Usage instructions:
Directions for use: Please refer to package insert. Test guidelines: Specimen collection and preparation: Determine the optimal time for urine collection. For best results, collect urine at about the same time each day. Some women have found that their best specimen is after 12 noon. Do not collect the first urine specimen after waking up. Reduce liquid intake approximately 2 hours prior to urine collection. Record the date, cycle day and time of urine collection. See the test results chart at the end of this package insert. Urine can be stored at room temperature for up to 8 hours, or at 2 - 8 degrees C for up to 24 hours. Do not freeze. For best results, test urine on the same day that it is collected. If refrigerated, let urine reach room temperature before testing. Do not shake the container. If a sediment forms at the bottom of the collection container, allow the sediment to settle. Use only urine from the top of the container. When to start testing: 1. Determine the subject's menstrual cycle length. The menstrual cycle length is the number of days from the first day of the subject's period (menstrual bleeding) to the last day before the next period starts. 2. Determine the days to count ahead after the period to start testing. Find the subject's menstrual cycle length on the first row of the chart below, and read the corresponding days to count. Ahead in the second row. This is the number of days after the period to begin testing. Menstrual cycle length: 21 - 22 - 23 - 24 - 25 - 26 - 27 - 28 - 29 - 30 - 31 - 32 - 33 - 34 - 35 - 36 - 37 - 38. 6 - 6 - 7 - 7 - 9 - 10 - 11 - 12 - 13 - 14 - 15 - 16 - 17 - 18 - 19 - 20 - 21. Days to count ahead: Finally, determine the day to start testing. Starting from and including the first day of the last period, count ahead the number of days indicated in the previous step. This is the day on which testing should begin. As a basic guideline, it is recommended to test once a day for five days. Note: If uncertain about the length of the subject's menstrual cycle, use the shortest menstrual cycle length (21 days) when reading the chart. In this case, it may be necessary to test for more than 5 days. Example: The subject's usual menstrual cycle length is 28 days. The chart indicates to count ahead 11 days from the subject's last period. The subject's last period started on the 3rd. Starting from and including the 3rd, count ahead 11 days to arrive at the 13th. Urine collection and testing should start on the 13th and proceed through the 17th. Direction for use: Note: Allow the test, urine specimen and/or controls to reach room temperature (15 - 30 degrees C) prior to testing. 1. Determine the day to begin testing. (See the above section: When to start testing). 2. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. 3. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 2 - 3 full drops of urine (approximately 70-100 pl) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (5). See illustration below. 4. Wait for the coloured line(s) to appear. Read results at 10 minutes. Do not interpret the result after 10 minutes. Add 2-3 full drops of urine specimen into the sample well. Interpretation of results: Negative: Only one line is visible in the control line region (C), or two lines are visible, but the line in the test line region (1) is lighter than the one in the control line region (C). This indicates that no LH surge has been detected. Positive: Two lines are visible, and the line in test line region (1) is the same as or darker than the one in the control line region (C). This indicates probable ovulation in 24 - 36 hours. Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor. Quality control: A procedural control is included in the test. A coloured line appearing in the control line region (C) is an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. A positive result indicates that the urine specimen contains the level of LH that would indicate the beginning of ovulation. Ovulation should begin in 24 - 36 hours. A negative result indicates that no LH surge has been detected and daily testing should continue. Not every woman ovulates mid-cycle therefore, a positive result may not appear during the selected days of testing. If you see no positive result, continue testing with the LH Ovulation Test Device (Urine) for several more days. If negative results persist, test again during the next menstrual cycle.

Storage instructions:
Store at room temperature or keep refrigerated at 2 - 30 degrees C. Keep from direct sunlight, moisture and heat. Do not freeze this test. Store as packaged in the sealed pouch either at room temperature or refrigerated (2 - 30 degrees C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.

Warnings:
Keep out of reach of children. For OTC and professional in vitro diagnostic use only. Do not use after the expiration date. Do not eat, drink or smoke in the area where the specimens or kits are handled. Do not use test if pouch is damaged. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Humidity and temperature can adversely affect results.

Information not available.