Validation & Verification
Organise a study around intended use, performance claims and the questions that its data must answer. The topics connect study design, analysis and reporting.
Curriculum
- Validation vs verification and intended use
- Precision, repeatability, reproducibility and ruggedness
- Accuracy and method comparison
- Linearity and analytical measurement range
- LoB, LoD and LoQ
- Carryover
- Reference intervals and verification
- Clinical cut-offs and decision limits
- Sensitivity, specificity, PPV and NPV
- ROC curves and AUC
- Sample stability and pre-analytical variables
- Inter-instrument and inter-laboratory comparison
- Verification of commercial assays
- Validation of laboratory-developed tests
- Validation and verification case studies
Continue exploring
This page is a curriculum outline. Find the first seven released lessons on the Academy home page. Further lessons and cases are in development.