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.

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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.

Reference Range Resources

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.

pSMILE Total Allowable Error (TEa) Tables

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

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