Optimal Analytical Performance for POCT

Quality specifications for the reliability performance characteristics of laboratory tests, particularly precision and bias, are necessary prerequisites for creation and control of analytical quality. Many strategies have been promulgated for setting these. Recently, the available approaches have been fixed into a hierarchical framework that has now been agreed by experts in the field to be the best current approach to a global strategy to set quality specifications in laboratory medicine. They should be incorporated into quality planning strategies everywhere i rrespective of the settings in which laboratory medicine is practised, including POCT. Models higher in the hierarchy are preferred to lower approaches but lower approaches are better than none and should be used if all that are available.