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

Menopause (FSH) Rapid Test for Home Use

Menopause is a natural biological process in a woman's life, marking the end of fertility and the cessation of ovulation. Long-term effects of menopause include the end of menstrual cycles, hormonal changes, and symptoms such as hot flashes, mood swings, sleep disturbances, vaginal dryness, and increased risk of osteoporosis.

FSH (follicle-stimulating hormone) is a key hormone produced by the pituitary gland that regulates ovarian function and stimulates ovulation. FSH levels rise during menopause as the pituitary attempts to stimulate the ovaries.

The Menopause (FSH) Rapid Test detects the presence of FSH in urine and is suitable for home use.

Menopause Rapid Test Specifications

Product name: Menopause (FSH) Rapid Test for Home Use
Sample type: Urine
Package: 1 test/box
Format: Test cassette
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418, MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, CHINA, imd.assuretech@diareagent.com
EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com
Expiration date: 2026.09.30
CE-marked in vitro diagnostic medical device in accordance with Directive 98/79/EC (IVDD). This product remains legally marketable under the transitional provisions of Regulation (EU) 2017/746 (IVDR).

Contents:

• 1 test cassette

• 1 disposable sample pipette

• 1 user manual

When to Test?

• If menstruating: test during the first week of the menstrual cycle (days 2–7, with day 1 being the first day of menstruation).

• If menstruation is irregular or absent: the first test can be taken any time during the month, with a second test one week later.

Test Procedure

1. Read the user manual carefully before testing. Allow the test device, urine sample, and controls to reach room temperature (15-30°C).

2. Remove the test device from its sealed pouch and use it immediately.

3. Place the test device on a clean, flat surface. Holding the dropper vertically, add 3 full drops of urine (approximately 120 μL) into the sample well (S) of the test cassette. Start the timer. Avoid air bubbles in the sample well.

4. Wait for the colored lines to appear. Read the result after 5 minutes but no later than 10 minutes.

Result Interpretation

• Positive: Two lines appear, and the test line (T) is the same intensity or darker than the control line (C), indicating elevated FSH levels.

• Negative: Two lines appear, but the test line (T) is lighter than the control line (C) or absent, indicating non-elevated FSH levels at testing time.

• Invalid: No control line (C) appears within 3–4 minutes; the test is invalid and must be repeated with a new test kit. Common causes include insufficient urine or incorrect test procedure. If the problem persists, discontinue use and contact the distributor.

Test Reliability

• Positive agreement: 100.0%

• Negative agreement: 98.7%

• Overall agreement: 99.2%

Instructions