Abbott BinaxNow Point of Care Ag Card Test

Abbott BinaxNow Point of Care Ag Card TestBinaxNOW COVID 19 Ag Card Product Description 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

BinaxNOW™ COVID-19 Ag Card Product Description

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.

Abbott BinaxNow AGCard 25 Pack 195-000 Box Contents:

The contents below are per a box (25 Tests):

Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip

Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent

Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test

Positive Control Swab (1) : Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab

Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained

Product Insert (1)

Procedure Card (1)