Test Method Validation and Verification

by mhanes2 published Sep 21, 2023, last modified May 08, 2025

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

by mhanes2 published Sep 21, 2023, last modified Jan 02, 2024

This folder contains resources to assist laboratories with quantitative validations such as Hematology and Chemistry.

Quantitative Validation Guidelines

by Anne Leach last modified Aug 08, 2023

General guidelines for performing validation on quantitative analytes.

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Calculation Spreadsheets

by Anne Leach published Sep 21, 2023

Includes tools to calculate acceptability of Accuracy, Linearity and Reference Range experiments.

Templates

by Anne Leach published Sep 21, 2023

Includes templates that can be customized for Quantitative Validation Plans and Quantitative Validation Summaries.

Reference Range Resources

by Anne Leach published Sep 21, 2023

Carryover References

by Anne Leach published Sep 21, 2023

Includes guidelines and a calculation spreadsheet for performing carryover studies.

Coagulation References

by Anne Leach published Sep 21, 2023, last modified Feb 22, 2024

Includes guidelines and templates for verification of coagulation analytes, including INR.

pSMILE Total Allowable Error (TEa) Tables

by Anne Leach last modified Jan 02, 2024

Recommended TEa limits for Chemistry, Hematology and Coagulation based on CLIA and other standards.

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Qualitative Validation Resources

by Anne Leach published Sep 21, 2023

This folder contains resources to assist laboratories with qualitative validations such as HCG, Rapid HIV, Viral Markers and Urinalysis.

by Anne Leach — last modified Sep 21, 2023 10:18 AM

Includes templates that can be customized for Qualitative Validation Plans and Qualitative Validation Summaries.

Mycobacteriology Validation Resources

by Anne Leach published Oct 19, 2023, last modified Sep 04, 2024

This folder contains guidelines and templates for validation of mycobacteriology testing methods.

pSMILE Validation Presentation

by Anne Leach last modified Feb 01, 2024

DAIDS Adverse Event Grading Tables

by mhanes2 published Sep 28, 2023, last modified Feb 01, 2024

Example Validations

by Anne Leach published Sep 21, 2023, last modified Sep 28, 2023

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.

Hepatitis Viral Load Quantitative Validation Guidelines

by Anne Leach published May 08, 2025