自建血清肌酐肌氨酸氧化酶法检测系统的有效性验证和参考区间调查

摘要

目的 对自建肌氨酸氧化酶法测定血清肌酐的检测系统进行有效性验证并建立新乡地区健康人群的参考区间.方法 对14 685名(年龄1～88岁)肾功能正常、无高血压、糖尿病、心血管病和慢性肾病家族史的健康体检者,采用经过有效性验证的检测系统进行血清肌酐的检测.对结果的频数分布进行正态性检验,性别间结果差异的比较采用t检验.符合正态性分布时,以(x±1.96s)为参考区间;不符合正态性分布时,取2.5%～97.5%百分位数为参考区间.结果 结果的频数分布为非正态性分布,男女之间结果差异有统计学意义(t=46.578,P=0.000).按照2.5%～97.5%百分位数确定血清肌酐的参考区间为:男53.0～108.0 μmol/L,女44.0～102.0 μmol/L.结论应该建立不同检测系统血清肌酐的参考区间.%Objective To validate validity of self-established measure system measuring serum creatinine by sarcosine oxidase method and to establish the reference range of Xinxiang healthy crowd. Methods 14685 (age from 1 to 88) healthy individuals,with normal kidney function , without hypertension , diabetes, cardiovascular diseases , were enrolled and detected for the serum level of creatinine by measure system through validity validation. Normal condition test of results' frequence number distribution and t test for results' reference compare between male and female were performed. The reference value were ascertained by (-x± 1. 96s) for according with normal condition distribution and 2. 5-97. 5 percent digit for not according with normal condition distribution.Results The results' frequence number distribution was not normal condition distribution. There was statistical meaning for results' difference between men and wornen(t= 46. 578,P=O. OOO). The reference range of serum creatinine by 2. 5-97. 5 percent digit were 53. 0-108. O μmol/L for male and 44. 0-102. O μmol/L for femal. Conclusion We should establish different measure system and reference value range of serum creatinine.