CLSI - EP39
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
active, Most Current
| Organization: | CLSI |
| Publication Date: | 1 November 2021 |
| Status: | active |
| Page Count: | 144 |
scope:
This guideline establishes a definition of "surrogate sample" and an approach for selecting, preparing, and using these samples. It discusses surrogate sample:
• Composition
• Technical preparation
• Selection criteria
• Documentation and planning
• Use in specific performance study types
The intended users of this guideline are in vitro diagnostic (IVD) device developers, laboratorians, and regulators. This guideline does not describe performance study design, which is covered in other standards and guidelines (see CLSI document EP191).
Document History
EP39
November 1, 2021
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
This guideline establishes a definition of “surrogate sample” and an approach for selecting, preparing, and using these samples. It discusses surrogate sample:
• Composition
• Technical preparation...