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.
Document identifier
CLSI EP35
Title
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition, EP35Ed1E
CLSI Category
Evaluation Protocols
Publication date
2019-12-01
International Relationship
| Price |
180 vnd |
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