【INTENDED USE】

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

【SUMMARY】

Human luteinizing hormone (hLH) is a glycoprotein hormone secreted by the anterior pituitary. In view of the characteristic variation of hLH during the menstrual cycle, and sensitive measurement of LH is an important tool in the diagnosis and management of infertility in females. Approximately 12-24 hours after the LH surge, the wall of the enlarged follicle ruptures at ovulation and the mature ovum is extruded. Detection of the hLH surge can aid in predicting the time of ovulation. The onset of the LH surge precedes ovulation by approximately 30 hours.

Ovulation is the release of an egg from the ovary. The egg 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).This is known as the “LH surge” and usually takes place in the middle of the menstrual cycle.LH triggers the release of an egg from the ovary.

The LH Rapid Test Device is a complete system to help you predict the time of ovulation and peak fertility. It is during this fertile time that pregnancy is most likely to occur.

The LH Rapid Test Device detects the LH surge in urine,signaling that ovulation is likely to occur in the next 24-36 hours.

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

【DIRECTIONS FOR USE】

Allow the test device,urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

Remove the test device from the sealed pouch and use it as soon as possible.

Place the test device on a clean and level surface.Hold the dropper vertically and transfer 3 full drops of urine (approx.100mL) to the specimen well of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well. See the illustration below.

Wait for the red line(s) to appear.Read the result at 5 minutes when testing a urine specimen.Do not interpret results after the appropriate read time.It is important that the background is clear before the result is read.