FDA approves new coronavirus antigen test with fast results

National News

FILE – This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2. Also known as 2019-nCoV, the virus causes COVID-19. The sample was isolated from a patient in the U.S. On Tuesday, April 21, 2020, U.S. health regulators OK’d the first coronavirus test that allows people to collect their own sample at home, a new approach that could help expand testing options in most states. The sample will still have to be shipped for processing back to LabCorp, which operates diagnostic labs throughout the U.S. (NIAID-RML via AP)

U.S. regulators have approved a new type of coronavirus test that administration officials have promoted as a key to opening up the country.

The Food and Drug Administration on Saturday announced emergency authorization for antigen tests developed by Quidel Corp. of San Diego. The test can rapidly detect fragments of virus proteins in samples collected from swabs swiped inside the nasal cavity, the FDA said in a statement.

The antigen test is the third type of test to be authorized by the FDA.

Currently, the only way to diagnose active COVID-19 is to test a patient’s nasal swab for the genetic material of the virus. While considered highly accurate, the tests can take hours and require expensive, specialized equipment mainly found at commercial labs, hospitals, or universities.

A second type looks in the blood for antibodies, the proteins produced by the body days or weeks after fighting an infection. Such tests are helpful for researchers to understand how far a disease has spread within a community, but they aren’t useful for diagnosing active infections.

Antigen tests can diagnose active infections by detecting the earliest toxic traces of the virus rather than genetic code of the virus itself.

The FDA said that it expects to authorize more antigen tests in the future.

Quidel said Saturday that the test can provide an accurate, automated result in 15 minutes. The FDA’s emergency authorization “allows us to arm our health care workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment,” Douglas Bryant, CEO of Quidel, said in a statement.

The company said it specializes in testing for diseases and conditions including the flu and Lyme disease.

The U.S. has tried to ramp up testing using the genetic method, but the country’s daily testing tally has been stuck in the 200,000 to 250,000-per-day range for several weeks, falling far short of the millions of daily tests that most experts say are needed to reopen schools, businesses, churches and other institutions of daily life.

That’s led White House adviser Dr. Deborah Birx and other federal officials to call for a “breakthrough” in the antigen tests.

“There will never be the ability on a nucleic acid test to do 300 million tests a day or to test everybody before they go to work or to school, but there might be with the antigen test,” Birx told reporters last month.

Recently, the National Institutes of Health announced $1.5 billion in research grants aimed at fast-tracking the development of rapid, easy-to-use testing approaches — including antigen tests — by the fall.

___

Krisher reported from Detroit. Associated Press reporter Matthew Perrone in Washington contributed to this report.

Copyright 2020 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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