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Abbott Laboratories receives federal approval for COVID-19 test that offers results in 15 minutes

Maine CDC Director Dr. Nirav Shah said the first shipment of the tests could arrive in Maine within the coming week, and will include about 26,000 tests.
Credit: Getty Images/iStockphoto

Westbrook-based Abbott Laboratories has recently received approval from the federal government on a new testing device called the BinaxNOW™ COVID-19 Ag Card rapid antigen test.

According to Abbott Laboratories and Maine CDC Director Dr. Nirav Shah, the test offers results in 15 minutes.

Antigen testing seeks to identify the spiky proteins on the surface of the virus itself.

"Maine will soon be receiving approximately 26,000 of these BinaxNOW tests as part of its initial allocation," Dr. Shah said. "We understand from the federal government that subsequent allocations will also be made to the state of Maine throughout the end of the year."

Abbott Labs said it will ship tens of millions of tests across the country in September and will ramp manufacturing to 50 million tests a month in October. It is manufacturing the test at massive scale in two new U.S. facilities. 

Dr. Shah said Maine's first shipment of the tests could arrive within the coming week. He said Maine CDC will provide updates on when the tests are received and how they are deployed.

"The bottom line here is that the availability of at least 26,000 initial tests using this rapid testing platform represents a welcome addition to the types of tests that are already available in Maine," Dr. Shah said. "These particular tests have the benefit of returning a result within approximately fifteen minutes, if not sooner. They can, as I mentioned, also be used in a variety of settings given that the testing device itself is rather small and self contained. All of these advancements mean that we will be able to continue offering greater and greater availability of testing options to as many individuals in Maine as we can." 

RELATED: FDA authorizes rapid $5 coronavirus test that doesn't need specialty equipment

Dr. Shah said the federal government and the U.S. CDC have recommended that one of the principal uses for the new tests be in and among schools. Dr. Shah said the tests will helpful if students or teachers exhibit symptoms of COVID-19 during the school day.

"Having that early look at what might be happening at the school level when someone starts exhibiting symptoms helps public health folks at my agency get a quicker sense of what might be happening. If the test returns positive, that takes us down one pathway. If it returns a negative result, that immediately takes us down a separate pathway," Dr. Shah said, adding that there's not great data on how the tests will work with people who have not shown symptoms of the virus. However, nothing is ruled out. "What we have seen of the data suggests that the accuracy of the test and the test performance is best when it is done among symptomatic individuals."

Dr. Shah said Maine CDC is also looking at other settings where being able to identify positive vs. negative very quickly would be particularly useful to help inform the immediate public health response. No final decisions have been made and discussions are ongoing

"It takes more than having the test to use the test," Dr. Shah said. "There also has to be a healthcare provider who can observe the operation and conduct of the test to make sure it's being done correctly."

Dr. Shah said Maine CDC is currently planning so that when the tests arrive in Maine, they can rapidly deploy them to where they'll do the most good.

RELATED: Maine's first recipient of Abbott Labs' rapid COVID-19 test is Martin's Point Health Care

The BinaxNOW test can be displayed on Abbott's new optional app — available at no charge — for iPhone and Android devices called NAVICA™. The app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.

"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Robert Ford, Abbott's president and chief executive officer, said. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use and scalable test, and a digital health tool to help us have a bit more normalcy in our daily lives."

According to Abbott Labs, here's how the test works:

  • The healthcare worker opens the card and lays it flat on a countertop.
  • Extraction reagent is added to the test card, which is about the size of a credit card.
  • A nasal swab is taken from the patient.
  • A technician inserts the swab into the test card, folds over the cover and in 15 minutes, reads the result.
  • People who use the app and receive a negative test result will get a temporary encrypted digital health pass via a QR code (similar to an airline boarding pass) sent to the NAVICA app. The digital pass is renewed each time a person receives a negative test result and includes the date of the latest test result submission. Organizations will be able to view and verify the information on a mobile device to help make entry into these places easier, along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
  • Those who test positive will receive a message through the app telling them to quarantine and talk to their doctor.

Abbott Labs also notes on its website the following characteristics that make the test particularly useful:

  • Easy to use.
  • Affordable.
  • Highly portable, requiring no instrumentation.
  • Reliable, with 97.1% sensitivity and 98.5% specificity.
  • Fast, with results in 15 minutes.

RELATED: FDA fast-tracks COVID-19 testing device made in Scarborough

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