The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of guideline EP39 —A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests.
EP39 establishes a standard definition of a surrogate sample. It presents a hierarchical approach for determining when to use surrogate samples and selecting an appropriate one. It also describes elements of a surrogate sample plan and includes technical preparation guidance for the characteristic to be measured or detected and for artificial matrix compositions. The guideline provides examples for specific performance study types.
EP39 expanded on a framework that was developed and published by The Medical Device Innovation Consortium (MDIC) in 2017 by a committee of experts.
