Early Pregnancy test for self-testing

 
PRINCIPLE

The EXACTO® EARLY pregnancy test is a test that detects human chorionic gonadotropin (hCG) in urine as a
way to detect pre gnancy. The test uses a combination of antibodies that detect the presence of the pregnancy
hormone hCG in a selective manner. The test is performed by urinating directly on the absorbent sampler or by
immersing it in urine. The result is read through appearance of coloured lines.

PRECAUTIONS

Please read all the information in this leaflet before performing the test.
• Do not use after the expiry date indicated on the aluminum pouch.
• Store in a dry place at a temperature between 2°C and 30°C. Do not freeze.
• Do not use the test if the pouch is torn or damaged.
• Keep out of reach of children.
• For in vitro diagnostic use only. Do not swallow.
• Do not open the test aluminium sachet before taking the test.
• The urine test must be discarded in accordance with local regulations.

EQUIPMENT PROVIDED
• Test
• Instruction leaflet

INSTRUCTIONS
1. Take the test out of its aluminum pouch and use it within one hour.
2. Remove the cap from the test and direct your urine stream onto the absorbent sampler for 15 seconds or
immerse it for at least 15 seconds in a urine sample collected into a clean container.
3. Place the cap back on the end and place the test on a clean and stable surface. As soon as you have done
so, start the stopwatch.
4. The result should be read after 3 minutes at the least and will no longer be reliable after 10 minutes.
READING THE RESULTS
POSITIVE
Two distinct coloured lines will appear. One line will appear in the round window (C) and a second line will be
visible in the square window (T). One line may be clearer than the other; they will not necessarily look identical.
This result means that you are probably pregnant.
NEGATIVE
A coloured line will appear in the round window (C). No line will appear in the square window (T). This result
means that you are probably not pregnant.
INVALID
The result is invalid if no coloured line appears in the round window (C), even if a line appears in the square
window (T). You will need to take the test again.

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LIMITS
1. Medicinal products that contain hCG (such as Pregnyl, Profasi, Pergonal and APL) can give a false positive
result. Alcohol, oral contraceptives, painkillers, antibiotics and hormone treatments that do not contain hCG
should not affect the test result.
2. Drinking lots of liquids before taking the test could dilate your urine and hCG hormone.
To increase the chances of receiving an accurate early diagnosis, it is recommended to use first-morning urine,
which usually contains a higher concentration of hCG, the pregnancy hormone.
3. A positive result at the start of pregnancy must be interpreted with caution because the risk of a miscarriage
is high in the weeks immediately following conception. To confirm continued pregnancy, it is recommended to
perform a second test using first-morning urine on the first day of your late period.
4. In some clinical situations, the test may give a false positive result, for example in the event of breast or lung
cancer or trophoblastic diseases.
5. A diagnosis of pregnancy must be confirmed by medical advice after an assessment of clinical and laboratory
data.
ADDITIONAL INFORMATION
1. How does the urine test work?
The EXACTO® EARLY pregnancy test detects a hormone that your body produces during pregnancy (human
chorionic gonadotropin - hCG) in your urine. The hCG level in urine increases the further along in your pregnancy you are.

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2. When is the earliest I can take the test once I suspect that I might be pregnant?
You can take the EXACTO® EARLY pregnancy test from the eighth day after having sex, i.e. more than 5 days after
conception. To date, a study has shown that 69% of pregnant women receive a positive test result. Comment:
Do not confuse sex and conception. The latter may take place at any time during the 3 days following sexual
intercourse. That is why it is considered that 5 days after conception is equivalent to 8 days after sex. If you
receive a negative result but suspect that you might be pregnant, it is recommended to perform a second test on first-morning urine on the first day of a late period. If you suspect you might be pregnant but the second test also gives a negative result, consult a doctor for a more accurate diagnosis. You can take the test at any time of day; however, if you are pregnant, morning urine contains the highest levels of the pregnancy hormone.

3. Do I have to take the test using first-morning urine?
Although the test can be performed at any time of day, first-morning urine is usually the most concentrated of
the day and therefore contains the most hCG.

4. How accurate is the test?
A clinical assessment has been performed to compare the results obtained using the EXACTO® EARLY pregnancy
test and a different urinary hCG test available on the market. The clinical study performed on samples collected
from the first day of a late period included 608 urine samples: both tests identified 231 positive results and 377
negative results. The results showed an accuracy rate of > 99% for the quick hCG pregnancy test compared to
the other urine hCG test.

5. How sensitive is the test?
The EXACTO® EARLY pregnancy test detects hCG in urine when it exceeds a concentration of 10 mIU/ml (using
the WHO international standard). Adding LH (300 mIU/ml), FSH (1,000 mIU/ml) and TSH (1,000 μIU/ml) to
negative (0 mIU/ml hCG) and positive (10 mIU/ml hCG) samples did not lead to any cross reactions.

6. What should I do if the result is positive?
This means that your urine contains hCG and that you are probably pregnant. Consult your doctor to confirm your
pregnancy and discuss its management.

7. How can I be sure that the test was performed correctly?
A coloured line will appear in the round window (C), which indicates that you have followed the test procedure
correctly and that a sufficient amount of urine has been absorbed.

8. What should I do if the result is negative?
This means that the hCG hormone was not detected in your urine. This points to no pregnancy or a very early
pregnancy with undetectable hCG levels. You should take a new test on the first day that your period is late. If the result is negative again and your period is late, consult your doctor.

BIBLIOGRAPHY
1. Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma afterinduced abortion,
spontaneous abortion and removed ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394.
2. Dawood MY, BB Saxena, R Landesman Human chorionic gonadotropin and its subunits inhydatidiform mole
and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181.
3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopicproduction of human chorionic gonadotropin by
neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45.

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