Why do I need this test?

According to estimates, today around half of the world’s population are infected with Helicobacter pylori, although not every infection produces symptoms. The bacterium Helicobacter pylori (“H. pylori”) causes conditions such as gastritis and stomach ulcers.There is as yet no immunisation available against the infection, which occurs in both children and adults. However, use of the appropriate medication (such as antibiotics) can eliminate the bacterium.

General information:
The stomach lining and duodenum are both protected against stomach acid by a protective coating. If this protective function is disturbed in any way, the mucous membrane of the stomach can be damaged, leading to ulcers. This typically happens due to H. pylori infection, which also
increases the risk of developing stomach cancer.

In most cases, H. pylori infection can be treated very successfully using a combination of antibiotics and antacids. Once the bacteria have been eliminated, the gastritis is generally cured.

PLEASE NOTE:
If you have already been infected with H. pylori in the past and the infection was eliminated using antibiotics, this test may yield a positive reading even more than one year following treatment, although the infection is no longer present.

Test components:

Sealed foil pack with test cassette and desiccant, buffer bottle with 0.5 ml buffer solution, lancet, instructions.

1) Wash your hands with soap and rinse with clear warm water.

2) Tear the protective pouch (from the notch) and only get out the device and the pipette. Dispose of the small desiccant bag.

3) Push the orange small rod into the body of the lancet until hearing a CLICK indicating the device is activated – fig A.

Be careful no to push the trigger because the needle can come out too early.

4) Remove the orange rod by turning it on the left or on
the right. – Fig. B

5) Clean the end of the forefinger or of the middle finger with a cotton pad damped with alcohol. Massage the end of the finger, from the base of the finger to the end, to enhance the blood flow.

6) Strongly press the extremity of the lancet on the part of the finger which is cleaned with alcohol in order to obtain a very good contact. Press on the trigger button. – fig. C

The tip retracts automatically and safely after use.

7) Keeping the hand down massage the end that was stung to obtain a blood drop. – fig. D

8) Without pressing the pipette bulb, put it in contact with the drop. – fig. E

The blood migrates into the pipette through the capillarity to the line indicated on the pipette. You may massage again your finger to obtain more blood if the line is not reached. As far as possible, avoid of air
bubbles.

9) Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb. – fig. F

10) Wait for the blood totally being dispensed in the well. Using the dropper bottle, add 5 drops of diluent into the sample well of the device – fig. G

11) Read the result after 10 minutes.

RESULT INTERPRETATION

READ THE RESULT AFTER 10 MINUTES. DO NOT READ THE RESULT AFTER 15 minutes. The intensity of the line colour does not have any importance for the interpretation of the test result.

Positive result

Two coloured lines appear in the window under the marks T (Test)
and C (Control). The intensity of the line T may be clearer than the
intensity of the line C. This result means that the there is the presence of the antibodies anti-HP in blood and that you should consult a doctor.

Negative result

Only one coloured line appears under the C mark (Control). This
result means that the presence of the antibodies anti-HP in blood
was not detectable.

In-valid result

No line appears or a coloured line appears under the mark T (Test)
without any line under the mark C (Control). In this case, it is not
possible to interpret the test, which must be considered as non valid. It is recommended to repeat the test with a new test device and a new blood sample.

I have an H. pylori infection. What should I do?

Please visit your doctor, who will arrange for the appropriate examinations to be undertaken in order to confirm the diagnosis. Using treatment with antibiotics, your doctor will in most cases be able to completely destroy the bacteria and thus avoid any further associated intestinal symptoms.
It might be helpful to take these instructions with you to show your doctor, so you can give him or her a better idea of the type of test carried out.

I have stomach pains, but I seem not to be infected by H. pylori. What should I do?

Consult your doctor for a detailed examination.

IMPORTANT NOTE:
Always consult your doctor before making any important medical decisions.

Product information:

• Not being infected with H. pylori does not necessarily mean that you cannot get a stomach ulcer for another reason.
• Although the test is very accurate, false results may arise in very rare cases.
• This is an immunological test for the detection of antibodies against H. pylori in blood.
• Test components of animal origin (such as antibodies) are potentially infectious material, but present no risk to health provided that all test components are used in accordance with instructions. The buffer solution contains harmless concentrations of sodium azide.

To download the full instructions for use please click on the link below;

Stomach Ulcer – EN-ES-PT
Stomach Ulcer – DE-FR-IT