Abbott BinaxNOW™ COVID-19 Ag Card

Easy to use 15 min. rapid antigen test for detecting active infections of COVID-19

• Cost-effective, high performing test designed for decentralized testing
• Visually read results in 15 min.
  • No instrument required
• Simple test procedure using direct nasal swab
• Onboard extraction allows swab to be directly inserted into test card
• Room temperature storage

Includes:

• 40 cardboard, book-shaped hinged test cards with test strips
• 1 x 7.5 mL extraction reagent bottle with reagent
• 40 sterile nasal swabs
• 1 positive control swab
  • Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen
• 1 negative control swab
• 1 product insert
• 1 procedure card

Notes:

• Emergency Use Authorization (EUA) supports testing in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation

Certifications/Compliance

EUA

Content And Storage

2°C to 30°C

CPT Code

87811

Clia Complexity

Waived

Detectable Analytes

SARS-CoV-2 Nucleocapsid Protein Antigen

Detection Method

Lateral flow immunoassay

Sample Type

Direct Nasal Swab

Sensitivity

84.6%

Type

COVID-19 Test

Disposable

Single-use

For Use With (Application)

Lateral Flow Immunoassay

Includes

40 cardboard, book-shaped hinged test cards with test strips, 1 x 7.5 mL extraction reagent bottle with reagent, 40 sterile nasal swabs, 1 positive control swab containing non-infectious recombinant SARS-CoV-2 nucleocapsid antigen, 1 negative control swab, 1 product insert, 1 procedure card

Material

Plastic test strip with nitrocellulose

Organism Group

SARS-CoV-2

Packaging Type

Cardboard kit box with individually foiled wrapped test cards

Quantity

40 Tests

Specificity

0.985

Target Organism Class

SARS-CoV-2

Test Time

15 min.