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SCREEN MOM TEST Ovulation Description The LH Ovulation Test is a lateral flow immunoassay for the qualitative detection of an LH surge in urine, which indicates that ovulation is likely to occur within the next 24-36 hours. The test uses a combination of antibodies that includes the LH monoclonal antibody to selectively detect high levels of LH. Precautions 1. Do not use beyond the expiration date printed on the sealed package. 2. Do not use if the package is torn or damaged. 3. Store in a dry place at 2-30°C or 36-86°F. Do not freeze. 4. Keep out of reach of children. 5. Do not open the test package until you are ready to start the test. 6. For in vitro diagnostic use only. Not for internal use. 7. The used test must be disposed of according to local regulations. How to use Determine the day to start testing using the When to Start Testing table. 1. Bring the package to room temperature before opening. Remove the test device from the sealed package and use it within one hour. 2. Remove the cap and place it over the Thumb Grip. 3. Hold the device by the capped handle with the absorbent tip exposed and pointing down directly into the urine stream for at least 15 seconds until completely wet. Note: Do not urinate on the Results Window. If you prefer, you can urinate into a clean, dry container and then immerse the absorbent test tip in the urine for at least 15 seconds. 4. After removing the test from the urine, immediately replace the cap on the absorbent tip, place the test on a flat surface with the Result Window facing up and begin timing. 5. When the test begins to work, you may notice a light color flowing 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 colored lines appear, with the line in the Test region the same color or darker than the line in the Control region. This indicates that you will likely ovulate within the next 24–36 hours. NEGATIVE: Two colored lines appear, but the line in the Test region is lighter than the line in the Control region, or there is no line in the Test region. This indicates that no LH surge has been detected and daily testing should continue. NULL: The result is null if no colored line appears in the Control region, even if a line appears in the Test region. The procedure must be repeated with a new test. Limits 1. For in vitro self-diagnosis use only. 2. This test cannot be used as a method of birth control. 3. Test results should not be affected by painkillers, antibiotics, or other commonly used medications. Medications containing hCG or LH can affect the test and should not be taken when using the Rapid LH Ovulation Test (Urine). Additionally, the test does not work properly on women who are pregnant, going through menopause, or taking birth control pills. Format Case containing 4 pieces. BIBLIOGRAPHY: Elkind-Hirsch, K; Goldzieher, J.W.; Gibbons, W. E. and Besch, P. K. Obstetrics and Gynecology, 67(3): 450-453, 1986
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