【Product Name】Detection Kit for Human growth hormone (hGH) (Enhanced chemiluminescence immunoassay.)

【registration certificate number】 京食药监械（准）字2014第2400098号

       This kit is mainly used for quantitative determination of Human growth hormone (hGH)in human serum in vitro.

Human growth hormone (hGH), a glycoprotein hormone secreted by the anterior pituitary, is an important hormone regulating metabolism. Its main function is to promote the liver to release glucose, promote lipolysis and oxidation, promote synthesis of protein and stimulate enlargement of cranial, mandibular and cartilage hypertrophy, epiphyseal cartilage hyperplasia, promote certain tumor growth and stimulate lactation. Clinically available glucose hGH inhibition test and arginine hGH challenge test can be used to understand the function of hypothalamus and pituitary gland, it is of great significance to diagnose the function of the whole pituitary gland, pituitary dwarfism, acromegalic surgery, and the diagnosis of diseases such as cauchy's syndrome and hypothyroidism.

        The kit uses a sandwich method. The hGH-specific antibody is bound to a solid support, and then it is combined with the hGH antigen in the test sample to form an immune complex. Anti-hGH-HRP is added and bound to hGH antigen in the immune complex to form   Anti-hGH-HRP-hGH antigen-hGH solid-phase antibody complex, the binding amount of anti-hGH-HRP increases with the increase of hGH content in the sample. After addition of the substrate solution, an optical signal is generated by the action of HRP. The intensity of light signal varies with the change of anti-hgh -HRP content. Therefore, the determination of the optical signal can reflect the hGH content in the sample. According to the relative luminescence intensity and concentration of hGH series calibrators, the standard curve can be drawn through the double logarithmic mathematical model or other suitable mathematical models, and the content of hGH in the sample to be tested can be calculated by the relative luminescence intensity from the standard curve.

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.

Common symptoms: amenorrhea, no beard, depression, cryptorchidism

Children with idiopathic growth hormone deficiency at birth are often tall and have normal body weights, and begin to slow growth after several months. However, it often not to be found and their differences are more pronounced after 2 to 3 years of age and among their peers, but growth is not completely stopped, only growth speed is very slow, generally no more than 4 ~ 5 cm a year. Adult height does not exceed 130cm.  Bone age is naive, bone epiphysis can not integrate at a long time, the tooth mature slowly. Body shape is generally well-proportioned, the adult still maintains the childhood type and the appearance, the skin is more delicate and dry, wrinkled, the subcutaneous fat is slightly full.

Patients’ sexual organs are not developed, secondary sex signs are absent during puberty such as male genitals are small, similar to children, small testicles, often accompanied by cryptorchidism, no beard; women showed primary amenorrhea and the breasts do not develop. The lack of a single growth hormone can lead to sexual organ development and secondary sexual characteristics, but often significantly delayed. Some patients are still lack of TSH and / or adrenocorticotropic hormone (ACTH), but most are only found in the endocrine hormone examination.

Mental development is normal, academic performance has no difference with the same age, but as they grew older, they often feel depression, not gregarious and have a sense of inferiority due to their short stature.

Before the diagnosis of growth hormone deficiency, suspected patients should first determine whether it is dwarf, it is usually not easy to find within 1 years old unless the condition is serious, because growth retardation is not particularly obvious less than 1 years old, severe cases occur after 6 months; Patient needs to measure height, and then compared with normal value, less than 30% of normal can be determined; it can also be calculated by the formula (1 to 12 years old): 80+ age (age) * 5, the result is below 30% of the value can be determined, if the result is less than 20%, observation should be strengthened.   In particular, there is a small amount of GH secretion in the body, although the body length index of children is short, it is still a distance from 30% of the index.

In addition to clinical manifestations, the diagnosis of growth hormone deficiency mainly depends on the determination of GH deficiency to eliminate the dwarf caused by other reasons. There are many causes of growth and developmental disorders, some of them are different from pituitary dwarf in clinical manifestations, while others are exactly the same.

Clinical laboratory, physical examination center.