Product Description
One Step
HCG Pregnancy Rapid Test Kit
(Urine)
Package Insert
A rapid, one step test for the qualitative detection of human
chorionic gonadotropin (hCG) in human urine.
For in vitro diagnostic use only.
PRODUCT NAME
One Step HCG Pregnancy Rapid Test Kit (Urine)
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 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
Established in Year 2014,CHANGCHUN ZYF SCIENCE AND TECHNOLOGY Co., Ltd. is a high-tech enterprise devoted to the R&D, manufacturing, and sales of high-quality diagnostic products including laboratory equipment and clinical diagnostic reagents.
We can offer more than 30 kinds of urine analysis strips sold well and enjoyed high reputation from both domestic and overseas markets. Based on the principle of "customer first, quality first", our products continue to cover world-wide markets with the advantages of stable performance and high accuracy.
We registered MR International Healthcare Technology Co., Ltd. in Hong Kong for overseas sales. Through MR, we also possess some manufacture facilities in Zhejiang, Guangdong and Jiangsu provinces of China in order to help reduce the cost while caring about the quality.
We are committed to provide most reliable medical devices and solutions to people in every corner of the earth. Accomplishing the mission of "maximizing the reliability of medical products" is our goal. We do care about obtaining the trust from our partners and patients. We are dedicated to innovation in the fields of Rapid Test, POCT, In-Vitro Diagnostics, and Medical Consumables, such as vacuum tubes, tube holders, etc.