One Step LH Ovulation Rapid Test

INTENDED USE

Home Ovulation Test cassette is an in vitro diagnostic (IVD) qualitative test for rapid detection of human luteinizing hormone (LH) in urine at a sensitivity of 20mIU/ml.

INTRODUCTION

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 Home Ovulation Test cassette 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 Home ovulation Test cassette 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.

PRINCIPLE

Home Ovulation Test cassette is a qualitative, two site sandwich immunoassay for the determination of human luteinizing hormone (LH) in urine specimens. The membrane was precoated with LH specific antibodies on the test region. During the test, the specimen is allowed to react with the LH monoclonal antibody-colloid gold conjugate, which was pre-dried on the test cassette. The mixture then moves upward on the membrane chromatographically by the capillary action. For a positive specimen, the conjugate binds to the LH forming an antibody-antigen complex. This complex binds to the LH antibody as a capture regent on the test region and produces a colored band when LH concentration is equal to or greater than 20mIU/ml. The y.b.t Home Ovulation Test cassette also provides a built-in process control. A colored band should always appear in the Control Region, regardless of the presence of any urinary LH. This control band verifies that 1) sufficient urine volume was added 2) proper urine flow was obtained 3) the test is functioning correctly. The absence of a control band may indicate the test was not performed correctly or that the test did not function correctly.

MATERIALS SUPPLIED

a.One pouched cassette with desiccant.

b.One piece of operating instruction

MATERIALS NOT PROVIDE BUT REQUIRED

1.Urine specimen collection container, either plastic or class.

2.Timer.

SPECIMENS COLLECTION AND STORAGE

1.Determine the time you will collect your urine. For best results, collect your urine at about the same time each day, for example, between 10:00AM and 8:00PM. Some women have found that their best specimen is after 12 noon. Do not collect your first urine after waking up.

2.Reduce your liquid intake approximately 2 hours prior to urine collection.

3.The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (18months).

PRECAUTION

1.For in vitro diagnostic use only.

2.Do not use it after expiration date.

3.Test device should remain sealed until use.

WHEN TO START TESTING

1.Determine the Length of Your Menstrual Cycle.

2.our Menstrual Cycle Length is the number of days from the first day of your period (menstrual bleeding) to the last day before your next period starts. Think back over the last few months to decide what your usual cycle length has been.

3.Circle your usual cycle length on the WHEN TO START CHART below. Select the number directly underneath.

4.Starting the first day of your last period, count ahead the selected number of days on your calendar. This is the day you should begin testing.

Contact: Nico Lee
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