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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

Hurricane Delta once again became a major hurricane on Thursday, with top winds of 120 mph as of 10 p.m. CT. The hurricane has regained much of the fury it lost crossing the Yucatan Peninsula on Wednesday.In an update Thursday morning, the NHC said that Delta is expected to "grow in size" throughout the day on Thursday before bringing dangerous conditions to the Gulf Coast early Friday morning.Storm surge and hurricane warnings are already in effect for parts of the Gulf Coast, particularly along the Louisiana shoreline.Louisiana cities likely to see damaging winds from the hurricane include Alexandria, Lafayette, New Iberia, and Morgan City, according to the National Hurricane Center. On Thursday afternoon, the National Hurricane Center said Hurricane Hunters found that Delta had a 30-mile wide eye. Government hurricane forecasters say they expect Delta to continue strengthening until early Friday morning, but then begin to weaken as strong shear is expected to affect the hurricane. 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.Delta luckily spared two Mexican resort towns, Cancún and Playa del Carmen, from deaths or major damage after the storm made landfall on the Yucatan Peninsula, CNN reports. 1632

Hurricane Zeta made landfall Wednesday afternoon with sustained winds estimated at 110 mph, a category 2 storm. That's just 1 mile from being classified as a category 3 storm, according to the National Hurricane Center. By 10 p.m. CT, nearly two hours after landfall, Hurricane Zeta's top winds were down to 80 mph. The hurricane was expected to become a tropical storm in the early morning hours of Thursday. 417

HOUSTON (AP) — A 2?-year-old Guatemalan child has died after crossing the border, becoming the fourth minor known to have died after being detained by the Border Patrol since December and raising new alarms about the treatment of migrant families seeking asylum in the United States.The boy died Tuesday after several weeks in the hospital, American and Guatemalan authorities said. Tekandi Paniagua, Guatemala's consul in Del Rio, Texas, said the boy had a high fever and difficulty breathing, and authorities took him to a children's hospital where he was diagnosed with pneumonia.U.S. Customs and Border Protection said the boy's mother told agents her son was ill on April 6, three days after they were apprehended near an international bridge in El Paso, Texas.RELATED: 8-year-old Guatemalan boy in Customs and Border Protection custody dies after treatment for illnessThe agency said the child was taken to a hospital in Horizon City, Texas, that day, and transferred to Providence Children's Hospital in El Paso the next day.The boy remained hospitalized for about a month before dying Tuesday. The Washington Post first reported his death.All four children who have died after being apprehended by the Border Patrol were from Guatemala, which is ravaged by violence, poverty, and drought. More than 114,000 people from Guatemala have been apprehended by the Border Patrol between October and April.Many have been detained in Mexico, which has faced pressure from the U.S. government to restrict migration. Mexico's National Immigration Institute said Thursday that a 10-year-old girl died in custody Wednesday night, a day after arriving with her mother at an immigrant detention center in Mexico City.RELATED: 7-year-old Guatemalan girl died in Border Patrol custodyIn early December, 7-year-old Jakelin Caal Maquín died of a bacterial infection . Felipe Gomez Alonzo, 8, died on Christmas Eve of a flu infection .Juan de León Gutiérrez, 16, died on April 30 after officials noticed he was sick at a youth detention facility operated by U.S. Department of Health and Human Services. The medical examiner in Corpus Christi, Texas, said Juan had been diagnosed with a rare condition known as Pott's puffy tumor, which can be caused by a severe sinus infection or head trauma."The death of a single child in custody of our government is a horrific tragedy," said Jess Morales Rocketto, chair of the advocacy group Families Belong Together. "Four in six months is a clear pattern of willful, callous disregard for children's lives."President Donald Trump's administration has for months warned that the U.S. immigration system was at a "breaking point." The administration has asked for .5 billionin emergency humanitarian funding and for Congress to change laws that would allow agencies to detain families longer and deport them more quickly.Many immigration detention facilities are overflowing and unequipped to house familieswith young children, especially as the numbers of families crossing the U.S.-Mexico border surge to record highs. The Border Patrol made 99,000 apprehensions on the southern border just in April. More than half were parents and children traveling together.The Guatemalan foreign relations ministry said the family was from the area of Olopa in Chiquimula state, east of Guatemala City. Juan de León Gutiérrez was from the same state, part of Guatemala's "dry corridor" where a prolonged drought for nearly two years has led to destroyed crops and malnutrition.The Border Patrol's challenges are particularly acute in El Paso, at the western edge of Texas and across from Juarez, Mexico.Felipe Gomez Alonzo, the 8-year-old who died in late December, had been detained with his father for a week before falling sick. CBP acknowledged it transferred Felipe and his father between stations because it didn't have space at the El Paso station. The last place Felipe and his father were detained was a highway checkpoint.After Felipe's death, the Department of Homeland Security announced it would expand medical checks and ensure that all children in Border Patrol custody would receive "a more thorough hands-on assessment at the earliest possible time."CBP did not immediately answer questions Thursday about where the 2?-year-old child and his mother had been detained before the child fell sick, or whether the any signs of illness had been detected before April 6.In recent weeks, the Border Patrol in El Paso has detained families for hours outside in a parking lot and under an international bridge. Migrant parents complained of having to sleep at that location on the ground outside or in poor conditions in tents.The agency this month opened a larger, 500-person tent in El Paso as well as in South Texas' Rio Grande Valley.___Associated Press journalists Cedar Attanasio in El Paso, Texas; Sonia Pérez D. in Guatemala City; and Christopher Sherman in Mexico City contributed to this report. 4941

I just found out the @USPS is sending this postcard to every household and PO Box in the nation. For states like Colorado where we send ballots to all voters, the information is not just confusing, it’s WRONG. (Thread) pic.twitter.com/RoTTeJRJVl— Jena Griswold (@JenaGriswold) September 12, 2020 303