CLSI EP39
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
This guideline defines what a surrogate sample is, offers recommendations for when to use surrogate samples, and outlines a process for selecting the most appropriate surrogate samples.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline EP39—A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests 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. This guideline provides examples for specific performance study types.
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 EP19).
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
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Clinical and Laboratory Standards Institute guideline EP39—A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests 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. This guideline provides examples for specific performance study types.
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 EP19).
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.