Rapid Test, Strip, for Lh

INTENDED USE
The Rapid LH Test Strip is a rapid chromatographic immunoassay for the semi-quantitative detection of human luteinizing hormone (LH) in women's urine to predict the time of ovulation. The test is intended for healthcare professional and home use.
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 Rapid LH Test Strip 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 Rapid LH Test Strip 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
The Rapid LH Test Strip is a qualitative or semi-quantitative, two site sandwich immunoassay for the determination of human luteinizing hormone (LH) in urine specimens. The membrane was precoated with sheep anti-hLH on the test region. During the test, the specimen is allowed to react with the mouse anti-hLH monoclonal antibody-colloidal conjugate, which was pre-dried on the test strip. 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 25mIU/ml. The Rapid LH Test Strip 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 serves as a reference of the color intensity of about 25mIU/ml hLH. When the intensity of the test band is equal to or stonger than that of the control/reference band, the test result is positive, indicating that the LH surge is likely in progress.
STORAGE
The kits should be stored at temperature 4-30° C, and will be stable in the sealed pouch for the duration of the shelf life.
PRECAUTION
1. For in vitro diagnostic use only.
2. Do not use after expiration date.
3. Test device should remain sealed until use.
4. Handle all specimens as potentially infectious.
REAGENTS AND MATERIALS PROVIDED
1. Rapid LH Test Strip with desiccant.
2. Instructions for use
MATERIAL REQUIRED BUT NOT PROVIDED
1. Urine collection container.
2. Timer or clock.
SPECIMENS COLLECTION
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 urine can be stored at room temperature for up to 8 hours or in the refrigerator for up to 24 hours. Do not freeze. If specimen was refrigerated, it must be equilibrated to room temperature before testing.