タイトルまたは説明

【INTENDED USE】
Onestep Pregnancy Urine Tests for self-testing is a rapid,one-step lateral flow immunoassay for the qualitative determination of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy.
It is intended for both prescription use and over-the-counter use. 
【PRINCIPLE】
The test is a one-step, qualitative, double antibodies sandwich lateral flow immunochromatographic assay. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. Each test device contains mouse monoclonal anti-β-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal anti-α-hCG antibody (on the Test Line) and goat anti-mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. 
When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane.
During the test, hCG in the urine specimen reacts with the dye conjugate (mouse anti-β-hCG antibody- colloidal gold conjugate) and forms a complex.  The complex migrates along the membrane to the mouse anti-α-hCG antibody test region (T), and remains captured in the T line.