Division 3.1.2 Conventional validation procedures

The calculation of the parameters in accordance with conventional methods requires the performance of several individual experiments. Each performance characteristic has to be determined for each major change (see under applicability/ruggedness above). For multi-analyte methods, several analytes can be analysed simultaneously, as long as possibly relevant interferences are ruled out previously. Several performance characteristics can be determined in a similar way. So, to minimise workload, it is advised to combine experiments as much as possible (e.g., repeatability and within-laboratory reproducibility with specificity, analysis of blank samples to determine the decision limit and testing for specificity).