HP H.Pylori Rapid Test Cassette Immunochromatography (Feces Specimen) CE ISO
【H. pylori INTRODUCTION】
Helicobacter pylori (also known as Campylobacter pylori) is a spiral-shaped with a typical flagellum, Gram negative bacteria, infecting gastric mucosa. It 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, so as to be classified as carcinogen agent type I.
Many H. pylori strains have been isolated: among them, the strain expressing CagA antigen is strongly immunogenic and, according to this, it is of utmost clinical importance because it is associated to the cytotoxic factor. It is widely reported in many literature articles that, in infected patients showing antibodies against CagA gene product, the risk of gastric cancer is up to five times higher than the reference group infected with a CagA negative bacterial strain.
At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies requires endoscopy of the gastric mucosa with a histologic, cultural and urease investigation, which are cost-effective and require long times to come to a correct final diagnosis. Alternatively, non-invasive methods are available such as Breath Test, which is extremely complicated and not highly selective, or classical ELISA and immunoblotting assays.
【H. pylori Ag RAPID TEST INTENDED USE】
The H. pylori Antigen Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
【MAIN CONTENTS】
One pouch containing a rapid test cassette with desiccant.
Specimens dilution tube with buffer
Package insert
【PRECAUTIONS】
For professional in vitro diagnostic use only.
Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch
is damaged. Do not reuse tests.
Used testing materials should be discarded according to local regulations
【H. pylori Ag DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Best results will be obtained if the assay is performed within 6 hours after collection.
2) Unscrew and remove the dilution tube applicator stick. 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) Place the applicator stick 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 2-3 (80-100 μL) drops of solution into the specimen well (S) of the test device. Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in
observation window. As the test begins to work, you will see color move across the membrane.
3. Wait for the colored band(s) to appear. The result should be read in 15 minutes.
Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well(S) of a new test device and start afresh following the instructions mentioned above.
【INTERPRETATION OF RESULTS】
POSITIVE:
The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE:
The presence of only control line (C) within the result window indicates a negative result.
INVALID:
If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
