H. pylori Antigen Rapid Test

INTENDED USE

The H. pylori Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigen in human stool specimen. . This kit is intended to be used as an aid in the diagnosis of H. pylori infection.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment: 

Best results will be obtained if the assay is performed within 6 hours after collection.

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).

Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

2. Testing

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.

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 interpret the result 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 device and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.

1. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

2. LIMITATIONS OF THE TEST

   1. 1. The pyloriAntigen Rapid Test Device (Feces) is for professional in vitro diagnostic use, and should be used for the qualitative detection of Helicobacter pylori only.
   2. 2. Following certain antibiotic treatments, the concentration of pyloriantigens may decrease to the concentration below the minimum detection level of the test. Therefore, diagnosis should be made with caution during antibiotic treatment.

   3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.