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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

Hurricane Sally made landfall near Gulf Shores, Alabama, Wednesday morning, bringing with it Category 2-strength winds and life-threatening storm surge.The National Hurricane Center reports that the slow-moving storm made landfall at 5:45 a.m. ET with maximum sustained wind speeds of 105 mph.In an update published less than an hour before landfall, the NHC warned that "significant flash and urban flooding" was likely into inland Alabama and central Georgia.The storm is currently projected to slowly move eastward, carving through Alabama and central Georgia before reaching South Carolina by Friday afternoon. 622

House Speaker Nancy Pelosi’s office is responding to criticism after she got her hair done inside a San Francisco salon, amid a citywide coronavirus restrictions on salons.A statement from her office acknowledges Pelosi and her staff relied on the information provided by someone at the salon about what was allowed by the new city regulations that went into effect last Friday, according to multiple outlets.The statement came after Fox News shared a video showing Pelosi inside the salon. Fox talked to the salon’s owner, Erica Kious, who told the news outlet, “it was a slap in the face” that Pelosi could go in and “get her stuff done” while the owner and others can’t work.Kious said it was an independent stylist who rents a chair from her."This business offered for the speaker to come in on Monday and told her they were allowed by the city to have one customer at a time in the business," Pelosi's Deputy Chief of Staff Drew Hammill said in the statement. "The speaker complied with the rules as presented to her by this establishment."The statement also says Pelosi wore a mask except for a brief time when she was getting her hair washed.The new restrictions in San Francisco say hair salons can operate outdoors, and that some procedures, like color and chemical treatments, still cannot be done. 1316

If you've been hearing the disembodied voice of a laughing young woman or child in your home lately, there's (probably) no need to call a ghost hunter.According to The Verge, Amazon confirmed on Wednesday that "Alexa," the voice of Echo smart speakers, may cackle unprompted from time to time.In a statement to Scripps National, an Amazon spokesperson confirmed that the company is changing how to make Alexa laugh. "In rare circumstances, Alexa can mistakenly hear the phrase 'Alexa, laugh,'" Amazon said. "We are changing that phrase to be 'Alexa, can you laugh?' Which is less likely to have false positives, and we are disabling the short utterance 'Alexa, laugh.' We are also changing Alexa’s response from simply laughter to 'Sure, I can laugh' followed by laughter."A number of users caught Alexa's laughter on video and posted the clips on social media, saying the laughter appeared to be unprompted, often coming in the middle of the night. So Alexa decided to laugh randomly while I was in the kitchen. Freaked @SnootyJuicer and I out. I thought a kid was laughing behind me. pic.twitter.com/6dblzkiQHp— CaptHandlebar (@CaptHandlebar) February 23, 2018 1200

In a heartbreaking Facebook post, a Maryland animal shelter announced they found a puppy with its ears cut off tied to a tree in Baltimore. BARCS say they got a call saying someone had found two dogs tied to a tree and several other puppies in an empty lot. When the officer arrived, they found one of the puppies was bleeding from the head and the other puppies were for sale. The puppies were immediately taken to BARCS where they were seen by a vet. They named the injured dog Claude and determined that his ears were removed using poor instruments, like household objects, leaving him with tissue damage, pain, and infection. Claude is only 10 weeks old and BARCS says he is trying to do normal puppy things, but cannot because of the pain. He received emergency surgery but the veterinarians had to remove untreated infected tissue, so he lost even more of his ear structure. BARCS is now asking for money so they can continue to help Claude so he can find a loving home and recover. You can donate by clicking here, but make sure your gift is dedicated to him by including his name in the additional comments section of the donation form.  1198

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