**This test is authorized for use at the Point of Care (POC) ONLY, i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Abbott BinaxNOW Covid-19 Antigen Test 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.
COVID-19 Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets the requirements to perform moderate, high or waived complexity tests.
BinaxNOW COVID-19 Antigen Test Specs:
- Detects active COVID-19 infection
- Detects multiple COVID-19 strains, including the DELTA variant*
- Get your COVID-19 test results in just 15 minutes
- Easy to follow, illustrated step-by-step instructions
- Requires a minimally invasive nasal swab sample
- Know your COVID-19 test result now, without the need to wait for results
Abbott BinaxNow Box Contents:
The contents below are per a box (40 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)