LH One Step Ovulation Rapid Test with CE certificate Test Device

For professional in vitro diagnostic use only.

INTENDED USE

The LH One Step Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of luteinizing hormone (LH) in urine to aid in the detection of ovulation.

Materials Provided

Materials Required But Not Provided

WHEN TO START TESTING

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.

Example: The subject’s usual menstrual cycle length is 28 days. The chart indicates to count ahead 11days from the subject’s last period. The subject’s last period started on the 3^rd. Starting from and including the 3^rd, count ahead 11 days to arrive at the 13^th. Urine collection and testing should start on the 13^th and proceed through the 17^th. (See the Example Specimen Calendar below).

Example Specimen Calendar

( ) -- First day of the last period

< > -- Begin testing with the LH One Step Ovulation Test

SUMMARY

Ovulation is the release of an egg from the ovary. The egg then passes into the fallopian tube where it is ready to be fertilized. In order for pregnancy to occur, the egg must be fertilized by sperm within 24 hours after its release. Immediately prior to ovulation, the body produces a large amount of luteinizing hormone (LH) which triggers the release of a ripened egg from the ovary. This “LH surge” usually takes place in the middle of the menstrual cycle.¹

The LH One Step Ovulation Test is a complete system to help predict the time of ovulation, and peak fertility. It is during this fertile time that pregnancy is most likely to occur.

The LH One Step Ovulation Test detects the LH surge in urine, signaling that ovulation is likely to occur in the next 24-36 hours. The test utilizes a combination of antibodies including a monoclonal LH antibody to selectively detect elevated levels of LH.

Important: The LH surge and ovulation may not occur in all cycles.