ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test
25 Tests/Kit
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.
For in vitro diagnostic use.
For Rx use only.
Efficient
1 sample - 3 results to aid in a differential diagnosis at the point-of-care
Rapid
Actionable results at 15 minutes to help improve patient management decisions during the patient visit
Instrument-free
User-friendly test procedure for non-lab settings
Accurate
- 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%
Time to result: 15 minutes
Sample type: Anterior nasal or nasopharyngeal swab specimen
Interpretation: Visually read (no instrument required)
Method: Lateral flow
Storage conditions: 2 to 30oC (35 to 86oF)
ViraDx Emergency Use Authorization Number (EUA): EUA220131
This product has not been FDA cleared or approved, but has been authorized by FDA under and EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vito diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
