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 –individually wrapped for single use
- Negative Control Swab: 1 each –individually wrapped for single use
- Documentation: Product Insert, Procedure Card
Performance Data
- Sensitivity: 97.1%
- Specificity: 98.5%
Product Non-Refundable, Non-Returnable
