[1]李婷婷,赵海建,王 薇,等.京津冀地区56家临床检验结果互认实验室18个常规化学项目参考区间结果分析[J].现代检验医学杂志,2017,32(06):154-159.[doi:10.3969/j.issn.1671-7414.2017.06.001]
　LI Ting-ting,ZHAO Hai-jian,WANG Wei,et al.Analysis of Reference Intervals of 18 Routine Biochemistry in 56 Mutual Recognition Laboratories in Beijing-Tianjing-Hebei Region[J].Journal of Modern Laboratory Medicine,2017,32(06):154-159.[doi:10.3969/j.issn.1671-7414.2017.06.001]
点击复制

京津冀地区56家临床检验结果互认实验室18个常规化学项目参考区间结果分析()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年06期
页码:
154-159
栏目:
质量控制·实验室管理
出版日期:
2017-12-25

文章信息/Info

Title:
Analysis of Reference Intervals of 18 Routine Biochemistry in 56 Mutual Recognition Laboratories in Beijing-Tianjing-Hebei Region
文章编号:
1671-7414(2017)06-154-06
作者:
李婷婷1; 2; 赵海建1; 王 薇1; 何法霖1; 钟堃1; 袁 帅1; 王治国1
1.北京医院 国家老年医学中心 卫生部临床检验中心/ 北京市临床检验工程技术研究中心,北京 100730; 2.北京协和医学院研究生院,北京 100730
Author(s):
LI Ting-ting1; 2; ZHAO Hai-jian1; WANG Wei1; HE Fa-lin1; ZHONG Kun1; YUAN Shuai1;  WANG Zhi-guo1
1.National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Centerof Gerontology, Beijing 100730,China; 2.Graduate School of Peking Union Medical College,Beijing 100730,China
关键词:
参考区间;  检验;  质量控制;  生物化学;  临床实验室
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.06.001
文献标志码:
A
摘要:
目的 通过分析京津冀地区检验结果互认实验室18个常规化学互认项目参考区间结果,评价互认实验室参考区间的一致性。方法 实验室通过基于WEB方式的室间质量评价(EQA)软件系统上报参考区间相关信息,后台将回报数据另存为Microsoft Excel 2007文档,然后选出该次京津冀地区互认的实验室(56家)以及互认的18个常规生化项目,包括钾(K)、钠(Na)、氯(Cl)、钙(Ca)、磷(P)、总蛋白(TP)、清蛋白(ALB)、总胆固醇(TC)、三酰甘油(TG)、肌酐(CRE)、尿素(URE)、尿酸(UA)、葡萄糖(GLU)、丙氨酸氨基转氨酶(ALT)、天门冬氨酸氨基转氨酶(AST)、γ-谷氨酰基转移酶(GGT)、乳酸脱氢酶(LDH)和肌酸激酶(CK),并对这些项目的参考区间上下限及来源进行分析。结果 实验室参考区间来源不一,对于有参考区间卫生行业标准的项目(包括K,Na,Cl,Ca,P,TP,ALB,CRE,URE,ALT,AST,GGT,LDH和CK)主要来源于行业标准(23.1%～48.1%),试剂/仪器厂家说明书(17.3%～41.8%)或《全国临床检验操作规程》(18.9%～37.0%); 对于没有行业标准的项目(包括TC,TG,UA和GLU)主要来源于试剂/仪器厂家说明书(>41%)和《全国临床检验操作规程》(>45.3%)。超过一半的实验室(50.9%～58.9%)对引用的参考区间进行了验证。各实验室间K,Cl,Ca,P,GLU参考区间上下限相差较小,其他项目差异较大。结论 互认实验室常规化学参考区间上下限存在不一致,为保证京津冀地区检验结果的可比性应建立基于区域性人群或中国人群的参考区间。
Abstract:
Abstract:Objective To evaluate reference intervals consistency of 18 routine biochemistry among mutual recognition laboratories by analyzing the information of reference intervals of these laboratories in Beijing-Tianjing-Hebei region.Methods Laboratories submitted thedata of reference intervals via interval quality assessment(EQA)software whichwas based on WEB,then the background of the software save the data as Microsoft Excel 2007 document.Finally,the mutual recognition routine biochemical projects,including Kalium(K),Sodium(Na),Chlorinum(Cl),Calcium(Ca),Phosphorus(P),Total protein(TP),Albumin(ALB),Total cholesterol(TC),Triglyceride(TG),Creatinine(CRE),Urea(URE),Uric acid(UA),Glucose(GLU),Alanine amino transaminase(ALT),Aspartate aminotransferase(AST),γ-glutamyltranspeptidase(GGT),Lactate dehydrogenase(LDH)and Creatine kinase(CK)of 56 mutual recognition laboratories were chosen,and perform analysis on upper and lower limits of reference intervals and their sources.Results The sources of reference intervals differ among different laboratories.As for projectsowning hygiene professional standards(including K,Na,Cl,Ca,P,TP,ALB,CRE,URE,ALT,AST,GGT,LDH,CK),the primary sources were hygiene professional standards(23.1%～48.1%),manufacturer instructions of reagents/instrument(17.3%～41.8%)and National Clinical Laboratory Procedures(18.9% ～37.0%),as for projects which didn't have professional standards(including TC,TG,UA and GLU),the main sources were manufacturer instructions of reagents/instrument(>41.1%)and National Clinical Laboratory Procedures(>45.3%).Moreover,more than half of laboratories(50.9%～58.9%)had verified the reference intervals.There were little difference among laboratories in the upper and lower limits of Cl,Ca,P,K and GLU,but bigger difference for other projects.ConclusionThe upper and lower limits of reference intervals werenot consistent among laboratories.In order to ensure the comparability of the test results in beijing-tianjin-hebei region,laboratories should use reference intervals based on the population of beijing-tianjin-hebei region or China.

参考文献/References:

[1] 北京、天津、河北卫计委.关于开展京津冀地区医疗机构临床检验结果互认试点工作的通知[Z].京卫医(2016)139号. Beijing, Tianjing, Hebei Municipal Commission of Health and FamilyPlanning.Notification on the work of clinical test results mutual recognitionin beijing-tianjin-hebei region medical institution[Z].Jingwei Medical(2016)139.
[2] 王 薇,钟 堃,白 玉,等.全国常规化学检验项目参考区间现状调查分析[J].中华检验医学杂志,2011,34(12):1139-1143. Wang W,Zhong K,Bai Y,et al.Investigation and analysis of reference intervals of routine clinical chemistry assays in China[J].Chin J Lab Med,2011,34(12):1139-1143.
[3] 王 薇,钟 堃,何法霖,等.我国糖化血红蛋白参考区间和切值调查与分析[J]. 中华糖尿病杂志,2014,6(12):859-863. Wang W,Zhong K,He FL,et al.Investigation and analysis of reference intervals and cut-off value of glycated hemoglobin A1c in China[J].Chin JDiabetes Mellitus,2014,6(12):859-863.
[4] 中华人民共和国卫生部.临床常用生化检验项目参考区间 第1部分:血清丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶和γ-谷氨酰基转移酶WS/T 404.1-201[S].北京:中国标准出版社,2013. Ministry of Health of People's Republic of China.Reference intervals for common clinical biochemistry tests.Part 1:Serum alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase and γ-glutamyltansferase WS/T 404.1-201[S].Beijng:Standards Press of China,2013.
[5] 中华人民共和国卫生部.临床常用生化检验项目参考区间第2部分:血清总蛋白、白蛋白WS/T 404.2-2012[S].北京:中国标准出版社,2013. Ministry of Health of People's Republic of China.Reference intervals for common clinical biochemistry tests.Part 2:Serum total protein and albumin WS/T 404.2-201[S].Beijng:Standards Press of China,2013.
[6] 中华人民共和国卫生部.临床常用生化检验项目参考区间第3部分:血清钾、钠、氯WS/T 404.3-2012[S].北京:中国标准出版社,2013. Ministry of Health of People's Republic of China.Reference intervals for common clinical biochemistry tests.Part 3:Serum potassium sodium and chloride WS/T 404.3-201[S].Beijng:Standards Press of China,2013.
[7] 中华人民共和国卫生和计划生育委员会.临床常用生化检验项目参考区间第5部分:血清尿素、肌酐WS/T 404.5-2015[S].北京:中国标准出版社,2015. National Health and Family Planning Commission of the People's Republic of China.Reference intervals for common clinical biochemistry tests.Part5:Serum ureaand creatinineWS/T 404.5-2015[S].Beijng:Standards Press of China,2015.
[8] 中华人民共和国卫生计划生育委员会.临床常用生化检验项目参考区间第6部分:血清乳酸脱氢酶、肌酸激酶WS/T 404.6-2015[S].北京:中国标准出版社,2015. National Health and Family Planning Commission of the People's Republic of China.Reference intervals for common clinical biochemistry tests.Part6:Serum lactate dehydrogenase,creatine kinase WS/T 404.6-2015[S].Beijng:Standards Press of China,2015.
[9] 国家卫生计划生育委员会.WS/T 404.7-2015临床常用生化检验项目参考区间第7部分:血清总钙、无机磷、镁、铁[S].北京:中国标准出版社,2015. National Health and Family Planning Commission of the People's Republic of China.Reference intervals for common clinical biochemistry tests.Part7:Serum calcium,phosphoorus,magnesium,iron WS/T 404.7-201[S].Beijng:Standards Press of China,2015.
[10] 中华人民共和国卫生部医政司.全国临床检验操作规程[S].3版.南京:东南大学出版社,2006. Department of Medical Administration in Ministry of Health of People's Republic of China.National Clinical Laboratory Procedures[S].3th Ed.Nanjing:Southeast University Press,2006.
[11] 王治国.临床检验生物学变异与参考区间[M].北京:人民卫生出版社,2012. Wang ZG.Biological variation and reference intervals of clinical laboratories[M].Beijing:People's Medical Publishing House,2012.
[12] 钟 堃,王 薇,何法霖,等.国内临床化学9项常规项目参考区间与即将发布的卫生行业标准的比较和分析[J].现代检验医学杂志,2015,30(3):38-42. Zhong K,Wang W,He FL,et al.Comparison and analysis of the reference intervals of 9 serum routine chemical analytes between the current application ofclinical laboratories and the latest health industrial standards draft for approval[J].J Mod Lab Med,2015,30(3):38-42.
[13] 王 薇,钟 堃,何法霖,等.全国干化学胆红素检测室间质量调查结果分析[J].现代检验医学杂志,2014,29(2):159-162. Zhong K,Wang W,He FL,et al.Results analysis of serum bilirubin testingin dry chemistry external quality survey[J].J Mod Lab Med,2014,29(2):159-162.
[14] 钟 堃,王 薇,何法霖,等.半胱氨酸蛋白酶抑制剂C和β2微球蛋白参考区间的调查与分析[J].现代检验医学杂志,2015,30(4):32-38. Zhong K,Wang W,He FL,et al.Investigation and analysis of refirence intervals of cystatin C and β2-Microglobulin[J].J Mod Lab Med,2015,30(4):32-38.
[15] 钟 堃,王 薇,何法霖,等.全国231家临床实验室23项干化学与湿化学检验项目参考区间的比较和分析[J].现代检验医学杂志,2015,30(1):145-148. Zhong K,Wang W,He FL,et al.Comparison of the reference intervals of 23analytes between wet chemistry and dry chemistry in 231 clinical laboratories in China[J].J Mod Lab Med,2015,30(1):145-148.
[16] 章晓燕,王 薇,何法霖,等.全国网织红细胞计数参考区间和决定限现状调查与分析[J].现代检验医学杂志,2016,31(3):158-161. Zhang XY,Wang W,He FL,et al.Investigation and analysis of reference intervals and decision limits of reticulocyte count in China[J].J Mod Lab Med,2016,31(3):158-161.
[17] International Organization for Standardization.Medical laboratories-requirements for quality and competence[S].Geneva,Switzerland,ISO15189:2012,2012. 收稿日期:2017-02-10 修回日期:2017-07-22

相似文献/References:

[1]张灵玲,张朝明,谢国丽.中性粒VCS参数表达的性别差及差异表达的临床应用[J].现代检验医学杂志,2015,30(06):86.[doi:10.3969/j.issn.1671-7414.2015.06.025]
　ZHANG Ling-ling,ZHANG Chao-ming,XIE Guo-li.Gender Differences of Neutrophil VCS Parameter Expression and Clinical Application of Differential Expression[J].Journal of Modern Laboratory Medicine,2015,30(06):86.[doi:10.3969/j.issn.1671-7414.2015.06.025]
[2]刘晓鸽,姚伟,房笃智.健康成人血浆D-二聚体免疫比浊法正常参考区间的建立[J].现代检验医学杂志,2015,30(06):98.[doi:10.3969/j.issn.1671-7414.2015.06.029]
　LIU Xiao-ge,YAO Wei,FANG Du-zhi.Establishment of the Normal Reference Range of Plasma D-Dimer Immune by Turbidimetric Method in Healthy Adults[J].Journal of Modern Laboratory Medicine,2015,30(06):98.[doi:10.3969/j.issn.1671-7414.2015.06.029]
[3]张诗诗,王 薇,赵海建,等.我国血清总胆红素和直接胆红素检验项目参考区间现状与即将发布行业标准的分析比较[J].现代检验医学杂志,2017,32(03):152.[doi:10.3969/j.issn.1671-7414.2017.03.043]
　ZHANG Shi-shi,WANG Wei,ZHAO Hai-jian,et al.Analysis and Comparison of Reference Intervals of Serum Total Bilirubin and Serum Direct Bilirubinwith Upcoming I ndustry Standards in China[J].Journal of Modern Laboratory Medicine,2017,32(06):152.[doi:10.3969/j.issn.1671-7414.2017.03.043]
[4]黄钰君,伍绍国,丘媛媛,等.广州地区正常儿童血清叶酸参考区间调查[J].现代检验医学杂志,2017,32(04):125.[doi:10.3969/j.issn.1671-7414.2017.04.036]
　HUANG Yu-jun,WU Shao-guo,QIU Yuan-yuan,et al.Investigation of the Normal Reference Range for Serum Folate of Healthy Children in Guangzhou Region[J].Journal of Modern Laboratory Medicine,2017,32(06):125.[doi:10.3969/j.issn.1671-7414.2017.04.036]
[5]吴爽,张书婉,张涛元,等.西安地区0～12岁健康儿童血清S100蛋白参考区间的建立[J].现代检验医学杂志,2019,34(01):124.[doi:10.3969/j.issn.1671-7414.2019.01.032]
　WU Shuang,ZHANG Shu-wan,ZHANG Tao-yuan,et al.Establishment of Biology Reference Interval of Serum Protein S100 Level in Healthy Children between 0 and 12 Years Old in Xi’an[J].Journal of Modern Laboratory Medicine,2019,34(06):124.[doi:10.3969/j.issn.1671-7414.2019.01.032]
[6]史剑飞,卢北玲,李　俏,等.西安地区健康儿童血清缺血修饰清蛋白参考区间的建立[J].现代检验医学杂志,2019,34(06):118.[doi:10.3969 ／ j.issn.1671-7414.2019.06.029]
　SHI Jian-fei,LU Bei-ling,LI Qiao,et al.Establishment of Reference Interval for Serum Ischemic Modified Albumin of Healthy Children in Xi’an Area[J].Journal of Modern Laboratory Medicine,2019,34(06):118.[doi:10.3969 ／ j.issn.1671-7414.2019.06.029]
[7]谭玉华,曹春玲,邢晓敏,等.国产Auto TRFIA-4 型自动荧光免疫分析仪与试剂盒检测妊娠相关血浆蛋白A 的性能评价与参考区间的建立[J].现代检验医学杂志,2020,35(04):75.[doi:10.3969/j.issn.1671-7414.2020.04.018]
　TAN Yu-hua,CAO Chun-ling,XING Xiao-min,et al.Performance Evaluation of Domestic Auto TRFIA-4 Model Automatic Fluorescence Immunoassay and Kit for Detection of Pregnancy Associatied Plasma Protein A and Establishment of Reference Interval[J].Journal of Modern Laboratory Medicine,2020,35(06):75.[doi:10.3969/j.issn.1671-7414.2020.04.018]
[8]霍豆,秦爽,邢瑞青,等.西安地区健康成人尿液mAlb, Cr 水平以及mAlb/Cr 比值参考区间的建立[J].现代检验医学杂志,2020,35(05):118.[doi:10.3969/j.issn.1671-7414.2020.05.030]
　HUO Dou,QIN Shuang,XING Rui-qing,et al.Establishment of Reference Interval for UmAlb,Ucr and UmAlb/ UCr in Healthy Adults in Xi’an Area[J].Journal of Modern Laboratory Medicine,2020,35(06):118.[doi:10.3969/j.issn.1671-7414.2020.05.030]
[9]吴汝香,黄林娟,林　珊,等.福州地区 0~3岁健康儿童外周血红细胞膜六项脂肪酸指标参考区间调查[J].现代检验医学杂志,2021,36(01):96.[doi:10.3969/j.issn.1671-7414.2021.01.024]
　WU Ru-xiang,HUANG Lin-juan,LIN Shan,et al.Investigation on Reference Intervals of Sixfatty Acids Indexes of Peripheral Blood Erythrocyte Membrane in Healthy Children Aged 0~3 Years in Fuzhou[J].Journal of Modern Laboratory Medicine,2021,36(06):96.[doi:10.3969/j.issn.1671-7414.2021.01.024]
[10]肖春海,董志武,王伟伟,等.上海地区 14~92 岁健康人群 8 项血细胞参数的参考区间研究[J].现代检验医学杂志,2021,36(03):108.[doi:10.3969/j.issn.1671-7414.2021.03.025]
　XIAO Chun-hai,DONG Zhi-wu,WANG Wei-wei,et al.Reference Interval Study for 8 Blood Cell Parameters inHealthy People Aged 14 to 92 in Shanghai[J].Journal of Modern Laboratory Medicine,2021,36(06):108.[doi:10.3969/j.issn.1671-7414.2021.03.025]

备注/Memo

备注/Memo:
基金项目:北京市自然科学基金资助项目(7143182); 北京医院课题资助(BJ-2015-025)。 作者简介:李婷婷(1990-),女,硕士研究生,研究方向为临床实验室管理。 通讯作者:王治国,研究员,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2017-12-26