COVID-19 & Flu A+B

Symptoms for common respiratory conditions including COVID-19 and influenza are nearly identical. So when patients present with these symptoms, the treatment imperative will be to quickly and reliably diagnose these patients to manage to the treatment pathway AND isolation measures required.

^{**The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 & Flu A+B is intended for the qualitative detection of SARS-CoV-2 and/or influenza A and B nucleocapsid antigens directly from anterior nasal swab samples taken from individuals who are suspected of a viral respiratory infection consistent with  COVID-19 by a healthcare provider, within the first six days of symptom onset}

^{•This product has not been FDA cleared or approved; but has been authorized by FDA under an 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.}

^{•This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro 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.}

^{Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet the requirements to perform moderate, high or waived complexity tests.  This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.}