Description
One
Step Ovulation Test (Urine) Package Insert
A rapid, one step test for the qualitative detection of
luteinizing hormone (LH) in urine.
For professional in vitro diagnostic use only.
INTENED USE
The LH One Step Ovulation Test Kit is a rapid chromatographic
immunoassay for the qualitative detection of luteinizing hormone
(LH) in urine to aid in the detection of ovulation.
SUMMARY
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 *4 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 LH One Step Ovulation Test kit 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 LH Ovulation Test kit detects the LH surge in urine,
signaling that ovulation is likely to occur in the next *4**6
hours.
Important: The LH surge and ovulation may not occur in all
cycles.
REAGENTS
The test device contains anti-LH particles and anti-LH
antibody coated on the membrane.
PRECAUTIONS
For professional in vitro diagnostic use only. Do not use
after expiration date.
Do not eat, drink or smoke in the area where the specimens or
kits are handled.
Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout the procedure and follow the standard procedures for
proper disposal of specimens.
Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated
(2**0°C). The test device is stable through the expiration date
printed on the sealed pouch. The test device must remain in the
sealed pouch until use. DO NOT FREEZE. Do not use beyond the
expiration date.
SPECIMEN COLLECTION AND
PREPRATION
Determine the time you will collect your urine. For best
results, collect your urine at about the same time each day, for
example, between *0:*0AM and 8:*0PM. Some women have found that
their best specimen is after *2 noon. Do not collect your first
urine after waking up.
Reduce your liquid intake approximately 2 hours prior to urine
collection.
Be sure to write down the cycle day, date and time that you
collected your urine in the “Test Results Chart”.
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 *4 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 *0 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.
MATERIALS
Materials provided
Test devices
Disposable specimen droppers
Materials required but not
provided
Specimen collection container
Timer
WHEN TO START TESTING
Determine the Length of Your Menstrual Cycle.
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.
Circle your usual cycle length on the WHEN TO START CHART
below. Select the number directly underneath.
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.
WHEN TO STAR CHART
Circle Your Usual Cycle Length
|
*1
|
*2
|
*3
|
*4
|
*5
|
*6
|
*7
|
*8
|
*9
|
*0
|
*1
|
*2
|
*4
|
*3
|
*4
|
*5
|
*6
|
*7
|
*8
|
|
6
|
6
|
7
|
7
|
8
|
9
|
*0
|
*1
|
*2
|
*3
|
*4
|
*5
|
*6
|
*7
|
*8
|
*9
|
*0
|
*1
|
*2
|
Count ahead this many days STARTING WITH THE FIRST DAY of your
LAST period.
Note: If you are unsure about your cycle length, you may want
to use your shortest cycle length when reading the chart. If you do
this, you may need to test for more than 5 days.
Example: My usual cycle length is *8 days. My last period
started on the third. The “When to Start Chart” shows that I will
count ahead *1 days beginning with the third. When I count *1 days
ahead on the calendar, I find that I will collect and test my urine
starting on the *3th. (See “Sample Calendar” below).
Please contact us for more information.
