Status COVID-19/Flu A&B Rapid Antigen Test (33225)

Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Product Specifications Tests/box 25 Sample type Nasopharyngeal swab Time to results 15 minutes COVID-19 Sensitivity 93.1% , Specificity 100% Flu A Sensitivity 91.4%, Specificity 95.7% Flu B Sensitivity 87.6%, Specificity 95.9% Kit storage conditions Room temperature (1.6°C to 30°C/35°F to 86°F) Internal controls Included External controls Not included CLIA complexity Waived* Certification FDA EUA Additional Information The Status™ Covid-19/Flu A&B test has not been FDA cleared or approved, but has been auth