The US Food and Drugs Administration has given clearance for the marketing of the PP-CAP IgA enzyme immunoassay kit developed by Enteric Products, a subsidiary of E-Z-EM Inc, of Westbury, New York, USA.
The test detects IgA antibodies to HP in human serum or plasma.
Under the terms of the approval it is to be used as a second-line test in adults with symptoms of gastrointestinal disease who have tested negative to IgG antibodies.
In trials the new test has shown a sensitivity of 93.1 per cent and a specificity of 89 per cent when compared with other tests that included a urea breath test.
Anthony Lombardo, president of E-Z-EM, said: "Our new PP-CAP assay gives the practitioner an important new method of diagnosing HP infection in patients. It essentially provides an additional tool for completing the diagnostic puzzle and will allow for the proper treatment of conditions such as gastric and duodenal ulcers and chronic gastritis.
"Existing blood tests, such as our HM-CAP assay, detect only IgG antibodies. This single antibody focus may cause some patients to go undiagnosed and untreated. Our new PP-CAP assay will test for another antibody, IgA, and will offer the physician a more complete picture of antibody response when used in conjunction with HM-CAP."
Report Copyright: Englemed Health News at http://www.internationalmedicalnews.com