ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test

ViraDx SARS-CoV-2/Flu A+B Rapid Antigen 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 influenza B directly from anterior nasal or nasopharyngeal swab specimens obtained from patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Product Specifications Tests/Box 25 Sample type Nasopharyngeal or Anterior Nasal Swab Time to results 15 minutes COVID-19 93.8% Sensitivity / 100% Specificity Flu A 92.2% Sensitivity / 94.2% Specificity Flu B 90.0% Sensitivity / 94.3% Specificity Kit contents (25) Test Devices, (25) Extraction Reagent in Capsules, (25) Sterile Swabs, (1) Positive Control Swab, (1) Negative Control Swab, Package Insert  Storage 35-86°F (2-30°C) CLIA complexity Waived Certification FDA EUA CPT Codes COVID-19: 87811QW Flu A: 87804QW Flu B: 87804QW-59 More