The Food and Drug Administration issued an emergency-use authorization Wednesday for what it called a “fast and efficient” COVID-19 test developed by Abbott Laboratories that will be available for $5 and which can provide results within 15 minutes of testing.
The FDA said its emergency-use authorization allows Abbott to market “the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer.”
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
“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,” he said.
President Donald Trump was set to announce Thursday a $750 million deal with Abbott that will see the U.S. government purchase 150 million tests, according to CNBC.
“Under President Trump’s leadership, the U.S. is leading the world in testing,” White House communications director Alyssa Farah said in a statement to the outlet. “This is a major development that will help our country to remain open, get Americans back to work, and kids back to school. The Trump Administration is proud to partner with Abbott labs to make this purchase possible to help the American people.”
According to the FDA, the test is administered by a health care provider, who “swabs the patient’s nose and twirls that sample on a test card with a testing reagent added.”
The rest, the agency said, is simple.
“After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result,” the FDA said.
The test is designed to be given to patients who are experiencing COVID-19 symptoms, the agency added.
Abbott said in a news release that in tandem with the portable test, which is roughly the size of a credit card, it is releasing a “complementary phone app, which allows people to display their … test results when asked by organizations where people gather, such as workplaces and schools.”
The app will provide those who don’t have the disease with the information they need “when entering facilities requiring proof of testing,” the company said.
Abbott is gearing up to ship tens of millions of tests in September, and expects to ship out 50 million tests a month beginning in October.
“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, a professor of molecular virology and microbiology at the Baylor College of Medicine.
“With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. 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,” he said.
Abbott said the test can be performed by “doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training.”
“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Dr. Charles Chiu, a professor of laboratory medicine at the University of California, San Francisco. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it.”
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