H.Pylori Antigen Rapid Test (Feces)
【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.
【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.
The presence of the gene itself determines the persistence of the infection, the ulceration and the protein associated, VacA toxin is frequently the main cause of infiltrations in the gastric mucosa.
This antigen associated to others, such as CagII, CagC, seems to act as starting agent of a sudden inflammatory response which can provoke ulceration (peptic ulcer), allergic episodes, and a decrease of the therapy efficacy.
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 requiring 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.
【PRINCIPLE】
The H. pylori Antigen Rapid Test (Feces) has been designed to detect Helicobacter pylori through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-H. pylori monoclonal antibody on the test region. During the test, the specimen is allowed to react with colored anti-H. pylori monoclonal antibody colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough H. pylori antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
【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.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
【SAMPLE COLLECTION】
• The H. pylori Antigen Rapid Test (Feces) is intended only for use with human fecal specimens.
• Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
• Bring specimens to room temperature prior to testing.
• Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
【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 4 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 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 at 10 minutes.Do not read after 20 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 cassette 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.
For further operation or performance details, please refer to final instruction manual.
Your message must be between 20-3,000 characters!