Rapid Fecal H. Pylori Antigen Test
NTENDED USE
The H. pylori Antigen Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative, presumptive detection of Helicobacter pylori antigen in human fecal specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.
INTRODUCTION
Helicobacter pylori (also known as Campylobacter pylori) is a spiral-shaped gram negative bacteria which infects the gastric mucosa. H. pylori causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma. Many H. pylori strains have been isolated. Among them, the strain expressing CagA antigen is strongly immunogenic and is of utmost clinical importance. Literature
articles report that in infected patients producing antibodies against CagA, the risk of gastric cancer is up to five times higher than reference groups infected with CagA negative bacteria. Other associated antigens such as CagII and CagC seems to act as starting agents of sudden inflammatory responses which can provoke ulceration (peptic ulcer), allergic episodes, and decrease of therapy efficacy. At present several invasive and non-invasive approaches are available to detect
this infection state. Invasive methodologies require endoscopy of the gastric mucosa with histologic, cultural and urease investigation, which are expensive and require some time for diagnosis. Alternatively, non-invasive methods are available such as breath tests, which are extremely complicated and not highly selective, and classical ELISA and immunoblot assays.
PRINCIPLE
The H. pylori Antigen Rapid Test Device (Feces) detects Helicobacter pylori through visual interpretation of color development on the internal strip. Anti-H. Pylori antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-H. pylori antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient H. pylori antigens in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that
the proper volume of specimen has been added and membrane wicking has occurred.
Material provided
1. H.pylori test 
2. Specimens dilution tube with buffer
3. Package insert For operating instructions
Needed but not provide
Timer

STORAGE AND STABILIRY
The test device can be stored under refrigeration and room temperature (2-30^oC) and will be stable until the expiration date. Do not use after the expiration date
SAMPLE COLLECTION
1. The H. pylori Antigen Rapid Test Device (Feces) is intended for use with human fecal specimens only.
2. Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
3. Bring specimens to room temperature prior to testing.
4. If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

ASSAY PROCEDURES
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Use clean, dry containers for specimen collection. Best results will be obtained if the assay is performed within 6 hours after collection.
2) Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
3) Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
2. Testing
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of solution into the pad of strip
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the membrane.
3) Wait for the colored band(s) to appear. The result should be read within 10minutes. Do not interpret the result after 20 minutes.
Note: If the specimen does not migrate due to the presence of particles, centrifuge the extracted specimens contained in the extraction buffer vial. Collect 100 μL of supernatant, dispense into the specimen well (S) of a new test device and start again, following the instructions described above.


READING THE RESULT
Positive: Presence of two colored bands, one in the control region (C) and another in the test region (T), indicates presence of antibodies to H. pylori in specimen.
Negative: Presence of a colored band in the control region (C) with no band in the test region (T) indicates absence of antibodies to H. pylori in the specimen.
Invalid: If after 10 minutes no band is visible, or if a band appears in the test region (T) only, the result is invalid. If invalid, the assay should be repeated using a new test kit.
Note:Do not interpret results after 15 minutes.