Division 3.1.2.7 Ruggedness (major changes)

The analytical method should be tested under different experimental conditions, which include for example, different species, different matrices or different sampling conditions. The changes introduced should be major. The importance of these changes can be evaluated, for instance, using the Youden approach (15)(16). Each performance characteristic should be determined for all major changes that have been shown to have a significant effect on the performance of the assay.