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The Food and Drug Administration on Wednesday authorized the first rapid coronavirus test that doesn’t need any special computer equipment to get results.The 15-minute test from Abbott Laboratories will sell for , giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.It’s the latest cheaper, simpler test to hit the U.S. market, providing new options to expand testing as schools and businesses struggle to reopen and flu season approaches. The FDA also recently greenlighted a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks.Both tests have limitations and neither can be done at home. Several companies are developing rapid, at-home tests, but none have yet won approval. Abbott’s new test still requires a nasal swab by a health worker, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories.And in general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases. The agency granted Abbott’s test an emergency use authorization late Wednesday for patients with suspected COVID-19.The two additions should help expand the number of available tests. The U.S. is now testing about 690,000 people per day, down from a peak of 850,000 daily tests late last month. Many public health experts believe the country will soon need to test vastly more people to find those who are infected, isolate them and contain the virus.The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for COVID-19 screening. While considered highly accurate, the tests rely on expensive, specialized machines and chemicals. Shortages of those supplies have led to repeated delays in reporting results, especially during a spike in cases last month.Government and health experts view rapid tests that can be run outside the laboratory system as key to boosting capacity.“Those screening tests are what we need in schools, workplaces and nursing homes in order to catch asymptomatic spreaders,” said Dr. Jonathan Quick of the Rockefeller Foundation, in an interview earlier this month. The nonprofit group has called for the U.S. to conduct about 4 millions per day by October, mostly rapid, point-of-care tests.Abbott’s BinaxNOW is the fourth rapid test that detects COVID-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself. It’s considered a faster, though sometimes less precise, screening method. The other tests need to be inserted into a small machine.Inside the Abbott test is a specially coated strip that interacts with COVID-19 antigens. The patient’s nasal swab is inserted into the card and a few drops of a chemical solution are added. Markings appear on the card to indicate whether the sample is positive or negative — much like a pregnancy test.Two other makers of antigen tests — Quidel and Becton Dickinson have said they haven’t been able to meet demand for the tests. A third, LumiraDx, plans to begin shipping its recently approved antigen tests by the end of this month. Abbott expects to begin shipping tests in September, reaching 50 million tests a month in October.The influx of antigen tests will go a long way toward meeting the Trump administration’s projection that 90 million COVID-19 tests a month will be available by September if needed. But U.S. “testing czar” Adm. Brett Giroir has stressed that the U.S. can contain the outbreak with far fewer tests.“That’s the capacity ... we do not need that many tests to safely and sensibly reopen,” Giroir told reporters on a recent call. He pointed to several key indicators that have been falling, including new infections and hospitalizations, even as testing has slowed.Earlier this month, the FDA authorized Yale’s saliva-based test, which is expected to cut the time and cost compared with similar tests. It’s the fifth COVID-19 saliva tests OK’d by regulators. All require lab processing.Developed by Yale’s School of Public Health, SalivaDirect can use any sterile container to collect a sample, not the special tube needed with earlier tests, and requires less chemicals. Outside experts welcomed the new approach but noted its limitations.“It’s not a rapid test, it’s a laboratory-based test that will still be prone to the same massive delays as any other test,” said Dr. Michael Mina of Harvard University.___Follow Matthew Perrone on Twitter: @ AP_FDAwriter.___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. 5201

The FDA continued on Monday to warn the public about using methanol-based hand sanitizers that the agency calls “dangerous.”The FDA has published a “Do Not Use” list of products. As of Monday afternoon, 87 products are on the do not use list. Adding to the confusion for consumers, many of the products do not have methanol on the label.Methanol can be toxic when absorbed through the skin as well as life-threatening when ingested, the FDA said. Retailers are being encouraged to recall these products.Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death, the FDA warns."Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA's list of dangerous hand sanitizer products," said FDA Commissioner Stephen M. Hahn, M.D. "We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers."The FDA’s warnings come following a hand sanitizer shortage in the consumer and commercial markets. Amid the shortage companies that do not ordinarily produce hand sanitizers began bottling products before obtaining FDA approval. 1771

The European leg of Lady Gaga's "Joanne World Tour" has been postponed as the singer grapples with health issues, Live Nation announced Monday.In a statement posted on the promoter's site, Live Nation revealed that the portion of the tour that was set to begin September 21 in Barcelona, Spain, and conclude on October 28 in Koln, Germany, has been postponed until 2018."Lady Gaga is suffering from severe physical pain that has impacted her ability to perform," the statement read. "She remains under the care of expert medical professionals who recommended the postponement earlier today." 599

The driver who plowed down pedestrians and cyclists on a New York bike path is a "soldier of the caliphate," the ISIS terror group said on its weekly newspaper, without providing evidence to back up its claim.The attack Tuesday killed eight people and left more than a dozen others injured."One of the Islamic State soldiers in America attacked on Tuesday a number of crusaders on a street in New York City," the al-Naba newspaper reported Thursday.The terror group provided no evidence that ISIS had knowledge of the attack before it happened or it was involved in planning it. The article did not name the attacker.Suspect Sayfullo Habibullaevic Saipov has told authorities that he was inspired to carry out the attack after watching ISIS videos and closely followed the terror group's playbook for an attack.While ISIS did not claim direct responsibility for the attack, it described the attacker as one of its soldiers.Suspect's link to ISISThe 29-year-old Uzbek native was charged with providing material support to ISIS, violence and destruction of motor vehicles, said Joon H. Kim, acting US attorney for the Southern District of New York.Saipov drove a rental truck down a bike path in New York's Lower Manhattan, crashed into a school bus and then jumped out, brandishing imitation firearms, officials said. He was shot by New York police Officer Ryan Nash in the abdomen and taken into custody.He didn't enter a plea Wednesday to the federal terror charges.Saipov was so devoted to ISIS, he wanted to display the terror group's flag in his hospital room, documents show. He had about 90 videos and 3,800 images on a cell phone featuring ISIS propaganda, including video of a beheading, according to the complaint.This is the first time the terror group has put such a claim on its newspaper before releasing it on its media wing, Amaq news agency, which is its first point of publication for claims of responsibility.The wording of the ISIS statement -- not claiming the attack as an outright act of ISIS and saying the person carrying the attack is one of its "soldiers" -- mirrors ISIS' language in statements after an attack in France and the nightclub shooting in Orlando last year.No warning signsThose who crossed Saipov's path are trying to reconcile the man they met and the one they are now hearing about.When approached in the lobby of her Brooklyn apartment building, the suspect's mother-in-law said she was in shock."I don't know what happened," she said.Those who knew him in Tashkent, Uzbekistan, and in at least three states he bounced between since coming to America say they saw no warning signs of Saipov being radicalized."He was happy that he was here, he had a family here, and he was a truck driver and his business was really good," said Makhina Kadirova, a childhood friend.His neighbors described him as a quiet and said his family didn't socialize often.Trump calls for death penaltyOn Twitter, President Donald Trump said Saipov should be executed and added that he "would love" to send him to the Guantanamo Bay detention camp in Cuba."NYC terrorist was happy as he asked to hang ISIS flag in his hospital room. He killed 8 people, badly injured 12. SHOULD GET DEATH PENALTY!' the President tweeted Wednesday night.Presidents typically do not comment on pending criminal cases because their statements could be seen as influencing a potential jury pool.Concrete barriersThe Lower Manhattan bike path where the attack took place has reopened, CNN affiliate WPIX reported, as New York started installing concrete barriers to prevent similar terror incidentsThe work started Thursday as part of a statewide review of shared-use paths, according to the New York State Department of Transportation.A total of 57 barriers are being positioned diagonally along the path, leaving enough space for bicycles but not for larger vehicles, CNN affiliate WABC reported. But some local cyclists think the barriers are problematic."There's no way two bikes can pass each other there and the runners as well," New York City resident James Petty told WABC. "There's going to be accidents."Similar concrete barriers were placed in May after a man drove a car onto a crowded sidewalk in Times Square, killing a teenage woman and injuring at least 22 people.  4290

The Dalai Lama has a new fan. And so does Aaron Rodgers. Each other.The Green Bay Packers' all-world quarterback is on a world trip taking him to India, where he met the Tibetan buddhist leader and gave him an NFL football and a Green Bay Packers hat.Rodgers and his beloved, Danica Patrick, are traveling to India to help with the Starkey Hearing Foundation, according to the Green Bay Press-Gazette. They will be giving hearing aids to some people who may be hearing for the first time.Rodgers has undergone a long spiritual journey beyond his time as a quarterback with the Packers. He often expressed his Christian faith during his rookie year in 2005, won the Bart Starr award which reflects on that belief. Yet he talked in 2016 about his spirituality, not necessarily believing God has one team he roots for over another, and the specifics of his purpose on earth. 879

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