![]() Hafer said a point of debate has been when, not so much whether, home antigen tests detect an infection, including recent variants. But so far, the early signs are positive.”ĭr. “Our team here at UMass Chan is one of several groups of different scientists who are looking at that in more depth and more completely to be able to say for sure. “There’s a lot of interest right now in whether the tests that are out in the market can detect omicron,” said Nathaniel Hafer, PhD, assistant professor of molecular medicine and lead investigator of the RADx Tech Clinical Studies Core Logistics Team. With the latest dominance of the highly transmissible omicron variant, health officials, researchers and consumers want to know how effective rapid home tests are in this evolving pandemic. Yet sufficient test supply is just one challenge. To help meet this demand, two new products, one manufactured by SD Biosensor and distributed by Roche and the other manufactured by Siemens, received FDA emergency use authorization in December through the ITAP program. The demand for rapid at-home tests has grown exponentially as the SARS-CoV-2 virus mutates and new variants spread. The NIH initiative, called Independent Test Assessment Program, provides resources for independent clinical studies and helps manufacturers meet FDA authorization protocols through an accelerated pathway. is affected by the omicron variant, which has been raging across the globe since late fall.Īlso, another slate of studies by the RADx Tech team will provide data to help the Food and Drug Administration quickly assess the quality of tests, including those on the market in other countries, to get more tests on U.S. ![]() UMass Chan Medical School researchers and their partners in the National Institutes of Health Rapid Acceleration of Diagnostics initiative are starting new studies to determine if the performance of at-home COVID-19 antigen tests currently on the market in the U.S.
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