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1. SPECIMEN
Q: When is the best time of day to obtain a urine specimen for
testing?
A: For best results, collect 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 the first urine after waking up
because it is concentrated and may give a false positive result. Also, heavy
intake of fluids prior to testing will dilute the hormone in your urine. It is
suggested that fluid intake be limited for about two hours before urine is
collected.
Q: How can specimens be stored prior to testing?
A: You can store your urine for testing later in the day. Your urine can be
stored at room temperature for up to 8 hours or in the refrigerator for up to 24
hours. Do not freeze it. For best results, test your urine on the same day that
it is collected. If you refrigerate your urine, let it reach room temperature
before testing (about 30 minutes). Do not shake the container. If sediment forms
at the bottom of the collection container, allow the sediment to settle. Use
only urine from the top of the container.
Q: Can "cloudy" urine samples be used for testing?
A: Urine specimens exhibiting visible precipitates should be centrifuged,
filtered, or allowed to settle to obtain a clear specimen for testing.
2. TEST PROCEDURE
Q: Can the One-Step LH Ovulation Predictor Tests be used to
avoid pregnancy?
A: No, the tests should not be used as a form of birth control.
Q: At what point in a woman’s cycle should the test be used?
A: The LH test should be taken around the middle of the menstrual cycle. A
woman needs to first determine her cycle length. She then reads a chart included
with the LH Ovulation Predictor Test to determine when she should start testing.
If she has correctly measured her cycle, she should detect her LH surge within 5
days of beginning to test. However, not all women ovulate mid-cycle, so it is
possible that additional testing beyond the 5 days is necessary.
Q: If the test is used before the specimen and test reach room
temperature, is the result reliable?
A: No. The test and the specimen must be at room temperature (15-30° C)
before the test is performed.
Q: If too much or not enough of the specimen sample was added, is the result
still reliable?
A: No, an incorrect amount of specimen sample can affect the test result. It
should be repeated with a new test and the appropriate amount of sample.
Q: If the LH Strip was immersed into the specimen sample beyond the maximum
line (MAX), is the result still reliable?
A: No, this can affect the test performance and result. It should be
repeated with a new test, taking care not to pass the maximum line during strip
immersion.
Q: Occasionally, the drops of specimen may appear as air bubbles; are these
counted as true drops on the test device?
A: No. It is important that when using a dropper, the full amount of drops
is dispensed onto the test and air bubbles are not trapped in the specimen well.
Q: If the LH test was dropped on the floor prior to using it, will it still
work?
A: If the test is intact and the exposed membrane in the "reaction
window" was not damaged, it can still be used and expected to function
properly.
Q: Liquid/specimen sample/water was inadvertently dropped onto the
"reaction window" of the test. Will it still work?
A: No. Addition of any type of liquid into any other location other than the
test’s designated sample port renders the test invalid. Use a new test.
3. INTERPRETATION
Q: When the specimen sample is added to the test, red/pink fluid
can be seen migrating up the membrane. Is this normal?
A: A red/pink background is normal as the sample flows up the test strip and
will not affect the test result. As long as it does not interfere with the
interpretation of the line(s), the background can be disregarded.
Q: How does one know that the test has been performed properly?
A: As an internal procedural control, a red line appearing in the Reference
(R) region confirms the addition of sufficient specimen volume and the
performance of correct procedural technique.
Q: How long will the line remain visible?
A: The test should be read at 5 minutes for best results. A positive (Surge)
result will never disappear. The colored line(s) may become darker and a tinted
background may appear after several hours. Some negative results may later
display a faint second color line because of evaporation from the test region.
Therefore, you should not read the result after 10 minutes and discard the test
once you have read the result.
Q: Can the result be read before the specified read time?
A: No. Even though a positive result may appear earlier, it is important
that the test be allowed to fully develop for 3 minutes (for the midstream test)
or 5 minutes (for the strip and device tests)
Q: Once a positive result is seen, when is the best time to have intercourse?
A: Ovulation is likely to occur within 24-36 hours. This is the most fertile
time. Sexual intercourse within this time frame is advised.
Q: A patient had a positive result and had intercourse during these fertile
days but has not become pregnant. Why could this be?
A: There are many factors that can affect the ability to become pregnant. It
can take normal, healthy couples many months to achieve pregnancy and often they
may need to use the test kit for 3-4 months before achieving pregnancy. If
pregnancy is not achieved after 3-4 months, a physician should be consulted.
Q: The test was performed with water and a positive result was obtained. Why
would this happen, and should this cause a concern about the performance of the
test?
A: The One-Step LH tests are for use with urine specimens only.
Product performance using any other types of samples, including water, has not
been validated and should not be relied upon. Only urine specimens should be
used on the One-Step LH tests.
4. STORAGE
Q: How should the test kits be stored?
A: Store the kits at room temperature.
Q: If the foil pouch has been opened, should the test be used right away?
A: Because humidity in the air can affect the integrity of the test, it is
recommended that the test be used immediately once the foil pouch has been
opened. Likewise, if a pouch is found to be punctured or have a broken seal, do
not use the test inside.
Q: Can the test be used beyond the expiration date on the foil pouch?
A: No. The test should not be used under any circumstances past its
expiration date.
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