Abstract
We examine limitations of common analytical performance specifications for quantitative assays. Specifications can be either clinical or regulatory. Problems with current specifications include specifying limits for only 95% of the results, having only one set of limits that demarcate no harm from minor harm, using incomplete models for total error, not accounting for the potential of user error, and not supplying sufficient protocol requirements. Error grids are recommended to address these problems as error grids account for 100% of the data and stratify errors into different severity categories. Total error estimation from a method comparison can be used to estimate the inner region of an error grid, but the outer region needs to be addressed using risk management techniques. The risk management steps, foreign to many in laboratory medicine, are outlined.
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