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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 good news is Americans are getting COVID-19 test results back, on average, a day faster than they were over the summer. The troubling news, according to experts, is that it is still taking three days on average for Americans to find out their COVID-19 status and this is not quick enough to help with contact tracing and quarantine efforts to slow the spread.Researchers from several universities, including Harvard, Northeastern, Northwestern and Rutgers universities, have been collecting data and conducting surveys for months since the beginning of the coronavirus pandemic.“Prompt test results constitute the foundation of a successful COVID-19 containment strategy,” researchers state at the beginning of their paper.Data now shows, of the participants who got a test for the coronavirus in late September, the average wait time was 2.7 days.In early August, the group announced their survey data showed the average wait time nationwide was 4.1 days. More than 30 percent of participants reported, at the time, they didn’t get test results back until four days or longer.The percentage of people getting results within 24 hours is also increasing; the September survey showed 37 percent of people getting results back in one day, compared to 23 percent over the summer.“Rapid turnaround of testing for COVID-19 infection is essential to containing the pandemic. Ideally, test results would be available the same day. Our findings indicate that the United States is not currently performing testing with nearly enough speed,” researchers said.Disparities still exist for Americans who are Black or Hispanic. Although wait times are shorter for these groups as well compared to summer numbers, they are still, on average, a day or more longer than white test takers.In the latest survey, Black Americans reported waiting an average of 4.4 days for results, and Hispanics reported waiting 4.1 days. By comparison, white and Asian Americans reported wait times of 3.5 and 3.6 days on average, respectively.Also troubling for trying to control the spread of the coronavirus, the data shows how many of those who tested positive had some sort of conversation about contact tracing.“Only 56% of respondents who received a positive COVID-19 test say that they were contacted for the purpose of contact tracing,” the survey found.The survey talked to more than 52,000 people across all 50 states and the District of Columbia. 2434

The former football coach for The Ohio State University, Earle Bruce, died early Friday morning, ESPN reports.Bruce was the coach for the Buckeyes from 1979 to 1987 and had the difficult task of replacing legendary Buckeyes coach Woody Hayes. He was well-regarded, leading the team to four Big Ten titles and had a 5-3 record in bowl games. A number of his players, such as Jim Lachey, Keith Byars and Pepper Johnson, went onto pro careers. 478

The FDA warned the public on Thursday to not use hand sanitizers packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.The FDA said that some products are being packaged in items such as water bottles and food pouches, and may contain flavors such as chocolate or raspberry. The FDA said that ingesting alcohol-based hand sanitizers can cause significant cardiac injury, including death.The FDA said that one consumer bought a plastic bottle of hand sanitizer thinking it was water.“Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer,” the FDA said.“I am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages. These products could confuse consumers into accidentally ingesting a potentially deadly product. It’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning,” said FDA Commissioner Stephen M. Hahn, M.D. “Manufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers.“The FDA continues to monitor these products and we’ll take appropriate actions as needed to protect the health of Americans.” 1475

The Food and Drug Administration issued an emergency use authorization on Tuesday to a rapid at-home coronavirus test, the first of its kind to receive such an approval.The Lucira COVID-19 All-In-One Test Kit tests can be administered at home via nasal swab. Within 30 minutes, a test display will light up to give the patient’s results. The FDA says that those who receive a negative COVID-19 test but display symptoms should continue to quarantine as a negative test does not preclude someone from having the virus.Those ages 14 and over can self-administer the test at home. Juveniles must have the test administered by a health care professional.“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”Previously, the only at-home tests for the coronavirus required samples to be sent to a lab, which meant the time to get results was significantly delayed. 1342