【Product Name】Detection Kit for Human Placental Lactogen (HPL) (Enhanced chemiluminescence immunoassay)

【registration certificate number】 京食药监械（准）字2014第2400311号

       This kit is mainly used for quantitative determination of human placental lactogen (HPL) in human serum in vitro.

Human Placental Lactogen (HPL) is a single-chain polypeptide hormone synthesized and secreted by placental syncytiotrophoblasts. It consists of 191 amino acids and has a molecular weight of 22.3 kD. HPL is mostly in villus clearance and maternal blood, secretion also increased when the body suffers from breast cancer, choriocarcinoma and malignant teratoma. HPL content in the blood of pregnant women is related to the weight of fetus and placenta. HPL has obvious lactation activity and growth-promoting effect. Determination of HPL content in serum has important meaning for the monitoring of placental function in pregnant women and speculating fetal development.

        This kit uses competitive approach. The reagents used in the kit are HPL standard, horseradish peroxidase labeled HPL (HRP-HPL), microplate coated with HPL antibody, chemiluminescent substrate (with enhancer), enzyme-labeled antigen competes with unlabeled antigen (antigen of test sample) for coating a limited number of wells binding site of the specific antibody in the microplate and combines into antigen-antibody complex, the number of unlabeled antigen (antigen of test sample ) affects the number of antigen-antibody complex,  the more antigens in the sample to be tested, the less labeled antigen-antibody complex formed. Unbound labeled antigen is removed after the immune reaction, it can produce optical signals by adding chemiluminescent substrate, the optical signal will decrease with the increase of antigen in the sample to be tested. According to the relative luminescence intensity of HPL series and its concentration, the dose-response curve can be drawn by log-logit mathematical model or other suitable mathematical model fitting and the content of HPL in the tested sample can be calculated from this curve by the relative luminescence intensity.

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.

        The increase of HPL can be found in the following situations: twin or multiple births, pregnant women with diabetes, large placenta, the blood group of mother and child are not compatible (Rh blood type), pregnancy syndrome, giant children, sickle cell crisis and jaundice of pregnancy.

The reduction of HPL can be seen in the following situations: hydatidiform mole (low HPL,high HCG), threatened abortion, pregnancy-induced hypertension with placental disease, intrauterine growth retardation, small placenta, stillbirth and premature delivery.

Clinical laboratory, physical examination center.