HELICOBACTER PYLORI SELF-DIAGNOSTIC TEST SOFARMAPIU'

Description
A 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 precoated with anti-H. pylori on the test line region. During the test, the sample reacts with the anti-H. pylori antibody particle. The mixture migrates up the membrane by capillary action and reacts with the anti-H. pylori on the membrane, generating a colored line.
The presence of this colored line in the test region 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 membrane wicking has occurred.

How to use
Before performing the test, stool samples must be collected following the instructions.
Wash your hands with soap and rinse with water.

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

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

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

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

INVALID: The control line (C) does not appear. Insufficient specimen 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, discontinue use of the test kit immediately and contact your local distributor.

Warnings
For in vitro diagnostic self-testing only.
Read all information in the package leaflet before performing the test.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
If the package is damaged or has been opened, do not use it.
Use a clean container to collect the fecal sample.
Strictly follow the indicated time.
Use the test only once. Do not disassemble or touch the test window of the test device.
The used test must be disposed of according to local regulations.
Keep out of reach of children.
The test should be used to detect H. pylori antigens in stool samples only. Neither the quantitative value nor the rate of increase in H. pylori antigen concentration can be determined with this qualitative test. The test will only indicate the presence of H. pylori in the sample and should not be used as the sole diagnostic criterion for H. pylori as a causative agent for peptic or duodenal ulcers.
As with all diagnostic tests, all results should be interpreted in conjunction with any other clinical information available to the physician.
If the result is negative and clinical symptoms persist, further testing using other clinical methods is recommended. A negative result never precludes the possibility of H. pylori infection.
Following some antibiotic treatments, the concentration of H. pylori antigens may decrease to a concentration below the minimum detection level of the test. Therefore, diagnosis should be made with caution during antibiotic treatment.

Conservation
Store at room temperature or refrigerated (2-30°C). Do not freeze.
Shelf life in intact packaging: 24 months.

Format
The kit contains:
- testing device;
- sample collection tube with extraction solution;
- paper for collecting feces;
- package leaflet.

Cod. SF002