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18 Central MA Life Sciences Report indings from a new study led by UMass Chan Medical School researchers are the basis for a safety communication issued by the U.S. Food and Drug Administration (FDA) regarding serial use of at-home antigen tests for COVID-••. The study results show that at-home antigen tests are more likely to detect COVID-•• within the first week of infection when a person without symptoms tests three times, at ƒ„-hour intervals, and a person with symptoms tests twice, according to the study by UMass Chan researchers and partners supported by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. The UMass Chan team, in close collaboration with the FDA and NIH, has been working for the past year to ensure that the best evidence was generated for performance of rapid antigen tests in asymptomatic people, according to Apurv Soni, MD, PhD'Œ•, assistant professor of medicine and principal investigator on the study. The FDA's safety communication recommends that people perform repeat, or serial, testing following a negative result on any at-home COVID-•• antigen test, regardless of whether a person has COVID-•• symptoms. "To our knowledge, this is one of the largest studies to date that examined the e'ectiveness of taking multiple COVID-•• rapid antigen tests at specific intervals over two weeks," said co-author Nathaniel Hafer, PhD, assistant professor of molecular medicine and lead investigator of the RADx Tech Clinical Studies Core Logistics Team. The study analysis looked at ",•–• eligible people nationwide. Participants took an at-home antigen test using retail testing kits available in the United States, and collected a sample for a molecular PCR test, using nasal swabs for both types of test samples. They tested themselves every ƒ„ hours for •" days. During the test period, •"ƒ participants tested positive for SARS-CoV-Œ infection based on molecular PCR assays. Using an at-home antigen test twice over ƒ„ hours resulted in detection of more than •– percent of infections when symptomatic people started testing within the first week of infection, the study reports. An implication of findings from this study is that people who suspect they are infected with the SARS-CoV-Œ virus but have not developed symptoms should exercise caution, such as wearing masks and avoiding crowded places, for at least six days until three at-home antigen tests taken ƒ„ hours apart have been performed, according to the study's authors. Dr. Hafer added that this large-scale study was made possible by its novel app-based digital enrollment and reporting features, developed by the UMass Chan Program in Digital Medicine, and "demonstrates that it's possible to rapidly enroll and conduct clinical research with digital techniques." ■ FDA advice on serial testing based on UMass Chan-led research By Susan E.W. Spencer | Aug. ••, Œ–ŒŒ UMass Chan Medical School: leading the way in the heart of the commonwealth Apurv Soni, MD, PhD'Œ• S P E C I A L A DV E R T I S I N G S E C T I O N