Detecting the presence of (an agent)

MDCG 2020-16 uses this distinction when applying the IVDR classification rules. The intended purpose should say clearly which kind of detection the test performs.

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.

MDCG 2020-16 Rev.5, Section 2, Definitions