RAPID DETECTION OF HELICOBACTER PYLORI IN HUMAN FECAL SPECIMENS

The H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in human fecal specimens. It is a noninvasive way to detect H. pylori when endoscopy is not required, using antibodies specific to H. pylori antigen.

The test is intended for use with fecal specimens that are fresh, frozen, or in transport media. The kit can be used with an automated wash system and read either visually or by spectrophotometer.

Approximately half the global population is infected with Helicobacter pylori. Most have no symptoms, a minority of these people develop gastritis of these a few develop gastric ulcers or gastric cancer.

The standard procedure to diagnose H. pylori involves endoscopy with biopsy, some patients may benefit from non-invasive tests, such as a fecal antigen test. These tests can also verify that H. pylori infection has been eradicated after treatment.

H. PYLORI CHEK™

• Detects H. pylori-specific antigen
• Utilizes preserved or unpreserved fecal specimens
• ELISA microwell format
• Results in approximately 60 minutes
• Simple and clear interpretation of results

• Performance Characteristics in comparison to a composite reference method (rapid urease and histology)
  • Sensitivity 100%
  • Specificity 96.1%
• Limit of Detection (LOD)
  • 6.70 ng/ml in fecal matrix
  • 26.57 ng/ml for specimens in Cary Blair media
  • 18.19 ng/ml for specimens in C&S media

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Product Code: TLI-T5051                     H PYLORI CHEK™ (96 wells)