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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

I would like to extend my deepest condolences to the family members who died in a house fire in Green Valley Ranch overnight. I want to assure their neighbors and loved ones that we will move swiftly to determine what caused this tragedy.— Michael B. Hancock (@MayorHancock) August 5, 2020 297

IKEA is ending the publication of its iconic catalog after 70 years.The Swedish retailer cited the reason for ending it was due to consumers shopping online.IKEA said last year, their online retail sales increased by 45% worldwide, and they saw 4 billion users on its website."For both customers and co-workers, the IKEA Catalog is a publication that brings a lot of emotions, memories, and joy. For 70 years, it has been one of our most unique and iconic products, which has inspired billions of people across the world," said Konrad Grüss, Managing Director, Inter IKEA Systems B.V in a press release. "Turning the page with our beloved catalog is, in fact, a natural process since media consumption and customer behaviors have changed. To reach and interact with many people, we will keep inspiring with our home furnishing solutions in new ways."IKEA said they are transforming as a company and will focus more on "being more digital and accessible" by improving their digital services and launching new apps.“We are not starting from scratch. We have been transforming many aspects of how to reach and interact with our customers, and the work continues to find new ways to amplify unique IKEA home furnishing knowledge, products, and solutions in the best possible way - to inspire the many people through new ways, channels, and formats,” said Grüss.The company first released its catalog in 1951 in Sweden. At its peak in 2016, IKEA distributed 200 million copies in 69 different versions and 32 languages.In fall 2021, the company said a book would be released that'll be filled with "great home furnishing inspiration and knowledge." 1651

IMPERIAL BEACH, Calif. (KGTV) - 40 undocumented immigrants were arrested at two human smuggling houses in South San Diego County Monday, according to Customs and Border Protection officials.Border Patrol agents received information Monday afternoon that immigrants were being housed at the Serenaded apartments on Elder Ave. in Imperial Beach.Upon entry into a unit, agents found 22 Mexican nationals hiding inside, officials said. A second search led to the discovery of 18 more immigrants.Three dozen men between 16 and 49 years old and four women, ages 24 to 46, were taken into custody.One of the men is a previously deported felon with convictions for domestic violence, agents said.“Identifying and dismantling smuggling organizations is our top priority,” said Chief Patrol Agent Rodney S. Scott.  “These organizations cannot be allowed to operate with impunity inside of our communities.” 909

Immigration and Customs Enforcement officers arrested 115 San Diego and Imperial County, California residents in a three-day sting targeting federal immigration law violators, officials said Friday.Among the group were 50 convicted criminals and seven people who re-entered the United States after being deported. All but seven of the arrests took place in San Diego County, according to ICE.Those arrested include a Center Street Locos Gang member in Oceanside who had been deported four previous times. He had multiple criminal convictions including grand theft, controlled substance for sale, and driving under the influence.A Kazakhstan citizen wanted by authorities in that country on charges of tax evasion and embezzlement was taken into custody in Oceanside. Interpol had issued a ‘Red Notice’ arrest warrant for him in November.Another high-profile arrest included a Mexican citizen who had served a federal prison term in 2009 after being convicted of illegal re-entry after deportation.  Officials said he had three criminal convictions for spousal abuse and had previously been removed from the U.S. to Mexico on ten prior occasions.  RELATED: ICE arrests 150 in Northern California, blasts Oakland mayor over warningAn immigrant who illegally reenters the United States after having been previously removed faces a felony prison term of up to 20 years, according to ICE. Four of the people arrested in the sting will face federal criminal prosecution for illegal re-entry after deportation. Those who are not facing federal charges may be immediately removed from the United States.“This week’s operation targeted public safety threats, such as convicted criminal aliens, individuals with final orders of removal, those who illegally re-entered the country after being removed, and individuals who have otherwise violated our nation’s immigration law,” said Greg Archambeault, field office director for ICE Enforcement and Removal Operations in San Diego. The three-day sting comes after a report in the Los Angeles Times indicating more immigrants with no criminal history were arrested by San Diego's Immigration and Customs Enforcement from October to December 2017 than anywhere else in the country. ICE officers arrested 1,622 people without criminal records, and 637 people with criminal records in San Diego during the first fiscal quarter of 2018, according to the LA Times.RELATED: San Diego murder suspect was undocument immigrant, sources sayICE said there are public safety targets who have not yet been arrested, including a Mexican citizen convicted of statutory rape and sex with a minor in 2012 and a known gang associate convicted of domestic violence in 2010. Both men had been previously removed from the U.S.In a news release, ICE officials cited California state laws that affect the way the agency operates. 2875