Ceriotti Ferruccio, Boyd James C, Klein Gerhard, Henny Joseph, Queraltó Josep, Kairisto Veli, Panteghini Mauro
Diagnostica e Ricerca San Raffaele S.p.A. Milano, Italy.
Clin Chem. 2008 Mar;54(3):559-66. doi: 10.1373/clinchem.2007.099648. Epub 2008 Jan 17.
Reference intervals for serum creatinine remain relevant despite the current emphasis on the use of the estimated glomerular filtration rate for assessing renal function. Many studies on creatinine reference values have been published in the last 20 years. Using criteria derived from published IFCC documents, we sought to identify universally applicable reference intervals for creatinine via a systematic review of the literature.
Studies were selected for inclusion in the systematic review only if the following criteria were met: (a) reference individuals were selected using an "a priori" selection scheme, (b) preanalytical conditions were adequately described; (c) traceability of the produced results to the isotope dilution-mass spectrometry (IDMS) reference method was demonstrated experimentally, and (d) the collected data received adequate statistical treatment.
Of 37 reports dealing specifically with serum creatinine reference values, only 1 report with pediatric data and 5 reports with adult data met these criteria. The primary reason for exclusion of most papers was an inadequate demonstration of measurement traceability. Based on the data of the selected studies, we have collated recommended reference intervals for white adults and children.
Laboratories using methods producing traceable results to IDMS can apply the selected reference intervals for serum creatinine in evaluating white individuals.
尽管当前重点强调使用估算的肾小球滤过率来评估肾功能,但血清肌酐的参考区间仍然具有重要意义。在过去20年里,已经发表了许多关于肌酐参考值的研究。我们依据发表的国际临床化学与检验医学联合会(IFCC)文件中的标准,通过对文献进行系统综述,试图确定适用于所有人群的肌酐参考区间。
仅在满足以下标准时,研究才会被选入系统综述:(a)参考个体采用“先验”选择方案进行选取;(b)对分析前条件进行了充分描述;(c)通过实验证明所产生的结果可溯源至同位素稀释-质谱(IDMS)参考方法;(d)所收集的数据得到了充分的统计学处理。
在37篇专门论述血清肌酐参考值的报告中,只有1篇儿科数据报告和5篇成人数据报告符合这些标准。大多数论文被排除的主要原因是未能充分证明测量的可溯源性。基于所选研究的数据,我们整理了针对白人成年人和儿童的推荐参考区间。
使用能产生可溯源至IDMS结果的方法的实验室,在评估白人个体时可应用所选的血清肌酐参考区间。