FDA, CDC, NIH to Begin Validating COVID-19 Antibody Tests as More Enter the Market
As the US begins to turn to antibody testing to help navigate new phases of the COVID-19 pandemic, an interagency collaboration will aim to evaluate these diagnostic products and their accuracy, according to a FierceBiotech report.
The FDA will work with the Centers for Disease Control and Prevention as well as the infectious disease and cancer research arms of the National Institutes of Health (NIH) to help generate validation data and make sure blood tests are finely tuned to detect the specific antibodies for the novel coronavirus and not for other pathogens, which may cause false positive results.
“As the country starts to see positive signs that the mitigation efforts, like stay-at-home orders and social distancing, are working in our fight against the COVID-19 pandemic, the question of when we can return to work and resume our normal activities is one of the most critical issues facing our nation,” FDA Commissioner Stephen Hahn said in an agency statement.