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Sample Transmittal Letter Document Form

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in this short video we'll review clsi's new guideline ep39 a hierarchical approach to selecting surrogate samples for the evaluation of in vitro medical laboratory tests first edition the new ep39 guideline establishes a definition of a surrogate sample provides recommendations for determining when to use surrogate samples and describes a process for selecting the most appropriate surrogate sample the intended users of this guideline are laboratory professionals in vitro diagnostic device developers and regulators the ep39 guideline does not describe performance study design which is covered in other standards and guidelines please see clsi document ep19 free on clsi's website for more information surrogate samples serve an important role in the development validation and verification of laboratory tests surrogate samples may be needed for many reasons including when there is limited sample volume when there are inadequate numbers of patient samples with concent

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