Rapid Diagnostic Helicobactor Pylori Antibody Test Kit In Vitro Diagnosis Reagents

Product Description
Helicobactor Pylori Antibody Test
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Helicobactor Pylori Antibody TestCountry of originShanghai,china
ModelColloidal Gold Immunoassay Technologies
Dimension63cm*41cm*29cm
Warranty2 yearsBrand NameEUGENECertificationCE
Colorwhite
Sizestrip/cassette/midstream
Processing Time5-10 minutes
Quality/sensitivity
97.10% ; accuracy:97.80%
Helicobactor Pylori Antibody Test
Usage:
The EUGENE® H. Pylori Ab Rapid Test is a lateral flow immumochromatographic assay which uses recombinant antigens to detect the antibodies (IgG, IgM, and IgA) to H. Pylori in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Helicobacter Pylori (H. Pylori). The test is recommended for professional use only. All results must be interpreted together with other clinical information available to the physician.
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SUMMARY:
Helicobacter Pylori is a corkscrew-shaped, gram-negative rod that lives in the mucous layer of the stomach. H. pylori infection is now accepted as the most common cause of gastritis, and is etiologically involved in gastric ulcer, duodenal ulcer, gastric adenocarcinoma and primary gastric B-cell lymphoma.1,2 The organism is very common, infected at least half of the world’s population. H. pylori infection is typically acquired in childhood. once acquired, infection persists chronically, probably continuing in the. stomach throughout life. The damage to gastric structure and function of stomach is constant and direct. Approximately one in six of H. pylori infection develops peptic ulcer disease and a small portion of H. pylori infection leads to gastric cancer.3 The diagnostic tests for H. pylori can be classified into two categories: Invasive and Noninvasive tests. Direct detection by invasive test procedures requires an endoscopy and biopsy specimens from antrum and stomach body.4 The presence of H. pylori is then confirmed by direct culture, histological examination or rapid urease test. The endoscopy and biopsy specimens offer direct detection of active H. pylori infections. Although the procedure is highly specific and high positive predictive value, the cost and discomfort to the patients are very high. The most widely available noninvasive test is probably the serological based test. The serology test detects H. pylori specific IgG antibody in patient serum with current or prior infection.5,6 Serology test is a simple, convenient test with relative high sensitivity. The EUGENE® H. Pylori Ab Rapid Test is an immunochromatographic assay that uses specific antigen-coated colloidal gold to detect the presence of H. pylori antibodies in serum specimens. The test is simple and easy to perform and the test results can be visually interpreted within 15 minutes
STORAGE AND STABILITY
Store the kit in cool and dry places at a temperature between 2-30°C. Do not freeze. The shelf-life of the kit under these storage conditions is 24 months.
Accuracy
All results of each 10 of three batches of EUGENE® H.Pylori Ab rapid tests were positive with high color uniformity when tested with National Accuracy References.
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