The H. Pylori Ag Rapid Test Device (Feces) is a rapid chromatographic immunoassay for the qualitative detection of antigens to H. Pylori in feces to aid in the diagnosis of H. Pylori infection.
The H. Pylori Ag Rapid Test Device (Feces) is a screening immunochromatographic assay to detect Helicobacter Pylori antigen in stool samples.
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.
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1.Specimen collection and pre-treatment:
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.
2)Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
3)Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
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 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.