Some rapid Covid-19 tests are less accurate in people without symptoms than in those with symptoms. But the new FDA policy takes into account that repeated tests over time, for screening purposes, can improve the overall accuracy of the results.
“In light of evolving science and management’s interest in facilitating the establishment of test programs by schools, communities and other locations, and expanding access to home tests, we, the FDA, are offering additional options for test developers to obtain authorized screening requests, “an FDA official told POLITICO.
Companies can apply for permission to market an over-the-counter test for use at home or at the point of care if there is evidence that the test performs well in people with Covid-19 symptoms and if repeated testing can help. mitigate false results. The agency is launching a new model for test developers seeking an emergency use authorization for a screening test that is used for repeated testing.
“It is important to note that the test, even the serial test, is of limited value if it is not combined with adequate attenuations for individuals with a positive test (such as quarantine), good contact tracking and effective behavioral protocols (such as wearing a mask, hand washing and social detachment), even for individuals with a negative test, “states an FDA fact sheet on the new policy.
Background: Some Public health groups, including the Rockefeller Foundation, and public health experts like Harvard University’s Michael Mina, have argued for months that increasing the availability of Covid-19 tests could help control the Covid-19 pandemic.
What is the next: The FDA also released a newsletter that aims to help groups establish screening testing programs. The Biden administration is working to create four coordination centers across the country to increase testing in K-8 schools and underserved environments.
“The fact sheet will help schools, workplaces, communities and other locations while they are selecting a test for screening and will help them understand the difference between the tests used for the diagnosis of suspected COVID-19 compared to those used For screening asymptomatic individuals, ”Stenzel said.
But even if the FDA authorizes more tests in the coming weeks, it may take some time for the supply to keep up with demand.
“The interest will be high, but my feeling is that there are still a lot of supply chain problems – I don’t think there will be an excess of testing right away,” said Heather Pierce, senior director of scientific policy at the Association of American Medical Colleges.