humans. In males it is less well defined, it is thought to be vital in regulating the secretion of gonadotropin and fertility, whereas in females it acts as growth hormone for tissues which are related to the reproductive organs. Its measurement has been used in helping to detect lack of estrogenes which are likely to be expressed in menopause, delayed puberty,  primary and secondary amenorrhoea. It can also be useful in evaluating fertility, detecting any menstrual irregularities and monitoring the ovarian follicular function during the induction phase of ovulation.

In plasma estradiol is found to be bound to either sex hormone binding globulin (SHBG) or albumin, with only a small fraction 1-3% being present in the free form. It is this free portion which has the biologically active part. Another important point is that it is this free hormone which is also released in equal amounts in saliva. Due to the fact that the levels tend to fluctuate, this makes the use of repeatedly collected saliva samples in order to get an accurate profile of this hormone quite attractive.

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 (96 Wells): Break apart strips that are coated with polyclonal anti-estradiol antibody.
• Standard 0-5: Concentrations 0, 1, 5, 10, 50, 100 pg/ml.
• Control Low And Control High.
• Enzyme Conjugate: Consisting of antibody conjugated to horseradish peroxidase (HRP).
• TMB Substrate Solution.
• Stop Solution.
• Wash Solution (Concentrated).

SENSITIVITY

The minimum sensitivity detection limit of human free 17β estradiol (17b-diol, 17 beta estradiol) using current 17 beta estradiol salivary ELISA kit was approximately 0.06 pg/ml. The dynamic range for this assay is 1.0 – 100.0 pg/ml.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 0.6 – 100 pg/mL.
– Specificity (Cross Reactivity): Percentage indicates cross reactivity at 50% displacement compared to Estradiol. Estradiol-17ß (100%), Estrone (6.86%), Estriol (2.27%), Fulvestrant (0.9%), Testosterone (0.033%), 17-Hydroxyprogesterone (0.003%).
– Sensitivity: 0.6 pg/mL at the 95 % confidence limit.
– Intra Assay: 2.4 – 8.3%
– Inter Assay: 2.8 – 12.0%
– Recovery: 85.4 – 112.0%
– Linearity: 88.5 – 112.8%
– Drug Interferences: Patients being treated with the drug fulvestrant (Faslodex®) could lead to falsely elevated test results.
– Interfering Substances: Blood contamination greater than 0.16% that may be present in the saliva samples will affect results (this usually can be seen by the eye).
– High-Dose-Hook Effect: None

REFERENCES

1. Salivary estradiol as a surrogate marker for serum estradiol in assisted reproduction treatment. Clin Biochem. (2017) 50 (3): 145-149. Fiers T., et al.
2. Progesterone and estradiol in the saliva and plasma during the menstrual cycle. Am J Obstet Gynecol. (1983) 147 (5): 557-62. Choe J.K., et al.
3. Sensitive salivary-estradiol assay for monitoring ovarian function. Clin Chem. (1990) 36 (10): 1769-73. Worthman C.M., et al.
4. Saliva as a medium for investigating intra- and interindividual differences in sex hormone levels in premenopausal women. Cancer Epidemiol Biomarkers Prev. (2001) 10 (1): 59-64. Gann P.H., et al.

ADDITIONAL INFORMATION

• Full Name: Free 17 Beta Estradiol Saliva ELISA Kit
• Reactivity: Human
• Sample Type: Saliva
• Sensitivity: 0.06 pg/ml

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