Quantitative Validation Resources

by mhanes2 published Sep 21, 2023, last modified Oct 23, 2025

Quantitative Validation Guidelines

by Anne Leach last modified Oct 23, 2025
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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, last modified Oct 23, 2025

Coagulation References

by Anne Leach published Sep 21, 2023, last modified Oct 23, 2025

pSMILE Total Allowable Error (TEa) Tables

by Anne Leach last modified Oct 09, 2025

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

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Hepatitis Viral Load Quantitative Validation Guidelines

by Anne Leach last modified Oct 23, 2025