CLSI 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.

This edition of the document was corrected in June 2020 and September 2021. Read the correction notices by accessing the link above, and learn more about our correction process here.

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Chairholder: Nils B. Person, PhD, FAACC

Date of Publication: December 19, 2019

Order Code PDF: CLSI EP35Ed1E
ISBN Number: 978-1-68440-063-8

Order Code Print: CLSI EP35Ed1
ISBN Number: 978-1-68440-062-1

Edition: First

Pages: 82

CLSI EP35 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI EP35 Abstract

Clinical and Laboratory Standards Institute guideline EP35—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures provides information for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types. During development, medical laboratory measurement procedures are typically validated for the most common specimen type. However, it can be clinically useful to test the measurand in multiple specimen types, including different fluids (eg, serum, plasma, whole blood, urine, cerebrospinal fluid, saliva), anticoagulants, and collection devices. By following the recommendations in this guideline, developers of laboratory measurement procedures do not necessarily need to repeat the full measurement procedure validation for each specimen type. EP35 applies to both quantitative measurement procedures and qualitative examinations. This guideline is useful to developers of commercial and laboratory-developed tests and medical laboratory personnel.