Specification of analytical requirements in programmes of external data evaluation.


Authors: B. Friedecký;  J. Kratochvíla
Authors‘ workplace: SEKK s. r. o., Pardubice
Published in: Klin. Biochem. Metab., 26, 2018, No. 2, p. 87-91

Overview

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. Keywords: analytical performance specification, clinical outcomes, biological variation, State of the art, harmonization.


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