Respiratory Test Kit QuickVue® Professional Use SARS Antigen 25 Tests CLIA Waived (M-1183198)

Name: TEST KIT, SARS ANTIGEN QUICKVUE PROFESSIONAL USE (25/KT) • For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations • 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 • Product ships with minimum 60 days dating • Please see attached letter for detailed information on a 1 year extension on expiration dating • The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms • The QuickVue SARS Antigen test does not differentiate between SARS-CoV and SARS-CoV-2 • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities • Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed; negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions • Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 • The QuickVue SARS Antigen test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings • Accurate detection with direct anterior nares swab samples: 96.6% PPA and 99.3% NPA • Simple workflow follows a similar format to CLIA-waved QuickVue assays, just sample, dip, and read • Each kit contains everything needed to perform the test, including Nasal Swabs and positive and negative controls