BinaxNOW COVID-19 Ag Card, ABBOTT, OTC, At Home Use, 2 test per kt, 6 kits per cs

• BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's Emergency Use Authorization


• The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal (nares) swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms


• 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


• 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 SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions


• Sensitivity (PPA) 84.6% (entire population)


• Sensitivity (PPA) 95.6% (those with PCR cycle threshold [Ct] < 33)


• Specificity (NPA) 98.5%


• Onboard extraction allows the swab to be directly inserted into the test card


• Visually read results in 15 minutes - no instrument required


• The BinaxNOW COVID-19 Ag Card does not differentiate between SARSCoV and SARS-CoV-2