H. pylori Antigen Rapid Test
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.H. pylori Antigen Rapid Test
The H. pylori Antigen Rapid Test Device (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.
Relative Sensitivity: 99.24% （95%CI: 95.41%～>99.99%）
Relative Specificity: >99.9% （95%CI：99.96%～100%）
Accuracy: 99.72% （95%CI：98.26%～>99.99%）
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.
1).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).
1).Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
2).Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
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.
1）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.
2.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.
1.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.
2.Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
Hangzhou Immuno Biotech Co.,Ltd is the original organization in Immuno Group. The team of Hangzhou Immuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Gradually, IMMUNO was well known as a good R&D partner and good supplier of veterinary rapid test products. With great patience and continuous investment in design and development of IVD relative reagents and test kits, we got several encouraging achievements in the past year, especially in veterinary diagnostic field.