Diagnostic Kit（Colloidal gold）for Antibody 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（Colloidal gold）for Antibody to Helicobacter Pylori is suitable for qualitative detection of HP antibody in human blood, serum or plasma samples. This test is intended for healthcare professional use only. This reagent is used to aid the diagnosis of gastric helicobacter pylori infection.

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

SUMMARY
Helicobacter 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 HP infection rate of about 90%. The world health organization has put HP listed as the first kind of carcinogen, and specific risk factors for gastric cancer. HP detection is HP infection diagnosis^[1]. The kit is a simple, visual semiqualitative test that detects HP in human blood, serum or plasma samples, it has high detection sensitivity and strong specificity. This kit based on colloidal gold immune chromatography analysis technology to the qualitative detection of HP antibody in whole blood, serum or plasma samples, which can give a result within 15 minutes.

ASSAY PROCEDURE
1 Take out the test card from the foil bag, put it on the level table and mark it.
2 Adding sample：
Serum and plasma: add 2 drops of serum and plasma samples to the add sample hole with plastic drip, then add 1 drop sample diluent, start timing.
Whole blood: add 3 drops of whole blood sample to the sample hole with a plastic drip, then add 1 drop sample diluent, start timing.
Fingertip whole blood: add 75µL or 3 drops of fingertip whole blood to the sample hole with a plastic drip, then add 1 drop sample diluent, start timing.
3 .The result should be read within 10-15 minutes, and it is invalid after 15 minutes.