17ß-Estradiol Saliva Luminescence Immunoassay Bulk

Available as an IVDR-compliant product!

Intended use

Luminescence immunoassay for the in-vitro-diagnostic quantitative determination of 17beta-Estradiol in human saliva.

Intended purpose

The 17beta-Estradiol Saliva Luminescence Immunoassay is intended for the measurement of 17-betaEstradiol in human saliva. Estradiol is the most important natural estrogen and present in both women and men. The measurement of the hormone level is useful for detection of estrogen deficiency. Estradiol has an impact on puberty, primary and secondary amenorrhea and menopause. This test is not intended for assessing placental function in complicated pregnancy. Additional hormone assays are recommended for an interpretation of the estradiol level. The 17beta-Estradiol Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiterplate luminescence reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as luminescence microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated manually from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges). The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use. The test kit is intended for manual use.

Summary and explanation

17beta-Estradiol [1, 3, 5 (10) -estratriene-3, 17beta-diol; E2] is a C18 steroid hormone and an important natural estrogen, which derives from the precursor cholesterol and belongs to the group steroid hormones called estrogens, which is present in women and men.[1; 2] Estradiol is the major estrogen in the body involving different functions within the human physiology throughout life. [3] Estradiol, the most potent bioactive estrogen, is primarily synthesized from testosterone in the ovarian follicles in females, whereas in males it is produced by the testes and extraglandular conversion of androgens.[4; 5] Estradiol is synthesized from testosterone or estrone, a derivative of cholesterol.[6] The main hormones responsible for advancing secondary sexual characteristics are two androgens: testosterone and dehydroepiandrosterone (DHEA), which facilitate masculine development, and estradiol, an estrogen which facilitates feminine development.[7] Estradiol is the primary estrogen released from the gonads and other peripheral tissues.[8] Levels of 17beta-Estradiol secretion increased with pubertal progression. Estradiol is an important hormone present in both women and men. Estrogen deficiency in boys and in girls but especially in young girls it has an impact on puberty. Girls with delayed puberty show advancing pubertal maturation when administered estradiol. The measurement of estradiol levels is useful regarding puberty to investigate if early puberty (precocious puberty) occurs in girls. Estradiol is 4 - 9 times higher in late adolescent girls as compared to childhood.[9] Ovarian volumes increase with pubertal breast stage and correlate positively with circulating estradiol levels.[10]Amenorrhea is classified into primary and secondary amenorrhea. Primary amenorrhea is defined as the absence of menarche by the age of 14 years, while secondary amenorrhea describes the absence of menses for more than six months in previously menstruating women.[11] In older women estrogens level should be observed in regards to menopause.[12] Additionally, estradiol plays a role in ovulation, menstrual cycle and menopause and in this regard the function of ovaries and placenta.[13-17] In addition to its role as a natural hormone, estradiol is used in the realm of hormone replacement therapy during menopause.[18] Naturally estradiol levels both in women and men decline with age, however, the estradiol level in older men are higher than in postmenopausal women and serve different functions in the male body (bone maturation and sex interest). Estradiol levels are related to body fat mass, bone health, affect skin metabolism and sex interest in men. Estradiol levels in men are higher than in postmenopausal women and comparable to estradiol levels in the early follicular phase. It is also worth mentioning that a correlation between testosterone and estradiol levels exists due to testosterone being the major precursor of estradiol.[19] Additional parameters should be measured for an interpretation of the results e.g. DHEA or testosterone.[7] Other physiological aspects where estradiol is involved are amenorrhea (primary and secondary) and menopause, which are indicated by low estradiol levels.[11; 21] In serum steroid hormones are bound to sex hormone binding globulin (SHBG) and to serum albumin, only 1 - 3 % of estradiol circulates in plasma and is present in its free form. Only this portion represents the bioactive form of the endocrine regulation. However, in saliva only the free hormone is present as the protein bound hormones cannot pass the membranes into the oral cavity. A good correlation between hormones in saliva with the free fraction in serum. [20] Proportions of estradiol levels in saliva are similar, between 0.2 % and 7.9 % of total serum concentrations.[22] Therefore, the measurement of estradiol in saliva is very attractive for clinicians due to its manifold advantages over venipuncture - being non-invasive, less stressful for the patient, multiple samples can be collected by a layperson after a short introduction. Steroid hormones have distinct circadian rhythms, especially estradiol and progesterone in females are strongly correlated with the menstrual cycle [23; 24].