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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 just received this from the Attorney General. Those in our caucus who refused to take precautions are responsible for Dick Hinch's death. pic.twitter.com/mMLwkPE7F2— William M Marsh MD (@wmarshcc8) December 10, 2020 235

Hurricane Delta has made landfall near Creole, Louisiana, as a Category 2 hurricane, but as it's moved inland, it has weakened to a Category 1 storm.WATCH LIVE: According to the National Hurricane Center, the storm made landfall at 6 p.m. CT with maximum sustained winds of 100 mph.A Florida Coastal Monitoring Tower near Lake Arthur, Louisiana, sustained wind of 77 mph and a gust to 96 mph, the NHC said. A NOAA National Weather Service water level gauge at Freshwater Canal Locks, Louisiana, recently reported a storm surge of over 8 feet above ground level. Louisiana has taken the brunt of the impact of the 2020 hurricane season. Hurricanes Marco and Laura have already made landfall in the state, causing inland flooding and significant damage along the coast. Hurricane Sally also did significant damage nearby Gulf Shores, Alabama, when it made landfall in September.The Associated Press reports that Delta marks the sixth time this year that evacuations have been ordered from Louisiana's barrier islands.After making landfall this afternoon, forecasters expect Delta to move north and dump heavy rain on the rest of Louisiana before moving west into Mississippi on Saturday. 1193
In a little more than a decade, more than 40 million diabetics worldwide could be left without insulin, the drug that is needed to help control the disease. It's a dire prediction from a study published in the journal Lancet Diabetes and Endocrinology that could have life-altering consequences. Health expert Dr. Dahlia Wachs likened insulin to being the key to a door. In most people, it's a naturally occurring hormone the pancreas secretes when we eat sugar so that it can go from the bloodstream and into our cells.But it's a different matter for the millions of people whose bodies either don't make insulin or who have insulin resistance."Type 1 diabetics — they are very dependent on insulin," Wachs said. "They don't make insulin. They get very skinny and we have to give them insulin. There really isn't a lot of other treatments for these Type 1 diabetics.”A shortage of insulin in drug form poses major challenges. "So those with Type 2 diabetes, many of them can take pills, but if they are in poor control we have to give them insulin," Wachs said.Wachs said insulin is expensive to make. She says only three major pharmaceutical companies make it. And the demand isn't the highest here in the United States but other parts of the world, including Africa and Asia. However, the U.S. will have the third highest number of people living with diabetes by 2030.Diabetes is growing at an epidemic rate in the U.S. More than 12 percent of the adult population in Nevada is diabetic, according to the Centers for Disease Control. Every year, 10,000 people are diagnosed with diabetes and an estimated 75,000 have diabetes and don't know it. "So what can we do to prevent the shortage? Well, try to prevent diabetes," she said.That means controlling obesity, exercising and eating healthy. 1943
Hundreds of students at Sage Creek High School in Carlsbad witnessed a graphic and emotional presentation about DUI driving Tuesday. The program is called "Every 15 Minutes" is presented by the CHP and other local first responders. Teens saw fellow students injured or dead after a drunk driving crash and also saw another student arrested for getting behind the wheel intoxicated. The two day program will conclude Wednesday with a mock funeral and a presentation by a CHP officer who lost family members in a DUI crash last year. 565
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