Rustad P, Felding P, Lahti A, Hyltoft Petersen P
Fürst Medical Laboratory, Søren Bulls Vei 25, NO-1051 Oslo, Norway.
Scand J Clin Lab Invest. 2004;64(4):343-70. doi: 10.1080/00365510410006306.
In the Nordic Reference Interval Project (NORIP), data from 102 Nordic clinical chemical laboratories were obtained. Each laboratory reported analytical data on up to 25 of the most commonly used clinical biochemical properties, including results from each of a minimum of 25 reference individuals. A reference material consisting of a liquid frozen pool of serum with values traceable to reference methods (used as the project "calibrator" for non-enzymes to correct reference values) was measured together with other serum pool controls in each laboratory in the same analytical series as the project samples. The data on the controls were used to evaluate the analytical quality of the routine methods. For reference interval calculations, only such reference values on enzymes were accepted that were obtained by applying the International Federation of Clinical Chemistry (IFCC) compatible methods (37 degrees C), while "calibrator"-corrected reference values were used in the cases of non-enzymes. For each property, gender- and age-specific reference intervals were estimated, based on simple non-parametric calculations and using objective criteria to perform partitioning into subgroups. It is concluded that the same reference intervals are applicable in all five Nordic countries. The following descriptive data for the considered properties are presented in the tables: number of measurement values from each country and measurement system, certified/indicative target values for controls, differences between methods and measurement systems together with coefficients of variation, effects of control correction on the measurement values, differences between subgroups as determined by age, gender, country and material, and comparison of the new reference intervals with those presented in standard textbooks. The 25 components involved in this project were (listed in alphabetical order): Alanine transaminase, albumin, alkaline phosphatase, amylase, amylase pancreatic type, aspartate transaminase, bilirubin, calcium, carbamide, cholesterol, creatine kinase, creatininium, gamma-glutamyltransferase, glucose, HDL-cholesterol, iron, iron-binding capacity, lactate dehydrogenase, magnesium, phosphate, potassium, protein, sodium, triglyceride and urate.
在北欧参考区间项目(NORIP)中,获取了来自102个北欧临床化学实验室的数据。每个实验室报告了多达25种最常用临床生化特性的分析数据,包括至少25名参考个体的各项结果。一种由血清液体冷冻混合样本组成的参考物质,其值可溯源至参考方法(用作项目中针对非酶类的“校准物”以校正参考值),在每个实验室与其他血清混合对照品一起,在与项目样本相同的分析系列中进行测量。对照品的数据用于评估常规方法的分析质量。在计算参考区间时,仅接受通过应用国际临床化学联合会(IFCC)兼容方法(37摄氏度)获得的酶类参考值,而非酶类情况则使用经“校准物”校正的参考值。对于每种特性,基于简单的非参数计算并使用客观标准进行亚组划分,估计了性别和年龄特异性参考区间。得出的结论是,相同的参考区间适用于所有五个北欧国家。表格中呈现了所考虑特性的以下描述性数据:每个国家和测量系统的测量值数量、对照品的认证/指示目标值、方法和测量系统之间的差异以及变异系数、对照品校正对测量值的影响、按年龄、性别、国家和物质确定的亚组之间的差异,以及新参考区间与标准教科书中给出的参考区间的比较。该项目涉及的25种成分(按字母顺序列出):丙氨酸转氨酶、白蛋白、碱性磷酸酶、淀粉酶、胰型淀粉酶、天冬氨酸转氨酶、胆红素、钙、尿素、胆固醇、肌酸激酶、肌酐、γ-谷氨酰转移酶、葡萄糖、高密度脂蛋白胆固醇、铁、铁结合能力、乳酸脱氢酶、镁、磷酸盐、钾、蛋白质、钠、甘油三酯和尿酸。