Apr 10, 2020 - Health

The FDA's about-face on coronavirus antibody testing

Caitlin Owens, author of Vitals

A nasal swab from a coronavirus test. Photo: Ben Hasty/MediaNews Group/Reading Eagle via Getty Images

In terms of regulatory flexibility, the FDA's approach to coronavirus antibody testing is a 180-degree turn from its approach to diagnostic testing.

The big picture: The antibody tests, also known as serological tests, essentially detect whether someone's immune system has reacted to the coronavirus, helping determine whether they have had it — regardless of whether they had symptoms.

  • The tests will help determine how widespread the coronavirus outbreak has been, something currently unknown because of diagnostic testing failures.

By the numbers: Only one test has received an emergency use authorization from the FDA , but more than 80 test developers have notified the agency that they have non-authorized tests available for use, which is allowed.

  • The agency eventually adopted a similarly flexible approach to diagnostic tests.
  • But the Trump administration has been widely criticized for its early decisions to rely on tests made by the CDC, and for being slow to allow commercial and academic labs to participate.

Yes, but: The FDA's rationale for keeping a close hold on who was making coronavirus tests was that it was important for the tests to be accurate.

  • Scott Becker, executive director of the Association of Public Health Laboratories, has raised concerns about questionable serological tests that have appeared on the market, and has voiced these concerns about the "wild, wild West" environment to the administration, per the Washington Post.

Go deeper: Why the U.S. is so far behind on coronavirus testing

Go deeper

Primary elections test impact of protests, coronavirus on voting

Election official at a polling place at McKinley Technology High School in Washington, D.C. Photo: Drew Angerer/Getty Images

In the midst of a global pandemic and national protests over the death of George Floyd, eight states and the District of Columbia held primary elections on Tuesday.

Why it matters: Joe Biden, the presumptive Democratic nominee, needs to win 425 of the 479 delegates up for grabs in order to officially clinch the nomination. There are a number of key down-ballot races throughout the country as well, including a primary in Iowa that could determine the fate of Rep. Steve King (R-Iowa).

Iowa Rep. Steve King defeated in GOP primary

Rep. Steve King. Photo: Alex Wroblewski/Getty Images

State Sen. Randy Feenstra defeated incumbent Rep. Steve King in Tuesday's Republican primary for Iowa's 4th congressional district, according to the Cook Political Report.

Why it matters: King's history of racist remarks has made him one of the most controversial politicians in the country and a pariah within the Republican Party.

Updates: George Floyd protests continue past curfews

Police officers wearing riot gear push back demonstrators outside of the White House on Monday. Photo: Jose Luis Magana/AFP via Getty Images

Protests over the death of George Floyd and other police-related killings of black people continued Tuesday across the U.S. for the eighth consecutive day — prompting a federal response from the National Guard, Immigration and Customs Enforcement and Customs and Border Protection.

The latest: Protesters were still out en masse even as curfews set in in New York City and Washington, D.C. Large crowds kneeled at Arizona's state capitol nearly an hour before the statewide 8 p.m. curfew, and a peaceful march dispersed in Chicago ahead of the city's 9 p.m. curfew.