Innovita Flu A/B Antigen Rapid Test

The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay that qualitatively detects and differentiates influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs. It is intended as an aid in the differential diagnosis of acute influenza A and B infections in patients with respiratory symptoms. Negative results are presumptive and should be confirmed by viral culture or FDA-cleared molecular assay.

The device uses a double antibody sandwich immunoassay format with latex microsphere-labeled monoclonal antibodies in the specimen zone and capture antibodies at the test line. Results are read visually as red-purple lines indicating presence of antigen. The time to result is 10–30 minutes. It is substantially equivalent to the CareStart Flu A&B Plus predicate in specimen type (nasopharyngeal swabs), assay result format (qualitative), technology (immunochromatographic), device format (cassette), and detection method (visual line interpretation).

Not stated in this summary.

The Innovita device demonstrates substantial equivalence through identical intended use (rapid differential diagnosis of acute flu A/B from nasopharyngeal swabs), equivalent technology (immunochromatographic assay with visual readout), and comparable assay performance. Analytical validation shows excellent sensitivity and specificity across multiple circulating viral strains, no cross-reactivity with 49 common organisms, and 100% reproducibility across operators, sites, and lots. Clinical performance data from 1101 specimens show 85.7% positive percent agreement and 99.5–100% negative percent agreement against FDA-cleared molecular comparator, meeting or exceeding predicate device performance standards.