Surrogate Sample Framework

The Framework proposes uniform terminology and recommendations where surrogate samples might be justifiably used in IVD validation studies. Ultimately, the goal of the Surrogate Sample Framework is to improve IVD innovation, reduce inefficient use of costly biological test materials, and ultimately improve timely patient access to safe and effective IVDs.

The framework aligns stakeholders as to the preferred surrogate sample selection by IVD performance study as well as definitions and terminology of surrogate samples and related terms.