H. pylori Antigen Test Card

 The H. pylori Antigen Card Test is a qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment of H. pylori in peptic ulcer patients. This product is intended for Laboratory use only. This product is not intended for use in emergency rooms or point of care facilities.

 

Most common in children causing a stomach infection. Risk: developing countries, crowded conditions, where there is no reliable clean water, contracting from another. Found in Russia, Asia, Central America, and some parts of Africa.

​

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. The organism is common and infects at least half of the world’s population with infection typically acquired in childhood. The 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.

​

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. The presence of active H. pylori infection is then confirmed by direct culture, histological examination or rapid urease test. The procedure is specific with high positive predictive value. It is expensive and causes discomfort to the patients. 

​

Serology Test is the widely available noninvasive test. It detects H. pylori specific IgG antibody in patient serum with current or prior infection. It is a simple, convenient test with relative high sensitivity; with main limitation as the inability to distinguish current and past infections. Antibody may be present in the patient’s serum long after eradication of the organism. The urease breath test (UBT) with 14C or 13C labeled urea, is a noninvasive test based on the urease activity of the organism. UBT detects active H. pylori infection and is highly sensitive and specific. The UBT requires a high density and active bacteria and should not be performed until 4 weeks after therapy to allow residual bacterial to increase to a sufficient number for detection.