INTENDED USE
A rapid test for the qualitative detection of follicle stimulating hormone (FSH) in urine.
For professional in vitro diagnostic use only.
PocTell® FSH Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of menopause.
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Cut-off |
Shelf life |
Kit Size |
|
FSH |
Strip or Cassette |
Urine |
5 mins |
25mIU/ml |
24 months |
25T/Kit |
TEST PRINCIPLE
PocTell® FSH Rapid Test Device (Urine) 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. Absence of this colored line suggests a negative result. 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.
DIRECTIONS FOR USE
Allow the test, urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and level surface. Hold the dropper vertically and transfer 2-3 full drops of urine (about 80-120 uL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).
3.Wait for the colored line(s) to appear. Read results at 5 minutes. Do not read the result after 10 minutes.
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