BinaxNOW: Expiration Dates and Facing the "Kraken"

What to know about your at-home tests as COVID-19 continues to evolve.

Diagnostics Testing|Feb. 14, 2023

Tissues. Decongestants. Bandages. Tweezers. Thermometers. At-home rapid tests.

All are essentials we've come to keep well stocked in our medicine cabinets. As the seasons, illnesses and our needs change, these essentials stay consistent in our lives. Which is why we're sharing the latest updates with our BinaxNOW COVID-19 Self Tests so they can continue to have a positive impact in your lives even as COVID-19 and its many variants — including the XBB.1.5 or "Kraken" you may have recently heard about — continue to change.

Update 1: Your BinaxNOW Self Test May Have a Longer Shelf Life

When you reach for your stash of BinaxNOW Self Tests — whether you're experiencing symptoms or had a recent exposure — it's important to ensure your test and the components aren't expired.

��«��Ƶ recently received an extension from the U.S. FDA for BinaxNOW Self Tests from 15-month expiration dates to 22-months.��

Here's how you can confirm what your new expiration may be:

Look on the back of your box for both the expiration date (next to the hourglass symbol) and lot number (next to the words LOT).
Visit the to see if your test kit’s lot number has a new expiration date. The FDA has also included of all at-home COVID-19 tests that have an EUA and whether they have an extended expiration. ��

Update 2: BinaxNOW Keeps Up with Changing Variants

Virus variants. It's in their nature to change and adapt to keep themselves alive. And to have perpetually confounding nick-names, such as .

Despite the alphabet soup of variant names, it's important for our COVID-19 tests to continue to detect the virus. Our team of researchers have confirmed that our BinaxNOW tests continue to detect the Omicron variant and its sub-variants, including XBB.1.5. Why is that? While the Omicron variant contains mutations to the spike protein, our tests do not rely on the spike gene to detect the virus.

Update 3: New Guidance on Testing Timing

One of the benefits of at-home tests is that they can be done frequently and provide answers within minutes. As COVID-19 continues to evolve, recent research and regulatory guidance has confirmed that frequent testing – particularly when you are unsure when you were exposed – can increase the chances of catching the virus when it is detectable in people with or without symptoms.

All at-home self tests will have new labels to reflect the importance of frequent testing:

If you test positive, this should be considered a positive
If you test negative within the first seven days of experiencing COVID-like symptoms, test again with at least 48 hours in between tests
If you test negative with no symptoms, test again two more times with at least 48 hours between each test

At-home self-tests, just like our other medicine cabinet essentials, are here to stay. Which is why it's important to know the latest and greatest updates with the products you keep on hand. We'll keep you stocked up on the latest information, while you stay prepared with tests at home. It's a match made in medicine cabinet heaven.��

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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.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

The BinaxNOW™ COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They 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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