Description
Rapid chromatographic immunoassay for the qualitative detection of H.pylori antigens in human stool samples, providing results in 10 minutes.
In the test, the membrane is pre-coated with anti-H.pylori on the test line area. During the test the sample reacts with the anti-H.pylori antibody particle. The mixture migrates upwards on the membrane by capillary action to react with the anti-H.pylori on the membrane generating a colored line.
The presence of this colored line in the test area indicates a positive result, while its absence indicates a negative result.
To serve as a procedural control, a colored line will always appear in the control line region indicating that an adequate volume of sample has been added and that membrane wicking has occurred.

Instructions for use
Before testing, stool samples must be collected according to the instructions.
Wash your hands with soap and rinse with water.

Sample collection
The stool sample should be collected in stool collection paper or clean collection containers. Use paper for stool collection, avoiding contamination of the sample by taking precautions so that the sample or side of the paper containing the sample does not come into contact with contaminating objects, including toilet cleaners.

Testing procedure
Unscrew the cap of the sample collection tube, then insert the applicator into the stool sample in at least 3 different sites, randomly.
Do not collect the stool sample. Screw and tighten the cap on the sample collection tube, and shake the sample collection tube vigorously to mix the sample and extraction solution for 2 minutes.
Bring the bag to room temperature before opening it. Remove the test device from the foil pouch and use it as soon as possible. The best results are obtained if the test is performed immediately after opening the foil pouch.
Open the cap of the sample collection tube and break off the tip. Invert the sample collection tube and transfer 2 full drops of the extracted sample to the sample well (S) of the test device. Avoid the formation of air bubbles.
Start the timer and read the results after 10 minutes. Do not read the results after 20 minutes.

Interpretation of results
POSITIVE: two colored lines appear, the test line (T) and the control line (C). The color intensity in the test line region (T) will vary depending on the concentration of H.pylori antigen present in the sample . Therefore, any shade of color in the area of ​​the test line (T) should be considered positive.
This result means that the presence of H.pylorin antigen has been detected in the stool and that you should consult a doctor.

NEGATIVE: Only the control line (C) is displayed, the test line (T) does not appear.
This result means that the presence of H.pylori antigen in the stool is not detectable.

INVALID: The control line (C) is not displayed. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the control line (C) not appearing.
Review the procedure and repeat the test with a new test device. If the problem persists, stop using the test kit immediately and contact your local distributor.

Warnings
For in vitro diagnostic self-analysis only.
Read all the information contained in the information leaflet before carrying out the test.
Do not eat, drink or smoke in the air