Test Method Validation and Verification
This folder contains guidelines, templates and calculation spreadsheets to assist laboratories with performing validation and verification of test methods. Also included are example validations and reference documents.
Quantitative Validation Resources
This folder contains resources to assist laboratories with quantitative validations such as Hematology and Chemistry.
Quantitative Validation Guidelines
General guidelines for performing validation on quantitative analytes.
Calculation Spreadsheets
Includes tools to calculate acceptability of Accuracy, Linearity and Reference Range experiments.
Templates
Includes templates that can be customized for Quantitative Validation Plans and Quantitative Validation Summaries.
Customizable template for preparation of a validation plan for a Quantitative Method.
Customizable template for preparation of a summary of validation of a Quantitative method.
Reference Range Resources
Customizable template for use in screening healthy participants in a reference range study.
Carryover References
Includes guidelines and a calculation spreadsheet for performing carryover studies.
Coagulation References
Includes guidelines and templates for verification of coagulation analytes, including INR.
Customizable template for preparation of a verification plan for INR.
Customizable template for preparation of a verification summary for INR.
pSMILE Total Allowable Error (TEa) Tables
Recommended TEa limits for Chemistry, Hematology and Coagulation based on CLIA and other standards.
Qualitative Validation Resources
This folder contains resources to assist laboratories with qualitative validations such as HCG, Rapid HIV, Viral Markers and Urinalysis.
General guidelines for performing validation on qualitative analytes.
Includes templates that can be customized for Qualitative Validation Plans and Qualitative Validation Summaries.
Mycobacteriology Validation Resources
This folder contains guidelines and templates for validation of mycobacteriology testing methods.
Validation guidelines for TB methods including culture, DST, molecular and IGRA.
Example Validations
Includes examples of both qualitative and quantitative validation experiment calculations and results. Please also see the pSMILE Validation Guidelines for Quantitative and Qualitative Methods for additional guidance and templates.