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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

In a series of unusually candid remarks, the US general in charge of the nation's nuclear arsenal has issued a stark warning that Russia and China are "aggressively" developing new high-speed, or hypersonic, weapons that the US currently has no defense against.The weapons might not be operational for several years, but Gen. John Hyten, the four-star head of US Strategic Command, is warning that changes to missile defenses are urgently needed or the US will be unable to detect them when they are operational."China has tested hypersonic capabilities. Russia has tested. We have as well. Hypersonic capabilities are a significant challenge," Hyten told CNN in an exclusive interview. "We are going to need a different set of sensors in order to see the hypersonic threats. Our adversaries know that."Hyten and other military officials say the current generation of missile detecting satellites and radars won't be enough to detect these new generation weapons. Hypersonic is generally defined as a speed of Mach 5 or over 3,806 miles per hour."We've watched them test those capabilities," Hyten told Congress last week. But with unusual public candor about potential US military shortfalls, he acknowledged "we don't have any defense that could deny the employment of such a weapon against us, so our response would be our deterrent force, which would be the triad and the nuclear capabilities that we have to respond to such a threat."Hypersonic missiles fly into space after launch, but then come down and fly at high speeds on a flight path similar to an airplane. Their lower trajectory make them more difficult for US missile defense satellites and radars to detect. Russia has openly stated it is developing high-speed air-launched missiles as well as underwater hypersonic drones.The Pentagon is currently writing a review of its missile defenses to help determine what new capabilities might be needed to deal with new classes of attack weapons. Hyten gave Congress a hint of what may be in that review stating "the first thing we need is better sensor capability, better tracking capabilities to make sure we can characterize and then respond to that threat."He also called for improved US warheads, essentially "better kill vehicles on the top of our interceptors so that those kill vehicles become more and more lethal." The Pentagon is also working on concepts for interceptor missiles that repel a barrage of enemy attack missiles. Current US missile defenses are designed to only shoot down a small number of enemy missiles.The US focus has largely been to work on hypersonic technologies across the board. But Russia is now well into testing some of its systems. Earlier this month Russia showed video of what the Kremlin said was an air-launched hypersonic ballistic missile.When asked how far along the Russian hypersonic program is, Hyten told CNN, "I don't want to put a who's winning the race, I'll just say there is a race."When asked how soon it could be before the Russians have an operational hypersonic weapon that could reach the US, Hyten said, "It's similar to the North Korea problem. If you continue to pursue that technology, you will get there. And the Russians will get there, the Chinese will get there and we'll get there -- and we'll have to figure out how to deal with that." 3323

HUNTINGTON BEACH, Calif. (AP) — Wildlife officials say a goose is recovering after being found with a large arrow through its neck at the same Southern California park where a goose and a gull swallowed prescription pills last month.The Los Angeles Times reported Monday that the goose flew around with the arrow in its neck for a week before it was finally captured at Carr Park in Huntington Beach.The arrow was removed and the bird was given antibiotics, IV fluids and painkillers. It's expected to fully recover.Shortly before Christmas, a Canadian goose and a ring-bill gull had their systems flushed after eating pills — including sedatives — that someone dumped in the park. Both birds have recovered after being treated at a wildlife center.Officials don't know whether the two incidents are related. 816

If you've ever wanted to be an FBI agent, but don't have a law enforcement background, now is your chance. FBI Supervisory Special Agent Martin Hellmer says in the cyber division, there's a place for you."There is a critical need for cyber minded people, technically trained people, across the board," he said.In the current day and age, Hellmer says people might not realize how much of a role technology, the Web, and cyber topics play in the FBI's ability to successfully investigate criminal matters."Most of what we do, whether we're investigating a bank robbery, a fugitive case, or a computer intrusion, a sophisticated computer intrusion, involves some sort of technical component, and therefore requires some technical know-how," Hellmer said. "Behind every computer or any smart device is a person. So there's always a human component to any sort of crime that that person might be conducting using their computer, smartphone, or any other sort of device."There is a big difference between cyber crime, and cyber warfare, according to the supervisory special agent."Cyber crime entails some sort of victimization of someone else. We usually think of that as financial victimization, or harassment, that sort of thing," he said. "Cyber warfare would entail a national security component."Now, more than ever according to Hellmer, the FBI is in need of cyber-minded people."System administration, general information technology, software engineering, network engineering, computer science," he said. "Any of those disciplines, or a background in any of those disciplines, is a need for the FBI right now."As cyber criminals are getting smarter and better at what they do, Hellmer says by recruiting bright minds, the FBI can always stay one step ahead of them."As criminals become more advanced in technical know-how and committing crimes online," he said. "We at the FBI try to remain one step ahead of them by hiring technically-minded people, smart people, who know cyber."If you'd like to learn more about careers at the FBI, click here. 2087

ICYMI – @BarackObama joined a group of NBA Champions and first-time poll workers from @MoreThanAVote during #NBAFinals Game 1 to highlight the importance of voting. Don’t wait, make your voting plan and sign up to work the polls today at https://t.co/RzbxxkFmLa pic.twitter.com/lFQLfcuEG3— NBA (@NBA) October 1, 2020 324