One Step Fertility Test Kit Fsh Menopause Test

• Customization: Available
• Type: IVD Instrument
• Sensitivity: 25miu/Ml
• Model NO.: fsh
• Shelf Life: 2 Years
• Certification: ISO13485/CE
• Specimen: Urine
• Transport Package: Foil Pouch
• Specification: 2.5mm/3mm/4mm/5mm/6mm
• Trademark: David or Neutral
• Origin: China

Product Description

            One Step Fertility Test Kit FSH Test 25miu/ml

INTENDED USE
The Onestep FSH  Urine Tests for self-testing (Midstream) is a rapid, one-step, visual test for the qualitative   detection of follicle stimulating hormone (FSH) in human urine.
It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.
Note: The test can not be used to determine ovulation. The test does not detect all kinds of fertility issues. The test may not be accurate if pregnant at the time of testing. The test can not be used for birth control. 

PRINCIPLE OF THE PROCEDURE
The test device is a two site sandwich immunoassay. The membrane is pre-coated with anti-α-FSH capture antibody on the Test line region and goat anti-mouse antibody on the Control line region. The test device is an immunoassay containing mouse monoclonal anti-β-FSH antibody conjugated to colloidal gold and monoclonal anti-α-FSH as a capture antibody on the Test line region of nitrocellulose membrane.
During testing, the urine specimen reacts with a colored conjugate (anti-β-FSH monoclonal antibody-colloidal gold conjugate) that is pre-dried on the test strip.
As the test specimen flows through the membrane assembly of the device, the highly specific monoclonal anti-β-FSH antibody-colloidal gold conjugate complexes with the FSH in the specimen and travels on the membrane due to capillary action along. This complex moves further on the membrane to the test region (T) where it is immobilized by anti-α-FSH antibody coated on the membrane, leading to formation of a colored band. The unbound complex, if any, move further on the membrane and are subsequently immobilized by the goat anti-mouse antibodies coated on the membrane at the control region (C), forming a colored band.