Intended Use: The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum. This test is intended to aid in the diagnosis of H. pylori infection in adult patients 18 years or older with clinical signs and symptoms of gastrointestinal disease. The QUANTA Lite™ H. pylori IgA should be performed and interpreted in conjunction with the QUANTA Lite™ H. pylori IgG for the detection of IgG antibodies to H. pylori.
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