LH One Step Ovulation Rapid Test with CE certificate uncut sheet

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

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region (C) is an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

A positive result indicates that the urine specimen contains the level of LH that would indicate the beginning of ovulation. Ovulation should begin in 24-36 hours.

A negative result indicates that no LH surge has been detected and daily testing should continue.

Not every woman ovulates mid-cycle, therefore, a positive result may not appear during the selected days of testing. If you see no positive result, continue testing with the LH One Step Ovulation Test for several more days. If negative results persist, test again during the next menstrual cycle.

LIMITATIONS

• For professional in vitro diagnostic use.
• This test may not be used as a form of birth control.
• The test results should not be affected by pain relievers, antibiotics and other common drugs. Medication containing hCG or LH may affect the test and should not be taken while using the LH One Step Ovulation Test. In addition, the test will not work properly for subjects who are pregnant, in menopause, or are taking birth control pills.
• Keep out of the reach of children.