Menopause self-diagnosis test

Product Description

Rapid test for the qualitative detection of follicle-stimulating hormone (FSH) in a urine sample. Indicated for in vitro self-diagnostic use.

Indications

The Menopause Test is a rapid diagnostic device designed to detect the concentration of follicle-stimulating hormone (FSH) in a urine sample. FSH is a key indicator of the hormonal changes that occur during perimenopause and menopause. By monitoring FSH levels, the test allows for an early indication of the possible onset of menopause, helping women better understand their hormonal cycles.

Directions for use and Dosage

The urine sample must be collected in a clean, dry container. A first morning urine sample is preferable as it generally contains the highest concentration of FSH; however, urine samples collected at any time of the day can be used. Urine samples that have visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear sample for analysis.

• If you have monthly menstrual cycles, perform the first test during the first week of the cycle (days 2-7, considering day 1 as the first day of menstruation). If the result is negative but symptoms persist, repeat the test one week later.
• If you no longer have symptoms, perform the first test during the first week of the cycle (days 2-7, considering day 1 as the first day of menstruation). If you have regular periods, test any time during the month and repeat the test 1 week later.

Before testing, allow the urine sample and/or controls to reach room temperature (15-30°C).

1. Determine the day to start testing. (See previous section: "WHEN TO START TESTING").
2. Bring the pouch to room temperature before opening it. Remove the test from the sealed pouch and use it within one hour.
3. Remove the cap from the test stick, place the absorbent tip in your urine stream or dip the absorbent tip (=2/3) into the urine of a clean container for at least 10-15 seconds.
4. Replace the cap on the test stick, then place the test stick on a clean, stable surface with the control window facing up and start the timer immediately.
5. When the test begins the detection process, you may see a light-colored stream moving across the control window. Read the result after 3 minutes. Do not interpret the result after 10 minutes.

Reading the Results

• Positive: Two lines are visible and the line in the test area (T) is equal to or darker than the line in the control area (C). A positive result means that the FSH level is higher than normal. Record the results and compare them to the graph above for interpretation.
• Negative: Two lines are visible, but the line in the test region (T) is fainter than the line in the control region (C), or no line appears in the test region (T). A negative result means that the FSH level is not currently elevated. Record the results and compare them to the graph above for interpretation.
• Invalid: The control line does not appear. The most likely reasons for the control line not appearing are insufficient sample volume or improper procedural techniques. Review the procedure and repeat the test with a new test. If the problem persists, stop using the test kit immediately and contact the distributor.

Warnings

• Do not use after the expiration date.
• The test must remain in the sealed pouch until use.
• Store in a dry place at 2-30°C (36-86°F). DO NOT FREEZE.
• Do not use if the pouch is torn or damaged.
• Keep out of reach of children.
• For in vitro diagnostic use only.
• Do not open the foil pouch of the test until use. You are not ready to start testing.
• Use the test only once.
• The used test must be disposed of according to local regulations.

Storage

Store in the pouch at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.

Format

• 2 test sticks;
• User Manual;
• Biohazard pouch for the disposal of biohazardous specimens.