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MUNUS MEDICAL TEST MENOPAUSE SELF-DIAGNOSTIC Description Rapid test for the qualitative detection of follicle-stimulating hormone (FSH) in a urine specimen. For in vitro self-testing only. How to use The urine sample should 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 day can be used. Urine samples with 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 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 test a week later. - If you no longer have regular periods, take the test at any time during the month and repeat with a second test 1 week later. Before performing the test, allow the urine specimen and/or controls to reach room temperature (15-30°C). 1. Determine the day to start the test. (See previous section: WHEN TO START THE TEST). 2. Allow the pouch to reach room temperature before opening. 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 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 clear stream moving through 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 region (T) is equal to or darker than the line in the control region (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 the FSH level is not currently elevated. Record the 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 repeat the test with a new test. If the problem persists, discontinue use of 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 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. Shelf life in 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
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