How does Helicobacter Pylori test work?
When present in gastric epithelium, HP bacteria induce the production of specific antibodies by the immune system. These circulating antibodies are able to recognize the bacteria and to stick on them. Helicobacter Pylori test detects specifically these anti-HP antibodies in blood and therefore shows the bacteria presence.
When can this test be used?
Helicobacter Pylori test should be performed in condition of repeated stomach or intestine pains (stomach ache, acidic reflux…). The test can be performed at anytime of the day.
The presence of highly pathogen strains of Helicobacter pylori (HP) colonizing the epithelium surface of the stomach or intestine can induce chronic gastritis that could lead to ulcer and/or cancer. Currently, 90% of the patients suffering of gastric ulcers are infected with bacteria HP. Therefore it is important to spot the bacteria in order to easily eliminate it using specific antibiotic drugs. The detection of circulating antibodies directed against the bacteria is the most efficient way to diagnose its presence as antibodies are produced by the immune system during the infection process. A positive result can be obtained for patients previously infected with the bacteria HP.
Helicobacter Pylori Test is a highly specific immunological rapid test easy to use for the detection of anti-HP antibodies with a finger prick of whole blood sample.
The box contains the material necessary to perform a test:
– 1 sealed aluminium pouch containing:
1 test device, 1 desiccant pouch, 1 plastic pipette.
Only open the protective pouch when you are ready to perform the test. The desiccant bag should not be used.
– 1 diluent vial containing 1 mL of diluent.
– 1 sterile lancet for blood sampling.
– 1 instruction leaflet.
- This test is exclusively intended to in vitro diagnostic. External use only. DO NOT SWALLOW.
- Carefully read the instructions before performing the test. The test is only interpretable if the instructions are carefully respected. Follow strictly the indicated time, blood and diluent quantities.
- Store between +4°C and +30°C. Do not freeze.
- Do not use after the expiry date printed on the label and on the protective pouch or if the pouch is damaged.
- Do not re-use the test.
- Keep out of the reach of children.
- After use, all components can be discarded in a dustbin.
- Not suitable for children under 2 years’ old.
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 the testing follows:
- Wash your hands thoroughly. Use soap and warm water. Dry your hand with clean towel.
- Prepare the test device and the pipette. Take them out from the protective pouch (tear at the notch) and place them in the reach of your hands (you will need them later). Dispose the small dessicant bag.
- Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the lancet cap twisting it off ¼ turn until you feel it separates from the lancet and then continue twisting it (2-3 rotations). Don’t pull just twist and discard the cap when finished .
- Clean the end of the forefinger or of the middle finger with cotton damped with alcohol. Rub the chosen finger towards the tip to later on enhance the blood stream.
- Press platform firmly against the previously cleaned finger, and press the release trigger button.
- The tip will automatically retract into the body of the device.
- Rub the finger’s end to obtain enough whole blood sample.
- Without pressing the bulb, put in contact the plastic pipette with the blood sample. 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.
- Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb.
- Wait 30-40 sec for the blood being totally absorbed into the sample well. Unscrew the blue cap of the diluent vial (leave the white cap tightly screwed) and add the diluent as follows:
Hold the diluent vial vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop.
- Read the result after 10 minutes. Do not interpret 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 colour intensity of the T line may be clearer than the intensity of the C line. This result means that blood sample contains anti-HP antibodies and that you should consult a doctor.
- Negative result
Only one coloured line appears under the mark C (Control). This result means that no anti-HP antibodies are detected in the blood sample.
- Non valid result
No line appears or a coloured line appears under the mark T (Test) without any line under the mark C. 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 another Helicobacter Pylori test.
QUESTIONS AND ANSWERS
Can the results be incorrect?
The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if Helicobacter Pyloritest gets wet before test performing or if the quantity of blood added to the sample well is not correct. The pipette provided in the box allows making sure the collected blood volume is correct.
How to interpret the test if the colour and the intensity of the lines are different?
The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test lines.
What is the line that appears under the mark C (Control) for?
When this line appears, it only means that the test was performing well.
If I read the result after 15 minutes, will the result be reliable?
No. The test should be read within 10 minutes after adding the diluent. The result is reliable up to 15 minutes.
What do I have to do if the result is positive?
If the result is positive, it means that anti-HP antibodies are present in blood and that you should consult a doctor to show the test results. Then, the doctor will decide whether additional investigation should be performed as the anti-HP antibodies could be due to previous infection already cured.
What do I have to do if the result is negative?
If the result is negative, it means that the test could not detect anti-HP antibodies in blood sample. Meanwhile it is recommended to consult a doctor if stomach ache or gastric reflux persists.