BinaxNOW COVID-19 AgCARD By Abbott - (40 Count) CLIA Waived 195-000 - 1 Box (40 Tests)

Description Of Our BinaxNOW™ COVID-19 Ag Card

For Rapid Detection Of SARS-CoV-2 | FDA EUA | IVD Use | RX Only

Performance Data Submitted To The FDA By Abbott:

• Sensitivity: 97.1%

• Specificity: 98.5%

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.