Menopause (FSH) Rapid Test for Home Use (1 pc/box)

In accordance with applicable legislation, the IVD self-testing product may be sold online to private individuals in accordance with the relevant regulations. Please note that by placing an order, you waive your right to receive professional information regarding the use of the self-testing product. Detailed instructions for use are included in the test packaging and are also available on the website.

Menopause Rapid Test for Home Use

Menopause is a natural biological process in a woman's life that marks the end of the fertile period and the cessation of ovulation. Long-term effects of menopause include the end of the menstrual cycle, hormonal changes, and various symptoms such as hot flashes, mood changes, sleep disturbances, vaginal dryness and an increased risk of osteoporosis.

FSH (follicle-stimulating hormone) is an important hormone in the reproductive system, produced by the pituitary gland. FSH plays a role in regulating ovarian function and stimulates the ovulation process. FSH levels increase during menopause because the pituitary gland attempts to stimulate ovarian activity so that eggs can be produced.

The Menopause (FSH) Rapid Test detects the presence of FSH using a urine sample. The test is suitable for home use.

Menopause Rapid Test Specifications

Product name: Menopause (FSH) Rapid Test for Home Use
Sample: urine
Quantity: 1 pc/box
Format: Test cassette
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands
Expiry date: 2026. 09. 30.

Contents of the Menopause Rapid Test Kit

• 1 test cassette
• 1 disposable sample collection pipette
• 1 instruction leaflet

When should the test be performed?

• If the person being tested still has regular monthly menstruation, the first test should be performed during the first week of the menstrual cycle (days 2–7). (Day 1 is the first day of menstruation.)
• If the person being tested no longer has regular menstruation, the first test can be performed at any time during the month, and the second test should be performed 1 week later.

Testing procedure

Read the instructions for use carefully before performing the test! Before testing, allow the test, urine sample and/or controls to reach room temperature (15–30 °C).

1. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean, flat surface. Hold the dropper vertically and dispense 3 full drops of urine (approximately 120 μL) into the sample well (S) on the test cassette. Start the timer. Avoid trapping air bubbles in the sample well (S).
3. Wait for the coloured lines to appear. Read the result after 5 minutes. Do not read the result after 10 minutes.

Interpretation of results

Positive

Two lines are visible, and the colour intensity of the line in the Test Line area (T) is equal to or darker than the line in the Control Line area (C). A positive result means that the FSH level is higher than normal.

Negative

Two lines are visible, but the line in the Test Line area (T) is lighter than the line in the Control Line area (C), or there is no visible line in the Test Line area (T). A negative result means that the FSH level is not elevated at this time.

Invalid

If there is no line in the Control Line Area (C) after 3–4 minutes, the result is invalid. The test must be repeated. The test is not reusable. The most likely reasons for an invalid result are that an insufficient amount of urine sample was used or that the test was not performed correctly. Check the instructions for use and repeat the test with a new test device. If the problem persists, discontinue use of the test kit and contact the distributor.

Reliability of the Menopause Rapid Test

• Positive agreement: 100.0%
• Negative agreement: 98.7%
• Overall agreement: 99.2%