FDA authorizes Abbott’s 15-minute, $5 COVID-19 card test ‘BinaxNOW’

Abbott Laboratories’ new technology might change the game in how the spread of the COVID-19 pandemic is curbed. The health care company has just received emergency use authorization from the FDA for its BinaxNOW COVID-19 test. The test works similar to a pregnancy test and costs only $5, returns results in 15 minutes, and is the size of a card.

BinaxNOW is not a complete testing solution but is an antigen test. This means that the card looks for proteins on the surface of the SARS-CoV-2 virus rather than the genetic sequence of the entire virus. Antigen tests are cheaper, faster, and easier to scale. However, there are concerns about antigen testing due to its slightly less accurate nature.

“Abbott’s BinaxNOW™ COVID-19 Ag Card is a rapid, reliable and affordable tool for detecting active coronavirus infections at massive scale.” – Abbott Laboratories
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Researchers still argue that affordable antigen testing solutions like BinaxNOW may be the most efficient way to curb the spread of the novel coronavirus. Abbott claims that its test diagnoses a COVID-19 positive accurately 97.1 percent of the time and COVID-19 negative accurately 98.5 percent of the time. The argument that many researchers use is that a tiny percent of false-positives and false-negatives at a larger scale may be more effective than a lack of testing and long turnaround times.

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Many tests in the United States still have turnaround times up to a few days or even a week. “With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus,” said Joseph Petrosino, a professor of molecular virology and microbiology at Baylor College of Medicine, in a statement from Abbott.

Due to its affordable and card-sized form factor, the BinaxNOW test could be quickly deployed to schools, doctors’ offices, and even emergency rooms, according to the FDA’s statement. The test just requires a nasal swab that is inserted into the BinaxNOW card. A colored line then appears on the card if the patient has tested positive.

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“Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Jeff Shuren, director of the FDA Center for Devices and Radiological Health, in a statement.

Abbott is also launching a mobile application that can be used in sync with the testing cards. The application will present a “digital health pass” that they can show on their phones if they have tested negative. Abbott Laboratories CEO Robert Ford said that the combination of BinaxNOW and the card creates a “comprehensive testing solution.”

BinaxNow

Abbott’s press release says that the company plans on manufacturing 50 million BinaxNOW test cards per month by October. Hopefully, that number can be ramped up much higher with more funding and support from the federal government. Antigen testing, though not a complete alternative for regular tests, still prove to be a useful tool in slowing the spread of the pandemic and reopening America.

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Source: The Verge

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