Diagnostic Kit（LATEX）for Antigen to Helicobacter Pylori
For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE
Diagnostic Kit（LATEX）for Antigen to Helicobacter Pylori is suitable for the presence of H. Pylori antigen in human fecal samples. This test is intended for healthcare professional use only. Meanwhile, this test is used for the clinical diagnosis of infantile diarrhea in patients with HP infection.

PACKAGE SIZE
1 kit /box, 10 kits /box, 25 kits,/box, 50 kits /box.

SUMMARY
H.pylori infection and chronic gastritis, gastric ulcer, gastric adenocarcinoma, gastric mucosa associated lymphoma has the close relation, in gastritis,gastric ulcer, duodenal ulcer and gastric cancer in patients with H.pylori infection rate of about 90%. The world health organization has listed HP as the first type of carcinogen and is clearly a risk factor for gastric cancer. HP detection is the important means of diagnosis of HP infection^[1]. The kit is a simple and intuitive qualitative detection, detecting the helicobacter pylori in human excrement, which has high detection sensitivity and strong specificity. The results can be obtained in 15 minutes based on the high specificity of the dual antibody sandwich reaction principle and the emulsion immunochromatography analysis technique.

ASSAY PROCEDURE
1.Take out the sampling stick, inserted into the faeces sample, then put the sampling stick back, screw tight and shake well, repeat the action 3 times. Or using the sampling stick picked about 50mg faeces sample, and put in a faeces sample tube containing sample dilution, and screw tightly.
2.Use disposable pipette sampling take the thinner faeces sample from the diarrhea patient, then add 3 drops (about 100µL) to the fecal sampling tube and shake well, put aside.
3.Take out the test card from the foil bag, put it on the level table and mark it.
4.Remove the cap from the sample tube and discard the first two drops diluted sample, add 3 drops (about 100uL) no bubble diluted sample verticaly and slowly into sample well of the card with provided dispette, start timing.
5.The result should be read within 10-15 minutes, and it is invalid after 15 minutes.