FSH test to support menopause assessment
The menopause FSH test is a qualitative rapid test for detecting follicle-stimulating hormone in urine at 25 mIU/ml. An elevated FSH level may support assessment of the onset of menopause but does not establish menopause or the cause of symptoms on its own.
Who is the test intended for?
The test is intended for professional use and has not been tested for home use.
What does the test measure?
The test detects FSH qualitatively in urine. FSH levels can vary during the menstrual cycle and between days, so more than one specimen and other investigations may be needed.
When is testing performed?
With regular periods, the IFU instructs starting within one week of the beginning of menstruation and repeating the test one week later. With irregular or absent periods, testing may start at any time and be repeated after one week. First morning urine is recommended.
Test procedure
- Allow the test and urine specimen to reach room temperature.
- Collect urine in a clean, dry container.
- Immerse the strip up to the marked maximum line.
- Place the strip on a flat, dry surface.
When should the result be read?
Read the result at 3 minutes. Do not interpret the result after 10 minutes.
How is the result interpreted?
A positive result shows test line T as dark as or darker than control line C. A negative result shows a lighter test line or no test line. The test is invalid if the control line is absent.
Does a positive result establish menopause?
No. A positive result indicates an elevated FSH level and must be assessed with the menstrual cycle, symptoms, medicines and other investigations.
Storage and limitations
- Store at 2–30 °C. Do not freeze.
- Use the test immediately after opening the foil pouch.
- Hormone treatments, contraceptives and other factors affecting FSH may alter the result.
- For single use only.
Manufacturer: Hangzhou AllTest Biotech Co., Ltd.
EU authorised representative: MedNet EC-REP GmbH.
Importer: Abcell Oy.
Read the English instructions for use (FFS-101).
Order the menopause FSH test for professional assessment of elevated FSH.
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