Product Name High accuracy Medical machine urine pregnant test hcg pregnancy test
Intended Use The reagent is used to detect the HCG in urine qualitatively according to the principle of double antibody sandwich method. Human chorionic gonadotropin (HCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization, ncluding protein subunits of α and β. Its function is to stimulate the corpus luteum to continue producing progesterone, to maintain the endometrium suitable for embryo attachment and embryo implantation. In normal pregnancy, HCG can be produced as early as 4 to 5 days after conception, HCG levels continue to rise very rapidly until delivery, peaking in about 8-10 weeks into pregnancy, and fall to normal level 2 weeks after the delivery
Principle The One Step HCG Pregnancy Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of
human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy. The test utilizes antibodies including a monoclonal HCG-β antibody and goat anti-mouse IgG on the nitrocellulose membrane with colloidal gold marked anti-HCG-α monoclonal antibody as an mark tracer. The reagent is used to detect the HCG in urine according to the principle of double antibody sandwich method and gold immunochromatography assay There is a control line (C) controlling the reaction process shown on the coated film. Based on test line’s (T) appearance to determine whether the tested sample contains HCG (Human Chorionic Gonadotrophin) or not.
Main Components Basic components: Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent paper and PVC board.
Colloidal gold marked pad coated with HCG-α monoclonal antibody, nitrocellulose membrane coated with HCG-β monoclonal antibody control line coated with goat anti-mouse IgG.
Storage and Expiry Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry place, valid for 24 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.
Limitation 1. The reagent only can be used for screening tests, just like all qualitative detection reagents.
2. Concentration of HCG cannot be determined by this qualitative test.
3. This reagent is designed for the qualitative screening test. A confirmed pregnancy diagnosis should be made only by a physician after all clinical and laboratory findings have been evaluated.
4. False negative results may occur when the HCG levels of the ectopic pregnancy are below the sensitivity level of the test. When pregnancy is still suspected, a b-mode ultrasonograph diagnosis is suggested.