Newscen Biopharm Co., Limited
Professional Manufacturer of Rapid Test Devices
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H. Pylori rapid Test Cassette
For the qualitative detection of antibodies to h. Pylori in serum /plasma and whole blood
Summary and Explanation of The Test
The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal and gastric adenocarcinoma. Antibodies to H.pylori are developed in individuals infected with H. pylori as a serological response. Detecting these specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection. It may be used either as an adjunction to endoscopy or as an alternative measure in symptomatic patients.
Principle
The H. pylori Rapid Test is a lateral flow, immunochromatographic-screening test. H. pylori antigens are precoated onto membrane as a capture reagent on the test band region.
During the assay the specimen serum is allowed to react with H. pylori antigens-gold conjugate. The mixture then moves laterally on the membrane chromatographically to the test region with immobilized antigens of H. pylori. If H. pylori antibodies are present in the specimen, two colored bands are formed on the test region. One colored band in the test region indicates a negative result.
Interpretation of Results
Negative:
Only one pink band appears. This indicates that no H. pylori antibodies have been detected.
Positive:
Two pink bands appear. This indicates that the specimen contains H. pylori antibodies.
Invalid:
If no band appears, this indicates a possible error in performing the test. The test should be repeated using a new device.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).