基于间接法建立肾功能检验项目的生物参考区间

Establishment of biological reference interval of renal function test items based on indirect method

目的:通过间接法建立江苏地区、广东地区、河北地区肌酐、尿素、尿酸干化学法的参考区间。方法:收集连云港市中医院、广州市番禺区妇幼保健医院、河北大学附属医院2023年1月1日―2023年6月3日实验室信息系统(LIS)数据。利用K-S检验对数据进行正态性检验,四分位间距法剔除离群值,采用Mann-Whitney U检验对性别、年龄段分类统计,采用百分数法(P2.5~P97.5)确立各组参考区间,并与说明书参考区间比较。结果:血浆肌酐、尿素、尿酸性别之间均有统计学意义。肌酐男性30岁以下组与31~60岁组之间无统计学意义,可以合并建立参考区间,其余各年龄段之间均有统计学意义,需各自建立参考区间。肌酐的生物参考区间:>60岁男性为41.59~159.00μmol/L,≤60岁男性为41.00~138.80μmol/L;>60岁女性为35.20~114.27μmol/L,31~60岁女性为34.20~99.64μmol/L,≤30岁女性为28.56~74.54μmol/L。尿素的参考区间:>60岁男性为3.50~11.20 mmol/L,31~60岁男性为3.10~9.90 mmol/L,≤30岁男性为2.39~8.95 mmol/L;>60岁女性为3.20~10.20 mmol/L,31~60岁女性为2.63~9.27 mmol/L,≤30岁女性为2.20~7.70 mmol/L。尿酸的参考区间:>60岁男性为165.35~570.93μmol/L,31~60岁男性为189.13~586.38μmol/L,≤30岁下男性为189.24~607.76μmol/L;>60岁女性为140.37~165.63μmol/L,31~60岁女性为142.70~477.71μmol/L,≤30岁女性为169.90~486.45μmol/L。男性各年龄段肌酐、60岁以上女性肌酐、60岁以上男性女性尿素的自建参考区间与现行参考区间相对偏差大于RCV,说明自建参考区间与现行参考区间的差异有统计学意义,需要自建参考区间。其余项目的自建参考区间与现行参考区间的相对偏差小于RCV,说明差异无统计学意义。结论:肌酐、尿素、尿酸有性别和年龄之间的差异,部分项目与现行参考区间有差异,需自建参考区间。间接法建立检验项目的生物参考区间是一种可行的方法。

Objective To establish the reference interval of creatinine,urea and uric acid based on dry chemical system in Jiangsu、Guangzhou and Hebei by indirect method.Methods Collect laboratory information system(LIS)data from Lianyungang TCM Hospital Affiliated to Nanjing University of Chinese Medicine,Panyu Maternal and Child Care Service Centre of Guangzhou,and The Affiliated Hospital of Hebei University from January 1,2023 to June 3,2023.The K-S test was used to test the normality of the data,the interquartile range method was used to eliminate outliers,the Mann Whitney U test was used to classify the sex and age groups,and the percentage method(P2.5-P97.5)was used to establish the reference interval of each group,and compared with the reference interval of the manual.Results plasma creatinine,urea and uric acid were significantly different between sexes.There is no statistical significance in creatinine between the male under 30 years old group and the 31-60 years old group,and the reference interval can be established in combination.There is statistical significance between the other age groups,and the reference interval needs to be established separately.The biological reference interval of creatinine is 41.59-159.00 umol/L for men over 60 years old,41.00-138.80 umol/L for men under 60 years old,35.20-114.27 umol/L for women over 60 years old and 34.20-99.64 umol/L for women over 30 years old under 60 years old.The reference interval of urea is 3.50-11.20 mmol/L for men over 60 years old,3.10-9.90 mmol/L for men over 30 years old,2.39-8.95 mmol/L for men under 30 years old,3.20-10.20 mmol/L for women over 60 years old,and 3.20-10.20mmol/L for women over 30 years old under 60 years old.The reference interval of uric acid is 165.35-570.93 umol/L for men over 60 years old,and 189.13-586.38 umol/L for men over 30 years old under 60 years old.The relative deviation of creatinine in men at all ages,creatinine in women over 60 years old,urea in men over 60 years old and urea in women over 60 years old are greater than RCV,indicating that there is a statistical difference between the self built reference range and the current reference range,and the self built reference range is required.The relative deviation between the self built reference range and the current reference range of other projects is less than RCV,indicating that the difference is not statistically significant.Conclusion There are sex and age differences in creatinine,urea and uric acid.Some items are different from the current reference interval,so it is necessary to establish a reference interval.Indirect method is a feasible method to establish the biological reference range of test items.