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Menopause Test Principles

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Test Principles

The CARE Menopause Test 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. With the onset of menopause, which equals the end of menstruations and thus the end of natural childbearing, FSH levels remain permanently elevated.

The CARE Menopause Test is a self-testing device for home-use, which 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
    • The test gives two choices of methods for collecting the urine sample
      • Hold the test stick pointed downward directly into the urine stream for 2-3 seconds or
      • Dip the test stick into a container of urine for 5 seconds not further than the gray band on the lower portion of the test stick
    • After the urine sample has been collected the test stick with the run off opening pointing down has to be pushed into the orange area on the back of the box.
    • Wait ten minutes

  • 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 100%.

  • Limitations
    Medications containing FSH and testing the urine of pregnant women may distort the test results. Hormone concentrations not influencing the test: HhCG 1,000 mlU/ml, HLH 1,000 mlU/ml, TSH 1,000 mlU/ml

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