Using uncertainty functions to predict and specify the performance of analytical methods

In both European legislation relating to the testing of food and the recommendations of the Codex Alimentarius Commission, there is a movement away from specifying particular analytical methods towards specifying performance criteria to which any methods used must adhere. This ‘criteria approach’ has hitherto been based on the features traditionally used to describe analytical performance. This paper proposes replacing the traditional features, namely accuracy, applicability, detection limit and limit of determination, linearity, precision, recovery, selectivity and sensitivity, with a single specification, the uncertainty function, which tells us how the uncertainty varies with concentration. The uncertainty function can be used in two ways, either as a ‘fitness function’, which describes the uncertainty that is fit for purpose, or as a ‘characteristic function’ that describes the performance of a defined method applied to a defined range of test materials. Analytical chemists reporting the outcome of method validations are encouraged to do so in future in terms of the uncertainty function. When no uncertainty function is available, existing traditional information can be used to define one that is suitable for ‘off-the-shelf’ method selection. Some illustrative examples of the use of these functions in methods selection are appended.