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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

How early is TOO early to start shopping for the holidays? While some think it's a sin to start this early, Walmart and Amazon feel August is a great time to begin your Christmas shopping.This week they released their holiday toy guides. Some of the top toys on the lists include: 298

If not for an attorney taking her case pro bono, a Barberton, Ohio woman’s request for 40 cents nearly landed her a 30-day stay in jail and a 0 fine under the city’s strict panhandling ordinance.Enacted in 1980, that ordinance could be repealed by the city council next month. If not, the woman’s attorney has threatened legal action over the “unconstitutional” ordinance.In February, Samantha Stevens, a single mother of one, was asking patrons of a McDonald’s in downtown Barberton for 40 cents so she could cover bus fare. A city police officer then issued the woman a summons for soliciting alms — better known as panhandling. Under city ordinance, it is considered a fourth-degree misdemeanor, which carries a potential 30-day jail sentence and a 0 fine.Civil rights attorney Becky Sremack came across the incident by reading the police blotter in the local newspaper, the Barberton Herald.“I wrote her a letter and offered pro-bono legal assistance at that point,” Sremack said. “It doesn’t really add up to charge someone criminally for asking another citizen for a small amount of money.”Not only does it not add up, it’s also unconstitutional, Sremack said.Laws prohibiting panhandling in public places have been repeatedly deemed unconstitutional by federal courts because soliciting or requesting money is considered protected speech under the First Amendment.Last week, Sremack filed a motion to dismiss the charge against Stevens on the grounds that the city’s anti-panhandling ordinance was unconstitutional. City prosecutors have since dismissed the charge.“The fundamental problem is that the government does not have the right to ban solicitation in a public place,” Sremack said. “Solicitation of money asking someone for help is free speech and is protected along with every other type of speech. It’s a basic free speech issue. The Constitution has to apply to the poor as well as to the rich.”Sremack then took the matter a step further, penning a letter to Barberton city leaders that if the city’s anti-panhandling ordinance isn’t repealed within a reasonable amount of time, she would be filing a lawsuit against the city. According to police records, a total of 30 panhandling summonses have been issued since January 2017.“Criminalizing is going to do nothing to reduce the need amongst the poor for help, for assistance,” Sremack said. “These resources would be better put into programs that address the underlying issue.”City Law Director Lisa Miller told Scripps station WEWS in Cleveland on Tuesday that city leaders had begun the process of repealing the 38-year-old ordinance before Sremack sent the letter. The possible repeal of the ordinance could go before a city council committee on May 7th. A vote on the measure could come as early as May 14th.Craig Megyes, the president of the Barberton City Council, said he anticipates that the ordinance will be repealed.The possibly unconstitutional ordinance only applies to soliciting in public places like sidewalks and street corners. Private property owners still have the right to prohibit panhandling on their property.“The Constitution protects speech that we like as well as speech we don’t like,” Sremack said. “Simply being made uncomfortable by seeing a neighbor in need is not enough to call it a crime.” 3315

In a 5-4 decision announced Monday, the Supreme Court struck down a Louisiana law that severely restricted abortion in the state, marking a win for abortion rights advocates.Chief Justice John Roberts, a crucial conservative swing vote, sided with liberal Justices Breyer, Ginsburg, Sotomayor and Kagan in issuing the majority opinion.According to The Associated Press, Roberts has favored restrictions on abortion in two previous Supreme Court rulings.The decision strikes down a Louisiana law that would have required physicians who perform abortions to also have admitting privileges at a hospital within 30 miles of the abortion clinic. The law would have reduced the number of physicians in the state who were legally permitted to conduct an abortion to one.The law was nearly identical to a Texas law that was declared unconstitutional by the Supreme Court in a 2016 decision.This story is breaking and will be updated. 933

In a few weeks, thousands of college students will begin their yearly right of fall by returning to the campus of Tufts University in Medford, Massachusetts, but a return to campus life this year will mean testing and quarantining for those students who chose to come back.Like colleges and universities across the country, Tufts is experimenting with a new plan that will allow more than 5,000 students to come back to campus while at the same time, instituting rigorous new guidelines in an effort to keep COVID-19 from spreading.The key to success, testing.“We wanted to test for COVID at a frequency that would catch people when they’re asymptomatic before they have a chance to spread,” explained Tuft’s President Anthony Monaco.Tufts plan for the fall is as complex as the virus itself. Students from outside the Northeast will be brought back to campus first, where they will be forced to quarantine for 14 days. Health officials expect at least a small portion of those students to test positive for COVID-19 the moment they step back on campus. Because of that, the university has constructed an extra 200 modular units of dorm space. The idea of the modular facilities is to give campus health officials a contained area to monitor students who test positive for the virus, while at the same time, keeping them out of the general population.After students from outside the Northeast are brought back to campus, students from the general area around New England will return.Every single student will be tested twice a week for COVID-19, something experts say will be a key component to safely reopening college campuses this fall. Regardless, school officials expect students to test positive for the virus throughout the fall.Researchers at Yale’s School of Public Health have been advising Tufts and hundreds of other colleges who are planning to resume some form of in-person learning this fall.“If we don’t test frequently, we give silent spreaders an opportunity to grab hold and this virus is hard to play catch-up with,” explained Professor A. David Paltiel, who recently published a study on how quickly the virus can spread through colleges if left unchecked.To study the virus, Paltiel and his colleagues used epidemic modeling to assemble hypothetical situations resembling a college campus. The study found that if you take 5,000 healthy students and add in only 10 students who have COVID-19, hundreds, if not thousands, of kids will be sick by Thanksgiving.“At that point, the only thing that keeps the virus from getting out of control is Thanksgiving break,” he said.That is why testing is key, the study found. When Paltiel took those same 5,000 kids and added in 10 students who have COVID-10, but tested every student twice a week, the study found that only about 100 students ended up catching COVID.“Many universities are planning to only test students who have symptoms, in our view that is a recipe for disaster,” he said.Only adding to the uncertainty of the situation, about 40 percent of college students said they would return to live near campus even if classes were held virtually. Paltiel and other health officials say because of that, it’s more beneficial to have students on-campus where they can be monitored and tested frequently.“It’s hard and it could be a nightmare, people who say we shouldn’t open campuses should remember the nightmare doesn’t go away,” he said. 3420

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