CLSI EP35
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
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 EP35 apply to both quantitative measurement procedures and qualitative examinations.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute 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 CLSI EP35, developers of laboratory measurement procedures do not necessarily need to repeat the full measurement procedure validation for each specimen type. CLSI EP35 applies to both quantitative measurement procedures and qualitative examinations. CLSI EP35 is useful to developers of commercial and laboratory-developed tests and medical laboratory personnel.
CLSI EP35 was revised in 2024 under the Limited Revision Process and replaces the first edition of this guideline, which was published in 2019. Several changes were made in this edition, including:
• Reformatting to help improve readability
• Updating and aligning terminology
• Updating one dataset and figures to include the minimum number of 40 samples
CLSI EP35 provides recommendations on establishing clinical equivalence or suitability for multiple specimen types for a single measurement procedure. This guideline provides a protocol for assessing equivalence or suitability for use of a different specimen type compared with the established primary specimen type for a medical laboratory measurement procedure or qualitative examination. CLSI EP35 provides a general framework for studies that establish equivalence among similar-matrix specimen types and clinical suitability among dissimilar-matrix specimen types. It also includes instructions for laboratory verification of alternate specimen types for commercial measurement procedures. This guideline applies to both quantitative measurement procedures and qualitative examinations. The intended users of CLSI EP35 are manufacturers, developers of medical laboratory measurement procedures, and laboratorians verifying alternate specimen types.
CLSI EP35 is intended to be used for specimen types for which the desired measurand has a known clinical indication and for which adequate clinical information is available to establish risk-based clinical performance goals. Establishing clinically based performance goals is beyond the scope of CLSI EP35.
CLSI EP35 focuses on the effect of specimen type on the analytical measurement procedure. There may also be preanalytical factors between specimen types that can affect results. These differences may require additional studies to characterize their effect on the results. Such preanalytical factors are outside of the scope of CLSI EP35.
Clinical and Laboratory Standards Institute 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 CLSI EP35, developers of laboratory measurement procedures do not necessarily need to repeat the full measurement procedure validation for each specimen type. CLSI EP35 applies to both quantitative measurement procedures and qualitative examinations. CLSI EP35 is useful to developers of commercial and laboratory-developed tests and medical laboratory personnel.
CLSI EP35 was revised in 2024 under the Limited Revision Process and replaces the first edition of this guideline, which was published in 2019. Several changes were made in this edition, including:
• Reformatting to help improve readability
• Updating and aligning terminology
• Updating one dataset and figures to include the minimum number of 40 samples
CLSI EP35 provides recommendations on establishing clinical equivalence or suitability for multiple specimen types for a single measurement procedure. This guideline provides a protocol for assessing equivalence or suitability for use of a different specimen type compared with the established primary specimen type for a medical laboratory measurement procedure or qualitative examination. CLSI EP35 provides a general framework for studies that establish equivalence among similar-matrix specimen types and clinical suitability among dissimilar-matrix specimen types. It also includes instructions for laboratory verification of alternate specimen types for commercial measurement procedures. This guideline applies to both quantitative measurement procedures and qualitative examinations. The intended users of CLSI EP35 are manufacturers, developers of medical laboratory measurement procedures, and laboratorians verifying alternate specimen types.
CLSI EP35 is intended to be used for specimen types for which the desired measurand has a known clinical indication and for which adequate clinical information is available to establish risk-based clinical performance goals. Establishing clinically based performance goals is beyond the scope of CLSI EP35.
CLSI EP35 focuses on the effect of specimen type on the analytical measurement procedure. There may also be preanalytical factors between specimen types that can affect results. These differences may require additional studies to characterize their effect on the results. Such preanalytical factors are outside of the scope of CLSI EP35.