FDA issues ‘removed’ list for COVID-19 antibody tests

The Food and Drug Administration (FDA) issued new guidance recommending health care providers stop using the COVID-19 antibody tests listed on the agency’s removed test list. The list includes tests for which identified performance problems remain unaddressed by the manufacturer, tests for which a commercial manufacturer of a serology test has not requested emergency use authorization within the period of time outlined by FDA guidance and tests the manufacturer has voluntarily withdrawn from the notification list. There has been controversy over how the agency is determining which tests to place on the removed list. More than 100 diagnostic tests for COVID-19 received emergency use authorization from the FDA. (FDA letter, 6/19/20)