The One Step Ovulation Test Strip is an in vitro diagnostic test device intended for the rapid detection of the human Luteinzing Hormones (LH) in urine to predict when there is a LH surge, and in turn, when you are likely to ovulate. You can easily carry out this test yourself. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
HOW DOES IT WORK?
The LH (Luteinizing Hormone), which is in the urine of women, will increase dramatically in the middle of the menstrual cycle. The LH increase triggers ovulation which is when the eggs are released periodically from normal fertile women. WHO experts state that LH testing is a reliable way to detect ovulation. Ovulation will occur after 24-48 hours following a positive test.
CONTENT OF THE TEST KIT
1. One pouch containing a test strip
2. Instruction manual.
WHAT ELSE DO YOU NEED?
1. A clean and dry plastic, or glass container to collect the urine in.
2. Timer or Clock
1. This kit is for external use only. Do not swallow.
2. Discard after first use. The test strip cannot be used more than once.
3. Do not use the test after the expiration date printed on the foil pouch.
4. Do not use the kit if the pouch is punctured or not well sealed.
5. Keep out of the reach of children.
STORAGE AND STABILITY
1. Store at 39°F to 86°F (4ºC to 30ºC) in the sealed pouch up to the expiration date.
2. Keep away from direct sunlight, moisture, and heat.
3. DO NOT FREEZE.
4. You should perform the test soon after opening the pouch. You should keep the test in a dry environment before use.
WHEN TO COLLECT URINE FOR THE TEST?
The length of the menstrual cycle is the duration from your first menstrual bleeding day to the day before the next bleeding begins. Determine the length of menstrual cycle before testing. Please refer to the chart below to determine when you should start testing. If your cycle is shorter than 21 days or longer than 38 days, consult a physician.
If you do not know your cycle length, you may begin the test 11 days after your first period since the average cycle length is 28 days. Perform 1 test each day over a 5 days period, or until the LH surge has been detected.
HOW TO COLLECT URINE?
Urine specimens may be collected in any clean, dry, plastic or glass container.
HOW TO DO THE TEST?
1. The test strip and urine have to be at room temperature 59-86ºF (15-30°C) for testing.
2. Remove the test strip from the sealed pouch.
3. Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface (such as the mouth of the urine container).
IMPORTANT: Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.
4. Read results in five minutes. Do not read results after more than 5 minutes.
HOW TO READ THE RESULTS
Negative (No LH Surge) :
Only one color band appears on the control region, or the test band appears but is lighter than the control band. This means there is no LH surge.
Positive (LH Surge) :
If two color bands are visible, and the test band is equal to or darker than the control band, ovulation will probably begin in the next 24-48 hours. If trying to get pregnant, the best time to have intercourse is after 24 but before 48 hours.
If no band is visible, or there is a visible band only in the test region and not in the control region, the result is invalid. Repeat with a new test kit.
1. The test works only when the test procedures are precisely followed.
2. This test may not be used as a form of birth control.
3. Consult a doctor if irregular or unusually long cycles are experienced.
One Step Ovulation Test has a sensitivity of 25 mIU/ml.
The following potentially interfering substances were added to LH negative and positive specimens and no interference was observed.
Acetaminophen, aspirin, ascorbic acid, atropine, caffeine, glucose, hemoglobin, tetracycline, ampicillin, albumin, bilirubin.
Last updated on May 14, 2015