[1]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):152-156.[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(03):152-156.[doi:10.3969/j.issn.1671-7414.2017.03.043]
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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()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年03期
页码:
152-156
栏目:
质量控制·实验室管理
出版日期:
2017-05-25

文章信息/Info

Title:
Analysis and Comparison of Reference Intervals of Serum Total Bilirubin and Serum Direct Bilirubinwith Upcoming I ndustry Standards in China
文章编号:
1671-7414(2017 )03-152-05
作者:
张诗诗1; 2; 王 薇2 ; 赵海建2; 何法霖2; 钟 堃2; 王治国1; 2
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):
ZHANG Shi-shi1; 2; WANG Wei2; ZHAO Hai-jian 2; HE Fa-lin2; ZHONG Kun2; WANG Zhi-guo1; 2
1.National Center for Clinical Laboratory/Beijing Engineering R esearch Center of Laboratory Medicine，Beijing Hospital，National Center of Gerontology，Bei jing 100730，China；
2.Graduate School of Peking Union Medical College，Beijing 100730，China
关键词:
血清总胆红素; 血清直接胆红素; 参考区间; 质量控制
分类号:
R446.112
DOI:
10.3969/j.issn.1671-7414.2017.03.043
文献标志码:
A
摘要:
目的 分析我国临床实验室血清总胆红素(total bilirubin ，TBIL)、直接胆红素(direct bilirubin，DBIL)检验项目的参考区间现状，并与即将发布 的行业标准WS/T404第4部分进行比较。方法 采用基于Web方式的室 间质量评价(EQA)软件，收集参加卫生部临床检验中心2014年全国临床常规化学血清TBIL，D BIL项目EQA活动中的所有临床实验室的参考区间相关信息，包括参考区间来源、分组与验证 情况、上下限、所用仪器、试剂、方法和校准物等。使用Microsoft Excel 2010和SPSS 19 .0 统计软件对数据进行统计分析。采用单样本均数t检验比较实验室使用参考区间与 即将发布行业标准的差异；并根据检测系统对来源比例最高的实验室中的配套实验室进行分 组，选取其中使用较多的3种配套系统所用参考区间分别与即将发布行业标准进行比较。〖H T5”H〗结果 纳入TBIL和DBIL项目参考区间来源分布调查的实验室分别为749和 709家；其中分布比例最高的均是试剂厂家说明书(TBIL 58.08%，DBIL 58.67%)，其次是 《全国临床检验操作规程》(3版)(TBIL 29.64%，DBIL 28.91%)，其他来源不足10%； 验证参考区间的比例分别是50.60%和49.93%。各项目实验室使用参考区间上、下限分别与 即将发布行业标准参考区间上、下限比较，差异有统计学意义(P<0.05)。各项目实验 室使用参考区间均比即将发布行业标准窄。血清TBIL，DBIL项目参考区间来源为试剂厂家说 明书的实验室中，使用配套系统的实验室分别占41.88%和41.48%；单样本均数t检验 结果显示，除Beckman检测系统对应的血清DBIL项目参考区间下限(P=0.068)和HITACHI 检测系统对应的血清DBIL项目参考区间上限(P=0.087)以外，各配套检测系统对应的各 项目参考区间上下限与行业标准的差异均有统计学意义(P<0.05)。结论 目前我国临床实验室血清TBIL，DBIL项目参考区间使用情况不够科学合理，与即 将发布行业标准比较差异有统计学意义。应该尽快发布行业标准WS/T 404第4部分，帮助临 床实验室建立合适的参考区间，促进参考区间使用规范化。
Abstract:
Objective To analyze the reference intervals of se rum total bilirubin (TBIL) and serum direct bilirubin (DBIL) by all Chinese clin ical laboratories and make a comparison with the upcoming part 4 of Industry Sta ndard WS/T 404．Methods Relevant information about refere nce intervals of all clinical laboratories participating in TBIL and DBIL testin g items of 2014 national external quality assessment scheme of clinical routine chemistry was collected by a web-based external quality assessment software，in cluding source，grouping，verification，upper and lower limits of reference inte rvals and instruments，reagents，methods and calibrators used．Microsoft Excel 2 010 and SPSS 19.0 were applied to statistical analysis．The comparison between reference intervals used and the upcoming Industry Standard was conducted by the simple mean t test．Laboratories derived from the highest percentage of sou rce distribution whose reagent and instrument were matching with each other were grouped according to the test systems used and the differences of reference int ervals between three mainly used test systems and the upcoming Industry Standard were also compared with the single sample mean t test．Results The number of laboratories participated in the investigation about so urce distribution of reference intervals for TBIL and DBIL was 749 and 709　resp ectively．For these two items，the highest sources were both instructions of rea gent(TBI L 58.08%，DBIL 58.67%)，next were both National Clinical Laboratory Operation Rules (3rd Edition) (TBIL 29.64%，DBIL 28.91%)，the percentages of other sourc es were all less than 10%．Besides，there were respectively 379 (50.60%) and 35 4 (49.93%) laboratories verifying their reference intervals for TBIL and DBIL． The difference of the comparison between reference intervals used and the upcomi ng Industry Standard had statistical significance (P<0.05)．The using refer ence intervals were narrower than the upcoming Industry Standard for both items ．In all laboratories with reference intervals from instructions of reagent，the mating laboratories respectively accounted for 41.88% and 41.48% for item TBIL and DBIL．As the single sample mean t test showed，the comparison of the re ference intervals between three mainly used test systems in these mating laborat ories and the upcoming Industry Standard had statistical significance (P<0. 05)，except for the lower limit of DBIL with Beckman test system (P value wa s 0.068) and the upper limit of DBIL with HITACHI test system (P value was 0.087)．Conclusion Currently，the using situation of ref erence intervals about TBIL and DBIL by all Chinese laboratories was not scienti fic and rational enough and has significant difference with the upcoming Industr y Standard．Should publish the part 4 of Industry Standard WS/T 404 as soon as p ossible，which would help clinical laboratories establishing suitable reference intervals and promote the standardization of its usage．

参考文献/References:

［1］ Solberg HE．International Federation of Clinical Che-mistry，Sci entific committee，Clinical Section．Expert Panel on Theory of Reference Values ，and International Committee for Standardization in Haematology(ICSH) Standing Committee on Reference Values．Approved recommendation(1986)on the theory of ref erence　values．Part 1．The concept of reference values［J］．Clin Chim Acta，19 87(165)：111-118．
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备注/Memo

备注/Memo:
基金项目：北京市自然科学基金项目(7143182)，北京 医院课题资助(BJ-2015-025)。
作者简介：张诗诗(1991-)，女，在读硕士研究生，研究方向：实 验室质量管理，E-mail:Athena 0915@163.com。
通讯作者：王治国，硕士，研究员，主要从事临床检验质量控制 方法研究和室间质量评价工作，E-mail：zgwang@nccl.org.cn。
更新日期/Last Update: 2017-06-25