ImmunoCard STAT!® HpSA® is a CLIA-waived, easy-to-use, active infection test for H. pylori. A rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment.
- Follow Guideline Recommendations: Guidelines recommend testing for H. pylori with a non-invasive active infection test prior to prescribing a proton pump inhibitor following the ' Test, Treat, Retest, and Confirm Eradication ' protocol
- Follow National Health Plan Standards: Both CMS and private health plans nationwide have adopted the AGA and ACG guidelines for active H. pylori infection testing and are no longer reimbursing for serology
- Rapid Solution for H. pylori Testing: Less than 1-minute hands-on-time
- Patients prefer testing for active infections:ImmunoCard STAT!® HpSA® is less invasive and highly accurate with a sensitivity greater than 90% compared to endoscopy
A CLIA waived one-step lateral flow immunoassay for the direct detection of Helicobacter pylori antigens in stool specimens.