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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
IMPERIAL BEACH, Calif. (KGTV) - A recent break to a sewage pipe south of the U.S.-Mexico border is allowing sewage to flow freely into the Tijuana River Valley and Pacific Ocean, officials say.The International Boundary and Water Commission (IBWC) said they were alerted to the break in the Tijuana sewage pipe by Mexico authorities recently. The pipe broke Dec. 7, according to Imperial Beach Mayor Serge Dedina, though the city was notified Tuesday.IBWC officials said Wednesday, "CESPT (Tijuana Water Utility) has informed us through the Mexican Section that a rupture was discovered yesterday on the Colector Poniente in Southeast Tijuana. This rupture caused the soil above the pipe to collapse in an auto junkyard. Several sinkholes were discovered yesterday by the workers at the property and notified CESPT who then diverted the flows upstream to a stormwater collector which drains to the Tijuana River. "The IBWC estimated the flow of sewage into the Tijuana River to be at 300 liters per second, or approximately 7 millions gallons per day. RELATED: Judge mulls motion to dismiss suit aimed at cleaning up sewage from MexicoIn a press conference Tuesday, Dedina renewed calls against the IBWC for "failure" to stop sewage from making its way into the river valley and eventually, the Pacific Ocean along Imperial Beach. 1338

If the lyrics to "Let It Go" have been stuck in your head since 2013's "Frozen," new songs are right around the corner.Kristen Bell, who voices Anna, the younger sister of Princess Elsa [Idina Menzel] from the hit animated Disney film, shared a "Frozen 2" update on Thursday during an appearance on "Ellen.""I have recorded the movie," Bell said. "There will be edits before it's finished. I know the songs, I know the story. It's very good!"The film also features the return of Josh Gad [Olaf] and Jonathan Groff [Kristoff]."Frozen" grossed more than billion in the worldwide box office and became Disney's highest-grossing animated film of all time."Frozen 2" releases in theaters November 27, 2019. 718
If you can't beat Amazon, partner with it.Kohl's is doing another deal with Jeff Bezos. The department store chain said Tuesday that 82 stores in the Chicago and Los Angeles areas will soon accept return items from Amazon. Kohl's will pack and ship the merchandise back to the online retailing giant for free.Earlier this month, Kohl's announced a plan to sell the Alexa-enabled Echo home speaker, Fire TV, tablets and other Amazon-branded devices in 10 of its stores.The latest partnership between Kohl's and Amazon comes as traditional retailers try (and often fail) to adapt to a rapidly changing landscape. Toys 'R' Us filed for bankruptcy protection late Monday.Toys 'R' Us has been hurt by Amazon, as well as Walmart and Target. But other retailers are following the lead of Kohl's and have decided to work more closely with Amazon to boost sales.Sears, which also owns Kmart, has been one of the worst-performing retailers of the past decade. But the company announced in July that it would sell Kenmore appliances, including some that are compatible with Alexa, on Amazon.Related: Wall Street bets Amazon will doom department storesCooper Smith, director of Amazon research at L2, a firm that tracks the digital performance of brands, says he expects more retailers to partner with Amazon -- but they will need to be wary at the same time."Doing deals with Amazon makes sense. They can help get consumers to come back, especially around Black Friday," he said. "But these retailers will have to tread a careful line when partnering with Amazon."That's because Amazon isn't just working with other retailers. The company has opened its own physical stores, Amazon Books, that sells best-selling books and Amazon devices.And in its biggest brick-and-mortar move of all, Amazon bought Whole Foods this year for nearly billion. The deal recently closed, and now you can buy Amazon gadgets at the grocery store along with kale and quinoa.It should come as no surprise, then, that investors in Barnes & Noble and Kroger aren't too pleased with Amazon's increased clout in the real world. The stocks of both companies have plunged nearly 40% this year, while Amazon is up 30%.L2's Smith notes that Amazon has its sights set on clothing, too. That could pose a problem for Kohl's and Sears."Amazon is launching private label apparel brands of its own," Smith said, adding that this could hurt sales of bargain-priced fashion at Kohl's, Sears and other department stores.Related: Nordstrom may reinvent itselfNot every big traditional retailer is throwing in the towel.Chuck Grom, an analyst with Gordon Haskett, notes that Macy's recently hired Hal Lawton, formerly a senior executive at eBay, to be its president. Nordstrom is launching a format called Nordstrom Local with no inventory. The Local stores will have stylists who help people pick out clothes that they can order online. The stores will serve wine and beer, too."We continue to observe more and more collaboration between digitally native companies and traditional retailers -- a theme that we think will continue to build momentum in the coming quarters," Grom wrote in a report Tuesday.And Walmart continues to boost its own digital operations under the leadership of Marc Lore, who joined the retailer after Walmart bought his company Jet.com last year."Walmart has done an extremely great job online under Lore," Smith said. "It's shaping up to be an all-out price war between Walmart and Amazon, and if anyone can beat Amazon at its own game, it's Walmart."The-CNN-Wire? & ? 2017 Cable News Network, Inc., a Time Warner Company. All rights reserved. 3639
I will be leaving the great Walter Reed Medical Center today at 6:30 P.M. Feeling really good! Don’t be afraid of Covid. Don’t let it dominate your life. We have developed, under the Trump Administration, some really great drugs & knowledge. I feel better than I did 20 years ago!— Donald J. Trump (@realDonaldTrump) October 5, 2020 344
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