Calculation of the decision limit (CCα) and the detection capability (CCβ) for banned substances: The imperfect marriage between the quantitative and the qualitative criteria Original Research Article

Initially in the Decision 2002/657/EC the criteria for the calculation of the decision limit (CCα) and the detection capability (CCβ) have been estimated as purely quantitative (α-error is 1% and β-error is 5%). In 2004, the European Commission has issued a document to provide guidance for the interpretation of the 2002/657/EC. In this document it is mentioned that also qualitative criteria should be fulfilled. Therefore, the calculated CCα and CCβ must be verified by using fortified samples. The method should be able to detect/identify the target component in 50% of the cases at CCα and in 95% of the cases at CCβ.