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How accurate are the coronavirus tests used in the U.S.?Months into the outbreak, no one really knows how well many of the screening tests work, and experts at top medical centers say it is time to do the studies to find out.When the new virus began spreading, the Food and Drug Administration used its emergency powers to OK scores of quickly devised tests, based mainly on a small number of lab studies showing they could successfully detect the virus.That’s very different from the large patient studies that can take weeks or months, which experts say are needed to provide a true sense of testing accuracy.The FDA’s speedy response came after it was initially criticized for delaying the launch of new tests during a crisis and after the Centers for Disease Control and Prevention stumbled in getting its own test out to states.But with the U.S. outbreak nearly certain to stretch on for months or even years, some experts want the FDA to demand better evidence of the tests’ accuracy so doctors know how many infections might be missed.There have been more than 2 million confirmed coronavirus cases in the U.S. and more than 115,000 deaths, according to data compiled by Johns Hopkins University. Cases in nearly half of U.S. states are rising.In recent weeks, preliminary findings have flagged potential problems with some COVID-19 tests, including one used daily at the White House. Faulty tests could leave many thousands of Americans with the incorrect assumption that they are virus-free, contributing to new flare-ups of the disease as communities reopen.“In the beginning, the FDA was under a lot of pressure to get these tests onto the marketplace,” said Dr. Steven Woloshin of Dartmouth College, who wrote about the issue in the New England Journal of Medicine last week. “But now that there are plenty of tests out there, it’s time for them to raise the bar.”The FDA said in a statement that it has already asked multiple test makers to do follow-up accuracy studies, although it didn’t say for how many of the more than 110 authorized screening tests. The agency also said it is tracking reports of problems. Accuracy has also been an issue with blood tests that look for signs of past infections.No screening test is 100% accurate. So details on accuracy are routinely provided for tests of all types, including seasonal flu, hepatitis, HIV and cancers. For example, rapid flu tests are known to miss 20% or more of all cases, a factor doctors weigh when treating patients who have symptoms but test negative.For now, most COVID-19 tests in the U.S. don’t give data on real-world performance, including how often the tests falsely clear patients of infection or falsely detect the virus. That information is lacking for all but a few of the roughly 80 commercial screening tests available, according to an Associated Press review.The government’s emergency authorization process “requires a lower level of evidence,” the agency said. Makers need only show that a test “may be effective” instead of the usual requirement to demonstrate “safety and effectiveness.” They would have to meet that higher threshold once the U.S. government declares the emergency over.Many of the commercial test makers submitted results from 60 samples, the minimum number required and mostly used lab-produced specimens of the virus. The FDA now recommends the use of nasal swabs or other real samples from people screened for coronavirus.Experts say larger patient studies patients are needed to assess a test’s true performance.Lab testing bears little resemblance to actual — sometimes imperfect — conditions at hospitals, clinics and testing sites noted Dr. Robert Kaplan of Stanford University.“You’re testing people in parking lots, the patients themselves are extremely anxious and often unable to follow instructions,” said Kaplan, a former associate director of the National Institutes of Health.Kaplan and others say those differences could explain why some tests are not performing as expected.Last month, the FDA warned doctors of a potential accuracy problem with Abbott Laboratories’ rapid ID Now test, which delivers results in roughly 15 minutes. The test has been lauded by President Donald Trump and used to screen the president, his staff and visitors to the White House.The FDA alert followed a preliminary report by New York University that found Abbott’s test missed between a third to one-half of infections caught by a rival test in patients screened for the virus.Abbott rejected the findings, saying the researchers did not follow the instructions for using its test. The company pointed to alternate patient studies, including its own, that have found the test successfully detects between 91% and 95% or more of virus cases when compared to other tests.But similar problems with ID NOW’s accuracy have been flagged in preliminary reports by researchers at Stanford University, Loyola University and the Cleveland Clinic.For now, the FDA is requiring Abbott to conduct follow-up studies in several different patient groups.The FDA’s emergency standards “are still high but there is a significant difference in the body of work that what would go into a submission under the normal process,” said Abbott vice president John Hackett. “Our normal process takes years to bring these out.”Requiring bigger studies of all coronavirus tests could provide valuable information, but it could also strain the FDA’s already stretched staff and resources, said Dr. Daniel Schultz, former director of the FDA’s medical device center.Dr. Colin West of the Mayo Clinic worries doctors and patients have put too much confidence in the current crop of tests, when an unknown number of patients with COVID-19 are likely receiving false negative results.Even a modest error rate can have grave consequences during an outbreak like COVID-19. West gives the example of a test that is 95% accurate at detecting the virus and is used on 1 million people. That would still result in 50,000 people being incorrectly told that they don’t have the virus.“The negative test does not mean that I’m off the hook,” West said. “We just need to maintain that level of vigilance until we have a better sense of how good these tests really can be.”___Follow Matthew Perrone on Twitter: @AP_FDAwriter.___Follow AP pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6604
If you are way into politics, you are not the average American. Not even close.A new poll from the University of Pennsylvania's Annenberg Public Policy Center reveals how shockingly little people know about even the most basic elements of our government and the Constitution that formed it.Take your pick from this bouillabaisse:* More than one in three people (37%) could not name a single right protected by the First Amendment. THE FIRST AMENDMENT.* Only one in four (26%) can name all three branches of the government. (In 2011, 38% could name all three branches.)* One in three (33%) can't name any branch of government. None. Not even one.* A majority (53%) believe the Constitution affords undocumented immigrants no rights. However, everyone in the US is entitled to due process of law and the right to make their case before the courts, at the least.(And the First Amendment protects the rights to free speech, free exercise of religion, freedom of the press and the rights of people to peaceably assemble, in case you were wondering.)"Protecting the rights guaranteed by the Constitution presupposes that we know what they are," said Annenberg Director Kathleen Hall Jamieson. "The fact that many don't is worrisome."The Annenberg poll is far from the first to reveal not only our collective ignorance about the basic tenets of democracy but also the fact that we are even less informed than we were in the past.Take this Pew Research Center poll from 2010. When asked to name the chief justice of the Supreme Court, less than three in 10 (28%) correctly answered John Roberts. That compares unfavorably to the 43% who rightly named William Rehnquist as the chief justice in a Pew poll back in 1986.What did the 72% of people who didn't name Roberts as the chief justice in 2010 say instead, you ask? A majority (53%) said they didn't know. Eight percent guessed Thurgood Marshall, who was never a chief justice of the Court and, perhaps more importantly, had been dead for 17 years when the poll was taken. Another 4% named Harry Reid, who is not now nor ever was a Supreme Court Justice.What we don't know about the government -- executive, legislative and judicial branches -- is appalling. It's funny -- until you realize that lots and lots of people whose lives are directly affected by what the federal government does and doesn't do have absolutely no idea about even the most basic principles of how this all works.It leads to huge amounts of discontent from the public when they realize that no politician can make good on the various and sundry promises they make on the campaign trail. 2654

House Speaker Nancy Pelosi said Thursday that she's still hopeful lawmakers can reach an agreement on another COVID-19 stimulus bill, though Democrats and Republicans remain far apart in certain areas.Pelosi said Thursday that Democrats and Republicans still remain far apart when it comes to additional unemployment funding, as well as more funding for local and state governments.When asked if she believed this was the last chance to strike a stimulus deal ahead of Election Day, Pelosi said she would continue to hold out hope that Congress could reach a deal all the way up to election day.Pelosi's comments come the day that billions of dollars in stimulus funding provided through the CARES Act for the airline industry expired. American Airlines said Wednesday that it would go ahead with the furlough of nearly 20,000 pilots, and other airlines say massive layoffs are coming.There is reportedly bipartisan support to extend more funding for the airline industry, but Democrats are hoping to roll those benefits into a more extensive bill.White House press secretary Kayleigh McEnany blamed Pelosi for airline furloughs and layoffs during a briefing on Thursday, claiming that she wasn't "being serious" in her negotiations. 1241
IMPERIAL BEACH, Calif. (KGTV) - Organizers of the Imperial Beach Sun and Sea Festival say they're ready to go this year, despite a recent sewage spill from Tijuana."It's always on my mind," says Co-Chair Shirley Nakawatase. "I think it's an ongoing situation that we have at the beach."Nakawatase says the spill shouldn't impact the festival, because they only use ocean water for the sandcastle competition. If the water is considered unsafe, they can use fresh water purchased from Cal-Am."We're going to request daily testing to make sure the bacteria count is low," she says, noting that testing will begin on the Monday before the festival.A recent sewage spill dumped 3.5 million gallons of sewage into the ocean south of Imperial Beach, prompting a full closure of the coast in the area. So far this year, Imperial Beach has lost 50 days of beach time because of sewage-contaminated water.RELATED: Imperial Beach Coastline closed due to runoffThe Sun and Sea Festival brings thousands to Imperial Beach every summer for a day of sandcastle competition, concerts, food and more.This year's festival will be on July 13th. The theme is "Under the Sea.""It can just make people smile," says Co-Chair Leah Goodwin. "If you spend the whole day at the beach and give people a memory, that takes you away from some of the craziness. That's why we do this."As for the sewage concerns, Nakawatase says people don't need to worry."Nothing's going to spoil the party," she says. 1481
In an interview with Axios, which aired Monday night, President Donald Trump said he again believes that his administration has the coronavirus pandemic "under control," despite the fact that deaths linked to the virus are currently on the rise throughout the country.When Axios reporter Jonathan Swan pointed out to Trump that deaths are on the rise, Trump said it's as "under control as much as you can control it.""(Americans) are dying, that's true, and it is what it is," Trump said. "But that doesn't mean we aren't doing everything we can. It's under control, as much as you can control it. This is a horrible plague that beset us."Trump also reiterated the false claim that virus cases are on the rise in the U.S. solely because the country is doing more testing than any other country."Because we're so much better at testing that any other country in the world, we show more cases," Trump said.While the U.S. is conducting more tests than any other country, other statistics, like hospitalizations linked to the virus and deaths linked to the virus, are currently on the rise. In addition, Johns Hopkins reports that 7.7 percent of all COVID-19 tests in the U.S. are coming back positive — in South Korea, the positive test rate currently sits at 0.9 percent.Trump also attempted to prove through statistics that the United States' mortality rate was among the best in the world. He handed Swan a piece of paper that showed the U.S. mortality rate was falling among a proportion of confirmed cases.Swan then pointed out that the United States ranked among the worst in the world when viewing COVID-19 deaths as a proportion of the population."You can't do that," Trump said.Trump also stated in the interview that some experts have said that "you can test too much." When asked who was saying that, Trump told Swan to "read the manuals, read the books."None of Trump's top health experts have publicly advocated for less testing. Earlier this year, Dr. Anthony Fauci and several other coronavirus task force members said during a House hearing that they had not been directed to "slow down" testing, and said it was the administration's goal to conduct more testing.During that same interview, Trump also told Swan that he "wasn't sure" how history would view the legacy of Rep. John Lewis. 2308
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