Optimal analytical performance for point of care testing.

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