Glossary

Detecting the presence of an agent [MDCG 2020-16 rev.1]

MDCG

Means the direct detection of the agent, by detecting

  • the presence of the agent itself (e.g. bacterial, viral, fungal, parasitic, protozoal agents), or
  • the presence of structural components derived from the agent, such as antigens or nucleic acids.

 

[Definition according to MDCG 2020-16 rev.1 No. 2]