FDA Slashes Regulations For Tests In Desperate Effort To Meet Demand, But Admits There’s A Trade-Off With Accuracy
Frustration has been growing over the country's inability to properly test Americans to get an accurate count on just how bad the outbreak is. Meanwhile, rumors that the U.S. turned down tests offered by WHO are false -- WHO does not sell tests to wealthy countries, which usually prefer to make their own.
The Associated Press:
US Slashes Testing Rules To Speedup Coronavirus Screening
The Trump administration is slashing regulations governing test development in a bid to ramp up screening for the coronavirus amid nationwide frustration with the slow pace of the effort. The unprecedented steps by the Food and Drug Administration could boost testing capacity at some U.S. labs, but also complicate efforts to assure the accuracy of tests and track who receives them.More than eight weeks after the first U.S. case of COVID-19 was detected, the U.S. still struggles to conduct mass screening and provide definitive figures on the number of people tested. (Perrone, 3/17)
The Wall Street Journal:
New FDA Virus-Test Policy Could Boost Availability, But Reduce Reliability
A federal agency’s decision to allow lab companies to release coronavirus tests without prior government approval should help ease the shortage of test kits, but at the potential cost of compromised results, medical experts said Tuesday. “It’s a pretty good idea to allow for companies to get tests out in a national emergency,” said Paul Fey, research medical director at the University of Nebraska Medical Center. But he added that “these tests may not perform as well.” (Burton and Terlep, 3/17)
Stat:
Pharmalittle: FDA Gives States An OK To Authorize Coronavirus Tests
In response to a dire shortage of tests for detecting the novel coronavirus, the FDA gave states new powers to authorize labs to develop their own diagnostics, and it also approved new tests that will be distributed by LabCorp (LH) and Hologic (HOLX), STAT says. The agency will allow states to take responsibility for tests developed and used by laboratories within their borders, a step that is similar to what the FDA last week granted to the New York State Department of Health. The labs will not have to pursue an emergency clearance that is normally required. (Silverman, 3/17)
The Washington Post:
Coronavirus Testing Finally Gets Going In US, But There Aren’t Enough Lab Workers Or Protective Equipment
A small commercial laboratory in Georgia has been selling do-it-yourself coronavirus testing kits, despite the fact that the Food and Drug Administration has not approved at-home testing for people worried they may have been infected in the global pandemic. A physician at the health clinic working with the Georgia lab said there is no time to waste on federal bureaucracy. “We’re behind the eight ball. We need to start testing more people,” said David Williams, the chief executive of Southside Medical Center in Atlanta. (Johnson, McGinley, Eilperin and Brown, 3/17)
The New York Times:
Did Federal Officials Really Question W.H.O. Tests For Coronavirus?
At a time when the Trump administration is facing intense criticism for its failure to make coronavirus tests available to millions of nervous Americans, remarks by a federal health official on Tuesday appeared to suggest that the World Health Organization’s diagnostic tests were wildly inaccurate. In a somewhat rambling answer to a question related to W.H.O. tests, Dr. Deborah Birx, the White House coronavirus response coordinator, said: “It doesn’t help to put out a test where 50 percent or 47 percent were false positives. Imagine what that would mean to the American people. Imagine what that would mean to tell someone they were positive when they weren’t.” (McNeil, 3/17)
CNN:
WHO And CDC Never Discussed Providing International Test Kits To The US, Global Health Agency Says
No discussions occurred between WHO and the CDC about providing tests to the United States, WHO spokesperson Tarik Jasarevic told CNN on Tuesday, and WHO did not offer coronavirus tests to the CDC.
The United States, Jasarevic confirmed, doesn't ordinarily rely on WHO for tests because the US typically has the capacity to manufacture its own diagnostics. (Azad, 3/18)
The Washington Post Fact Checker:
What Did Dr. Anthony Fauci Say About Coronavirus Testing ‘Failing’?
A major issue in the U.S. government’s response to the outbreak of a novel coronavirus has been the availability of tests for people who believe they may have covid-19. The administration has been under fire for its failure to quickly expand testing for coronavirus across the United States. A still-unspecified manufacturing problem caused the Centers for Disease Control and Prevention (CDC) to distribute flawed tests to state and local health departments. The lack of tests, compared with countries such as South Korea that have tested tens of thousands of people, has meant the spread of the virus in the United States may have been hidden in the early weeks of the outbreak. (Kessler, 3/18)
The New York Times:
Inside The First Drive-Through Coronavirus Testing Center In New Rochelle
Any other place, any other time, the three white tents set against the Long Island Sound in the middle of a public park, with a line of vehicles waiting to get in, could have easily been the scene of a wedding or a garden party. But the appearance of the people underneath the tents — in silver hazmat suits, face shields and masks — told a different story. (Nir, 3/17)
Kaiser Health News:
As Coronavirus Testing Gears Up, Specialized Swabs Running Out
The two top makers of the highly specialized swabs used to test patients for the novel coronavirus are straining to keep up with the demand, even as both the Italian and U.S. governments are working with them to increase production, including at a key manufacturing site in the midst of Italy’s outbreak. The nasopharyngeal swabs required for the coronavirus tests are quite different from your standard Q-tips — and the exploding need for them has created a bottleneck in the soaring demand for diagnoses. (Weber and Jewett, 3/17)
Kaiser Health News:
Near Trump’s Florida Home, Drive-Thru COVID-19 Testing Gets Off To Rocky Start
A much-needed drive-thru coronavirus testing site opened here Monday, just a few miles from the Mar-a-Lago Club, home to the country’s most high-profile COVID-19 exposure. A week ago, President Donald Trump and a few top aides hosted a festive dinner with Brazilian officials, some later found to be ill with the novel coronavirus. Despite repeated assertions from White House officials that tests will soon be available to anyone who wants them, residents here found the reality much different. (Galewitz, 3/17)
Los Angeles Times:
His Wife Died After Contracting Coronavirus. He Can't Get Tested
After more than 30 years in advertising, Loretta and Roddy celebrated their retirement with a trip. They left their home in Orlando, Fla., for the Philippines on Feb. 4. At one point, they traveled to Thailand. They had layovers in Seoul on the way to the Philippines and the way back to the U.S. On March 8, they flew into Los Angeles International Airport. They planned to stay at Roddy’s sister’s house in Walnut for two nights and then fly back to Florida on March 10. (Wigglesworth, 3/17)
The New York Times:
My Coronavirus Test: 5 Days, A Dozen Calls, Hours Of Confusion
Almost a dozen calls with five health care providers over five hours. Two hours of hold music. Two hours in a hospital. Four days of anxiously checking an online portal for results. And lots of confusion. That’s the winding path through bureaucracy that took me from placing my first phone call last Wednesday to getting my positive coronavirus test results on Monday night. Five days in limbo. (Herrera, 3/18)
