Clinical and Laboratory Standards Institute EP10—Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures is intended to facilitate a limited, preliminary evaluation of the performance of a measurement procedure or device. Using the experimental design and data analysis procedure described, determination of whether a device has problems that require further evaluation or referral to the manufacturer can be done with a minimum expenditure of time and material. Included in Appendixes A and B are sample data sheets that should facilitate the analysis of the data. Appendix C contains a more sophisticated, powerful statistical method for determining the possible causes of imprecision.

This guideline was revised in 2024 under the Limited Revision Process and replaces CLSI EP10-A3, which was published in 2010. Several changes were made in this edition, including: 

• Reformatting and condensing sections to improve readability 

• Adding information on the Test Life Phases Model (see CLSI EP191) and at which phases CLSI EP10 may be applicable to users 

• Providing additional guidance in Chapter 2 on reference procedures and/or materials 

• Clarifying Subchapter 7.2 on visual inspection for outliers 

• Referencing related CLSI documents for guidance on validation or verification of described analytical performance characteristics, when applicable 

• Updating figures

Before starting an extensive evaluation of a new measurement procedure, kit, or instrument for in vitro diagnostic use, or when screening one or more candidate methods for additional consideration, it is often necessary to make a preliminary decision about its acceptability. This can be accomplished through a preliminary performance check to determine the feasibility and general analytical performance characteristics of a new method. This initial performance check is neither a rigorous investigation into the procedure’s long-term performance nor an evaluation of all factors that can affect results produced by the device. The primary purpose of this document is to help detect problems that would cause the end user to disqualify a candidate measurement procedure or require immediate correction, referral to the manufacturer, or expanded investigation. Accreditation organizations may have requirements for validation or verification that exceed the procedures in this document. 

Developers can also benefit by performing this protocol either as assays are developed or before they are validated. By performing more than five runs, developers can detect trends in the effects estimated by CLSI EP10 or document their absence.