EU Device Group Releases Guidance for Rapid COVID-19 Antibody Tests

The EU’s Medical Device Coordination Group has published guidance clarifying the minimum performance requirements for devices designed to detect antibodies against SARS-CoV-2.

The working group looked at global regulators’ decisions on COVID-19 antibody tests and compared instructions for use for more than 100 antibody tests that were marketed in Europe to “assess the state of the art from the perspective of real market performance.”

As part of postmarket surveillance, devicemakers should continuously monitor the performance of their devices, including for new cross-reacting agents that could lead to inaccurate results, the group said.