Description
MUNUS MEDICAL
TEST
MENOPAUSE
SELF-DIAGNOSTIC
DescriptionRapid test for the qualitative detection of follicle stimulating hormone (FSH) in a urine specimen. For in vitro self-diagnostic use only.
How to use
The urine specimen should be collected in a clean, dry container. A first morning urine specimen is preferable as it generally contains the highest concentration of FSH; however, urine specimens collected at any time of day may be used. Urine specimens that have visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for analysis.
- If you have monthly menstrual cycles, perform the first test during the first week of your cycle (days 2-7, considering day 1 as the first day of your period). If the result is negative but symptoms persist, repeat the second test one week later.
- If you no longer have regular periods, test at any time during the month and repeat with a second test 1 week later.
Allow the urine sample and/or controls to reach room temperature (15-30°C) before testing.
1. Determine the day to start testing. (See previous section: "WHEN TO START TESTING").
2. Allow the pouch to reach room temperature before opening. Remove the test from the sealed pouch and use within one hour.
3. Remove the cap from the test stick, place the absorbent tip in your urine stream or immerse the absorbent tip (=2/3) in the urine of a clean container for at least 10-15 seconds.
4. Replace the cap on the test, then place the stick on a clean, stable surface, with the control window facing up, and immediately start the timer.
5.When the test begins the detection process, you may notice 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 area (T) is fainter than the line in the control area (C) or no line appears in the test area (T). A negative result means that your FSH level is not currently elevated. Record your results and compare them to the graph above for interpretation.
NULL: The control line does not appear. The most likely reasons for the control line not appearing are insufficient sample volume or incorrect procedural techniques. Review the procedure and retest with a new test. If the problem persists, discontinue use of the test kit immediately and contact your distributor.
Warnings
- Do not use after the expiry 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 case is torn or damaged.
- Keep out of reach of children.
- For in vitro diagnostic use only.
- Do not open the foil test pouch until you are ready to begin testing.
- Use the test only once.
- The used test must be disposed of according to local regulations.
Conservation
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.
Validity with intact packaging: 24 months.
Format
Kit containing:
- 2 test sticks;
- user manual;
- Biohazard bag for the disposal of biologically hazardous samples.
Cod. MM-FFS-103H
