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Background:  Permissible limits of analytical imprecision and bias are usually derived either from biological variability or from the state of the art. Both concepts require information from external sources which often lack transparency and are difficult to integrate in medical decision-making. Additionally, physicians may be interested in knowing the probability of decision errors due to analytical uncertainty. Therefore, an approach was developed which combines all three concepts.

A new concept to derive permissible limits for analytical imprecision and bias considering diagnostic requirements and technical state-of-the-art