Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Influenza A/B virus antigen IVD kits use rapid immunochromatographic tests (ICT) to detect viral antigens in clinical samples, providing results within minutes. These point-of-care or lab-based tests help confirm flu infections quickly, enabling faster treatment decisions and infection control measures during outbreaks.

These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are often supplied as complete test kits, including reagents, swabs, and instructions, and are designed for professional use only—excluding self-testing scenarios.