Quantitative Validation Resources

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

last modified Aug 08, 2023

General guidelines for performing validation on quantitative analytes.

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Calculation Spreadsheets

published Sep 21, 2023

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

Templates

published Sep 21, 2023

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

Reference Range Resources

published Sep 21, 2023

Carryover References

published Sep 21, 2023

Includes guidelines and a calculation spreadsheet for performing carryover studies.

Coagulation References

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

last modified Jan 02, 2024

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

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