[1]苗玉发,张河战.43家食品药品检测机构实验室检测6项生化指标能力验证评价[J].现代检验医学杂志,2018,33(03):158-161.[doi:10.3969/j.issn.1671-7414.2018.03.041]
　MIAO Yu-fa,ZHANG He-zhan.Proficiency Testing Evaluation on Determination of 6 BiochemicalIndices in 43 Chinese Laboratories of Food and Drug Control Institutions[J].Journal of Modern Laboratory Medicine,2018,33(03):158-161.[doi:10.3969/j.issn.1671-7414.2018.03.041]
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43家食品药品检测机构实验室检测6项生化指标能力验证评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年03期
页码:
158-161
栏目:
质量控制·实验室管理
出版日期:
2018-07-17

文章信息/Info

Title:
Proficiency Testing Evaluation on Determination of 6 BiochemicalIndices in 43 Chinese Laboratories of Food and Drug Control Institutions
文章编号:
1671-7414(2018)03-158-04
作者:
苗玉发; 张河战
中国食品药品检定研究院,北京 100176
Author(s):
MIAO Yu-fa; ZHANG He-zhan
National Institutes for Food and Drug Control,Beijing 100176,China
关键词:
血糖;  血脂;  电解质;  均匀性和稳定性;  能力验证
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2018.03.041
文献标志码:
A
摘要:
目的 评价食品药品检测机构对血糖(GLU)、总胆固醇(CHO)、三酰甘油(TG)、钾离子(K+)、钠离子(Na+)以及氯离子(Cl-)等6种生化指标的检测能力。方法 分别采用单因素方差分析和t检验法对能力验证样品的均匀性和稳定性进行研究。用Kolmogorov-Smirnov 检验法研究43家实验室能力验证数据的正态性。按照美国临床实验室改进法案(CLIA'88)能力验证评价标准,对各实验室的结果进行评价。结果 GLU,CHO,TG,K+,Na+和Cl-的满意率分别为97.6%,97.6%,100%,90.9%,72.7%和84.8%。结论 通过该次能力验证研究,发现部分实验室的GLU,CHO,K+,Na+和Cl-指标检测能力存在缺陷,有利于促进实验室的质量改进。
Abstract:
Abstract:Objective To evaluate 6 biochemical indices detection ability for blood glucose(GLU),cholesterol(CHO),triglyceride(TG),potassium(K+),sodium(Na+)and chlorine(Cl-)in Chinese Institutions of Food and Drug Control.Methods The uniformity and stability of proficiency testing samples were analyzed by one-way ANOVA and t test,respectively.Normality test for proficiency testing data of 43 laboratories was performed by Kolmogorov-Smirnov test,and the proficiency testing results were evaluated according to American CLIA'88 evaluation criterias.ResultsThe satisfaction rates of GLU,CHO,TG,K+,Na+ and Cl- were97.6%,97.6%,100%,90.9%,72.7% and 84.8%,respectively.Conclusion Through this study,the detection ability defects of GLU,CHO,K+,Na+ and Cl- were discovered in several laboratories,and it can improve the quality of the laboratory.

参考文献/References:

[1] 党 珊,杨 飞,吕宏军,等.GIP受体抑制剂对诱导的糖尿病小鼠糖脂代谢的研究[J].现代检验医学杂志,2017,32(5):41-43,47. Dang S,Yang F,L(¨overu)HJ,et al.Study on glycolipid metablismof mice with diabetes induced by peptide receptor antagonist pro3(GIP)[J].JMod Lab Med,2017,32(5):41-43,47.
[2] 程俊杰,李 静,梁西强,等.高血压并发脑梗死患者不同血脂分层下病死率的分析研究[J].现代检验医学杂志,2017,32(3):97-100. Cheng JJ,Li J,Liang XQ,et al.Significance on cerebral infarction's fatality rate for the retrospective analysis of hypertension under serum lipids layer management[J].J Mod Lab Med,2017,32(3):97-100.
[3] 中华人民共和国国家质量监督检验检疫总局,中国国家标准化管理委员会.GB/T 28043-2011/ISO 13528:2003.利用实验室间比对进行能力验证的统计方法[S].北京:中国标准出版社,2011. General Administration of Ouality Supervision Inspection and Quarantine of the People's Republic of China,Standardization Administration of the People's Republic of China.GB/T 28043-2011/ISO 13528.Statistical methods for use in proficiencytesting by interlaboratory comparisons[S].Beijing:China Standsrd Press,2011.
[4] 中华人民共和国国家质量监督检验检疫总局,中国国家标准化管理委员会.GB/T 27043-2012/ISO/IEC 17043:2010.合格评定-能力验证的通用要求[S].北京:中国标准出版社,2011. General Administration of Ouality Supervision Inspection and Quarantine of the People's Republic of China,Standardization Administration of the People's Republic of China.GB/T 27043-2012/ISO/IEC 17043:2010.Conformity assessment-general requirements for proficiency testing[S].Beijing:China Standard Press,2011.
[5] 中国合格评定委员会.CNAS-CL03能力验证提供者认可准则[S].北京:中国标准出版社,2010. China National Accreditation Service for Conformity Assessment.CNAS-CL03 Accreditation criteria for proficiency testing providers[S].Beijing:China Standsrd Press,2010.
[6] 中国合格评定委员会.CNAS-GL03能力验证样品均匀性和稳定性评价指南[S].北京:中国标准出版社,2015. China National Accreditation Service for Conformity Assessment.CNAS-GL03 Guidance on evaluating the homogeneity and stability of samples used forproficiency testing[S].Beijing:China Standard Press,2015.
[7] CNAS-GL02能力验证结果的统计处理和能力评价指南[S].北京:中国标准出版社,2006. China National Accreditation Service for Conformity Assessment.CNAS-GL02 Guidance on statistic treatment of proficiency testing results and performance evaluation[S].Beijing:China Standard Press,2006.
[8] 程开书,孙建民,方 兰.血清肌酐两种测定方法偏倚的比较[J].检验医学与临床,2013,10(16):2092-2093,2095. Cheng KS,Sun JM,Fang L.Comparson the bias of two methods in detecting serum creatinine[J].Laboratory Medicine and Clinic,2013,10(16):2092-2093,2095.
[9] 向哲邑,吴佳丽,胡 敏.临床实验室的血脂检测与管理[J].中华检验医学杂志,2017,40(6):421-424. Xiang ZY,Wu JL,Hu M.Blood lipid frofiling and management in clinical laboratory[J].Chinese Journal of Laboratory Medicine,2017,40(6):421-424.

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备注/Memo

备注/Memo:
基金项目:国家“重大新药创新”科技重大专项(2018ZX09201017)。 作者简介:苗玉发(1980-),男,硕士,副主任药师,研究方向:药物安全性评价,E-mail:miaoyufa@nifdc.org.cn。 通讯作者:张河战,研究员,E-mail:zhanghz@nifdc.org.cn。
更新日期/Last Update: 2018-04-16