Fraser C G, Hyltoft Peterson P, Larsen M L
Department of Biochemical Medicine, Ninewells Hospital and Medical School, Dundee, Scotland.
Clin Chem. 1990 Sep;36(9):1625-8.
Strategies abound for the setting of analytical goals in clinical chemistry. Many, especially those more recently proposed for particular clinical situations, are concerned with tests used in diagnosis. We suggest a general theory for the setting of goals in situations that specifically involve the monitoring of individuals. Goals are calculated from the formula CVA less than [(delta c 2/2Z2)-CVB2]1/2, where CVA is the analytical imprecision (as coefficient of variation, CV); delta c is the percentage change in serial results that is considered clinically significant; Z is the Z-statistic, which depends only on the probability selected for statistical significance; and CVB is the average inherent within-subject biological variation (as CV). Examples given show applications in hematology and in monitoring diabetes mellitus, chronic renal failure, and hepatitis. The derived goals are for total random analytical error (imprecision and intermittent systematic variation), and provide objective criteria that should be achieved in practice. The effect of analytical variability on both variability in test results and the probability that a stated change can be considered significant should be calculated whether or not the goals are attained.
临床化学中设定分析目标的策略有很多。许多策略，尤其是那些最近针对特定临床情况提出的策略，都与诊断中使用的检测方法有关。我们提出了一种通用理论，用于在专门涉及个体监测的情况下设定目标。目标是根据公式CVA小于[（δc²/2Z²）-CVB²]¹/²计算得出的，其中CVA是分析不精密度（以变异系数CV表示）；δc是连续结果中被认为具有临床意义的百分比变化；Z是Z统计量，它仅取决于为统计显著性选择的概率；CVB是平均个体内固有生物学变异（以CV表示）。给出的示例展示了在血液学以及糖尿病、慢性肾衰竭和肝炎监测中的应用。得出的目标是针对总随机分析误差（不精密度和间歇性系统变异）的，并提供了在实际中应达到的客观标准。无论是否达到目标，都应计算分析变异性对检测结果变异性以及所述变化可被视为显著的概率的影响。
