Pregnancy urine test is a qualitative immunoassay for the detection of human Chorionic Gonadotropin (hCG) in human urine for the early detection of pregnancy.
The pregnancy test is based the detection of the human Chorionic Gonadotropin (hCG) in human urine. HCG is a hormone produced by the placenta. In normal subjects, hCG in urine provides an early indication of pregnancy. Genomix Pregnancy urine test uses a monoclonal antibody specific to hCG in a one-step lateral flow chromatographic immunoassay to accurately detect hCG.
This assay is one-step lateral flow chromatographic immunoassay. The test strip in the device includes:
1. a conjugate pad containing mouse monoclonal anti-hCG antibody conjugated to colloidal gold, and
2. nitrocellulose membrane containing a test line (T line) and a control line (C line).
When an adequate amount of specimen is applied to the sample pad of the device, hCG in the specimen binds to sites on the anti-hCG antibody-gold conjugate in the conjugate pad to form a complex and migrates along the membrane strip. If the specimen contains hCG at a level close to or greater than 25mlU/ml, the complex will bind to the capture antibody coated on the T line to develop a burgundy-colored band. If the specimen does not contain hCG or the hCG level is below the detectable level, the T line will not develop.
- Test devices, each sealed in a foil pouch with a dropper pipette and a desiccant.
- One package insert (Instructions for Use).
