Over-the-Counter Rapid COVID-19 Testing, in Your Hands
BinaxNOW Ag is now available over-the-counter, bringing accessible COVID-19 rapid self-testing to the masses.
Through the course of the COVID-19 pandemic, we've needed answers.
We've filed into long lines, ventured to doctors' offices and urgent care clinics, waited days for results or for home tests to arrive by mail, and postponed gatherings, celebrations and holidays.
Now, those much-needed answers will be in your hands.
Enter: our BinaxNOW COVID-19 Self Test
What is it?
Where can I get it?
How does it work?
Our trusted, affordable, easy-to-use 15-minute test can now detect COVID-19 in both symptomatic and asymptomatic people in your own home, on your own time, with none of the inconveniences and high prices of COVID tests' past.
With the BinaxNOW Self Test, we're fulfilling what we’ve always envisioned: Grabbing a test kit box from your local retailer and knowing your COVID-19 status in 15 minutes, free of hassle.
The authorization of our BinaxNOW Self Test will remove the remaining barriers that may have prevented the masses from accessing tests while permitting serial (frequent) testing for asymptomatic people, helping society collectively return to daily life. Our unmatched manufacturing scale and ability to meet demand means you'll see our tests stocked on shelves when and where you need them.
Finally, the BinaxNOW Self Test is available to all, directly from your local retailer with no doctor, proctor or prescription necessary. So, what does this mean?
While vaccines are rolling out, not all of us are able to receive them as soon as we'd like. And because not all of us are yet fully protected, the BinaxNOW Self Test provides some added peace of mind in minutes. In tandem with vaccines and public health measures, frequent testing with BinaxNOW Self Test can help catch infection and slow the spread of COVID-19.
As you start your day, you can swab your nose, kick off your morning routine while waiting 15 minutes for the test results, get your status, and gain an extra boost of confidence before running out the door.
The self test enables serial testing as well. Frequent testing entails testing yourself twice within three days, with 36 hours between tests.
You can have the extra protection needed to see a friend that you haven't seen since last year. Your family can more safely gather for celebrations. You can coordinate the COVID-conscious bridal showers, baby showers, and engagement celebrations you've been looking forward to. Your child can have a safer birthday party. You can have clarity before attending religious services, weddings, holidays, and days in the office.
Since announcing our BinaxNOW professional test last August, the rapid antigen test has revolutionized the testing process. We’ve ramped up capacity and have seen our tests make a difference in K-12 schools, workplaces, nursing homes, universities and in communities. We've created our NAVICA app to pair with BinaxNOW, allowing people to store, access and display their BinaxNOW test results. We've fulfilled a U.S. government order of 150 million BinaxNOW test cards and made BinaxNOW available for home use.
Our BinaxNOW Self Test can help restore a sense of confidence in moments that even just a few months ago may have felt like a distant dream.
No more lines, no more wait times, no more barriers and no more inconveniences. Answers, in your hands.
IMPORTANT SAFETY INFORMATION
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.
The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.
This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The BinaxNOW COVID-19 Ag Card 2 Home 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 with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. The BinaxNOW COVID-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.
The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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