This guideline provides information for characterizing the linearity interval of a measurement procedure, validating a linearity interval claim (to be performed by the manufacturer), and verifying an established linearity interval claim (to be performed by the end user).
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.
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 during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests (LDTs).
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. The recommendations in this guideline apply to both quantitative measurement procedures and qualitative examinations.