QuickVue® Professional Use SARS Antigen Nasal Swab Test Kit - Not for Home Use

Non-Returnable

• 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