首页|间接法建立湘西地区甲胎蛋白参考区间的探讨

间接法建立湘西地区甲胎蛋白参考区间的探讨

Discussion on establishing reference interval of alpha-fetoprotein in Xiangxi by indirect method

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目的:采用间接法建立湘西地区甲胎蛋白(AFP)的参考区间,探讨间接法建立参考区间的可行性.方法:选取湘西土家族苗族自治州民族中医院10907名体检者的AFP检测数据,采用Kolmogorov-Smirnov检验分析数据正态性,非正态分布数据通过广义Box-Cox变换转变为近似正态分布,采用Turkey法剔除离群值,用非参数法获得参考区间,计算参考限90%置信区间(CI)评估参考区间的稳健性.用参考变化值(RCV)和20例小样本验证参考区间.结果:AFP数据经广义Box-Cox变换后呈近似正态性分布,通过Turkey法剔除AFP数据123例,最终纳入10784例数据(男性6105例,女性4679例).AFP性别间差异有统计学意义(P<0.05),采用非参数法获得较为稳健的 AFP 参考区间(参考限 90%CI):男性≤6.43 ng/mL(6.31~6.51)、女性≤6.09 ng/mL(5.95~6.25).AFP男、女性参考区间经20例小样本验证并通过.新建参考区间与厂商提供参考区间的相对偏差低于参考变化值(RCV).结论:采用间接法建立了符合湘西地区人群的AFP参考区间.间接法建立参考区间简便、实用、可行,可作为实验室建立参考区间的替代选择.
Objective:To establish the reference interval of alpha-fetoprotein(AFP)in Xiangxi by indirect method,and to explore the feasibility of establishing the reference interval by indirect method.Methods:The AFP detection data of 10907 physical examinees in Chinese Medicine Hospital of Xiangxi Tujia and Miao Autonomous Prefertuce were selected.The normality of the data was analyzed by Kolmogorov-Smirnov test,and the abnormal distribution data was transformed into approximate norma distribution by generalized Box-Cox transform.The outliers were eliminated by Turkey method,the reference interval was obtained by nonparametric method,and the 90%confidence interval(CI)of the reference limit was calculated to evaluate the robustness of the reference interval.The reference interval was verified by reference change value(RCV)and 20 small samples.Results:After generalized Box-Cox transform,AFP data showed an approximate normal distribution.123 cases of AFP data were excluded by Turkey method,and finally 10784 cases(6105 males and 4679 females)were included.There was a statistical difference between the sexes in AFP(P<0.05).The nonparametric method was used to obtain a relatively stable reference interval of AFP(reference limit 90%CI):male≤6.43 ng/mL(6.31~6.51)and female≤6.09 ng/mL(5.95~6.25).The reference interval of AFP for male and female was verified and passed by 20 small samples.The relative deviation between the new reference interval and the reference interval provided by the manufacturer is lower than the reference change value(RCV).Conclusion:Indirect method was used to establish the reference interval of AFP,which accords with the population in Xiangxi.The indirect method is simple,practical and feasible,and can be used as an alternative to establishing reference intervals in laboratories.

Indirect methodXiangxi areaAlpha fetoproteinReference intervalConfidence interval

黄珍、朱华山、陈真

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湘西土家族苗族自治州民族中医院检验科,湖南吉首 416000

吉首大学第二附属医院/吉首市人民医院检验科,湖南吉首 416000

间接法 湘西地区 甲胎蛋白 参考区间 置信区间

2024

医学检验与临床
山东省千佛山医院

医学检验与临床

影响因子:0.294
ISSN:1673-5013
年,卷(期):2024.35(5)