FSH Card – Clear Menopause 3T

INTENDED USE
The Clear Menopause Rapid Test is a rapid lateral flow chromatographic immunoassay for the qualitative detection of Follicle-Stimulating Hormone (FSH) levels in urine to evaluate the onset of menopause in women.

WHAT IS MENOPAUSE/FSH HORMONE & HOW IT IS USEFUL
Menopause is a normal condition that all women experience as they age. The word “MENOPAUSE” can describe the changes women go through either just before or after their menstrual cycle stops, marking the end of their reproductive period.
In simple language after attaining MENOPAUSE, a woman no longer remains fertile and don’t able to reproduce or get pregnant.

Menopause which marks the end of the menstrual cycle is identified by high FSH Levels due to a lack of Ovulation. During menopause, Ovarian follicles are no more able to release eggs, even under high FSH Levels. The body signals the pituitary gland to secrete more FSH in order to induce Ovulation but in spite of high FSH Levels growth of ovarian follicles and Ovulation could not be stimulated during Menopause.

The CLEAR MENOPAUSE Rapid test kit detects consistently high FSH Levels which indicates that Ovaries are failing Ovulation and the woman is approaching Menopause. Therefore, FSH Levels are considered the best marker for Menopause determination.

WHEN TO TEST
If the subject is still having monthly periods, then the first test should be taken during the first week of her menstrual cycle (Days 2-7, with Day 1 being the first day of menstruation ). Repeat with the second test 1 week later.
If the subject is no longer having regular periods, the first should be taken at any time during the month and the second test should be taken 1 week later.

KIT COMPONENTS
Test Cassette packed in individual foil pouches with desiccant and disposable specimen dropper.

STORAGE AND STABILITY
The kit can be stored at 4-30°C till the expiration date printed on the sealed pouch. DO NOT FREEZE.

PRECAUTIONS

• For professional in vitro use only.
• Do not use it after the expiration date.
• The test should remain in the sealed pouch until use.
• Do not use a test if the pouch is damaged.
• The test should be discarded according to local regulations.

LIMITATIONS

• The test works only when the procedures are precisely followed.
• Taking the pill (Oral Contraceptive), using the patch contraceptive, hormone replacement therapy (HRT), estrogen supplements, or other forms of hormones may affect this test and cause a false negative reading.
• Ovarian and pituitary tumors can result in decreased FSH levels, which may cause a false negative result in the test. Although the test is very accurate in detecting FSH concentrations in urine at or above the cutoff point of the test, a very low incidence of false results can occur.
• The results of this test are not to be used to determine fertility or lack of fertility. This test is for FSH use only and is not to be used as a pregnancy or ovulation test. Decisions about contraception should not be made on the results of this test.
• If a negative result is given while some of the common symptoms associated with menopause are experienced, consult with the physician.