Rapid Test Kit QuickVue® Professional Use SARS Antigen Nasal Swab Sample 25 Tests

Features

• For use under an Emergency Use Authorization (EUA) only: https:www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Product ships from McKesson with minimum 30 days dating 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 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