Assessing the Suitable Performance of an Additional Specimen Type on a Measurement System

This webinar provides recommendations on the recently updated CLSI EP35 which establishes clinical equivalence or suitability for multiple specimen types for a single measurement procedure. A general framework for studies is provided that establishes equivalence among similar-matrix specimen types (serum vs plasma) and clinical suitability among dissimilar-matrix specimen types (serum vs urine) for quantitative measurement procedures and qualitative examinations. The program 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 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. 

Learning Objectives
Upon completion of this webinar, participants will be able to:
• Demonstrate how to assess the suitability (clinically equivalent performance) of a measurement procedure for an additional specimen type.
• Describe how to design a study to assess the suitability of a new candidate specimen type(s) with a similar or a dissimilar matrix from the primary specimen type.
• Interpret the data and conclude if a new specimen type(s) is suitable to add to a quantitative or qualitative measurement procedure.