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.
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
Includes guidelines and a calculation spreadsheet for performing carryover studies.
Coagulation References
Includes guidelines and templates for verification of coagulation analytes, including INR.
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.