INTENDED USE

The in vitro qualitative detection of human chorionic gonadotropin in human urine by double antibody sandwich immunocolloidal gold chromatography is suitable for the auxiliary diagnosis of early pregnancy in women of childbearing age, but not for the detection of trophoblast tumors.

SUMMARY AND EXPLANATION

Human chorionic gonadotropin (HCG), a glycoprotein secreted by the trophoblast cells of the placenta, is composed of alpha and beta dimeric glycoproteins. Among them, α-subunit is common to anterior pituitary hormone; The β-subunit is specific for HCG. The main function of HCG is to stimulate the corpus luteum, which is conducive to the continuous secretion of estrogen and progesterone to promote the formation of uterine decidua and the growth and maturation of the placenta. It is thought that HCG is produced by trophoblast transitional cells and syncytium. Proliferation is rapid during the first 8 weeks of gestation to maintain pregnancy. After about 8 weeks of gestation, HCG gradually decreases until it reaches a relatively stable level at about 20 weeks.

PRINCIPLE 

The test adopts the principle of immune colloidal gold chromatography technology, through the double antibody sandwich method and colloidal gold color technology. The test line (T line) of the reagent nitrate cellulose membrane was coated with anti-α-HCG antibody, and the control line (C line) was coated with rabbit anti-DNP polyclonal antibody and goat anti mouse IgG polyclonal antibody. Testing, urine samples of human chorionic gonadotropin (HCG) and colloidal gold bearing anti -β- HCG antibody colloidal gold resistance coupling combined into immune complex, the immune complex rely on membrane chromatography effect moves to test line, it reacts with anti-α-HCG antibody on the test line and is fixed on the test line, in line to form a red band. At the same time, the DNP-BSA colloidal gold conjugate and the unreacted anti-β-HCG monoclonal antibody colloidal gold conjugate on the colloidal gold bearing pad moved to the control line by membrane chromatography, reacted with rabbit anti-DNP polyclonal antibody and goat anti mouse IgG polyclonal antibody on the control line, and was fixed on the quality control line, forming a red band in the control line.The amount of human chorionic gonadotropin in urine samples was positively correlated with the color of the red band in the test area.
The red color band of the control line is used as the internal control standard of the reagent.Regardless of whether HCG exists in the sample, the color band of the control line should develop. If the color does not develop, the test has failed.