Some rapid Covid-19 tests are less accurate in people without symptoms than in people with symptoms. But the FDA’s new 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 the administration’s interest in facilitating the development of testing programs by schools, communities and other places, and expanding access to home testing, we offer the FDA additional options to test developers to meet authorized selection requirements. get, “an FDA official told POLITICO.
Companies can apply for permission to market a counter test for use at home or at the care center if there is evidence that the test performs well in people with Covid-19 symptoms and as repeated tests can help mitigate false results. . The agency is issuing a new template for test developers who need an emergency use permit for a screening test used for repeated tests.
“It is important to note that testing, even serial testing, is of limited value if it is not combined with appropriate mitigation for individuals who are positive (such as quarantine), good contact detection and effective behavioral protocols (such as wearing a mask, hand washing). and social distance), even for individuals who test negative, “reads an FDA fact sheet on the new policy.
Background: Some Public health groups, including the Rockefeller Foundation, and public health experts such as Michael Mina of Harvard University have argued for months that increasing the availability of Covid-19 tests could help control the Covid-19 pandemic to bring.
What’s next: The FDA has also released a fact sheet aimed at helping groups set up screening test programs. The Biden administration is setting up four coordinating centers across the country to increase testing in K-8 schools and underserved institutions.
“The factsheet will help schools, workplaces, communities and other places to select a test for selection and help them understand the difference between the tests used to diagnose suspected COVID-19 compared to the which is used to examine asymptomatic individuals, “Shuren and Stenzel said.
But even if the FDA authorizes more tests in the coming weeks, it could take time for the question to catch up.
“Interest will be high, but my sense is that there are still different issues in the supply chain – I do not think there will be an immediate plethora of tests,” said Heather Pierce, senior director of scientific policy at the Association of American Medical Colleges, said. .