INTENDED USE:
ViraDxTM 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 protein antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal or
nasopharyngeal swab specimens collected from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by
their healthcare provider, within the first five (5) days of onset of symptoms, when tested at least twice over three days with at least 48 hours
between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test
Item ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test Regulatory For Rx use only ViraDx Emergency Use Authorization Number (EUA): EUA220131 Kit 25 tests/kit Controls Included Time to Result 15 minutes Sample Type anterior nasal or nasopharyngeal swab Performance COVID-19 (Anterior nasal swab): Sensitivity 93.8%; Specificity 100%
COVID-19 (Nasopharyngeal): Sensitivity 93.1%; Specificity 100%
Flu A: Sensitivity 92.2%; Specificity 94.2%
Flu B: Sensitivity 90.0%; Specificity 94.3%
Intended Use For patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms.