Bacterial infectious disease IVDs

Intended purpose

Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.