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Potential accuracy issues with a widely used coronavirus test could lead to false results for patients, U.S. health officials warned.The Food and Drug Administration issued the alert Monday to doctors and laboratory technicians using Thermo Fisher’s TaqPath genetic test. Regulators said issues related to laboratory equipment and software used to run the test could lead to inaccuracies. The agency advised technicians to follow updated instructions and software developed by the company to ensure accurate results.The warning comes nearly a month after Connecticut public health officials first reported that at least 90 people had received false positive results for the coronavirus. Most of those receiving the false results were residents of nursing homes or assisted living facilities.A spokeswoman for Thermo Fisher said the company was working with FDA “to make sure that laboratory personnel understand the need for strict adherence to the instructions for use.” She added that company data shows most users “follow our workflow properly and obtain accurate results.”The FDA said one possible problem was related to the incorrect use of equipment that rapidly spins samples in preparation for processing. The agency’s letter tells lab workers to follow new instructions developed by the company for this step.A second issue relates to the software used on Thermo Fisher’s testing platform. FDA said labs must upgrade the software to a new version.Dr. Albert Ko of Yale’s School of Public Health said the potential accuracy problems have “pretty serious implications” given that Thermo Fisher’s test is used widely both in the U.S. and around the world to screen for coronavirus.The FDA statement did not provide any details on how many test results may have been affected by the problem.Lab tests are the backbone of U.S. screening for coronavirus, accounting for more than half of the roughly 750,000 tests developed daily. The tests look for traces of coronavirus’ genetic material in nasal swabs taken from patients.Thermo Fisher’s test was granted emergency use by the FDA in mid-March. The test runs on a large, automated machine used in hospital, government and commercial labs to look for diseases such as HIV, hepatitis and flu.The FDA has used its emergency powers to OK more than 200 tests for coronavirus since February. No test is perfect and all are expected to give at least a small percentage of false negatives and false positives.___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. 2656

President Donald Trump refuted a report from The Atlantic on Thursday that claimed he called Sen. John McCain and U.S. soldiers who died fighting for their country "losers" and "suckers."According to The Atlantic, in the days after McCain's death in August 2018, Trump told senior staff members that he did not want to support that "loser's" funeral and became "furious" that flags at the White House had been lowered to half-staff in McCain's honor.McCain spent more than five years in a Vietnamese war camp after his plane was shot down during the Vietnam war. During the 2016 presidential campaign, Trump responded to criticism from McCain by saying he liked soldiers who "weren't captured."The outlet also reported that Trump made similar comments during a trip to Paris in 2018, when a visit to nearby Aisne-Marne American Cemetery was canceled due to rain. While officials at the time claimed the Secret Service was unable to fly a helicopter due to the weather, senior staff members who were in Paris claim the trip was canceled because Trump believed his hair would be ruined in the rain.Trump also reportedly claimed the cemetery — a memorial site to hundreds of American soldiers who were killed during World War I — was "filled with losers" and "suckers."Much of the reporting was further confirmed in reports by The Washington Post and The Associated Press.In a series of tweets on Thursday evening, Trump denied the accusations, calling them "fake news." He claimed he called for flags at the White House to be flown at half-staff "without hesitation or complaint" following McCain's death."I never called John a loser and swear on whatever, or whoever, I was asked to swear on, that I never called our great fallen soldiers anything other than HEROES," Trump tweeted on Thursday. 1801

POWAY, Calif. (KGTV) - A state inspection found 12 flaws in Poway's drinking water delivery system less than three months before the city's precautionary boil water advisory.City officials remain adamant that the issues raised by the inspection had nothing to do with the nearly week-long advisory that ended Dec. 6. The September 2019 inspection, from the State Water Resources Control Board, raised a series of issues - some administrative. It says some of Poway's distribution system reservoirs haven't been cleaned or inspected in more than five years; that the city's coagulant feed pump meter isn't working, and that the city needs to update its water quality alarm systems for chlorine and clarity. RELATED: Poway businesses affected by boil water advisory get help from San Diego County"The following is a summary of our findings and a discussion of deficiencies observed during the inspection, which must be addressed to better protect public health and improve system reliability," says the inspection, dated Sept. 19. The city issued the precautionary boil advisory on Nov. 30 after a Thanksgiving rain storm. A storm drain overflowed and backed up into its water treatment facility's clearwell reservoir due to Thanksgiving rains. Residents began reporting brownish water. The city temporarily fixed the problem, but state officials have said they anticipate issuing fines. RELATED: Mayor: Water Crisis critics are politically motivatedPoway officials expressed shock at that revelation, citing the September report. The city has declined to release the report, but 10News obtained it from the state via a Public Records Act request. The city declined a request for an interview, but a spokeswoman said it has met the deadlines the inspection gave to address the issues it raised. 1802

President Donald Trump does not like the news that General Motors would close several plants and cut more than 10,000 jobs. Speaking to reporters on the White House lawn on Monday afternoon, Trump said he spoke with CEO Mary Barra and told her he wasn't happy with the decision."I told her I'm not happy about it," Trump told reporters."The United States saved General Motors and for her to take that company out of Ohio is not good," he continued. "I think she's going to put something back in soon."On Monday, GM announced it would close four US-based plants, including two in metro Detroit; the Detroit-Hamtramck Assembly Plant and the Warren Transmission Operations plant.According to a spokesperson for GM, the plants will be unallocated which means they will no longer produce vehicles in those plants in 2019. According to the company, the future of the plants will be part of contract talks with the UAW next year.“The actions we are taking today continue our transformation to be highly agile, resilient and profitable, while giving us the flexibility to invest in the future,” Barra said in a release. “We recognize the need to stay in front of changing market conditions and customer preferences to position our company for long-term success.”According to the release, GM will lay off 14,700 factory and white-collar workers. Of those, 8,100 will be white-collar workers that will either take buyouts or be laid off.The company said that the moves will help continue its focus on crossovers, SUVs and trucks. With the move, GM plans to cut 25 percent of the executive staff and 15 percent of the salaried and salaried contract staff.The transition also includes ceasing production of six vehicles; the Chevrolet Cruze, Volt and Impala, the Buick LaCrosse, Cadillac XTS sedan and Cadillac CT6 sedan. According to the company, the Detroit-Hamtramck Assembly Plant produces the Volt, Impala, LaCrosse and CT6.Trump said Barra told him the Cruze isn't selling well."Hopefully she’s going to come back and put something, but I told her I’m not happy about it," he added.Barra also was meeting with White House Economic Adviser Larry Kudlow on Monday, a White House official confirms. The meeting has apparently been on the books for weeks and it's just a coincidence that the meeting and the announcement happened on the same day. 2369

President Donald Trump announced on Tuesday he has fired Christopher Krebs, who was director of the Cybersecurity and Infrastructure Security Agency in the Department of Homeland Security. Krebs’ agency was among several that declared this month’s election the “most secure in American history.”The letter was signed last week by leaders of the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency, the U.S. Election Assistance Commission and the National Association of State Election Directors, among others. The Cybersecurity and Infrastructure Security Agency was established two years ago as a branch of Homeland Security during the Trump administration. Krebs was the first director of the agency, appointed by the Trump administration to the post in 2018.In bold, the authors of the statement wrote, “There is no evidence that any voting system deleted or lost votes, changed votes, or was in any way compromised.” This statement matches those from secretaries of state and boards of election throughout the US.“The November 3rd election was the most secure in American history,” the statement reads. “Right now, across the country, election officials are reviewing and double checking the entire election process prior to finalizing the result.”The group says that claims of election fraud are “unfounded.”“While we know there are many unfounded claims and opportunities for misinformation about the process of our elections, we can assure you we have the utmost confidence in the security and integrity of our elections, and you should too,” the statement read. “When you have questions, turn to elections officials as trusted voices as they administer elections.”Trump, who has filed a number of legal challenges to the election, challenged the assessment of many in the election security field.“The recent statement by Chris Krebs on the security of the 2020 Election was highly inaccurate, in that there were massive improprieties and fraud,” Trump said, adding several other misleading statements involving the 2020 election. “Krebs has been terminated as Director of the Cybersecurity and Infrastructure Security Agency.”Trump’s legal team has struggled to gain a foothold in a number of legal challenges to the election. For instance on Tuesday, Pennsylvania’s Supreme Court dismissed a suit as the Trump campaign claimed that campaign officials did not have “meaningful access” to observe the vote counting in Philadelphia. The state’s Supreme Court said that election officials followed state law.The CISA addressed election-related rumors, such as that dead people are able to vote in the election, a claim that Trump baselessly has repeated. "Every state has voting system safeguards to ensure each ballot cast in the election can be correctly counted. State procedures often include testing and certification of voting systems, required auditable logs, and software checks, such as logic and accuracy tests, to ensure ballots are properly counted before election results are made official. With these security measures, election officials can check to determine that devices are running the certified software and functioning properly," the agency wrote. “We conclude the Board did not act contrary to law in fashioning its regulations governing the positioning of candidate representatives during the precanvassing and canvassing process, as the Election Code does not specify minimum distance parameters for the location of such representatives. Critically, we find the Board’s regulations as applied herein were reasonable in that they allowed candidate representatives to observe the Board conducting its activities as prescribed under the Election Code,” the court ruled.The Associated Press projected on Nov. 7 that Joe Biden would win the presidential election with at least 290 Electoral College votes. The Associated Press has not called Georgia, but Biden holds a 14,000 vote lead there, and the state is expected to finish a hand recount there on Wednesday. 4026

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