Rapid antigen designed to provide reliable effects and peace of mind.
COVID-19 verification will continue to be a vital tool as our global communities continue to revel in seasonal waves of COVID-19. The BinaxNOW COVID-19 self-test is the same as the verification card for professional use, which has been in use since August 2020, and is the most studied and widely available immediate antigen test.
With BinaxNOW authorized for asymptomatic common use without a prescription, we perform checks directly for quick results, whenever and wherever you want them. You can now access our BinaxNOW control at your local retailer, over the counter or with your healthcare professional. This combination increases access to fast, simple, affordable, and reliable verification options.
No more queues, no more waiting times, no more barriers and no more inconveniences. Now they are in your hands.
The BinaxNOW™ COVID-19 Antigen Self-Test is a lateral immunological assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in Americans with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when double-checked outside of three days with at least 36 hours between controls. This control is legal for home use without a prescription with self-collected anterior nasal swab (nostrils) specimens from Americans 15 years of age or older or anterior nasal swab specimens collected through adults from Americans two years of age and older.
The BinaxNOW COVID-19 Ag 2 Card is a lateral immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in direct samples from previous nasal swabs of Americans symptomatic for COVID-19 tested twice over 3 days with at least 36 hours between tests within the first seven days from symptom onset.
This screening is legal for use with direct anterior nasal swab (nostrils) specimens from Americans without symptoms or other epidemiological reasons to suspect COVID-19, when checked twice over 3 days with at least 36 hours between checks. Testing is limited to qualified laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U. S. C. §263a, which meet the needs for performing controls of moderate, high, or exempt complexity. This control is legal for use at the point of care (POC), i. e. , in patient care facilities operating under a CLIA Exemption Certificate, Certificate of Compliance, or Certificate of Accreditation.
The BinaxNOW COVID-19 Ag Card 2 Home Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen on direct anterior nasal swabs (nostrils) of Americans with or without symptoms or other epidemiological reasons to suspect. -19 infection checks twice for 3 days with at least 36 hours between checks. This control is legal for home use without a prescription with samples of anterior nasal swabs (nostrils) collected by themselves from Americans over the age of 15 or anterior nasal swabs. Samples collected from adults from Americans aged two years and older. The BinaxNOW COVID-19 Ag Card 2 internal control should be performed only under the supervision of a telehealth monitor.
BinaxNOW™ COVID-19 tests have not been legal or approved by the FDA. They were legal through the FDA under an emergency use authorization. They have been legal only for the detection of SARS-CoV-2 proteins, and not for other viruses or pathogens, and are only legal while the declaration lasts that there are cases that justify the authorization of the emergency use of in vitro diagnostics for their detection. and/or diagnosis of COVID-19 pursuant to segment 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U. S. C. § 360bbb-3(b)(1), unless the statement is terminated or authorization is revoked sooner. For serial verification, BinaxNOW COVID-19 Antigen Tests must be performed twice over 3 days, at least 24 hours (and no more than 48 hours) apart. For symptomatic use, a single test may be used.
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