Abbott BinaxNOW™ COVID-19 Ag Card

Description

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

Specifications

• 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.