INTENDED USE

This test is intended for the in vitro qualitative/quantitative detection of Helicobacter pylori antigen in feline fecal specimens using a fluorescence immunoassay analyzer. It is used as an aid in the non-invasive diagnosis of active H. pylori infection, in the investigation of chronic gastritis, recurrent vomiting, and anorexia, and in monitoring treatment efficacy and post-therapy follow-up. Results should be interpreted together with clinical symptoms and other diagnostic methods.

PRINCIPLE

The test employs a sandwich fluorescence immunoassay. Anti-Helicobacter pylori monoclonal antibodies conjugated to fluorescent nanoparticles bind H. pylori antigens in the fecal extract on the conjugate pad. The complex migrates by capillary action along the nitrocellulose membrane and is captured at the T line by immobilized anti-H. pylori antibodies, forming a fluorescent sandwich complex. A portable fluorescence reader quantifies the T-line signal and provides a qualitative or semi-quantitative result, while the C line confirms the validity of the assay.

SPECIMEN

Feces (fecal swab). Collect a fresh fecal sample with the swab, elute in the provided buffer, mix thoroughly, and apply the prepared sample to the test device; fresh samples collected within 24 hours are preferred.