DPC News

FDA Warns About At-Home Kits

By Kaiser Health News, Morning Briefing

“This is not a test for the worried well,” said David Persing, the chief medical officer of Cepheid, the company that developed the test. Meanwhile, desperate Americans want a way to access tests, but the FDA is warning against fraudulent testing kits. Meanwhile, many are wondering why celebrities and officials can easily get tested while most Americans can not.

Stat: New Coronavirus Test Returns Results In 45 Minutes, But It May Be Limited To Hospitals A new diagnostic test for the novel coronavirus will return results in just 45 minutes, four times faster than existing machines. But the test, emergency use of which was cleared by the Food and Drug Administration Wednesday, will likely be used in only the most urgent situations: triaging patients who are already in the hospital or the emergency room, and testing health care workers who might be infected to see if they can return to work. (Herper and Facher, 3/21)

Stat: At-Home Tests For Coronavirus Are Here. Should You Take Them?  With delays in testing hampering the country’s ability to accurately track the new coronavirus and shelter-in-place orders keeping many Americans at home, startups are swooping in with a seemingly ideal solution: at-home tests. Over the next week, at least four startups are launching the first at-home tests for Covid-19. The companies, whose tests have been mostly greenlit — but not approved in the conventional sense — by the U.S. Food and Drug Administration under new guidelines instituted for the coronavirus crisis, aim for their diagnostics to offer some certainty to people who have up until now been unable to get tested as a result of the shortage of test kits. (Brodwin, 3/20)

Stat: FDA Warns New At-Home Coronavirus Tests Are ‘Unauthorized’  As a wave of at-home tests for coronavirus are coming on the market, federal regulators issued stern guidance saying that none of them has yet been approved for use and warning consumers to be wary of “unauthorized fraudulent test kits.” Hours after STAT reported on Friday that at least four startups would roll out at-home tests over the next week, the Food and Drug Administration released a statement saying: “We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for Covid-19.” (Brodwin, 3/21)

The Associated Press: Chaos, Inconsistency Mark Launch Of Drive-Thru Virus Testing Drive-thru sites have been opening around the United States to make it quicker and safer to test people for the new coronavirus. But much like the rest of the U.S. response to the pandemic, the system has been marked by inconsistencies, delays, and shortages. Many people who have symptoms and a doctor’s order have waited hours or days for a test. More than a week after President Donald Trump promised that states and retail stores such as Walmart and CVS would open drive-thru test centers, few sites are up and running, and they’re not yet open to the general public. (Smith, 3/22)

The Wall Street Journal: How The CDC’s Restrictive Testing Guidelines Hid The Coronavirus Epidemic As the coronavirus epidemic spread around the globe, the Centers for Disease Control and Prevention provided restrictive guidance on who should be tested, archived pages on its website show. While agencies in other countries were advising and conducting widespread testing, the CDC, charged with setting the U.S. standard for who should be tested for the virus, kept its criteria limited. A botched initial test batch also meant that tests were slow to be distributed and in short supply. Now, the Food and Drug Administration has allowed private laboratories to develop tests, and the CDC relaxed its criteria. And positive results across the U.S. have poured in. (Wang, Huth and Umlauf, 3/22)

CNN: You Want A Coronavirus Test — Here’s Why Your Doctor Probably Won’t Give You One  If you want to get a test for the novel coronavirus, you’re in good company. “One of my sisters called me yesterday [and said], ‘I have to have my daughter tested for coronavirus,'” New York Gov. Andrew Cuomo said at a press briefing Wednesday. The governor’s niece had a fever and flu-like symptoms. Yet he told his sister “there’s no reason for a test” since her daughter hadn’t traveled to a coronavirus hot spot or been in contact with anyone who had tested positive for the virus.  Across the United States, physicians are sending the same message: Not everyone who wants a test will get a test. (Cohen, 3/22)

Stateline: Coronavirus And The States: NY Ramps Up Testing; Idaho Patients Wait For Days  In New York, where positive tests discovered 2,300 new cases after testing 8,000 people in a day, Democratic Gov. Andrew Cuomo said the state’s testing is now at the level of South Korea or China.California has upped its capacity as well, increasing its test numbers by 20% in one day. Gov. Gavin Newsom, a Democrat, said a shortage of specimen swabs is stalling further expansion.Some states still lag in testing. Idaho patients are having to wait days for results, as samples are sent to labs in Washington or Colorado. One Idaho lab will now run only tests for patients who are hospitalized or deemed “high priority.” (Brown, 3/20)

The Hill: Trump Says Undocumented Immigrants Can Get Tested For Coronavirus Without Fear Of Deportation  President Trump on Sunday said undocumented immigrants should be able to get tested for coronavirus without fear of arrest or deportation. “The answer is yes, we will do those tests,” Trump said during a White House briefing. “You could say illegal alien, you could say illegal immigrant, you could say whatever you want to use your definition of what you’re talking about… Yes we will test that person,” he continued. “Because I think it’s important we test that person, and we don’t want to send that person back into wherever we’re going to be sending that person.” (Samuels, 3/22)

ABC News: On A Call With Trump Officials, Police Chief Pleads: ‘Stop Testing NBA Players, Start Testing First Responders’  At the end of an hour-long phone call with White House and Homeland Security officials, a police chief from outside San Francisco made a stark plea: “Stop testing NBA players, and start testing our first responders.” The appeal came during a call on Friday organized by the International Association of Chiefs of Police in order to provide police departments with information “to get through this crisis OK,” Dr. Alex Eastman of the Dallas Police Department said on the call. (Levine, 3/23)

CNN: Mike Pence Describes Taking A Coronavirus Test Vice President Mike Pence on Sunday described his novel coronavirus test as a “kind of invasive” and a “not comfortable” experience. Pence and second lady Karen Pence both tested negative for the virus Saturday afternoon after a staff member of his office had tested positive.”The test was quick, but it goes a fair amount to the sinuses and it is not comfortable,” Pence said at a White House press briefing. “That is probably a good opportunity to say again to any American looking on, if you do not have symptoms you do not need a test.” (Robertson and LeBlanc, 3/22)

ABC News: Man Learns His Fate Nearly A Week After Taking COVID-19 Test  An Atlanta resident who recently tested positive for coronavirus shared his story with ABC News, describing how difficult it was to receive treatment and get his results back. Billy Roberts, 46, tested positive for COVID-19 on Thursday, but his journey began after he attended a concert in Los Angeles and flew home March 1. (Jacobo, 3/21)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

SOURCE: https://khn.org/morning-breakout/45-minute-test-is-here-but-will-only-be-used-in-urgent-scenarios-fda-warns-about-at-home-kits/

Categories: DPC News

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