Test Method Validation and Verification
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
This folder contains resources to assist laboratories with quantitative validations such as Hematology and Chemistry.
General guidelines for performing validation on quantitative analytes.
Includes tools to calculate acceptability of Accuracy, Linearity and Reference Range experiments.
Includes templates that can be customized for Quantitative Validation Plans and Quantitative Validation Summaries.
Includes guidelines and a calculation spreadsheet for performing carryover studies.
Includes guidelines and templates for verification of coagulation analytes, including INR.
Qualitative Validation Resources
This folder contains resources to assist laboratories with qualitative validations such as HCG, Rapid HIV, Viral Markers and Urinalysis.
General guidelines for performing validation on qualitative analytes.
Includes templates that can be customized for Qualitative Validation Plans and Qualitative Validation Summaries.
Example Validations
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.
Mycobacteriology Validation Resources
This folder contains guidelines and templates for validation of mycobacteriology testing methods.
Validation guidelines for TB methods including culture, DST, molecular and IGRA.