Abstract
Analytical goals for rectilinearity based on within-subject biological variation have not yet been advocated. On the other hand, the statistical tests to evaluate rectilinearity may be too restrictive for clinical purposes. If rectilinearity of the least-squares regression is rejected by the statistical test used, we propose to compare the systematic error introduced using such a regression line as the calibration function, with the allowable total error. Since total error ideally should be less than the within-subject biological coefficient of variation ( C. V. Bw ) the goal for rectilinearity we propose is that the maximum allowable systematic relative error produced by the calibration function ( LoR i ) when a lack of rectilinearity really occurs is: LoR i < C. V. Bw −1.96 C. V. M , where C. V. M is the between-run metrological coefficient of variation of the measurement procedure, corresponding to the value of concentration under study.
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