Table 3.

Stages of validation of a diagnostic test (adapted from Conraths and Schares, 2006).

Stages of test validation
1. Feasibility studies
2. Assay development and standardization
- Optimization of reagents, protocols and equipment
- Preliminary estimate of repeatability
- Determination of analytical sensitivity and specificity
3. Determination of assay performance characteristics
- Diagnostic sensitivity and specificity
- Repeatability and reproducibility
4. Monitoring the validity of assay performance
5. Maintenance and enhancement of validation criteria