State Of Testing: FDA Cracks Down On ‘Wild West’ Marketplace; Flawed Data Misrepresents Spread; ‘Free’ Tests Aren’t So Free

The Associated Press: US Begins Crackdown On Unvetted Virus Blood Tests
U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work. The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products. The agency said in a statement that it expects the tests “will not be marketed or distributed.” It was unclear if any of the companies would face additional penalties. (Perrone, 5/21)

USA Today: FDA Investigates Lab As Tens Of Thousands Of COVID-19 Test Results In Florida Are Questioned
Federal regulators are investigating a Texas laboratory that a Florida hospital chain dropped last week because of delayed and unreliable COVID-19 test results. AdventHealth, which has 45 hospitals in nine states, terminated its Florida contract with MicroGen DX due to concerns about the validity of some of the 60,000 tests MicroGen had processed for the system because the lab left them at room temperature for days, according to an AdventHealth statement. (Gallion and O'lDonnell, 5/21)

NPR: Scientists Warn CDC Testing Data Could Create Misleading Picture Of Pandemic
The Centers for Disease Control and Prevention has acknowledged that it is mixing the results of two different kinds of tests in the agency's tally of testing for the coronavirus, raising concerns among some scientists that it could be creating an inaccurate picture of the state of the pandemic in the United States. The CDC combines the results of genetic tests that spot people who are actively infected, mostly by using a process known as polymerase chain reaction, or PCR, with results from another, known as serology testing, which looks for antibodies in people's blood. Antibody testing is used to identify people who were previously infected. (Stein, 5/21)

The Hill: CDC Acknowledges Mixing Up Coronavirus Testing Data 
The Centers for Disease Control and Prevention (CDC) acknowledged Thursday that it is combining the results from viral and antibody COVID-19 tests when reporting the country's testing totals, despite marked differences between the tests. First reported by NPR's WLRN station in Miami, the practice has drawn ire from U.S. health experts who  say combining the tests inhibits the agency's ability to discern the country's actual testing capacity. (Johnson, 5/21)

NPR: Getting An Antibody Test For The Coronavirus? Here's What It Won't Tell You
It's still not certain that antibodies measured by such a test would protect him from catching the virus again. And if the antibodies are protective, it's unknown how strong that protection might be or how long it might last. There are also questions about the reliability of many antibody tests being sold. Researchers are urgently trying to answer those uncertainties and figure how best to conduct antibody testing. (Stein, 5/21)

Atlanta Journal Constitution: ‘We’re Not Perfect.’ Kemp Orders Review After Coronavirus Data Missteps
Gov. Brian Kemp said Thursday he has ordered a review of how the state is reporting coronavirus figures, and he asked the public to have patience with health officials after a string of missteps raised questions about the accuracy of the latest data about the outbreak. “We’re not perfect. We make mistakes,” said Kemp of the criticism over mistakes in reporting data on COVID-19 in the state public health data website. He said increased pressure to more quickly update the data has likely contributed to the errors. (Bluestein and Mariano, 5/21)

The New York Times: These Labs Rushed To Test For Coronavirus. They Had Few Takers.
When a stay-at-home order in March all but closed the revered labs of the gene-editing pioneer Jennifer Doudna, her team at the University of California, Berkeley dropped everything and started testing for the coronavirus. They expected their institute to be inundated with samples since it was offering the service for free, with support from philanthropies. But there were few takers. (Thomas, 5/21)

Kaiser Health News: Congress Said COVID-19 Tests Should Be Free — But Who’s Paying?
Hospitals around the country are afraid to send out hundreds of thousands of bills related to COVID-19 testing. That’s because Congress mandated there would be no copays and no out-of-pocket costs for patients. But many employers with self-funded health plans seem to believe they’re exempt from the rules. When testing kits were still scarce, Vanderbilt University Medical Center in Nashville, Tennessee, fired up its clinical labs. It almost single-handedly took over testing in much of Tennessee. (Farmer, 5/22)

ABC News: Mayo Clinic Doctors Find Many COVID-19 Antibody Tests Fail Their Quality Standards: ABC News Exclusive 
A number of commercially available COVID-19 antibody tests, which look at a patient’s blood for signs of past infection, did not pass Mayo Clinic quality screening or meet their expectations for use, researchers from the hospital concluded in a joint investigation by the clinic and ABC News. One rapid finger-prick test even wrongly displayed a positive result for antibodies after researchers decided to use a saline-like solution, instead of a blood sample, to see what happened. An automatic fail, doctors said. (Abdelmalek and Christie, 5/21)

San Francisco Chronicle: Only 3 Bay Area Counties Meet Coronavirus Test Goals, Yet All Are Lifting Some Restrictions 
Just three of the nine Bay Area counties are conducting enough daily coronavirus tests to meet state standards to safely reopen — yet all are moving forward to lift shelter-in-place restrictions. Napa, Solano and Marin counties say they have met the testing benchmark set by Gov. Gavin Newsom — at least 150 tests per 100,000 people each day, the number Harvard researchers estimate will capture most positive cases in a community. Sonoma County may also be meeting the state benchmark, based on the tests it conducted Wednesday. (Ho, 5/21)