Europe – MDCG 2021-2 : Guidance on state of the art of COVID-19 rapid antibody tests

The COVID-19 pandemic is evolving rapidly, and so is the market of in vitro diagnostic medical devices for COVID-19. In particular, many rapid tests for the detection of antibodies against SARS-CoV-2 virus are becoming available. Determining what would be adequate performance for those tests is challenging. Directive 98/79/EC on in vitro diagnostic medical devices2 establishes that devices must be designed and manufactured3 in such a way that they are suitable for the intended purpose4 specified by the manufacturer, taking into account the generally acknowledged state of the art. The manufacturer should therefore justify why the device is suitable for the intended purpose claimed, in light of the state of the art. To facilitate the fulfilment of this legal requirement, the considerations presented in this guidance are intended to establish particular elements on the current state of the art for COVID-19 rapid antibody tests. It will also assist with understanding what the current state of the art is…