TEST
MENOPAUSAL WOMEN

AUTODIAGNOST

Description
Quick test for the qualitative detection of follicle-stimulating hormone (FSH) in a urine sample. Only for auto-diagnostic use in vitro.

Mode of use
The urine sample should be collected in a clean and dry container. A first sample of morning urine is preferable as it generally contains the highest concentration of FSH; however, urine samples collected at any time of the day may be used. The urine samples presenting visible precipitates must be filtered or left sediment to obtain a clear sample for analysis.
- In the presence of 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 the symptoms persist, repeat with a second test a week later.
- If you no longer have regular menstruation, run the test at any time during the month and repeat with a second test 1 week later.
Before testing, let the urine sample and/or controls reach ambient temperature (15-30 °C).
1. Determine the day to start the test. (See the previous section: "WHEN INITIATE THE TEST".
2. Bring the bag to room temperature before opening it. Remove the test from the sealed bag and use it within an hour.
3. Remove the stick cap, place the absorbent tip in the urine flow or dip the absorbent tip (=2/3) in the urine of a clean container for at least 10-15 seconds.
4. Take the cap back on the test, then place the stick on a clean and stable surface, with the control window facing up, and immediately start the timer.
5.Quando the test begins the detection process, you can notice a clear color flow that moves through the control window. Read the result after 3 minutes. Do not interpret the result after 10 minutes.
LETTURE OF RESULTS
POSITIVE: Two lines are visible and the line in the test area (T) is equal 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 with the chart above for interpretation.
NEGATIVE: Two lines are visible, but the line in the test area (T) is more soft than the line in the control area (C) or no line is displayed in the test area (T). A negative result means that the FSH level is not currently high. Record the results and compare them with the chart above for interpretation.
NULLO: the control line is not displayed. The most probable reasons for failure to display the control line are to be attributed to an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the analysis with a new test. If the problem persists, stop using the test kit immediately and contact the distributor.

Warnings
- Do not use after the expiry date.
- The test must remain in the sealed bag until use.
- Store in a dry place at 2-30 °C (36-86 °F). DON'T CONGEL.
- Do not use if the case is torn or damaged.
- Keep out of the reach of children.
- Just for in vitro diagnostics.
- Do not open the aluminum test bag until you are ready to start the test.
- Use the test once.
- The test used must be eliminated according to local regulations.

Conservation
Store in the packaging at room temperature or in the refrigerator (2-30 °C). The test is stable until the expiry date printed on the sealed envelope. The test must remain in the sealed envelope until use.
Validity of whole packaging: 24 months.

Format
Kit containing:
- 2 test sticks;
- user manual;
- Biohazard envelope for disposal of samples at biological risk.

Cod. MM-FFS-103H