Product Name
(HCG)Human Chorionic Gonadotrophin Rapid Test Kit (Immunochromatography)
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, including protein subunits of α and β. Its function is to stimulate
the corpus luteum to continue producing progesterone, to maintain the endometrium is suitable for
embryo attachment and embryo implantation. In normal pregnancy, hCG can be detected 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 human chorionic gonadotrophin 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-rat 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
Main Components
The testing kit is in the form of strip, cassette, and midstream. 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-rat 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. Concentration of hCG cannot be determined by this qualitative test.
2. 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.
3. 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.