Prima Menopause Test (2 Test Kit)

The MENOPAUSE FSH TEST is an immunoassay that detects FSH using specific gold-conjugated monoclonal antibodies present in the reaction strip. Menopause is caused by a change in the hormonal balance in a woman’s body. This change usually occurs when a woman approaches the age of 45, with clear signs appearing around age 55. An irregular menstrual cycle at this age is usually the first indication of the onset of menopause. Menopause occurs when the lifespan of the follicles ends, resulting in an increase in the level of follicle-stimulating hormone (FSH). FSH concentration increases during menopause from values lower than 20 mUI/mL to about 80 mUI/mL. The MENOPAUSE FSH TEST can detect FSH in urine once the concentration rises above 25 mUI/mL or more.

Evaluation reports show a correlation rate of over 94% (95% CI: 92.0 - 95.9%) with reference methods.

Open the protective bag and take out the test device. Discard the desiccant in the foil bag. Remove the protective cap — this exposes the absorbent tip (FIG A).

Turn the device so the results window faces up and the absorbent tip faces down. Place the absorbent tip directly under the flow of urine for at least 10 seconds (fig. B1).

WARNING: Make sure no drops of urine splash onto the reading window. Alternatively, you can collect urine in a clean, dry container without residues (container not included) and dip the absorbent tip into the urine for 10 seconds (fig. B2). Replace the protective cap on the absorbent tip (fig. C). Place the test strip on a dry, flat surface with the results window facing up (FIG D). * Do not open the sealed foil bag until just before performing the test. Take care to open it as marked.

* The desiccant bag should not be used. Dispose of it with household waste without opening it.

* Materials needed but not included: a device to measure time (i.e. timer, watch).

PRECAUTIONS

- Read the instructions for use carefully before performing the test. - The test is reliable only if all instructions are followed correctly. - Keep the test out of the sight of children. - Do not use the test after the expiry date or if the package has been damaged. - Follow exactly the procedure and time specified. - Store the test items at temperatures between +4°C and +30°C. Do not freeze. - Use the test only once. - The test is intended for external use only. DO NOT SWALLOW. - In vitro diagnostic device is for individual use. - After use, dispose of all items in accordance with applicable waste disposal laws. Consult a pharmacist for advice.