FDA AUTHORIZES THE FIRST AT-HOME COVID-19 TEST


16/12/2020




İrem UZUN -TDO- The U.S. Food and Drug Administration on Tuesday authorized the first test for COVID-19 that can be purchased at drug stores without a prescription and taken at home. The test, developed by the Australian digital diagnostics company Ellume, received emergency use authorization from the FDA. The test does not require sending samples to a lab, similar to how at-home pregnancy tests work.

LabCorp’s Pixel COVID-19 Test Home Collection Kit can be purchased online or over-the-counter at a store, according to an FDA announcement. Other at-home tests have only been available by prescription.  “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.  Anyone over age 18 can buy the test kit and register it on LabCorp’s website.

Similar to other antigen tests, FDA says a small percentage of positive and negative results from this test may be false. Therefore, FDA reminds patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection. 


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