【Product Name】Detection Kit for Follicle-stimulating hormone (FSH) (Enhanced chemiluminescence immunoassay)

【registration certificate number】 京食药监械（准）字2014第2400095号

【Packing】48 tests/box，96 tests/box.

       This kit is mainly used for quantitative determination of follicle-stimulating hormone (FSH) in human serum in vitro.

Follicle-stimulating hormone (FSH) stimulates the growth of testicular supporting cells and promotes the production of a protein that binds to androgen, through this protein, the developmental germ cells can obtain androgens with stable high concentrations, it also promote development of germ cell and make them differentiate into mature sperm. For women, FSH can promote the formation and maturation of follicle, can promote proliferation of granulosa cell, and secretion of follicle, FSH has synergistic effect with LH to promote ovulation and so on. It is a detection method to study and determine the hypothalamic - pituitary - gonadal axis function for the prediction of ovulation time. It also plays an important role in the monitoring of secretion therapy and the diagnosis of infertility.

      The kit uses a sandwich method. Microplates were coated with one antibody to make a solid-phase antibody and the other labeled with HRP into HRP-antibody. FSH (standard or test sample) is added to the wells coated with the antibody to form a complex called antibody-antigen-HRP labeled antibody. The unbound HRP-antibody was removed after the immunoreaction, the luminescence was measured with a photon counter after adding the luminescent substrate. With the increase of FSH concentration, the luminescence value gradually increases and keep a linear relation. Use linear fitting method of log (X) -log (Y) and the instrument software will automatically calculate the FSH 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.

          Luteal insufficiency refers to the lack of progesterone secreted by the corpus luteum, or premature declines of the corpus luteum, resulting in poor endometrial secretion and difficult or premature pregnancy; the high content can cause irregular menstruation or even affect pregnancy.

Clinical laboratory, physical examination center.