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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

HOUSTON, Texas – A businessman in Texas is facing federal charges after allegedly spending COVID-19 relief funds on improper expenses, including on real estate, a Lamborghini Urus and at strip clubs.Federal officials announced Tuesday that Lee Price III, 29, was taken into custody and charged with making false statements to a financial institution, wire fraud, bank fraud and engaging in unlawful monetary transactions.Price is accused of fraudulently obtaining more than .6 million in Paycheck Protection Program (PPP) loans. The loans provided by the Small Business Administration (SBA) are meant to support business owners struggling during the pandemic. Businesses must use the loan proceeds for payroll costs, interest on mortgages, rent and utilities.A criminal complaint alleges Price was involved in a scheme to submit fraudulent PPP loan applications to federally insured banks and other lenders, two of which received funding.Price Enterprises Holdings allegedly received more than 0,000, while a loan application listing 713 Construction was approved for over 0,000.The loan applications allegedly asserted both entities each had numerous employees and significant payroll expenses. However, neither entity has employees nor pays wages consistent with the amounts claimed in the loan applications, authorities say.Further, the individual listed as CEO on the 713 Construction loan application died in April 2020, a month before the application was submitted, according to the complaint.Price allegedly used the loan proceeds not for payroll expenses, but for lavish personal purchases, such as spending the loan money on a Lamborghini Urus, a Rolex watch and real estate transactions. He also allegedly spent thousands at strip clubs and other Houston night clubs. The complaint further alleges Price used a portion of the loan money to buy a 2020 Ford F-350 pickup truck. 1901

Hours after telling TMZ he wanted to walk his daughter down the aisle, Thomas Markle said he will have heart surgery Wednesday morning and cannot attend Prince Harry and Meghan Markle's wedding, the US-based celebrity news site reported.According to TMZ, Thomas Markle said surgeons will clear blockage in his heart, repair damage and put in a stent.Earlier in the day, Markle told TMZ he wanted to walk his daughter down the aisle as she marries Prince Harry at Saturday's royal wedding."I hate the idea of missing one of the greatest moments in history and walking my daughter down the aisle," he said, according to the first TMZ report.Markle has been involved in controversy since it was revealed he allegedly staged a series of photos captured by an American paparazzo.According to the TMZ report, Markle thinks that staging the photos was "stupid" but not a serious transgression.The first report said Markle was in the hospital after reportedly being treated for a heart attack a week ago.CNN has reached out to Thomas Markle for comment over phone and over email but has yet to receive an answer. When asked about the TMZ report, Kensington Palace declined to comment.Meghan Markle's half-sister, Samantha Markle, recently said she was the "culprit" who urged their father to stage the photos in an ill-fated bid to improve his image. She said her father had "suffered at the hands of the media" and had decided "enough is enough."Thomas Markle is a former lighting director who worked on popular TV shows "Married with Children" and "General Hospital," according to the Internet Movie Database. He met Meghan's mother, Doria Ragland, at a Hollywood studio in the late '70s and the pair split when their daughter was still young.CNN also contacted General Hospital in Rosarito, Mexico, where Markle is thought to have stayed previously, but officials would not say whether he is there.  1907

IMPERIAL BEACH, Calif. –  A former United States border patrol agent says he nearly lost his arm in 2010 after training in Silver Strand Waters in southern California.Joshua Willey says he contracted flesh-eating bacteria.“I just remember my arm was extremely swollen like I wanna say the size of a volleyball maybe, “ Willey said. “My family and I were told that I might have to have my arm amputated and that was hard to hear.”Willey joined the group, “Citizens against Sewage” Friday afternoon to demand action against the ongoing problem.President Trump is scheduled to visit San Diego next week to look at the border wall prototypes, and the group wants him to take a tour of the Tijuana River Valley and view the extensive sewage issues."Citizens against Sewage" also called for the commissioner of the U.S. International Boundary and Water Commission (IBWC) to resign or be reassigned for what they claim is a lack of action on the matter:IBWC sent the following statement to Scripps station KGTV in San Diego:"Our thoughts and prayers are with the Agent and his family. We have successfully pressed Mexico into taking emergency actions and that as a result fugitive illicit discharges are being intercepted.Mexico has told us and we are verifying that they are indeed taking steps to stop sewage from crossing the border. Commissioner Drusina will work until otherwise notified by the Administration." 1452

If you love bacon and beer, well, good news. Waffle House is collaborating with a brewing company in Georgia to produce a bacon-infused beer called Waffle House Bacon & Kegs.According to the Oconee Brewing Company, the beer is a 6.5 percent ABV red ale that will be available beginning Dec. 18 in a six-pack or on draft exclusively at the brewing company."The beloved scent of bacon stands out from the typical medium hop aroma of a red ale. The malty sweetness of the base beer blends perfectly with the salty, savory, and smokey bacon extract to create a delicious and unique beer," the brewery said on its website. "Bacon & Kegs pairs well with breakfast food items (obviously!) or can be enjoyed as a stand-alone, soon to be iconic beer."The packaging - that was created by agency Brock Company Creative - features the beer's name using the iconic lettering of the Waffle House sign, alongside a drawing of a Waffle House restaurant. 953