QuickVue® Professional Use Test Kit, SARS Antigen, for COVID-19

Kit contents include 25 individually packaged test strips, 25 reagent tubes, 25 vials of reagent solution with 340 µl salt solution, 25 sterile nasal swabs, SARS positive control swab, negative control swab, package insert and procedure card.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.