INSTRUCTIONS: OVULATION TESTS: Ovulation Test LH Urine Strip 

• Ovulation test urine cassette
• 7 Day Ovulation Home Test Kit

One Step Ovulation Test Strip For urine (Revised Jan. 30th, 2001) How the Test Works The One Step Ovulation Test will help you find the time when you are most able to become pregnant. It can help you plan your pregnancy. Luteinizing hormone (LH) is always present in human urine. It increases just before a woman's most fertile day of the month. This LH increase triggers ovulation. During ovulation an egg is released from the ovary. Because the egg can be fertilized only 6 to 24 hours after ovulation [1], detecting ovulation in advance is very important.

Before You Begin 1. Read this entire pamphlet carefully. Do not open the foil packet until you are ready to perform the test. 2. Do not use the test after the expiration date printed on the package. 3. Store at room temperature. Do not freeze. 4. The test can be used any time of day. 5. Select a well-lit room with a clean, flat surface for performing the test. When To Begin Testing You may do this test at any time of the day, but you should test at approximately the same time each day. Reduce your liquid intake for 2 hours before testing. To decide when to begin testing, determine the length of your normal menstrual cycle. The length of your cycle is from the beginning of one period to the beginning of the next (count the first day of bleeding or spotting as day 1). If your cycle length is irregular, that is, if it varies by more than a few days each month, take the average number of days for the last 3 months. Use the chart to work out the day you should begin testing. The day you begin testing is listed opposite the number of days in your normal cycle. Length of Normal Cycle (days) Starting testing this many days after your last period began 21 5 22 5 23 6 24 7 25 8 26 9 27 10 28 11 29 12 30 13 31 14 32 15 33 16 34 17 35 18 36 19 37 20 38 21 39 22 40 23 For example, if your period normally begins every 28 days, you should begin testing 11 days after the first day of your last period. Sun Mon Tue Wen Thur Fri Sat 1 2 day1 3 4 5 6 7 8 9 10 11 12day11 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Note: If the 2nd day of the month is the first day of menstrual bleeding (day 1), then the 12th day of the month is day 11 of your cycle. This is the day to begin testing. Procedure of the test 1. Remove the test strip from its foil pouch. 2. Holding the strip vertically carefully dip it into the specimen. Do not immerse the strip past the maximum line (Figure 1). 3. The strip can be removed from the specimen when red dye begins to migrate through the Result Window. Interpret test results at 5 minutes. Interpretation of the Test 1. As the test kit begins to work, a purple colored band will appear at the left section of the Result Window to show that the test is working properly. This band is the Control Band (C). 2. The right section of the Result Window indicates the test results. If another purple colored band appears at the right section of the result window, this band is the Test Band (T). Positive Result a. The presence of two purple bands of similar color and darkness within the result window, no matter which one appears first, means that an increase in LH is detected (Figure 2). b. The Test Band may be darker than the Control Band (Figure 2). Negative Result: a. The presence of a purple Control Band and a lighter purple Test Band means that an increase in LH is not detected. b. The presence of only one purple colored band (Control Band) within the Result Window indicates that no LH increase has been detected (Figure 2). Invalid Result: The test result is considered invalid if no purple colored band is visible within the Result Window (Figure 2). Not following the directions correctly or using a test after the expiration date can cause invalid results. Important: After you have read your result, the test should be discarded. Function of the Control Band The Control Band is used as a reference. If the Test Band is similar in color or darker than the Control band, the test result is positive. If the Test Band is lighter in color than the Control Band, the test result is negative. The Control Band is also used for procedural control to determine if the test reagent is working properly. How to Recognize the LH Surge After each test, you must decide if you are having an LH surge. If your test result is positive, you are probably having an LH surge. An LH surge can last from one to three days. If your test result is negative, you are probably not having an LH surge. Remember that a pink-rose test band lighter than the control band shows that there is only a very low level of LH in your urine. Limits of the Test 1. The t Ovulation Test is not reusable. The test works only if the instructions are followed precisely. Although the Ovulation Test is highly accurate in detecting ovulation, a low incidence of false results (positive when no ovulation exists or negative when ovulation is present) can occur. 2. The Ovulation Test should not be used for contraception. 3. Some prescription drugs, such as menotropins may affect the test result. Certain rare medical conditions or the onset of menopause can cause elevated levels of' LH. Some women do not ovulate every cycle and they will not see any increase in the level of LH during these non-ovulating cycles. Questions and Answers Q: How accurate is the Ovulation test? A: The Ovulation test has been shown to be over 99% accurate in laboratory testing and 99% accurate in consumer testing. Q: When can I do the test? A: After you determine the best day to start testing based on your monthly cycle (see When to Begin Testing), you can do the test any time that day. You do not have to use your first morning urine. However, you should do the test at about the same time each day. Reduce your liquid intake for 2 hours before testing. Q: What if no band appears in the result window? A: If no band appears in the result window after 5 minutes, the result is invalid and you should repeat the test using another test kit. (see Invalid Results) Q: I have used all five tests and I do not see a surge, What do I do? A: Since not every woman ovulates mid-cycle, you may not detect the LH surge in the first five days of testing. This could mean you have not ovulated yet and you should continue testing with additional ovulation tests. Q: I have tested for 8 days and I did not see my LH surge, what is wrong? A: About 90% of ovulating women with regular cycles will see their surge during 8-10 days of testing [2]. If you do not, it could mean that you have not ovulated this month. If you are having a short cycle this month, it is possible that you have ovulated before you started testing. If you are having a long cycle this month, you may not have ovulated yet. You may continue testing or test again next month. Don't worry; it is normal to have an occasional short or long cycle, or to have a cycle without ovulating. Q: I have used the ovulation test for three months, and each month I have seen a surge and have had intercourse that day or night. I have not become pregnant yet. What is wrong? A: First, it is important to remember that it can take normal, healthy couples many months to become pregnant. There are many factors, which affect your ability to become pregnant even if you have been able to have intercourse during your most fertile time. If after several months you have no success, consult your physician. Q: What could interfere with my test result? A: If you are actually pregnant, have recently been pregnant, or have reached menopause you may get a misleading result. Some prescription drugs, such as menotropins for injection and danazol may affect the result you see, please consult your physician if you question your test results. Q: If the Ovulation Test can determine my most fertile time, why can't I use it for contraception? A: Sperm can survive up to 72 hours, and this test predicts your LH surge only up to 24 to 36 hours in advance. Therefore, if you have intercourse before you discover your surge, the egg can still be fertilized. References [1] Apter D, Cacciatore B, Alfthan H, et al, " Serum Luteinizing Hormone Concentrations Increase 100-Fold in Females From 7 Years to Adulthood, as measured by Tim-Resolved Immunofluorometric Assay" J Clin Endocrinol Metab, 1989, 68 (1):53-7. [2] Nippoldt TB, Reame NE, Reich RP, et al, " The Roles of Estradiol and Progesterone in Decreasing Luteinizing Hormone Pulse Frequency in the Luteal Phase of the Menstrual Cycle." J Clin Endocrinol Metab, 1989, 69 (1): 67-76.

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