Test Method Validation and Verification
Quantitative Validation Resources
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
Coagulation References
General guidelines for verification of 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
Includes templates that can be customized for Qualitative Validation Plans and Qualitative Validation Summaries.
Mycobacteriology Validation Resources
Validation guidelines for TB methods including culture, DST, molecular and IGRA.
Plan template for DST methods
Summary Template for GeneXpert
Plan template for QFT validation
Summary template for QFT.
Plan template for HAIN LPA
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.
Example accuracy experiment calculations and results.
Permission granted by AngloLab to share this example.
Permission granted by AngloLab to share this example.
Permission granted by AngloLab to share this example.
Example Precision experiment calculations and results.
Example Reference Range Verification
Example Reference Range Verification
Example Reference Range Establishment
Example Reference Range Establishment