Assay Detects Anti-helicobacter Pylori IgG Antibodies

A rapid immunochromatographic assay detects antibodies against Helicobacter pylori in urine and aids in the diagnosis of H pylori infection.

The assay is available in the new Rapirun kit, which is suitable for use in both point-of-care and clinical laboratory settings. The test is easy to administer, economic, and convenient for the patient. Noninvasive testing for screening of H pylori infection is preferred over methods that require endoscopy. Approximately 81% of dyspeptic patients presenting to primary care receive noninvasive testing in the United States. Options include testing for specific anti-H pylori IgG antibodies, urea-breath tests (UBTs), and stool antigen tests.

The Rapirun kit was developed by the Otsuka Pharmaceutic Company (Tokyo, Japan) as an in vitro diagnostic device employing the immunochromatographic method that can detect low levels of anti-H pylori antibodies in urine. The operating procedures are simple, and test results can be determined by visual inspection in about 20 minutes.

Recent studies show that detecting anti-H pylori antibodies in urine to diagnose infection is an effective alternative to blood-based antibody tests. However, the concentration of IgG in urine is far lower than it is in serum. Because of the low concentration, a highly sensitive test like the Rapirun kit is required for detection of antibodies in urine.

Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka--people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative, original products, focusing its core businesses on pharmaceutical products for the diagnosis and treatment of disease and on consumer products for the maintenance of everyday health.

Additional Otsuka family technologies related to H pylori include the BreathTek UBT (13)C-urea breath test for determination of H pylori infection and the UBiT IR300 and POCone infrared spectrophotometers for measurement of (13)CO(2) level in breath.



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