Why Analytical Performance Specifications are Important and How They Can Be Established

Abstract

Performance specifications are important to be able to judge how good our analytical quality has to be. When we know the performance specifications, we can make rules for internal and external quality assurance, for calculating six sigma and ‘total allowable error’. How to set analytical performance specifications was discussed at the Strategic Conference of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2014. Four models were recommended. Model 1: based on the effect of analytical performance on clinical outcomes. Model 2: based on components of biological variation of the measurand. Model 3: based on state-of-the-art. Preference should be given to models 1 and 2.1 Recommendations have been made for how to allocate different measurands to different models.2 The work is now being taken forward by two groups in EFLM: the task group for setting analytical performance specifications based on outcome studies, and the task group for the biological variation database.