Abstract

Using approaches based on "medical needs" and biological variation, goals for analytical accuracy were assessed to 0.072-0.15 expressed as relative deviations, and goals for analytical precision were estimated to 0.022-0.14 expressed as relative standard deviations. A representative clinical method was evaluated using a reference method. On this basis, it is concluded that accuracy goals are fulfilled at high but not at low levels, and that precision goals are met according to medical needs but not with respect to biological variation.

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