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Exacto Ovulation TEST

PRINCIPLE
• Ovulation involves the release of an ovum from the ovary.
• The egg moves into the Fallopian tubes, where it is ready to be fertilised.
• Immediately before ovulation, the body produces a large quantity of luteinising hormone (LH), which triggers the release of the ovum
by the ovary.
This phenomenon is known as the “LH surge” and usually takes place in the middle of the menstrual cycle. It is during this fertile period that
pregnancy is most likely to occur. The test uses a combination of antibodies, including an LH monoclonal antibody responsible for detecting
increased levels of luteinising hormone (LH).
• The EXACTO® OVULATION test detects the LH surge in the urine, which suggests that ovulation will probably take place in the following 24
to 36 hours. For pregnancy to begin, the ovum must be fertilised by sperm within 24 hours following its release. Nevertheless, it is important
to note that sometimes there is no LH surge or ovulation during a cycle.
PRECAUTIONS
Read the information provided in this instruction leaflet carefully before performing the test.
• Do not use after the expiry date shown on the aluminum pouch.
• Store in a dry place between 2°C and 30°C. Do not freeze.
• Do not use if the test sachet is open or damaged.
• Keep out of reach of children.
• For in vitro diagnostic use only. Do not swallow.
• Open the aluminum pouch just before performing the test.
• The test should be discarded after use in accordance with local regulations in force.


BOX COMPOSITION
• 10 test pens
• 1 instruction leaflet


INDICATIONS
The EXACTO® OVULATION test is intended for women whose desire for a baby does not succeed spontaneously or for women taking
ovulation inducers to check the result of the treatment. It helps identify a woman’s most fertile period.


BEFORE STARTING THE TEST
The box contains 10 tests that help detect the occurrence of ovulation over several consecutive days. Determine the day on which you should
start the test using the table below.

1) Determine the average duration of your menstrual cycle. The duration of your menstrual cycle is the number of days from the first day of your period (start of bleeding) until the last day before the appearance of the period for the following cycle.
2) Circle the number corresponding to the average duration of your cycles in the table above.
NOTE: If your cycles are irregular, you can use your shortest cycle duration.
3) Use the example of the calendar above to determine the day when you should start the test. It is not recommended to use the first urine of the morning. For the most accurate result possible, the test should be performed at the same time each day. Drinking should be avoided in the two hours before performing the test.

Directions for use

Determine the date on which you should start the test using the table above.
1. Leave the aluminum pouch at room temperature before opening it. Remove the test from the aluminum pouch; it should be used as
quickly as possible.
2. Take off the cap.
3. Hold the test with the absorbent sampler pointing downwards.
Allow the absorbent sampler to soak for 15 seconds directly in the urine stream until it is completely moistened (see diagram). Ensure that the 5 holes in the plastic part of the test are placed in contact
with the urine.
Note: Do not urinate on the Test and Control windows. Alternatively, you can collect the urine into a clean,
dry container and immerse the absorbent sampler in the urine for 15 seconds.
4. After removing the test from your urine stream or container, replace the cap on the absorbent sampler
and place the test on a flat surface with the Test and Control windows facing upwards. Wait for 3 minutes.
5. As the test starts to function, you may see a pinkish purple colour migrating towards the Test and Control windows. Read the result after three minutes have passed. If no result appears, wait another minute. Do not read after 10 minutes.

TEST LIMITS
• The test may give false positive or false negative results.
• In most cases, erroneous results are due to not adhering to the directions for use.
• If you encounter any issues, read the directions for use again and repeat the operation using a new strip.
• If the problem persists, contact your pharmacist or our Customer Services.


QUESTIONS AND ANSWERS
1. Can I use the EXACTO® OVULATION test to avoid becoming pregnant?
No, the test cannot be used as a means of contraception.
2. How reliable is the EXACTO® OVULATION test?
A clinical study on 300 urine samples showed specificity higher than 99%, sensitivity higher than 99% and global accuracy higher than 99%.
3. How sensitive is the EXACTO® OVULATION test?
EXACTO® OVULATION test detects the presence of luteinising hormone (LH) in urine from 40 mIU/ml. No cross-reactions have been
observed in the concentrations tested after adding current medicinal products and hormones, including FSH (1,000 mIU//ml), hCG (100
mIU/ml) and TSH (1,000 μIU/ml).
4. Do alcohol or medicinal products affect the test result?
No, but it is recommended to consult your doctor if you are taking hormone treatment. A recent dose of an oral contraceptive, breastfeeding
or pregnancy can affect the test result.
5. Why is it not recommended to use first-morning urine to perform the test? At what time of day should I perform the test?
It is not recommended to use first-morning urine because it is particularly concentrated and could therefore give false positive results. Any
other time of day is suitable. For the most accurate result possible, it is best to collect the urine at the same time each day.
6. Does drinking affect the test result?
Drinking lots of liquids before performing the test will dilute the hormone in the urine. It is recommended not to drink in the two hours
before the test.
7. How long does the line stay visible?
The test should be read after three minutes. A positive result (presence of the LH surge) will not disappear. The lines may become darker and
a pinkish colouration of the membrane may appear after several hours. Some negative results may become slightly positive after a certain
time; this is due to evaporation in the Test window. As such, the test cannot be read more than 10 minutes after it has been performed. Discard
the test once it has been read.
8. Once a positive result has appeared, what it the best time to have sexual intercourse?
Ovulation should take place within 24 to 36 hours. This is when you will be in the most fertile period of your cycle. It is recommended to have
sexual intercourse during this period.
9. I use the temperature method. Can the EXACTO® OVULATION test replace the temperature method?
The EXACTO® OVULATION test does not replace the temperature method. The increase in basal temperature normally indicates that
ovulation has already taken place. The EXACTO® OVULATION test indicates that ovulation is about to take place.
10. I had a positive result and had sexual intercourse during my fertile period. I think I am pregnant. When is the earliest I can
know for sure?
Our EXACTO® PREGNANCY test can give a reliable, accurate result from the expected 1st day of your period.
11. I had a positive result and had sexual intercourse during my fertile period, but I am not pregnant. What should I do?
Many factors can affect your chances of becoming pregnant. For couples in good health, pregnancy may occur only after several months and
it is sometimes necessary to use the EXACTO® OVULATION test for 3 to 4 consecutive months to become pregnant. If you do not become
pregnant after 3 to 4 months, you and your partner should consult a doctor.
12. Does no period mean no ovulation?
No, because during periods of dieting, perimenopause or intense sports, periods may disappear but ovulation can occur nonetheless.