FSH Strip and Midstream Guides

FSH, or follicle-stimulating hormone, is excreted by the pituitary gland. During the follicular phase of the menstrual cycle, FSH fosters the growth and maturation of a woman’s eggs. If a woman experiences infertility or approaches menopause, it may be a sign of a low ovarian egg supply - and this is indicated by a high level of FSH. With infertility issues, the FSH hormone is released in higher-than-normal amounts to stimulate the ovaries into producing a mature egg and more estrogen. The FSH Urine Test is a test kit for the determination of FSH (human Follicular Stimulating Hormone) concentration in urine specimens.

TEST PROCEDURE: FSH TEST STRIPS

1. Testing should begin on cycle day 3. Follow up tests to confirm should be used on consecutive days folllowing (cycle day four and five). Cycle day 3 is defined as the third day of menstrual bleeding.
2. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test kit from the pouch and use it as soon as possible.
3. Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse past the MAX (marker line). Take the strip out after 3 to 4 seconds and lay the strip flat on a clean, dry, non-absorbent surface.
4. Wait 10-20 minutes and read result. It is important that the background is clear before the result is read. Do not read results after more than 30 minutes.

INTERPRETATION OF RESULTS Negative: Only one color band appears on the control region or the test band appears but is lighter than the control band. The FSH concentration of the sample is below the detection sensitivity of 25 mIU/mL. Positive: If two color bands are visible and the test band is equal to or darker than the control band, the FSH is present in the sample at or above the detection sensitivity of 25 mIU/mL.. Elevated levels of FSH should be confirmed by more than one FSH measurement. Positive results only measures that FSH level is at or greater than 25mIU/mL (above average) and the transition of menopause may be suggested. Please consult with a physician regarding a positive test result. Invalid: No visible band at all or no colored band appears on the control (C) region. A total absence of color in both regions is an indication of procedure error and/or that test reagent deterioration had occurred.

TEST PROCEDURE: FSH Midstream Tests

1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove test kit from the pouch.
2. Hold the handle (round end) and use the other hand to remove the cap and expose the absorbent tip.
3. Point the absorbent tip downward; place the absorbent tip in urine stream for at least 10 seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 10 second.
4. Re-cap the device and wait for color bands to appear. Depending on the concentration of FSH, positive result may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (10 minutes) is required. Do not read results after 30 minutes.

INTERPRETATION OF RESULTS

Negative: Only one color band appears on the control (C) region. Or the test (T) band is lighter than the control band. The FSH concentration of the sample is below 25mIU/ml.

Positive: Distinct color bands appear on the control (C) and test (T) regions. Test line is equal to or darker than the control band. The FSH is present in the sample at or above 25 mIU/ml. Elevated levels of FSH should be confirmed by more than one FSH measurement. Positive results only measures that FSH level is at or greater than 25mIU/mL (above average) and the transition of menopause may be suggested. Please consult with a physician regarding test results if positive.

Invalid: No visible band at all. Repeat test with a new test kit.

Question and Answer / Test Limitations

1. As with all diagnostic tests, results must be considered with other clinical information available to the physician. A definite clinical diagnosis should only be made by the physician after all clinical and laboratory findings have been evaluated.
2. Single measurement of FSH level may give misleading result due to the pulsatile nature of FSH secretion. Samples drawn at different times of the day may vary. Elevated levels of FSH should be confirmed by more than one FSH measurement. With positive results, please consult a doctor.
3. The test results should not be affected by pain relievers, antibiotics and other common drugs. After using the pill or patch that contains hCG or LH may affect the test result and should not be taken while using this test kit. In addition, the test will not work properly if you are pregnant or already menopausal.
4. A positive FSH test only measures that FSH level is at or greater than 25 mIU/mL (above average) and the transition of menopause is suggested. Menopause by definition is having gone 12 moths without a menstrual cycle. A positive FSH test does not give information on exactly when menopause will be reached.
5. If a negative result is given while some of the common symptoms associated with menopause are experienced, consult with the physician.
6. A low FSH level may be observed if there is a presence of a tumor in hypothalamus.

Q: Will the amount of liquid I drink affect the result?
A: Heavy intake of fluids before testing will dilute the hormone level in your urine. Limitation of the amount of fluid intake for about two hours before you collect your urine is suggested.
Q: How accurate is the test?
A: In both laboratory and consumer clinical studies, the FSH Urine Test has been proved to be greater than 99% accurate.
Q: Which factors may affect the test result?
A: The test results should not be affected by pain relievers, antibiotics and other common drugs. After using the pill or patch that contains hCG or LH may give a false positive result and should not be taken while using this test kit. In addition, the test will not work properly if you are pregnant or menopausal. Also, recent oral contraceptive use or breastfeeding can affect the results.
Q: What should I do if the positive result is observed?
A: A positive result only measures that FSH level is at or greater than 25mIU/mL (above average) and the transition of menopause is suggested. A positive FSH test does not give information on exactly when menopause will be reached. As all diagnostic tests, all results must be considered with other clinical information available to the physician.
Q: What should I do if the FSH Test result is negative while I experienced some of the common symptoms associated with menopause?
A: Consult with your physician as soon as possible.
Q: I am close to the age of menopause. My test reads positive but I still have regular periods. Why is this?
A: A positive FSH test only measures that FSH level is at or greater than 25 mIU/mL (above average) and the transition of menopause is suggested. Menopause by definition is having gone 12 moths without a menstrual cycle. A positive FSH test does not give information on exactly when menopause will be reached.

PRECAUTION

1. For in vitro (external) diagnostic use only. 2. Do not use test kit beyond expiry date. 3. The test device should not be reused. 4. Keep out of the reach of children.