Status™ Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. Performance characteristics for influenza A and B were established during the 2007-2009 and the 2014-2016 influenza seasons when influenza A/H1N1, A/H1N1 pandemic, A/H3N2, influenza B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance reports from the CDC. When other influenza viruses are emerging, performance characteristics may vary.