【Product Name】Detection Kit for Detection kit of Estradiol (E2) (Enhanced chemiluminescence immunoassay.)

【registration certificate number】 京食药监械（准）字2014第2400146号

       This kit is mainly used for quantitative determination of Estradiol (E2) in human serum in vitro.

Estradiol (E2) is one of the most bio-active steroid hormones in female estrogen, mainly derived from the ovary, corpus luteum and placenta, and a small amount of estradiol is secreted by the adrenal glands. For men, it is mainly produced by the testicles. The determination of concentration of E2 in serum is an important indicator of ovarian and thalamic-pituitary-gonad axis function evaluation.

        This kit uses competitive approach. Microplates were coated with E2 antibody to make a solid-phase antibody, calibrator of E2 (or sample to be tested) and HRP-E2 are added to the micropore coated with antibody, complex called E2 antibody-E2 and E2 antibody-HRP-E2 were formed. The binding amount of HRP-E2 is inversely proportional to the content of E2 in serum, the unbound HRP-E2 was removed after the immunoreaction, the luminescence was measured with a photon counter after adding the luminescent substrate. With the increase of E2 concentration, the luminescence value gradually decrease and keep a linear relation. Use double logarithm or other suitable fitting method and the instrument software will automatically calculate the E2 content of the sample.

1. High Sensitivity: chemiluminescence immuno assay can detect the substance that radioimmunoassay, enzyme-linked immunosorbent assay and other methods can not, early diagnosis of disease is of great significance.

2. Short Detection time: the optical signal measurement time of each sample is less than a second, which is very necessary for emergency situations in medical and health work (such as rescue, blood transfusion, emergency surgery, remote treatment, etc.).

3. Excellent stability: the validity period is up to one year, which is conducive to the popularization and application.

4. Simple and fast operation: Chemiluminescence immunoassay is simple and fast, the test can be completed one hour and projects commonly used can print report one hour.

5. Fast, good security: chemiluminescence immunoassay does not involve harmful chemical composition for human, although there are also waste exclusion, no harmful pollution to the environment.

1. Increase: It is seen in precocious puberty, male breast development, pregnancy (especially twins or multiple births), estrogen secretion tumor, ovulation drugs (such as clofuran), male feminization, ovarian cancer, anovulatory uterine bleeding , cirrhosis and so on.

2. Reduction: It is found in ovarian tumors, hydatidiform mole, intrauterine fetal death, pregnancy-induced hypertension, hypothalamic tumors, reduced pituitary gland function, ovarian insufficiency, ovariectomy, adolescent delay, primary and secondary amenorrhea, menopause, oral contraceptives and so on.

3. The pathogeny of the increase of estradiol value: 1) ovarian disease: ovarian granulosa cell tumor, ovarian germ layer tumor, ovarian adipose cell tumor, sex hormone generated tumor, it is all manifested as ovarian hyperactivity and increased estradiol secretion; 2) heart disease: myocardial infarction, angina, coronary stenosis; 3) others: systemic lupus erythematosus, cirrhosis, male obesity.

4. The pathogeny of the reduction of estradiol value: 1) ovarian disease: absence or hypoplastic of ovary, primary ovarian failure, ovarian cysts; 2) pituitary amenorrhea or infertility; 3) others: hypothyroidism or hyperthyroidism, Cushing's syndrome, Addison's disease, malignant tumors, a wide range of infections, renal insufficiency, brain and pituitary lesions and so on, which all can reduce estradiol in plasma.

Clinical laboratory, physical examination center.