Method Evaluation | Standards

CLSI’s Method Evaluation standards provide concise explanations and step-by-step instructions for evaluation of test method performance characteristics such as precision and accuracy. We provide your lab with the information needed to comply and keep up-to-date with the latest best practice guidelines and laboratory accreditation requirements.  

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EP19 | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition

This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents.

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EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition

This guideline provides recommendations for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types, such that the laboratory does not necessarily need to repeat the full measurement procedure validation for each specimen type.

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