Linearity

Linearity is part of the analytical performance data of a quantitative IVD and is checked across the claimed measuring interval. Results that fall outside the linear range may need dilution or other handling, which the instructions for use should describe.

The ability to provide measured quantity values that are directly proportional to the value of the measurand in the sample.

MDCG 2022-2, Section 4, Definitions (source: ISO 18113-1)