CLSI EP35 Webinar
Assessing the Suitable Performance of an Additional Specimen Type on a Measurement System
Date: 20 May 2025 | 12:00 PM – 1:00 PM ET
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.
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Free
{{FormatPrice(nonMemberPrice)}} List PriceLearning 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.
Advanced: Highly technical. For those with current skills/knowledge and extensive experience in a specialty area.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
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.
Advanced: Highly technical. For those with current skills/knowledge and extensive experience in a specialty area.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.