Pregnasure™ How To Use

Pregnasure™ Concept

Pregnasure™ Frequently Asked Questions

1. What is Pregnasure™ ?

Pregnasure™ test is a rapid qualitative self-test test for the determination of the hCG (human Chorionic Gonadotropin) levels in a whole blood sample for the detection of pregnancy.

2. When should I check if I am pregnant?

While pregnancy can be detected in urine about 1 week after a missed period, a whole blood test can detect pregnancy as early as a few days after impregnation.

3. How about Pregnasure™ accuracy?

A pregnancy whole blood test is known to be more accurate than a conventional urine test. This is the reason why whole blood / serum pregnancy tests are widely used in laboratories and hospitals. In addition, the volume of ingested liquids which may affect the urine test results due to the dilution of hCG, is not affecting the results of a whole blood pregnancy test.

The test accuracy is indeed very important as a pregnancy necessarily implies precautions as well as a change in lifestyle such as stopping smoking or drinking alcohol, reducing or even eliminating medications as well as certain foods.

4. After how long should I get and interpret Pregnasure™ test results?

You should be able to get and interpret Pregnasure™ test results within 5 to 10 minutes. In only 5 minutes, it is possible to detect an hCG concentration of 25 mIU/mL.. Do not interpret after 10 minutes.

5. How does Pregnasure™ work?

When a woman becomes pregnant, her body begins to produce a hormone called Human Chorionic Gonadotropin (hCG), which is released in the blood, then its concentration rises over time. Pregnasure™ Pregnancy test detects the hCG hormone in whole blood as it uses a specific pair of antibodies that detect the hCG hormone in whole blood at levels of at least 25 mIU/mL (determined against W.H.O.* reference) or greater.

6. When should I use Pregnasure™ ?

You can use the Pregnasure™ at any time of the day. Pregnasure™ can detect pregnancy earlier than a classical urine test because the hCG hormone produced in the placenta is first released in the blood stream, then into the urine. Therefore, there is no limitation to increase the test accuracy unlike the routine urine test.

7. Can Pregnasure™ results be incorrect?

The results are accurate as far as the instructions are carefully followed.

However, the result can be incorrect if Pregnasure™ test gets wet before performing the test or if the volume of the whole blood put in the sample well is not sufficient. The plastic pipette provided in the box allows making sure the collected whole blood volume is correct.

Moreover, certain drugs containing hCG or those used in combination with hCG (such as Pregnyl®, Porfasi®, Pergonal®) as well as rare medical conditions may lead to a false positive result. Alcohol, analgesics, antibiotics, birth control pills, hormone therapies containing clomiphene citrate (such as Clomid®, Serophen®) or painkillers should not affect the test result.

The test may also show a false positive result if you have had a miscarriage, abortion or have given birth within the past 8 weeks. This is due to the test is possibly detecting the hCG that is still present in your blood steam.

8. How to interpret the test results if the colour intensities of the T and C lines are different?

The color intensity of the lines has no impact on the results interpretation. The lines should only be homogeneous and clearly visible. The test should be considered positive whatever the color intensity of the test line (T) is.

9. What does the line that appears under the C mark (Control) mean?

When this line appears, it only means that the test is working well.

10. What if I read the result after 10 minutes? Will the results remain reliable?

No, the result should be read only within 5 to 10 minutes after adding the buffering solution and shall remain reliable up to 10 minutes.

Do not interpret the result after 10 minutes.

11. What should I do if the test result is positive?

If the result is positive, you should consult your general practitioner or gynecologist to discuss about your pregnancy and the next steps. Early prenatal care is important for a safe pregnancy.

12. What should I do if the test result is negative?

If the test result is negative, it is most likely that your blood does not either contain hCG or has very low levels of hCG (the test can detect hCG concentration as low as 25 mIU/mL), and probably you are not pregnant. However, you may have miscalculated the date of your period, especially if you have irregular periods. If your period does not start within a week, repeat the test. If you still get a negative result and your period has not started, you should consult your general practitioner or gynecologist. This delay could be caused by other reasons.

13. How Should I perform Pregnasure™ test?

Testing procedure always starts with a good preparation. Place the content of the box on a clean, dry and flat surface (e.g., table), then follow the next steps:

1. Wash your hands thoroughly using a soap and warm water, then dry your hand with a clean towel.

2. Prepare the test device and the pipette. Take them out from the protective pouch by tearing at the notch, then place them on the table and dispose the small desiccant bag.

3. Prepare the lancet. Hold the lancet without touching the release button. Unlock the lancet cap by twisting it off ¼ turn until you feel it separates from the lancet, then continue twisting it (2-3 rotations). Don’t pull just twist, then discard the cap when finished. (steps 1 &2).

4. Clean the end of your finger with the provided alcohol pad, then rub it for 10 to 15 seconds towards the tip to enhance the blood stream.

5. Press the lancet device firmly against the lateral side of your finger and press the release button. (step 3). The tip will automatically retract into the body of the lancet device.

6. Rub the finger’s end to obtain enough whole blood sample. (step 4)

7. Without pressing the bulb, put in contact the plastic pipette with the blood sample. (step 5) The blood migrates into the pipette through capillarity to the line indicated on the pipette. You may rub again your finger to obtain more blood if the line is not reached. As far as possible, avoid air bubbles.

8. Put the blood collected with the pipette into the sample well of the test device, by pressing on the pipette bulb. (step 6)

9. Wait 30-40 sec for the blood to be totally absorbed into the sample well. Unscrew the blue cap of the diluent vial (leave the white cap tightly screwed) and add the buffering solution in the sample well as follows:

Hold the buffering solution bottle vertically and slowly add exactly 4 drops in the sample well of the device (step 7) with an interval of 2-3 seconds between each drop.

10. Read the result within 5 to 10 minutes. Do not interpret after 10 minutes.

Please click on the link below to see an illustrative video on how you should use Pregnasure™.

Pregnasure - How to use Arabic subtitles - YouTube

14. What's inside Pregnasure™ pack?

Pregnasure™ pack contains all materials necessary to perform a test:

A. A sealed aluminum pouch containing:

· 1 test device

· 1 plastic pipette

· 1 desiccant bag.

Only open the protective pouch when you are ready to use the test. The desiccant bag should be disposed.

B. A sterile lancet for blood sampling.

C. A dropper bottle containing 1 mL of buffering solution.

D. An instruction leaflet.

E. An alcohol pad.

15. How do I interpret the test result?

1. Positive result

Two red lines appear in the window under the marks T (Test) and C (Control). The colour intensity of the T line may be clearer than the colour intensity of the C line. The test is positive indicating that the hCG level is 25 mIU/mL or higher and that you are pregnant.

2. Negative result

Only one red line appears under the mark C (Control). The test is negative indicating that the hCG level is below 25 mIU/mL and you are not pregnant.

3. Invalid result

No line appears at all or a red line appears only under the mark T (Test) without any line appearing under the mark C (Control). In this case, it is not possible to interpret the test result, and the results should be invalid. It is recommended that you repeat the test wile strictly following the instructions for use.

= Pregnant

= Not Pregnant

= Invalid Result