Follicle-Stimulating Hormone (FSH) Rapid Test

INTENDED USE

The Follicle-Stimulating Hormone(FSH) Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of follicle-stimulating Hormone (FSH) in urine specimen to aid in menopause detection. 

MATERIALS

Materials Provided

TEST PROCEDURE

Allow the test, urine specimen and/or controls to reach room temperature (15-30°C) prior to testing.

1. 1. Determine the day to begin testing. (See the above section: “WHEN TO START TESTING”).
2. 2. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
3. 3. Place the test cassette on a clean and level surface. Hold the sample dropper vertically and transfer 3 drops of urine(90μl) to the specimen well of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well.
4. 4. Wait for the red line(s) to appear. Read the result at 3 Do not interpret the result after 10 minutes.

5. INTERPRETATION OF RESULTS
   
   

   POSITIVE: Two colored bands appear on the membrane. And the line in test line region (T) is the same as or darker than the one in the control line region (C). This indicates the FSH level is higher than normal. Record the results and see the chart below to interpret results.

   NEGATIVE: Two lines are visible, but the line in the test line region (T) is lighter than the one in the control line region (C), or if there is no line in the test line region (T). A negative result means that the FSH level is not elevated at this time. Record the results and see the chart below to interpret results.

   INVALID: Control band fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.