The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization ...

In January 2020, the Food and Drug Administration (FDA) began considering the U.S. response to Covid-19. On February 4, after the declaration of a public health emergency, we began authorizing tests ...

Serology tests, also called antibody tests, help to identify people who have had a past infection with SARS-CoV-2, the virus that causes COVID-19 disease. Hundreds of these tests have been developed ...

Autoantibody assays may have significant differences due to the heterogeneity of autoantibodies, including epitope specificity, isotype, and affinity/avidity. This makes it challenging for clinical ...