间接法建立血清肌酐参考区间

Establishment of serum creatinine reference interval by indirect method

目的利用实验室信息系统(LIS)数据信息库建立一种以数学统计为基础的间接法参考区间获取模式,用于调查江西省吉安市健康人群血清肌酐(Cr)的参考区间。方法回顾性分析9 411名(男5 924名,女3 487名)20～90岁表观健康者的血清Cr检测结果,对数据进行正态性检验,非正态分布数据经正态转换后剔除离群值,同时使用非参数排序法计算P_(2.5)～P_(97.5)区间作为参考区间,并进行参考区间验证。结果正态性检验及转换后剔除离群值127个,最终纳入9 284个数据。不同年龄及性别各组间血清Cr水平差异有统计学意义(P<0.05),因此需按年龄及性别分别建立参考区间。采用非参数排序法确定血清Cr参考区间并通过验证,分别为:20～59岁男性65～110μmol/L;60～79岁男性62～124μmol/L;20～59岁女性46～79μmol/L;60～79岁女性49～85μmol/L。结论基于LIS数据信息库建立的血清Cr参考区间略高于行业标准中推荐使用的参考区间,与服务协议评审和临床沟通反馈的问题及趋势一致,建议根据实际情况建立适合的参考区间。

Objective To establish an indirect model based on mathematical statistics method and laboratory information system(LIS)data,and to investigate the reference interval of serum creatinine(Cr)in Ji'an,Jiangxi.Methods By a retrospective analysis of LIS data,9 411 healthy subjects(5 924 males and 3 487 females)from 20 to 90 years old were enrolled.Serum Cr was determined,and the results were analyzed by SPSS 19.0 software to obtain an approximate normal distribution if they were non-normal distribution through datum normality test.The outliers were identified and omitted,while P2.5-P97.5 as a reference interval was calculated using non-parametric sorting method and was verified.Results A total of 127 outliers were removed after datum normality test and conversion,and the total number of cases was 9 284.There was statistical significance for serum Cr levels between different age and sex groups(P<0.05).Therefore,age-specific and sex-specific reference intervals should be established.The reference intervals of serum Cr which had been verified were 65-110μmol/L for males of 20-59 years old,62-124μmol/L for males of 60-79 years old,46-79μmol/L for females of 20-59 years old and 49-85μmol/L for females of 60-79 years old,respectively.Conclusions The reference intervals of serum Cr based on LIS data are slightly higher than current recommended reference intervals,and they are consistent with the feedback from clinical clients and laboratories,so clinical laboratories should choose,verify or establish suitable reference intervals according to actual situation.