Abbott binaxnow point of care ag card test

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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)



Returns Policy

As a provider of personal protective equipment (PPE) and with our customers' safety in mind, we are unable to accept returns, exchanges or cancellations for these products. To contact the MQ Direct Customer Care Team, please call 201.855-9870 or Email


DOMESTIC SHIPPING POLICY Shipment processing time All orders are processed within 2-3 business days. Orders are not shipped or delivered on weekends or holidays. If we are experiencing a high volume of orders, shipments may be delayed by a few days. Please allow additional days in transit for delivery. If there will be a significant delay in shipment of your order, we will contact you via email or telephone. Shipping rates & delivery estimates Shipping charges for your order will be calculated and displayed at checkout. Shipment to P.O. boxes or APO/FPO addresses ships to addresses within the U.S., U.S. Territories, and APO/FPO/DPO addresses. Shipment confirmation & Order tracking You will receive a Shipment Confirmation email once your order has shipped containing your tracking number(s). The tracking number will be active within 24 hours. Customs, Duties and Taxes is not responsible for any customs and taxes applied to your order. All fees imposed during or after shipping are the responsibility of the customer (tariffs, taxes, etc.). Damages is not liable for any products damaged or lost during shipping. If you received your order damaged, please contact the shipment carrier to file a claim. Please save all packaging materials and damaged goods before filing a claim. INTERNATIONAL SHIPPING POLICY We currently do not ship outside the U.S.

Abbott BinaxNow Point of Care Ag Card Test


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