antibody tests were as the way to end lockdowns hailstorms. They are causing confusion instead

antibody tests were as the way to end lockdowns hailstorms. They are causing confusion instead

Aspen has been a hot spot early COVID-19 in Colorado, with a cluster of cases in March ensue tourist for his visit to the world famous skiing. The tests were scarce, making it difficult to know how the virus spread. So in April, billed as the Department of Public Health Pitkin County, had received 1,000 COVID-19 antibody tests, and that would be offered at no cost to residents, it seemed an interesting opportunity, efforts to evaluate progress in the spread to stop the virus. “This test will allow us to maintain the epidemiological data we were looking for” Aspen Ambulance District Director of Muething gift that Community online meeting place during an April 9. However, as soon as the plan has it come off the middle of reliability problems of Aytu BioScience test. Other ski resorts like Telluride, Col., and Jackson, WY and the less prosperous border community of Laredo, TX were also pulled to inform antibody tests, to leave decisions on how to Lockdown. But also not certain experience on their promises evidence. The antibody tests appeal is understandable. Although they may no active cases of COVID-19 Find identify people who have been previously infected with SARS-CoV-2, the crown, which causes the disease, health officials may provide important epidemiological information on how much it has spread to a communities and extent of asymptomatic cases. At least in theory, the antibodies would be present in such a person, if he had a severe case, little more than a dry cough or no discomfort. Even more appealing: These tests were billed as a way to restart local economies, identifying people who may be immune to the virus and could therefore safe again in public. But planned in these and other communities, test programs, they were the first to hundreds or thousands of test or cut back on hold. “I do not think these tests are ready for clinical use yet,” says University of California-San Francisco immunologist Dr. Alexander Marson, who studied their reliability. He and his team examined 12 different antibody tests and found all but one raised false alarms, which means that the antibodies had someone when they do not reach-with higher articles false positive rate of 16%. (The study is preliminary and has not been heard.) More than 100 antibody tests are presently in the United States, including the offers of commercial laboratories, research centers and small business enterprises. How serious questions in early May about the accuracy of these tests and the usefulness of the survey results, said the US Food and Drug Administration (FDA), will present the business needs of validation data and permissions emergency for their products. (Previously, companies were allowed to sell their test without review by the FDA as long as they did their validation and included a disclaimer.) The American Medical Association, said May 14 that the tests do not assess individual immunity, be used or when to end physical removal. And this week the Center for Control and Disease Prevention issued new warning guidelines that the antibody test results may have high false positive rates and should not be used to make decisions that go back to the people at work , schools, dormitories or other places where people get together. Once hailed as a solution, have collected evidence that have not been reviewed thoroughly by a regulatory agency, now it seems more an already add chaos fear and uncertainty. “To give people a false sense of security is now much danger,” says Dr. Riddell includes Travis, the health officer for Teton County, Jackson, WY. Precision problems raised gold standard for the confirmation of a COVID-19 active infection is to take a sample swab from the nose and throat, and the test for the presence of viral RNA. So far, there is no gold standard for testing can determine if the infection has come and gone-the-antibody tests that analyze blood for antibodies produced by the immune system to fight the SARS-CoV-2. It takes time for an infected person to produce antibodies, so these tests do not diagnose an infection in progress, only indicates that a person is experiencing the virus. In Aspen, county officials knew the FDA has not approved the testing of Aytu BioScience, importing companies based in Colorado from China. So they made their own validation testing before, said Bill Linn, spokesman for the Incident Management Team Pitkin County. “We must not feel quite reassured by our tests, we have to move on.” The purchase of 20,000 tests by the Chinese company Anhui medical Deep Blue in Laredo, upon presentation of one of the members had to make official said that the FDA-approved, but gave their city validation tests, only about 20% accuracy rate, says the spokesperson Rafael Benavides Laredo. Before Laredo could pay for the tests, says Benavides, execution, an arm of the US Immigration and Customs seized and commenced an investigation. Neither Anhui Deep Blue medical technology, or Aytu return requests for comment. In March Covaxx, a company led by two part-time residents Telluride, he had developed the tests offered city residents and the surrounding neighborhood with an antibody test. But the project was delayed indefinitely suspended after the results of the first provided by two rounds of testing whether the test facility of the company falls behind on treatment. The district is committed to making a second round of tests and scans, as the spokesperson Susan Lilly San Miguel County proceed. “The question is how to target the most important to be clinically and for the decision of the public health team ahead? And” retired officials, members of ACCIDENT communities On May 4, the FDA their testing policy antibody had need to follow the manufacturers to present validation data, but it is to be the best selling on the test without the normal process of evaluating and approving long including demonstrating safety and efficacy. In some areas rich government officials had already offer start-up practice with local investors. In Jackson, WY, for example, a venture capitalist with an investment in Covaxx, used the test in Telluride, offered to help the city receives 1,000 tests. But after reviewing the offer he rejected Teton County to be concerned about the accuracy of the test. “If a person tests positive, what does that mean? And is that information? We just do not know,” says Riddell. The spokesman Covaxx John Schaefer said in a statement that the test has been validated in more than 900 blood samples and tested by the FDA. After officials Teton County decided against testing a private non-profit of the Community antibodies, testing Teton sprung now COVID-19 antibody test for about 8,000 people for about a third of the inhabitants of the region. On 22 May, it had $396,000 raised by the community and tested 843 samples. The group has “done a lot” for the Covaxx test to test, says test Teton now chairman Shaun Andrikopoulos. “I will not call validation, why not go through an independent review committee, but we sent our samples to other laboratories.” Now do not share the test organizers Teton other concerns for the utility test. “We do not encourage people to make decisions, what they will do or how they are going according to the results behave,” says the spokesperson nonprofit, Jennifer Ford. What good is a test that does not use will be for practical purposes? “We think that knowledge is power, and data is the beginning of knowledge,” says Ford. But no reliable data do not give knowledge, there is an illusion of knowledge. remain many unknowns, and incorrect data may be worse than nothing. Even a very accurate test will generate a large number of false positives when used within a population, where only a few people have been infected. If only 4% of those infected was actually a test with 95% accuracy it would be generated for all 100 tests, five of which are nine false positive alarms. And this creates the risk that the tests could lead to think of people mistakenly believe that they could have catastrophic consequences that antibodies that make them immune if they have changed their behavior accordingly. For example, consider a person wrongly, he said in a nursing home for the antibody job was going to believe that they could not catch or spread the virus to anyone. It is not even certain known that brands antibodies anyone is immune. The researchers believe that exposure may confer some degree of immunity, but how strong that immunity might be and how long you can remain unknown, says Harvard epidemiologist Marc Lipsitch. So if what was burned, Aspen antibody test was shelved and instead focuses on the identification and isolation from people who are at risk of being more or less sick. “It ‘s actually a step back to the starting point,” says Linn. Given the remaining uncertainties about the immunity and COVID-19, the best methods for the pandemic in communities that face most of the time can be tested ones, says Linn. “Putting patients in places where they can be anyone sick. And ‘the bread and butter of epidemiology.” Kaiser Health News (KHN) is a non-profit news service that the health problems. It is an independent publishing program by the Kaiser Family Foundation, the not with Kaiser Permanente. connected
Picture copyright by Kelsey Brunner The time Aspen / AP