INTENDED USE
The FSH Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine to aid in the detection of menopause..
For in vitro self test use only.
| Storage |
2~30 º C |
| Specimen |
Urine |
| Component |
Rapid Test + Pipettes |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 5mins |
| Package |
40tests/box |
| Trademark |
Dewei |
| Origin |
China |
PRINCIPLE
The FSH Rapid Test is a qualitative, lateral flow immunoassay for the qualitative detection of human Follicle Stimulating Hormone in urine to evaluate the onset of menopause in women. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-FSH colored conjugate to form a colored line at the Test Line Region of the membrane which is darker than or the same shade as the line in the Control Line Region. To serve as a procedural control, a colored line will always appear in the Control Line Region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove test Strip, Device or Midstream from the sealed pouch.
2.1 Strip:
Remove test strip from the sealed pouch.Dip the arrowed end of the test strip into the
container with urine sample, take it out in 5
seconds and lay flat.
2.2 Device/Cassette:
Remove test device/cassette from the sealed pouch.Lay the device flat, add 2-3 drops of urine
specimen by sample dropper into the sample well.
2.3 Midstream/Pen:
Remove test midstream from the sealed pouch.
Open the midstream cup, dip the sample collection
head into urine sample, take it out in 5 to 10
seconds and lay it flat.
3. Read the results within 5 minutes.
INTERPRETATION OF RESULTS
POSITIVE: 2 colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only 1 colored band appears, in the control region (C). No colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
We offer both hCG, LH and FSH.
We have Strip, Device Cassette and Mistream Pen!
PRODUCT
COMPANY
R&D
PRODUCTION
SHIPMENT
EXHIBITIONS
Audited Supplier 
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