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. Additional EP documents relevant to end-user medical laboratories but not specific to the Verification Phase are also included.

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. Additional EP documents relevant to end-user medical laboratories but not specific to the Verification Phase are also included.

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.).

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

Accuracy

Reportable Interval 

Reference Interval 

Analytical Sensitivity, if applicable

Analytical Specificity, if applicable 

Fundamental Principles 


Instrument/Method Evaluation


Total Analytical Error (TAE) and Error Goals/Limits


Specimen/Sample Considerations 


Quality Control (QC) 


Risk Management



Source Document:
CLSI EP19 | A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods–3rd Edition

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