【Product Name】Detection Kit for Human chorionic gonadotropin (HCG) (Enhanced chemiluminescence immunoassay.)

【registration certificate number】 京食药监械（准）字2014第2400148号

       This kit is mainly used for quantitative determination of Human chorionic gonadotropin (β-HCG)in human serum in vitro.

        Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by placental syncytiotrophoblasts after implantation in the embryo. Therefore, the determination of HCG content in blood and urine can be diagnosed in pregnancy one week after pregnancy, detection of HCG in the first trimester of pregnancy is particularly important, the significantly increase of HCG during this period prompted the disease of multiple pregnancy. Reduction of HCG prompted abortion, ectopic pregnancy, stillbirth.

          The kit uses a sandwich method. Microplates were coated with one anti -HCG to make a solid-phase antibody and the other labeled with HRP into anti -HCG -HRP. HCG (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 anti -HCG -HRP was removed after the immunoreaction, the luminescence was measured with a photon counter after adding the luminescent substrate. With the increase of HCG concentration, the luminescence value gradually increases and keep a linear relation. Use double logarithm or other suitable fitting method and the instrument software will automatically calculate the HCG 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. Diagnosis of early pregnancy.

2. Judgement of abnormal pregnancy and placental function: ①Ectopic pregnancy; ②Diagnosis and treatment of abortion; ③Threatened abortion.

3. The diagnosis and treatment monitoring of trophoblastic tumor: ①the hydatidiform mole, malignant hydatidiform mole, chorionic epithelial carcinoma and testicular teratoma; ②Trophoblast cell tumor.

4. For endocrine diseases, such as pituitary disease, hyperthyroidism, gynecological diseases such as ovarian cysts and uterine cancer, HCG can also be increased.

Clinical laboratory, physical examination center.