‘It’s A Wild West Show Out There’: Lack Of FDA Oversight Creates Chaotic Marketplace For Blood Tests
Experts agree that widespread testing is needed for the country to re-open, but America continues to struggle to meet the mark. To speed the availability of quick blood tests to determine if someone has the virus, the FDA waived layers of usual reviews. But that lack of oversight might backfire as questionable tests flood the marketplace. Meanwhile, South Korea, which has won praise for its aggressive testing, is sending 600,000 kits to America this week.
The Associated Press:
Fears Of 'Wild West' As COVID-19 Blood Tests Hit The Market
Blood tests for the coronavirus could play a key role in deciding whether millions of Americans can safely return to work and school. But public health officials warn that the current “Wild West” of unregulated tests is creating confusion that could ultimately slow the path to recovery. More than 70 companies have signed up to sell so-called antibody tests in recent weeks, according to U.S. regulators. (Perrone, 4/12)
Reuters:
Broad Coronavirus Testing Crucial In Lifting Restrictions: U.S. Experts
The United States needs to ramp up testing for the coronavirus as the White House considers when and how to lift stay-at-home restrictions and lockdowns triggered by the pandemic, U.S. health experts said on Sunday. More than 2 million tests have been done in the country so far, but the tests are not available to many who need them, said Dr. Stephen Hahn, commissioner of the Food and Drug Administration. “We need to do more, no question about that,” Hahn said on ABC’s “This Week.” (Chiacu, 4/12)
The Hill:
FDA Commissioner On Coronavirus Testing: 'We Need To Do More, No Question About That'
Food and Drug Administration (FDA) Commissioner Stephen Hahn said Sunday that the U.S. needs to do more coronavirus testing, adding there’s “no question about that.” ABC’s “This Week” co-host Martha Raddatz asked Hahn why the U.S. is “still so far behind” other countries like the U.K., Germany and South Korea, who have tested millions of residents. Hahn responded calling the situation “complicated” and “rapidly moving,” noting the pressure on supply chains. (Coleman, 4/12)
ProPublica:
Coronavirus Tests Are Being Fast-Tracked By The FDA, But It’s Unclear How Accurate They Are.
Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate — known as “false negatives” — and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design. Neither the major test manufacturers, the U.S. Food and Drug Administration or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test-makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose. (DePillis and Chen, 4/10)
Reuters:
Exclusive: South Korea To Ship 600,000 Coronavirus Testing Kits To U.S. On Tuesday - Source
South Korea plans to send 600,000 coronavirus testing kits to the United States on Tuesday in the first such shipment following a request from U.S. President Donald Trump, a Seoul official told Reuters on Monday. (Shin and Cha, 4/13)
ProPublica:
He Spent $500,000 To Buy Coronavirus Tests. Health Officials Say They’re Unreliable.
When thousands of rapid COVID-19 tests were delivered to the South Texas city of Laredo late last month, it looked as if a visiting dignitary had arrived. With lights flashing and sirens blaring, Webb County sheriff’s deputies escorted a red tractor-trailer carrying the tests to a local emergency room, whose owner had purchased them from a Chinese manufacturer. Longtime Laredo Congressman Henry Cuellar, who helped facilitate the arrival of the tests, smiled broadly as he carried boxes of them inside the clinic. Believing the tests would detect an active infection, Laredo leaders hustled to set up a drive-through testing site to welcome anxious residents the following morning. (Schwartz, 4/10)
New Orleans Times-Picayune:
Why Testing For Coronavirus Immunity A 'Critically Important' Step For Louisiana's Recovery
With testing for coronavirus infections ramping up across the Louisiana, political leaders and hospital officials are starting to look ahead to a new type of test that will let patients know if they've developed immunity to the deadly virus. Unlike the tests now on the market used to confirm if someone with symptoms does in fact have COVID-19, the blood test, officially a serology test, is used to establish whether someone has developed antibodies to the disease after infection. (Williams and Karlin, 4/12)
San Francisco Chronicle:
Inside The Bay Area’s Efforts To Expand Coronavirus Testing So We Can Return To Normal Life
Many Americans — at first, perhaps just health care workers and first responders — may be able to walk into a pharmacy or hospital and get an antibody test, a pinprick blood test that will tell them if they’ve had the coronavirus and may have some immunity. If the test shows high enough levels of antibodies — proteins produced by the immune system to fight infection — they may get a certificate that allows them to go back to work. (Ho and Moench, 4/12)
