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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 thought your 2020 stress would magically disappear after the yelling stopped, you might have been surprised to find that you were still worried after the results of the presidential election.“For the majority of people, the stress actually didn’t decrease,” said Vaile Wright, a psychiatrist and also a member of the American Psychiatrist Association. The group recently released some numbers that might explain your extra high heart rate.According to the survey by the APA, 17% of Americans did have their stress go down. However, almost 30% said their stress increased.And it’s not a party issue. Over 80% of Democrats, Republicans, and Independents all listed the future of our nation as a significant source of stress“It’s not just whatever side won, it happens to be everybody right now really being concerned about the future of the nation,” said Wright.And three-fourths of Americans are still seriously stressed about the pandemic“We’ve seen increased levels of stress related to the federal response around the pandemic and that really does come down to the inconsistent messaging that we’re seeing. Different people are disproportionately affected by the pandemic specifically, but I don’t think anyone is related to the stress of it, especially as the numbers continue to climb,” said Wright.But it’s not all doom and gloom. Vaile says that there are some things happening that may help lower your blood pressure.“If we can hear some more good news, health news, like effective vaccines move to the market. The more that we have information that’s clear and consistent, that’s science based and that comes from reputable sources, I think those are the kinds of things that can reduce stress,” said Wright.Better coronavirus news combined with the possibility that President-elect Joe Biden can do a better job uniting the country can give Americans something to hope for as we head into 2021. 1918

If you want to buy Apple's highly-anticipated iPhone X in the U.S., you'll have to shell out 9 for it.If you live elsewhere, you'll have to pay even more.Apple charges different prices for its devices from country to country, depending in part on taxes and how each local currency compares with the U.S. dollar. 322

HPAKANT, Myanmar (AP) — Officials in Myanmar say a landslide at a jade mine in the country’s north has killed at least 162 people.The landslide took place in Kachin state, the center of the world’s biggest and most lucrative jade mining industry.The death toll surpasses the 113 killed in what previously was the worst such jade mining accident, in November 2015.The victims are usually freelance miners who settle near giant mounds of discarded earth that has been mined in bulk by heavy machinery in order to scavenge for small bits of jade. 551

If American religion were traded at a stock exchange, your broker might be telling you to sell. The trend lines don't look great and haven't for quite some time.Social scientists and religious leaders have lots of theories about the long, slow slide, blaming it on everything from the internet to the politicization of conservative Christianity.A new Pew Research Center study offers something different: a survey of 4,729 Americans telling us precisely why they do (or don't) attend religious services.Some of their answers are unsurprising. Americans who don't believe in religion don't often attend church. Because duh.But the survey may confound other stereotypes about other Americans who rarely, if ever, attend church. As it turns out, they're all not atheists, or even members of the "spiritual but not religious" crowd. Many say religion is important in their lives, and lean conservative, politically."The people who attend religious services less often are not a monolithic group," said Becka Alper, a research associate at Pew.First, here are the top 10 reasons given by Americans who attend religious services at least once a month, according to Pew. Survey respondents were allowed to give more than one reason. The percentage refers to people who said this was a "very important" reason for their decision: 1329