BinaxNOW COVID-19 Ag Card
For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results should be treated as presumptive, 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.
The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's EUA.
Kit Details
Test Card: 40 cards with test strips
Extraction Reagent: bottle containing 7.5 mL of extraction reagent
Nasal swabs: 40 sterile, single use specimen sampling swabs
Positive Control Swab: 1 each â??individually wrapped for single use
Negative Control Swab: 1 each â??individually wrapped for single use
Documentation: Product Insert, Procedure Card
Performance Data
Sensitivity: 97.1%
Specificity: 98.5%
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