CARE Products Inc
Innovative Medical Diagnostics

Rapid urine based FSH test for the medical professional

CARE FSH is an immunological test for the detection of follicle stimulating hormone (FSH) in urine. FSH is produced in the pituitary gland and is needed for reproduction. FSH levels usually fluctuate between 2 and 20 IU/L. After the onset of menopause FSH levels rise well above 20 IU/L and remain permanently elevated.

CARE FSH can be performed at any time. However, it is advisable to use the first urine in the morning when FSH levels are highest.

The test is positive when FSH levels are above 25 IU/L. In order to confirm a positive test result a second test should be performed after one week has elapsed.

  • How to use the test
    • Collect a urine sample in a clean container.
    • Using the included pipette, apply 2 drops of urine to the sample well of the test cassette.
    • Wait ten minutes and read the test result.

  • Result interpretation
    • Positive result
      The test is positive if the Test Line (lower line) is of equal or greater intensity than the Control Line (upper line). In case of a positive test, the second test should be taken after one week to verify the result. A second positive test is an indication that postmenopause has been reached.
    • Negative result
      The test is negative if only the Control Line is visible, which indicates that the test was performed correctly.
  • Accuracy
    The test is highly accurate. FSH standards were added to a matrix of real urine to produce several FSH concentrations with the result that both sensitivity and specificity of the test with real urine were 99%.

  • Limitations
    Full product specifications including limitations available upon request

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