Description

**Testing is limited to organizations certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.**

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 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., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Learn About The Abbott BinaxNOW COVID-19 Antigen Card Test

Discover the fast, proven, and trusted COVID-19 antigen card test that is readily available over-the-counter at retailers across the country. Easily perform this COVID-19 test with a simple nasal swab in the comfort and convenience of your own home. This COVID-19 antigen test is available under the FDA Emergency Use Authorization and is only available in the US.

For this BinaxNOW COVID Test Bulk product listing, there is 1 case of 40 COVID-19 antigen tests, authorized for point of care use.

• SIMPLE AND EASY TO USE: Requires just a shallow nasal swab that you can do yourself; includes easy-to-follow instructions.
• SEE RESULTS IN 15 MINUTES: Convenient, fast results anytime, anywhere; no need for a prescription or send to a lab.
• FOR AGES 2 TO ADULT: Indicated for children as young as 2 years old when administered by an adult and for all people 15 and older to self-administer.
• DETECTS ACTIVE COVID-19 INFECTION: Includes 2 BinaxNOW COVID-19 self-tests that are indicated for serial testing—simply test yourself twice within 3 days, at least 36 hours apart; designed to detect an active infection with or without symptoms. Detects multiple strains, including the DELTA variant.*
• FOR PERSONAL USE: This BinaxNOW COVID-19 antigen self-test does NOT meet the CDC testing requirements to enter the U.S. when returning from a trip abroad. For proof of a negative COVID-19 test, the BinaxNOW COVID-19 Antigen Card Home Test may be a better choice.
• OPTIONAL SELF-REPORT: Capture your COVID-19 test results in the NAVICA app (Apple and Google) for self-reporting.

BinaxNOW COVID-19 Antigen Card 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

FAQs about Abbott’s COVID-19 Antigen Test:

1) How long should people wait between taking BinaxNOW Antigen Tests?

The BinaxNOW COVID-19 antigen self tests should be administered twice over three days with at least 36 hours between each antigen test.

2) How do I know if I have a positive or negative test?

In order to check for a positive result, you will need to look at the result window for two pink (or purple) lines. Even a faint line next to the word "sample" on the BinaxNOW COVID-19 test card is a positive result. A negative result will only have one pink or purple line on the top half of the COVID-19 test results window where it says "control."

3) What do I do if my antigen self-test result is invalid from my BinaxNOW COVID Test Bulk?

If your BinaxNOW antigen test results window has any of the following, the test result may be invalid:

• No lines appear by control or sample
• The control line is blue and not pink/purple
• There is a pink/purple line by sample, but no line by control
• The control line is blue, but the sample is pink/purple

If any of the above BinaxNOW COVID-19 test issues arise with your antigen test, please contact: support@bttnusa.com to help or answer any further questions.

4) Who should use this COVID-19 self-test?

The BinaxNOW COVID-19 antigen self-test for over-the-counter use at home is indicated for all people aged 15 years or older and for children as young as 2 years old when the test samples are collected by an adult. This COVID-19 test can be used for people with and without symptoms.

5) How accurate is Abbott's BinaxNOW COVID-19 test?

According to studies, Abbott’s BinaxNOW COVID Test Bulk antigen self-test has an accuracy rate of 84.6% for detecting covid-19 infections, and 98.5% for correctly identifying covid-19 negatives.

6) What are COVID-19 antigen tests?

COVID-19 Antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus. The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for antigen tests that can identify SARS-CoV-2 (commonly known as COVID-19).

Downloads:

• Test Instruction PDF
• Abbott's Test Instructional Video