FDA Authorizes First Coronavirus Test for Asymptomatic People Without Known or Suspected Infection

The Food and Drug Administration issued an emergency use authorization for the first covid-19 test for asymptomatic people.
The Food and Drug Administration issued an emergency use authorization for the first covid-19 test for asymptomatic people.
Photo: Drew Angerer (Getty Images)

The Food and Drug Administration on Friday reissued an emergency use authorization for a test to screen people without symptoms of covid-19, the disease caused by the novel coronavirus. This authorization, the first for this kind of test aims to allow asymptomatic individuals who do not have symptoms and have no reason to believe they may be infected get tested.

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The real-time PCR test that received emergency use authorization is made by LabCorp, and initially received FDA authorization in mid-March for use only in people suspected of having covid-19. However, this reissued authorization allows LabCorp to use the test on anyone, not just on people suspected of having covid-19 by their health care provider. The FDA said it expanded the use of the LabCorp test after the company provided data demonstrating the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population.

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According to the FDA, the data provided by LabCorp affirms that the test is as accurate when used with the asymptomatic population as it is among people suspected of having covid-19.

In addition, the FDA will also allow LabCorp to carry out pool testing, enabling the lab to test up to five patient samples at once using a single test. This is the second test the FDA has authorized for pool testing in recent weeks. The agency considers pool testing to be an important public health tool because it allows more people to be tested quickly using fewer resources.

In a statement, FDA Commissioner Stephen Hahn stressed that asymptomatic testing was an important factor for the reopening of schools and workplaces.

“FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of covid-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” Hahn said.

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His comments aren’t surprising given the Trump administration’s insistence, which is absolutely appalling, that children go back to school. After threatening to cut funding for schools that didn’t fully reopen, President Donald Trump recently strong-armed the Centers for Disease Control and Prevention to support his call to reopen schools after calling the agency’s initial guidelines for reopening as “very tough and expensive.”

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Riiiight. It doesn’t matter if children, teachers, staff and even parents get sick and possibly die. As long as people go back to work.

The FDA highlighted that, until now, coronavirus tests have generally been authorized for people suspected of having covid-19 by their health care provider. Nonetheless, LabCorp’s test remains prescription-only. Samples can be collected by using home sample collection kits and by a health care provider. Additionally, the FDA said that only samples collected by a health care provider may be run in a pool at this time.

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“Today’s authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test. The FDA continues to work with test developers to expand access to covid-19 testing,” the agency said in a statement.

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While that may be a good step forward, it’s hard to understand how authorizing a new coronavirus test at a time when labs across the U.S. are facing overwhelming demand for tests and supply shortages will help. Seems like one of the best solutions in this situation might be to try to get cases down by practicing social distancing and wearing a mask. What a thought.

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Don Alexander

Act as if you have it. Wear a mask, stay away from people, wash your hands. Sacrifice today for a better future.