Abstract
Objective: Review on the determination of harmonized analytical performance specification. Methods: Based on the studies of EFLM Working Group for specification of analytical performance and the elucidation of their sense.
Results: Clinical outcomes, biological variation and state-of-art are three possible methods for derivation of analytical performance criteria-APS. Standardization methods, commutability of control materials and suitable target.
Values (means, reference method values) are necessary conditions for this specification. Discussion: Current state of analytical performance shows large differences in individual EQA programs.
This fact means impossibility for objective analytical quality assessment and should be immediately improved.