Menopause Test (FSH) | Urine Home Test | 2 Tests Included | Results in 10 Minutes

Intended use The SELFCHECK Menopause Test is registered with MHRA as a CE certified, in-vitro diagnostic medical device for self-testing. Mid-stream urine test Safe and easy to use Results at home in minutes CE certified for self-test use Contains 2 tests. This test is a specific, manual, qualitative, immunochromatographic (lateral flow), test for the detection of follicle stimulating hormone (FSH) in a midstream urine sample. In women over 45 years, menopause can usually be diagnosed by your doctor without the need for any tests. An FSH test is most useful for women under the age of 45 who are experiencing menopause symptoms, or when menopause is suspected. General information The SELFCHECK Menopause Test detects levels of FSH greater than 25 IU/L in a midstream urine sample. As the levels of FSH can fluctuate during certain stages of menopause, two tests are included in each kit, to be used one week apart, and only if both tests are positive should the possibility of menopause be considered. The test can be used at any time of the day, but it is recommended that an early morning sample be used, as this is the time of the day when the FSH levels in your urine are likely to be highest. Time to result The test gives a result in 10 minutes at home. Warnings A test for a single biomarker, such as FSH, is not a diagnosis. Not following the instructions exactly as written in the instructions for use may cause a false positive or false negative result. Do not change your medication, diet or lifestyle solely on the basis of a self-test - always discuss your result with an appropriate healthcare professional first. The measurement of FSH alone cannot indicate with 100% certainty that you are postmenopause or not. Always discuss your results with your doctor before making any changes to your lifestyle or medication. Due to the fluctuations in levels of FSH during the menstrual cycle it is possible to have levels of FSH in the urine approaching the cut-off for the test, which could give a positive result. In case of unexpected results please speak with your doctor. The measurement of FSH is not designed to check whether you can stop contraception and must not be used for this purpose. Always speak with your doctor before changing or stopping contraception. If you have just discontinued using a hormonal contraceptive, it is possible that your menstrual cycle may be irregular for some time, which can affect your result. It is recommended to wait two menstrual cycles before using the test. Accuracy This test has a cut-off of 25 mIU/mL of FSH for a positive result, and is calibrated to WHO 08/282 international standard. The test has an overall agreement of 94.29%, sensitivity of 90.77% and specificity of 100% with laboratory FSH tests. Although this test is reliable for the detection of FSH in urine, all medical tests can give false positive or false negative results. IMPORTANT: These figures refer to the agreement of the SELFCHECK test with laboratory FSH urine tests, and not to the accuracy of tests for the diagnosis of menopause. Further information NICE Guideline NG23 Menopause diagnosis and management: https://www.nice.org.uk/guidance/ng23 Information for health care professionals Principle, performance data, and regulatory information on the SELFCHECK Menopause Test for health care professionals. Reviewed 14th April 2026.