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One-Step LH Rapid Test Uncut Sheet
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.
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.
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.
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.
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).
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. Your 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.
1. Collect urine specimen with a clean dry container either plastic or class.
2. Remove the cassette from its protective pouch.
3. Add 2 drops (40-60ml) of urine to the sample well .
4. As soon as solvent front reached the membrane area place the cassette on a clean surface.
5. Wait for 10-15 minutes to read result. Do not try to interpret results after 15 minutes
INTERPRETATION OF RESULTS
Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test cassette.
concentrations. The negative result is 100%.
In the study, two replicate assays were performed with each of two specimens containing 0, 20mIU/ml LH. Correct negative and positive results were registered in 100% of the assays.
The study involved the same two specimens containing 0, 20mIU/ml LH. The samples were analyzed in 12 independent assays with y.b.t. Home Ovulation cassette originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
y.b.t Home Ovulation Test cassette has included a procedural control in the test. If a test cassette is valid and assay was performed properly a pink colored band will always appear in the membrane regardless positive or negative results.
It is recommended that negative and positive control specimens be used with each new kit. Users however, should follow their state and local regulations.
1. The test works only when the test procedures are precisely followed.
2. Do not reuse the test device.
3. For professional in vitro diagnostic use only.
4. 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 Home Ovulation Test cassette. In addition, the test will not work properly if you are pregnant, menopausal, or taking birth control pills.
Contact Person: Ms. Anna Lee