ARTICLE | Product Development

Comparing COVID-19 antibody tests

May 2, 2020 6:45 AM UTC

The performance metrics for the serological tests FDA has authorized so far serve as guideposts for sizing up the next wave of tests to come to market.

FDA has granted Emergency Use Authorization to nine COVID-19 serological tests, and is reviewing at least 140 more. Additional tests could receive EUA via the agency's "umbrella" pathway, in which tests are validated by certain government agencies outside of FDA, such as the serological test validation program led by NIH's National Cancer Institute (NCI)...