[1]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(03):38-42.[doi:10.3969/j.issn.1671-7414.2015.03.011]
 ZHONG Kun,WANG Wei,HE Fa-lin,et al.Comparison and Analysis of the Reference Intervals of 9 Serum Routine Chemical Analytes between the Current Application of Clinical Laboratories and the Latest Health Industrial Standards Draft for Approval[J].Journal of Modern Laboratory Medicine,2015,30(03):38-42.[doi:10.3969/j.issn.1671-7414.2015.03.011]
点击复制

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()
分享到:

《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年03期
页码:
38-42
栏目:
论著
出版日期:
2015-06-10

文章信息/Info

Title:
Comparison and Analysis of the Reference Intervals of 9 Serum Routine Chemical Analytes between the Current Application of Clinical Laboratories and the Latest Health Industrial Standards Draft for Approval
文章编号:
1671-7414(2015)03-038-05
作者:
钟 堃王 薇何法霖王治国
北京医院 卫生部临床检验中心,北京 100730
Author(s):
ZHONG KunWANG WeiHE Fa-linWANG Zhi-guo
Beijing Hospital,National Center for Clinical Laboratories,Beijing 100730,China
关键词:
常规生化 参考区间 卫生行业标准
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.03.011
文献标志码:
A
摘要:
目的 对全国医院检验科常规化学检验项目的参考区间进行调查,并与即将发布的卫生行业标准进行比较。方法 采用基于Web方式的室间质量评价(EQA)软件系统,收集2012年度参加全国常规化学参考区间调查的实验室所上报的数据,使用专业统计软件对数据进行统计分析。结果 共385家实验室回报了调查结果。在即将发布的卫生行业标准所涉及的检验项目中,绝大多数项目不分组或未给出分组时所使用的参考区间与行业标准相比较都存在显著统计学差异[t=-55.435~17.070,P<0.05,占86.1%(31/36)]。只有较少的实验室对参考区间进行了分组(约20%),部分实验室的分组规则与行业标准有一定的差异,与行业标准分组相同的实验室所给出的参考区间与行业标准相比也多存在极显著统计学差异[t=-39.365~13.155,P<0.01,占62.5%(10/16)]。结论 即将发布参考区间与实际工作中所应用的参考区间差异较大,推广已经建立的具有权威性的临床常用生化检验项目参考区间很有必要在实际工作中使用行业标准所给出的参考区间前应进行参考区间的评估和验证。
Abstract:
Objective To investigate the current application status of reference intervals in routine chemistry and compare with the current health industry standards draft for approval.Methods By using web-based external quality assessment(EQA)software system,collectedthe submitted data from the laboratories which attended national reference intervals investigation,used professional statistical software to analyze the data.Results 385 laboratories had submitted the investigation results.The vast majority of the analytes of attended laboratories had significant statistical differences in comparison with the health industry standardsdraft for approval in no grouping and not filled groups[t=-55.435~17.070,P<0.05,86.1%(31/36)].Only a few of laboratories' reference interval had been grouped(approximately 20%).There were some differences in grouping rules between laboratories and standards.Even though some of the laboratories adoptthe grouping rules as same as the standards,there were still big differencesin reference intervals between the laboratories and the standards[t=-39.365~13.155,P<0.01, 62.5%(10/16)].Conclusion Thereference intervals of routine chemistry analytes suggested by the health industry standards draft for approval had quite big differences from the reference intervals used in current clinical laboratories daily work.It is important to propel the authority health industry standards to use in the daily work of clinicallaboratories.The evaluation and validation of using them should be done first.

参考文献/References:

[1] Solberg H.Approved Recommendation(1986)on the theory of reference values.Part 1.The concept of reference values[J].Clin Chim Acta,1987,165(1):111-118.
[2] 中国合格评定国家认可委员会.CNAS-CL02:2012医学实验室质量和能力认可准则[S].北京:中国合格评定国家认可委员会,2012.
China National Accreditation Service for Conformity Assessment.CNAS-CL02:2012.Accreditation criteria for the quality and competence of medical laboratories[S].Beijing:China National Accreditation Service for Conformity Assessment,2012.
[3] 中华人民共和国卫生部.WS/T 404.1-2012.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[S].北京:中国标准出版社,2013.
Ministry of Health of People's Republic of China.WS/T 404.1-2012Reference intervals for common clinical biochemistry tests.Part 1:Serum alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase and γ-glutamyltansferase[S].Beijing:Standard Press of China,2013.
[4] 中华人民共和国卫生部.WS/T 404.2-2012.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[S].北京:中国标准出版社,2013.
Ministry of Health of People's Republic of China.WS/T 404.2-2012Reference intervals for common clinical biochemistry test-Part 2:Serum totalprotein and albumin[S].Beijing:Standard Press of China,2013.
[5] 中华人民共和国卫生部.WS/T 404.3-2012.临床常用生化检验项目参考区间.第3部分:血清钾、钠、氯[S].北京:中国标准出版社,2013.
Ministry of Health of People's Republic of China.WS/T 404.3-2012 Reference intervals for common clinical biochemistry test-Part 3:Serum potassium,sodium and chloride[S].Beijing:Standard Press of China,2013.
[6] 中华人民共和国卫生部.WS/T 405-2012.血细胞分析参考区间[S].北京:中国标准出版社,2013.
Ministry of Health of People's Republic of China.WS/T 405-2012 Reference intervals for blood cell analysis[S].Beijing: Standard Press of China,2013.
[7] 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.
[8] 钟 堃,王治国,王 薇,等.采用多中心相同检测系统建立人体参考区间[J].中华检验医学杂志,2010,33(8):790-792.
Zhong K,Wang ZG,Wang W,et al.Requirements for the production ofmulticentre reference intervals using the same measurement system[J].ChineseJournal of Laboratory Medicine,2010,33(8):790-792.
[9] 颜 虹.医学统计学[M].北京:人民卫生出版社,2006:172-173.
Yan H.Medical statistics[M].Beijing:People's Medical Publishing House,2006:172-173.
[10] 王 燕,康晓平.卫生统计学教程[M].北京:北京大学医学出版社,2006:56-57.
Wang Y,Kang XP.Health statistics[M].Beijing:Peking University Tymedical Press,2006:56-57.
[11] 尚 红,陈文祥,潘柏申,等.中国成人常用肝功能和电解质及血细胞分析项目参考区间[J].中华检验医学杂志,2013,36(5):393-394.
Shang H,Chen WX,Pan BS,et al.Reference intervals for common tests of liver function,electrolytes and blood cell analysis of Chinese adults[J].Chinese Journal of Laboratory Medicine,2013,36(5):393-394.
[12] Mu RQ,Chen WX,Pan BS,et al.First definition of reference intervals of liver function tests in China:a large-population-based multi-center studyabout healthy adults[J].PLOS ONE,2013,8(9):e72916.
[13] 叶应妩,王毓三,申子瑜.全国临床检验操作规程[S].第3版.南京:东南大学出版社,2006:595-606.
Ye YW,Wang YS,Shen ZY.National guide to clinical laboratory procedures[S].Third Edition.Nanjing:Southeast University Press,2006:595-606.
[14] Clinical and Laboratory Standards Institute.Defini-ng,establishing,and verifying reference intervals in the clinical laboratory; Approved guideline-third edition.CLST document C28-A3(ISBN1-56238-663-8)[S].Wayne:PA,CLSI EP28-A3,2008.
[15] 曾 洁,闫 颖,张传宝,等.北京地区汉族人群ALT,AST,GGT和LDH的参考区间研究[J].中华检验医学杂志,2011,33(12):1073-1077.
Zeng J,Yan Y,Zhang CB.Reference intervals for ALT,AST,GGT and LDH among the Han Chinese in Beijing area[J].Chinese Journal of Laboratory Medicine,2010,33(6):570-573.
[16] Clinical and Laboratory Standards Institure.User ve-rification of performance for precision and trueness; approved guideline-second edition[S].Wayne:PA,CLSI EP15-A2,2005.
[17] 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].Chinese Journal of Laboratory Medicine,2011,34(12):1139-1143.

相似文献/References:

[1]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(03):158.[doi:10.3969/j.issn.1671-7414.2016.03.045]
 ZHANG Xiao-yan,WANG Wei,HE Fa-lin,et al.Investigation and Analysis of Reference Intervals and Decision Limits of Reticulocyte Count in China[J].Journal of Modern Laboratory Medicine,2016,31(03):158.[doi:10.3969/j.issn.1671-7414.2016.03.045]
[2]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(04):32.[doi:10.3969/j.issn.1671-7414.2015.04.008]
 ZHONG Kun,WANG Wei,HE Fa-lin,et al.Investigation and Analysis of Reference Intervals of Cystatin C and β2-Microglobulin[J].Journal of Modern Laboratory Medicine,2015,30(03):32.[doi:10.3969/j.issn.1671-7414.2015.04.008]
[3]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(01):145.[doi:10.3969/j.issn.1671-7414.2015.01.044]
 ZHONG Kun,WANG Wei,HE Fa-lin,et al.Comparison of the Reference Intervals of 23 Analytes between Wet Chemistry and Dry Chemistry in 231 Clinical Laboratories in China[J].Journal of Modern Laboratory Medicine,2015,30(03):145.[doi:10.3969/j.issn.1671-7414.2015.01.044]
[4]乔 军,毛华杰,白家瑞,等.西安地区同型半胱氨酸参考区间的初步建立[J].现代检验医学杂志,2016,31(05):130.[doi:10.3969/j.issn.1671-7414.2016.05.037]
 QIAO Jun,MAO Hua-jie,BAI Jia-rui,et al.Investigation on Serum Homocysteine for Reference Range in Xi'an[J].Journal of Modern Laboratory Medicine,2016,31(03):130.[doi:10.3969/j.issn.1671-7414.2016.05.037]
[5]王丽娜,葛君琍,郭苗.宝鸡地区成年健康人群血清胱抑素C参考区间调查[J].现代检验医学杂志,2016,31(06):141.[doi:10.3969/j.issn.1671-7414.2016.06.042]
 WANG Li-na,GE Jun-li,GUO Miao.Investigation of Reference Range of Serum Cystatin C of Healthy People in Baoji[J].Journal of Modern Laboratory Medicine,2016,31(03):141.[doi:10.3969/j.issn.1671-7414.2016.06.042]
[6]何金泉,吴彩明,李国强.广东虎门地区健康人群低血红蛋白密度(LHD%)参考区间的建立和临床应用[J].现代检验医学杂志,2017,32(02):86.[doi:10.3969/j.issn.1671-7414.2017.02.023]
 HE Jin-quan,WU Cai-ming,LI Guo-qiang.Building the Reference Range of Low Hemoglobin Density(LHD%) of Healthy Population in Humen District of Guangdong and Discuss Its Clinical Application Value[J].Journal of Modern Laboratory Medicine,2017,32(03):86.[doi:10.3969/j.issn.1671-7414.2017.02.023]
[7]卢美红,鞠少卿,丛 辉,等.南通地区健康人群血清NSE电化学发光法检测参考区间的调查[J].现代检验医学杂志,2018,33(04):59.[doi:10.3969/j.issn.1671-7414.2018.04.015]
 LU Mei-hong,JU Shao-qing,CONG Hui,et al.Investigate of Serum NSE Reference Range of Healthy People in Nantong with Electrochemiluminescence[J].Journal of Modern Laboratory Medicine,2018,33(03):59.[doi:10.3969/j.issn.1671-7414.2018.04.015]
[8]刘纯岳,林帝金,方俊粤,等.健康成年人血清α-L-岩藻糖苷酶参考区间的建立及适用性评价[J].现代检验医学杂志,2018,33(05):102.[doi:10.3969/j.issn.1671-7414.2018.05.027]
 LIU Chun-yue,LIN Di-jin,FANG Jun-yue,et al.Establishment and Applicability Evaluation of Reference Interval for Serum AFU of Healthy Adults[J].Journal of Modern Laboratory Medicine,2018,33(03):102.[doi:10.3969/j.issn.1671-7414.2018.05.027]
[9]肖光军,刘艳婷,杨 洪,等.四川省遂宁地区表观健康成年人群血浆FMN,FMN/TP比值及FMN/ALB比值参考区间的建立[J].现代检验医学杂志,2019,34(02):56.[doi:10.3969/j.issn.1671-7414.2019.02.015]
 XIAO Guang-jun,LIU Yan-ting,YANG Hong,et al.Establishment of Reference Interval for PlasmaFMN,FMN/TP and FMN/ALB Value among Apparently HealthyAdult Population in Suining of Sichuan[J].Journal of Modern Laboratory Medicine,2019,34(03):56.[doi:10.3969/j.issn.1671-7414.2019.02.015]
[10]张 勇,刘 婧,扈会整,等.陕西省咸阳地区正常人群尿液有形成分参考区间的建立[J].现代检验医学杂志,2019,34(03):112.[doi:10.3969/j.issn.1671-7414.2019.03.027]
 ZHANG Yong,LIU Jing,HU Hui-zheng,et al.Establishment of A Reference Interval for Urine Formationin Healthy People in Xianyang Region,Shaanxi Province[J].Journal of Modern Laboratory Medicine,2019,34(03):112.[doi:10.3969/j.issn.1671-7414.2019.03.027]

备注/Memo

备注/Memo:
作者简介:钟 堃(1984-),男,硕士,助理研究员,研究方向为临床实验室管理。
通信作者:王治国,研究员,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2015-06-10