Home LH (Luteinizing Hormone) Ovulation Test Cassette
For the qualitative detection of Human chronic gonadotropin in
urine
Home Use LH Ovulation Rapid Diagnostic Kit By Urine Test For Women
Pregnancy Checking
Intended Use
Home Ovulation Test Midstream is an in vitro diagnostic (IVD)
qualitative test for rapid detection of human luteinizing hormone
(LH) in urine at a sensitivity of 20mIU/ml.
Principle
Home Ovulation Test Midstream 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 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 20mIU/ml.
The Home Ovulation Test Midstream 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
1. One pouched cassette with desiccant.
2. One piece of operating instruction
Materials Not Provide But Required
1. Urine specimen collection container, either plastic or class.
2. Timer.
Assay Procedure
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 (60-80ul) 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
Assay Procedure
1. Remove the midstream test device from pouch by tearing.
2. Take off the clear cap from sample end of device and put it to
other end of device to cover window area.
3. Hold the end of cap and put the urine holes in urinating stream
for 3-5 seconds.
4. Re-cap the device and lay it on flat 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.
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).
