photo This company recently received FDA clearance for this test for Helicobacter pylori, which detects H. pylori IgA antibodies.
     The PP-CAP IgA enzyme immunoassay kit is an in vitro qualitative test for the detection of IgA antibodies to H. pylori in human serum or plasma.
     The assay is used as a second line test in the diagnosis of H. pylori infection in adults with gastrointestinal disease symptoms who may have tested negative for IgG antibodies to the bacterium. The assay should be performed and interpreted in conjunction with the company’s HM-CAP EIA test for IgG antibodies to H. pylori.
     The IgA kit uses a proprietary antigen and has demonstrated a sensitivity of 93.1 percent and a specificity of 89.0 percent when compared to a combination reference method that includes the urea breath test and the HM-CAP test.
Enteric Products
Keyword: assay, H. pylori