FDA authorizes test to identify recent or prior COVID-19 infection

The Food and Drug Administration last week authorized for emergency use a test kit to help identify individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection. Only laboratories certified under the Clinical Laboratory Improvement Amendments that meet requirements to perform high or moderate complexity tests may use the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit. Negative results do not preclude acute COVID-19 infection, the agency said.