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September 1, 2025
Verifying Performance Claims for Medical Laboratory Tests
The table below lists Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol (EP) documents that cover the Verification Phase of the Test Life Phases Model and should be used in conjunction with CLSI EP19 when end-user medical laboratories verify performance claims for both laboratory-developed tests and regulatory cleared or approved test methods.
The table below lists Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol (EP) documents that cover the Verification Phase of the Test Life Phases Model and should be used in conjunction with CLSI EP19 when end-user medical laboratories verify performance claims for both laboratory-developed tests and regulatory cleared or approved test methods.
CLSI EP19 is a free fundamental resource that helps both test developers and end-user medical laboratories identify relevant CLSI EP documents for establishing and implementing test methods using the Test Life Phases Model (design, development, validation, verification, etc.). Additional EP documents relevant to end-user medical laboratories but not specific to the Verification Phase are also included.
The tables below are resources to guide laboratory professionals to CLSI EP documents and are not exhaustive lists. Additional guidance specific to analyte, platform, or specialty may be available in the CLSI document library.
*Provides guidance specifically for qualitative test methods.
CLSI Evaluation Protocol Verification Documents
Precision
- CLSI EP12 | Evaluation of Qualitative, Binary Output Examination Performance*
- CLSI EP15 | User Verification of Precision and Estimation of Bias
- CLSI EP21 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
Accuracy
- CLSI EP09 | Measurement Procedure Comparison and Bias Estimation Using Patient Samples
- CLSI EP12 | Evaluation of Qualitative, Binary Output Examination Performance*
- CLSI EP15 | User Verification of Precision and Estimation of Bias
- CLSI EP21 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
Reportable Interval
- CLSI EP06 | Evaluation of Linearity of Quantitative Measurement Procedures
- CLSI EP17 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
- CLSI EP34 | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
Reference Interval
Analytical Sensitivity, if applicable
Analytical Specificity, if applicable
- CLSI EP07: Interference Testing in Clinical Chemistry
- CLSI EP37: Supplemental Tables for Interference Testing in Clinical Chemistry
Fundamental Principles
Instrument/Method Evaluation
Total Analytical Error (TAE) and Error Goals/Limits
- CLSI EP21 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
- CLSI EP46 | Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures
Specimen/Sample Considerations
- CLSI EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
- CLSI EP39 | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
Quality Control (QC)
Risk Management
- CLSI EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources
- CLSI EP23 | Laboratory Quality Control Based on Risk Management
Source Document:
CLSI EP19 | A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods–3rd Edition