Linnet K
Department of Clinical Chemistry, Rigshospitalet, Copenhagen, Denmark.
Clin Chem. 1989 Feb;35(2):284-8.
Critical systematic and random analytical errors for 17 common clinical chemical components were estimated from published values for analytical imprecision, biological variation, and "medically important changes." Appropriate quality-control systems for these analytes are discussed on the basis of power considerations. The simple rule 1(3)s, with one control per run, is minimally sufficient for the analytes (about one quarter of those considered here) for which the magnitude of critical error is at least 3 analytical standard deviations. The more powerful rule 1(2)s, with one control per run, is the minimal requirement for analytes for which critical errors are about 2 analytical standard deviations; these are about half the remaining analytes. Greater power values are achieved by using multiple rules based on several controls per run. In general, this study does not support the view put forward by some authors that the quality-control rules in use today are too restrictive.
根据已发表的分析不精密度、生物学变异和“医学上重要变化”的值，估算了17种常见临床化学组分的关键系统误差和随机分析误差。基于效能考量，讨论了针对这些分析物的适当质量控制体系。对于关键误差幅度至少为3个分析标准差的分析物（约占此处所考虑分析物的四分之一），每次运行一个对照的简单1(3)s规则是最低限度的充分规则。对于关键误差约为2个分析标准差的分析物，每次运行一个对照的更有效能的1(2)s规则是最低要求；这些分析物约占其余分析物的一半。通过使用基于每次运行多个对照的多个规则可实现更高的效能值。总体而言，本研究不支持一些作者提出的观点，即当今使用的质量控制规则过于严格。
