SCREEN CHECK TEST Menopause Description Rapid slide test for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine samples. For in vitro self-diagnostic use only. Precautions - Do not use beyond the expiration date printed on the sealed package. - The test must remain in the sealed package until use. - Store in a dry place at 2-30°C or 36-86°F. Do not freeze. - Do not use if the package is torn or damaged. - For in vitro diagnostic use only. - Keep out of reach of children. - Do not open the test package until you are ready to begin testing. - Use only once. - The used test must be disposed of according to local regulations. When to take the test If you still have your period every month, take the first test during the first week of your cycle (days 2-7, with day 1 being 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 of the month and repeat it 1 week later. How to use Bring the test, urine specimen, and/or controls to room temperature (15-30°C) before testing. 1. Determine the day to take the test. 2. Allow the package to reach room temperature before opening. Remove the test device from the sealed package and use it immediately within one hour. 3. Remove the cap from the device and hold the test so that the absorbent tip is placed in the urine stream or place the absorbent tip (=2/3) into the urine sample in a clean container for at least 10-15 seconds. 4. Replace the cap on the test, then place it on a clean, stable surface with the test and control windows facing upwards, then immediately start the timer. 5. As the test begins to work, you may notice a light color running across the results window. Read the results after 3 minutes. If no results appear, wait another minute. Do not read the results after 10 minutes. Reading the results POSITIVE: Two visible lines appear, and the line in the test region (T) is equal to or stronger than the line in the control region (C). A positive result indicates that your FSH level is higher than normal. Record your results and compare them to the table to interpret your results. NEGATIVE: Two lines are visible, but the one in the test region (T) is lighter than the one in the control region (C), or there is no line in the test region (T). A negative result indicates that the FSH level is not elevated. Record the results and compare them to the table to interpret the results. NULL: No control line appears. The most likely causes for the control line not appearing are insufficient volume or incorrect procedural techniques. Review the procedure and repeat the test with a new device. If the problem persists, discontinue use of the kit immediately and contact your local distributor. Test interpretation For women experiencing pre-menopausal symptoms coupled with irregular menstrual cycles: 1st Test 2nd Test Interpretation Positive Positive Possible perimenopause. Discuss methods and therapies to promote postmenopausal health with your doctor. DO NOT stop contraception immediately. Positive or negative Negative or positive Probably the first stage of perimenopause. DO NOT stop contraception immediately. Negative Negative Probably not yet perimenopause. If symptoms persist, repeat the test the following month or investigate other possible causes of the symptoms. For women experiencing pre-menopausal symptoms WITHOUT a menstrual period in the previous 12 months: 1st Test Interpretation Positive Menopause is almost certainly underway. You can repeat the test. Discuss methods and therapies to promote post-menopausal health with your doctor. Limits There is a possibility that this test may produce false positive or false negative results. Consult your doctor before making any medical decisions. Invalid results may be caused by not following the instructions carefully. Review the instructions and/or repeat the test with a new device. If the problem persists, discontinue use of the kit immediately and contact your local distributor. Format Case containing 2 pieces. BIBLIOGRAPHY: 1. Turkington CA. The Perimenopause Sourcebook. Contemporary Books, New York, NY. 1998. 2. Perry S, OHanlan K. Natural Menopause: The Complete Guide. Reading, MA, Addison-Wesley, 1997. 3. Stanford, J.L., Weiss N.S., et al. Combined Estrogen and Progestin Hormone Replacement Therapy in Relation to Risk of Breast Cancer, J. Am. Med. Assoc. 1995; 274(2): 137-142. 4. Speroff L, Glass RH, Kase NG, Clinical Gynecologic Endocrinology and Infertility 5th Ed, Williams and Wilkins, Baltimore, MD. 1994; 588. 5. Jacobs DS, Demott DR, Grady HJ, Horvat RT, Huestis DW, Kasten BL, Laboratory Test Handbook 4th Ed, Lippincott Williams and Wilkins, Baltimore, MD. 1996