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CLSI EP35-Ed2
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures - 2nd Edition
CLSI EP35 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 CLSI EP35 apply to both quantitative measurement procedures and qualitative examinations.
Clinical And Laboratory Standards Institute [clsi]