5 autodiagnostic ovulation tests

Product Description

Self-test ovulation test.

Indications

Rapid chromatographic immunoassay for the qualitative detection of luteinizing hormone (LH) in urine to help detect ovulation. The test uses a combination of antibodies, including the hLH monoclonal antibody, to selectively detect elevated levels of hLH. The urine specimen advances laterally through the test due to capillary action. In the presence of hLH, an immunological reaction occurs between hLH and the labeled anti-hLH antibodies, resulting in a colored test line. Depending on the hLH concentration, the test line becomes lighter or darker. The other labeled antibodies are located on the control line. This reaction serves as proof of proper use and functioning of the test strip.

Directions for Use

Sample Collection and Preparation: Determine the optimal time for urine collection. For best results, collect urine at approximately the same time each day. Do not collect the first urine sample after waking up. Reduce fluid intake approximately 2 hours before collecting urine. Record the date, day of your period, and time of urine collection. Urine can be stored at room temperature for up to 8 hours or at 2-8°C for up to 24 hours. Do not freeze. For best results, test urine on the same day it is collected. If refrigerated, allow urine to reach room temperature before testing. Do not shake the container. If 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: Calculate when to start testing using the table. First, determine the length of your menstrual cycle. Your menstrual cycle length is the number of days from the first day of your period (menstrual bleeding) to the last day before your next period. Next, determine how many days after your period you should count to start testing. Find your menstrual cycle length on the first line of the table and read the corresponding number in the second line. This is the number of days after your period to start testing. If your menstrual cycle is shorter than 21 days or longer than 38 days, consult a doctor. If you don't know your cycle length, you can start testing 11 days after the first day of your period, as this is the recommended starting date. The average cycle length is 28 days. First-morning urine should not be used during the LH test. For best results, you should test at the same time every day. You should reduce your fluid intake about two hours before the test. Perform 1 test per day for a certain period or until the hLH surge is detected.

Test execution: Determine the the day you begin testing using the "When to Start Testing" table. Bring the pouch to room temperature (15-30°C) before opening. Remove the midstream test from the sealed pouch and use it within one hour. Remove the cap and hold the midstream test by the capped thumb grip with the exposed absorbent tip facing down directly into your urine stream for at least 15 seconds until completely wet. Do not urinate on the results window. If you prefer, urinate in a clean, dry container and then immerse only the absorbent tip of the midstream test in your urine for at least 15 seconds. After removing the midstream test from the urine, immediately replace the cap on the absorbent tip, place the midstream test on a flat surface with the results window facing up, and then begin timing. When the test begins to work, you may notice a light-colored stream moving across the results window. Read the results after 3 minutes. If no result appears, wait one more minute. Do not read the result after 10 minutes.

Reading Results

Positive: Two colored lines are visible and the line in the test zone (T) is equal to or darker than the line in the control zone (C). This indicates that ovulation will likely occur in the next 24-36 hours.

Negative: Two colored lines are visible, but the line in the test zone (T) is lighter than the line in the control zone (C), or there is no line in the test zone (T). This indicates that no LH surge was detected and that daily testing should be continued.

Invalid: The result is invalid if no colored line appears in the control zone (C), even if a line appears in the test zone (T). It would be advisable to repeat the procedure with a new test. If the problem persists, stop using the test kit immediately and contact your local distributor.

Warnings

For in vitro diagnostic use only. Not for internal use. For single use only. This test cannot be used as a form of birth control. Do not reuse tests. Test results should not be affected by painkillers, antibiotics, and other common medications. Medications containing hCG or LH may affect the test and should not be taken while using the Ovulation Test. Additionally, the test will not work properly for women who are pregnant, going through menopause, or taking birth control pills. Keep out of reach of children. Read all information in the package insert before testing. Do not use after the expiration date printed on the package. Do not use if the pouch is torn or damaged. Do not open the foil pouch until you are ready to begin testing. The used test must be disposed of according to local regulations.

Storage

Store in its original packaging at room temperature or in the refrigerator (2-30°C). Avoid exposure to direct sunlight, humidity, or heat. Do not freeze. The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not use beyond the expiration date. Shelf life in intact packaging: 24 months.

Format

The kit contains:

• Midstream test;
• package leaflet.