Good test hunting: FDA authorizations point to benchmarks for COVID-19 serology

The critical role of COVID-19 antibody testing in reopening society -- combined with controversy around the regulatory flexibility these tests have received and reports that some are performing poorly -- have put all eyes on evaluation metrics. FDA’s new guidelines for serological test validation by other government agencies provide a first glimpse into how the agency is defining high performance, and some of the tests it has approved itself fall short.

With COVID-19 testing universally seen as a cornerstone for returning to normal life, the obvious question is which tests will be informative and reliable enough to guide personal and public health decisions. ...