Menopause Rapid Test

Self-diagnostic test for determining follicle-stimulating hormone in urine.

2 tests in a package.

Menopause is caused by a change in the hormonal balance in a woman's body. This change generally occurs around the age of 45. However, the real symptoms are observed around the age of 55. Irregular menstrual cycles are the first sign of the onset of menopause (perimenopause). Follicle-stimulating hormone (FSH) is a hormone whose level increases during menopause. This test can detect the presence of FSH in urine when the concentration reaches 25 mIU/ml or greater.

CONTENTS
The kit contains two tests, together with one package insert.
Each test is packaged in a sealed aluminum pouch containing one
desiccant sachet.
The test should remain in the sealed pouch until use.
Do not use the desiccant sachet.

WARNING
1. This test is for in vitro diagnostic use. For external use only. DO NOT USE INTERNALLY.
2. Read the instructions for use carefully before performing the test.
The test is only reliable when the instructions for use are carefully followed.
3. Store at a temperature between +4°C and +30°C. Do not freeze.
4. Do not use the test after the expiration date stated on the label and the protective bag, or if the bag is damaged.
5. The test is intended for single use.
6. Keep out of reach of children.
7. Do not use the urine of pregnant women or women undergoing hormone therapy.
8. After use, all parts of the test can be disposed of as municipal waste.

Instruction leaflet:

MENOPAUSE-Check® TEST Ref. 11066Self-diagnostic test for the determination of follicle-stimulating hormone in urine
SUMMARY AND EXPLANATION
Menopause is caused by a change in the hormonal balance in a woman's body. This change generally occurs around the age of 45. However, the real symptoms are observed around the age of 55. An irregular menstrual cycle is the first sign of the onset of menopause (perimenopause).
Follicle-stimulating hormone (FSH) is a hormone that increases during menopause. This test can detect the presence of FSH in urine when the concentration reaches 25 mIU/ml or greater.
CONTENTS
The kit contains two tests, along with one package insert.
Each test is packaged in a sealed aluminum pouch containing one
desiccant sachet.
The test should remain in the sealed pouch until use.
Do not use the desiccant sachet.
WARNING
1. This test is for in vitro diagnostic use only. For external use only. DO NOT USE INTERNALLY.
2. Read the instructions for use carefully before performing the test.
The test is only reliable if the instructions for use are carefully followed.
3. Store at a temperature of +4 °C to +30 °C. Do not freeze.
4. Do not use the test after the expiry date stated on the
label and the protective bag, or if the bag is damaged.
5. The test is intended for single use.
6. Keep out of the reach of children.
7. Do not use urine from pregnant women or women undergoing hormonal treatment.
8. After use, all parts of the test can be disposed of as municipal waste.
INSTRUCTIONS FOR USE
1. Remove the test cassette from the protective bag by tearing along the
slit. Discard the desiccant bag.
2. Remove the cover of the test device. Turn the device so that the side without the display window is facing you and the absorbent tip is pointing down.
3. Hold the absorbent tip directly in the urine stream for 5 to 10 seconds. Make sure that no drops of urine enter the test and control region windows.
If you prefer, you can collect urine in a clean, dry container (not supplied) without any impurities and immerse the absorbent tip in the urine for 10 seconds.
4. Replace the cover of the test device. This will allow the urine sample to come into contact with the specific reagents and start the test.
5. Place the test device on a dry, flat surface with the window facing up.
6. Read the results after 10 minutes. Do not read the results after more than 15 minutes.
RESULT EVALUATION
To interpret the results, it is necessary to compare the color of the FSH line (test window) with the color of the control line (control window).
1. Positive result:
The result is positive if the FSH line is darker than the control line.
This result means that the FSH level is equal to or higher than 25
mIU/ml. In this case, it is necessary to perform a second test 5 or 7
days later, as the FSH concentration can change during the menstrual cycle. If a positive result is confirmed, you may be
in the menopausal process and it is recommended to consult your gynecologist for a definitive diagnosis.
2. Negative result:
The result is negative if the control line is darker than the FSH line.
This means that the FSH concentration is lower than 25 mIU/ml and you are probably not in the menopausal process.
Note: in some cases the FSH line may not form at all.
3. Invalid result:
If no control line appears, the test cannot be interpreted and must be considered invalid. In this case, we recommend repeating the test with a new test kit and a new urine sample.