One Step LH Ovulation Test

The One Step LH Ovulation Test is intended for the in vitro qualitative detection of luteinizing hormone (LH) in human urine, as an aid to diagnosis of ovulation in women of childbearing age. It isn’t automated. It is for self-testing. It is intended for use by lay person.

Ovulation is the release of an egg from the ovary. The egg then passes into the fallopiantube where it is ready to be fertilized. In order for pregnancy to occur, sperm must fertilizethe egg within 24 hours after its release. lmmediately prior to ovulation, the bodyproduces a large amount of Leutinizing hormone (LH), which triggers the release of aripened egg from the ovary. This is known as an “LH surge" usually takes place in themiddle of the menstrual cycle. lt is during this fertile time that pregnancy is most likely tooccur. Ovulation test detects LH surge in urine, signaling that ovulation is likely to occurin the next 24-36 hours. This period is considered to be the most fertile time. lt isimportant to note that an LH surge and ovulation may not occur in all cycles.

First, 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.

Next, 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

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.

If the subject’s period (menstrual bleeding) is less than 21 days or more than 40days,consult your physician.

1.The LH Ovulation test is formulated for use with fresh urine specimen.

2.Remove the strip from the foil pouch.

3.Immerse the strip into the urine with the arrow end pointing toward the urine.  Do not cover the urine over the MAX (maximum) line. You may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorbent clean surface.

4.Read the result within 10 minutes.

5.Discard the test device after single use in the dustbin.

Positive: Two lines are visible, and the line in test area(T) is the same as or darker than the one in the control area (C). This indicates that ovulation may occur within 24-48 hours.

Negative: Two lines are visible, but the line in the test area (T) is lighter than the one in the control area (C), or if there is no line in the test area (T). This indicates that no LH surge has been detected.

Invalid: The result is invalid if no distinct pink line appears in the control area, even if a line appears in the test area. It is recommended that in this case the test should be repeated. If the problem persists, contact your local distributor.