间接法建立生物参考区间

doi:10.3969/j.issn.1673-8640.2015.04.023

检验医学 ›› 2015, Vol. 30 ›› Issue (4): 391-396.DOI: 10.3969/j.issn.1673-8640.2015.04.023

间接法建立生物参考区间

沈隽霏, 宋斌斌综述, 潘柏申审校

上海复旦大学医学院附属中山医院检验科,上海 200032

收稿日期:2014-07-31 出版日期:2015-04-30 发布日期:2015-05-16
作者简介:null
作者简介:沈隽霏,男,1990年生,学士,技师,主要从事临床免疫检验工作。

通讯作者:潘柏申,联系电话:021-64041990-2376。
基金资助:
“十二五”国家科技支撑计划资助项目(2012BAI37B01);国家临床重点检验专科建设资助项目

Establishment of biological reference intervals by indirect method

SHEN Junfei, SONG Binbin, PAN Baishen.

Department of Clinical Laboratory, Zhongshan Hospital, Fudan University School of Medicine, Shanghai 200032,China

Received:2014-07-31 Online:2015-04-30 Published:2015-05-16

摘要/Abstract

摘要：

医学实验室为临床提供可靠的生物参考区间对正确指导临床诊疗过程有着重要的意义。近年来提出的间接法建立生物参考区间是一种简便、成本低廉的方法,适用于一些无法使用直接法建立生物参考区间的项目和实验室已有检验项目的定期评审。本文基于文献报道,介绍了间接法建立生物参考区间的基本步骤和方法,包括数据采集、数据变换、离群值的剔除和参考区间的取值。

关键词: 生物参考区间, 间接法, 数据变换, 离群值剔除

Abstract:

It is significant for clinical medical laboratories to provide reliable biological reference intervals, which is aimed at guiding proper clinical treatment process. The establishment of biological reference intervals by indirect method which has been arised in recent years has shown great significance in evaluating biological reference intervals periodically within laboratories and establishing biological reference intervals for those projects which cannot be made through direct methods. It is undoubtedly a simple and inexpensive method. This article reviews the basic methods in the process of establishing biological reference intervals by indirect method according to pertinent literatures, which consists of datum acquistion, datum transformation, outlier excluding and reference interval gaining.

Key words: Biological reference interval, Indirect method, Datum transformation, Outlier excluding

中图分类号:

R446.1

沈隽霏, 宋斌斌综述, 潘柏申审校. 间接法建立生物参考区间[J]. 检验医学, 2015, 30(4): 391-396.

SHEN Junfei, SONG Binbin, PAN Baishen.. Establishment of biological reference intervals by indirect method[J]. Laboratory Medicine, 2015, 30(4): 391-396.

参考文献 27

[1]	CNAS-CL02. 医学实验室质量和能力认可准则[S].
[2]	魏有仁. 参考值的几个基本问题[J]. 中国实验诊断学,1997,1(1):44-46.
[3]	Clinical and Laboratory Standards Institute. Defining,establishing,and verifying reference intervals in the clinical laboratory; approved guideline-third edition[S]. EP28-A3c,CLSI,2010.
[4]	GEFFIÉ A,FRIEDRICHS K, HARR K, et al.Reference values: a review[J]. Vet Clin Pathol,2009,38(3):288-298.
[5]	ARZIDEH F, WOSNIOK W,HAECKEL R.Indirect reference intervals of plasma and serum thyrotropin (TSH) concentrations from intra-laboratory data bases from several German and Italian medical centres[J]. Clin Chem Lab Med,2011,49(4):659-664.
[6]	CONCORDET D,GEFFRÉ A, BRAUN JP,et al.A new approach for the determination of reference intervals from hospital-based data[J]. Clin Chim Acta,2009,405(1-2):43-48.
[7]	GEFFRÉ A, CONCORDET D, BRAUN JP,et al.Reference value advisor:a new freeware set of macroinstructions to calculate reference intervals with Microsoft Excel[J]. Vet Clin Pathol,2011,40(1):107-112.
[8]	GROSSI E,COLOMBO R,CAVUTO S,et al.The REALAB project:a new method for the formulation of reference intervals based on current data[J]. Clin Chem,2005,51(7):1232-1240.
[9]	INAL TC, SERTESER M,COSKUN A,et al.Indirect reference intervals estimated from hospitalized population for thyrotropin and free thyroxine[J]. Croat Med J,2010,51(2):124-130.
[10]	GIAVARINA D, DORIZZI RM, FORTUNATO A.Indirect estimation of pediatric Health Related Limits for serum thyrotropin using the ADVIA Centaur analyzer[J]. Clin Biochem,2007,40(15):1143-1149.
[11]	HORN PS, FENG L,LI Y,et al.Effect of outliers and nonhealthy individuals on reference interval estimation[J]. Clin Chem,2001,47(12):2137-2145.
[12]	GRECU DS,PAULESCU E.Quality in post-analytical phase: indirect reference intervals for erythrocyte parameters of neonates[J]. Clin Biochem,2013,46(7-8):617-621.
[13]	田俊. 数据正态性简易判断方法及偏态数据幂变换法[J]. 中国公共卫生,2003,19(12): 1536-1538.
[14]	李运明,封宗超,李小凯,等. Box-Cox 变换及其在 SPSS 软件中的实现[J]. 数理医药学杂志,2009,22(5):569-571.
[15]	Li P. Box-Cox transformations: an overview [EB/OL]. (2005-04-11)[2013-05-10]. .
[16]	ARAL H,USTA M,CILINGIRTURK AM,et al.Verifying reference intervals for coagulation tests by using stored data[J]. Scand J Clin Lab Invest,2011,71(8):647-652.
[17]	茆诗松,周纪芗. 概率论与数理统计[M]. 2版. 北京:中国统计出版社,2007:232-239.
[18]	AITKENHEAD H, HEALES SJ.Establishment of paediatric age-related reference intervals for serum prolactin to aid in the diagnosis of neurometabolic conditions affecting dopamine metabolism[J]. Ann Clin Biochem,2013,50(Pt 2):156-158.
[19]	TUKEY JW.Exploratory data analysis. Reading[M]. New York: Addision-Wesley,1977:506-506.
[20]	杨旭武. 实验误差原理与控制[M]. 北京:科学出版社,2009:62-64.
[21]	KATAYEV A,BALCIZA C,SECCOMBE DW.Establishing reference intervals for clinical laboratory test results: is there a better way[J]. Am J Clin Pathol,2010,133(2):180-186.
[22]	徐中秀. 异常值的处理方法分析及其应用[J]. 系统工程理论与实践,1982,2(1):36-44.
[23]	邓勃. 关于异常值的检验与处理[J]. 大学化学,1995,10(4):5-9.
[24]	方积乾. 医学统计学[M]. 6版.北京:人民卫生出版社,2009:91-93.
[25]	ALPERT JS,THYGESEN K,ANTMAN E,et al.Myocardial infarction redefined-a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction[J]. J Am Coll Cardiol,2000, 36(3):959-969.
[26]	THYGESEN K,ALPERT JS, WHITE HD, et al.Universal definition of myocardial infarction[J]. J Am Coll Cardiol,2007,50(22):2173-2195.
[27]	HORN PS,PESCE AJ, COPELAND BE.A robust approach to reference interval estimation and evaluation[J]. Clin Chem,1998,44(3):622-631.

间接法建立生物参考区间

Establishment of biological reference intervals by indirect method

RichHTML

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献 27

相关文章 12

编辑推荐

Metrics

[1]	李雪文, 徐攀洋, 何冰, 邢东洋, 夏薇, 许建成. 间接法建立长春地区成人血清淀粉酶参考区间[J]. 检验医学, 2022, 37(5): 493-495.
[2]	纪伟, 田国力, 朱之星, 周卓, 王燕敏, 张潇分. 间接法建立上海地区新生儿G6PD筛查临界值的可行性[J]. 检验医学, 2022, 37(2): 112-116.
[3]	吴群, 沈隽霏, 吴文浩, 王蓓丽, 潘柏申, 郭玮. 间接法建立总胆红素和直接胆红素参考区间的探讨[J]. 检验医学, 2020, 35(8): 749-752.
[4]	杨术生, 李琼, 王伟, 范军秀, 方欢英. 间接法建立血清肌酐参考区间[J]. 检验医学, 2018, 33(10): 879-883.
[5]	崔小璠, 李蓉, 王华斌, 刘蕊, 潘文洁. 天津地区成人晨尿ACR及白蛋白浓度生物参考区间的调查研究[J]. 检验医学, 2015, 30(12): 1193-1197.
[6]	葛雅芳，沈云岳，唐振华. 妊娠期女性血细胞主要参数生物参考区间建立的初步探讨[J]. 检验医学, 2014, 29(11): 1097-1100.
[7]	唐红霞, 贾克刚, 韩雪晶, 何聪, 尚子轶, 甄利. PATHFAST检测系统检测高敏感心肌肌钙蛋白I的分析性能评价[J]. 检验医学, 2013, 28(7): 611-617.
[8]	顾春刚. 建立尿有形成分参考区间方法学的比较研究[J]. 检验医学, 2011, 26(12): 854-857.
[9]	项盈;李怀远;王静;郑建新;杨慧;傅启华. 儿童专科医院检验项目的生物参考区间验证[J]. 检验医学, 2011, 26(11): 793-794.
[10]	项盈;李怀远;王静;郑建新;杨慧;傅启华. 儿童专科医院检验项目的生物参考区间验证[J]. 检验医学, 2011, 26(11): 793-794.
[11]	陈桂山;杨有业;梁锦胜;温冬梅. 临床医学实验室生物参考区间的建立[J]. 检验医学, 2008, 23(04): 421-424.
[12]	陈桂山;杨有业;杨志钊. APTT、PT、FIB生物参考区间适用性验证探讨[J]. 检验医学, 2008, 23(01): 24-26.