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Method Validation Tools

Validation - Reference Interval 

New Assay Checklist (PDF)

Validation - Method Comparison

Validation - Accuracy (Link to SLT QC Calculators)

Validation - Precision (Link to SLT QC Calculators)

   References and Resources

Validation - Linearity, Reportable Range

SMILE Validation Guidelines and Templates - pSMILE Portal


SMILE The Nuts and Bolts of Method Validation - PowerPoint


How-Should-I Guide to Laboratory Method Validation - PowerPoint


Measurement verification - The Association for Clinical Biochemistry and Laboratory Medicine


Frequently Asked Questions on Reference Intervals and Biological Variation - Westgard


How to Validate A New Test (CAP) - PowerPoint


Linearity and Calibration Verification FAQ's (Maine Standards)


CMS Brochure 2 - Verification of Performance Specifications


COLA - LabGuide 13 How to Verify Performance Specifications


COLA - Method Validation Requirements


Validation - Carryover

New Assay Validation Forms & Examples (PDF)