期刊文献+

血清碱性磷酸酶测定结果的溯源性研究 被引量:2

Research on the Traceability of the Serum Alkaline Phosphatase Determination Results
下载PDF
导出
摘要 一项血清酶测定结果的可溯源性研究发现,碱性磷酸酶(ALP)在多种生化分析仪上的测定结果与校正物的定值相差悬殊,并且不同来源的ALP试剂盒的测定结果间也存在高低不一的系统误差。本文分析了系统误差的产生原因,从理论和实验两个方面排除了生化分析仪的原因,指出影响ALP测定结果的关键因素是缓冲液的种类,并以此为例说明在进行血清酶活性测定结果的溯源、校正和室间比对时,必须考虑构成检测系统的各个要素,包括试剂盒的性能质量和生化分析仪的参数设置。 A examination to the traceability of alkaline phosphatase(ALP) activity discovered that laboratory ALP activity measurement results existed big differences from the fixed value of enzyme reference material, and higher or lower system errors existed between ALP kits from different sources. This review analyzed the reason of these system errors, indicated that the key influencing factor was buffer system type in ALP assay. Taking ALP as an example, it indicated that traceability, calibration and external laboratory quality assessment of serum enzymes activity measurement must consider the every conditions of analysis system, including performance quality of reagent kit and parameter settings of analyzer.
作者 王卫兵
机构地区 首都医科大学
出处 《中国医疗设备》 2015年第12期49-52,共4页 China Medical Devices
关键词 碱性磷酸酶 生化分析仪 酶活性测定 结果溯源 室间质评 alkaline phosphatase biochemical analyzer determination of the enzyme activity result traceability room quality assessment
  • 相关文献

参考文献10

  • 1王清涛,童清,郭健.血清酶测定结果可溯源性研究[J].中华检验医学杂志,2003,26(12):761-763. 被引量:23
  • 2徐国宾,吴南,王清涛.要重视血清酶学测定的标准化工作[J].临床检验杂志,2007,25(3):161-164. 被引量:25
  • 3Schumann G,Bonora R, Ceriotti F, et al.IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C.International Federation of Clinical Chemistry and Laboratory Medicine.Part 6.Reference procedure for the measurement of catalytic concentration of gamma- glutamyltransferase[J].Clin Chem Lab Med,2002,40(7):734-738.
  • 4Recommendations of the German Society for Clinical Chemistry. Standardisation of methods for the estimation of enzyme activities in biological fluids.Experimental basis for the optimized standard conditions[J].Z Klin Chem Klin Biochem, 1972,10(6):281-291.
  • 5孟泽.CSMLS的碱性磷酸酶(ALP)催化活性浓度测定的推荐方法(讨论稿)[J].临床检验信息导报,1997,4(1):15-19. 被引量:3
  • 6Calibrators in Clinical Engymology (Prepared with purified human originated enzymes) Human Enzymes (For use as ERMS,Calibrators and control serums)[EB/OL].[2007-05-09] [2015-04-08].http://asahi kasei.co.jp/shindan/eng/j product 1/index. html,.
  • 7Tietz NW, Rinker AD,Shaw LM,et a/.IFCC methods for the measurement of catalytic concentration of enzymes Part 5.1FCC method for alkaline phosphatase(orthophosphoric-monoester phosphohydrolase,alkaline optimum, EC 3.1.3.1)[J].J Clin Chem Clin Biochem, 1983,21:731-748.
  • 8张秀明,庄俊华,徐宁,黄宪章,陈茶,尹一兵,梁伟雄.不同检测系统血清酶测定结果的偏倚评估与可比性研究[J].中华检验医学杂志,2006,29(4):346-349. 被引量:137
  • 9F6rard G,Edward J,Kanno T, et a/.Validation of an enzyme calibrator-an IFCC guideline.International Federation of Clinical Chemistry[J].Clin Biochem, 1998,31(6):495-500,.
  • 10张志强.血细胞分析仪校准系数变化分析[J].中国医疗设备,2014,29(5):61-63. 被引量:8

二级参考文献31

  • 1陈文祥.临床检验量值溯源与参考系统[J].中华检验医学杂志,2006,29(1):17-19. 被引量:41
  • 2.中华人民共和国国家标准.检测和校准实验室能力的通用要求[M].北京:中国标准出版社,2001.1-18.
  • 3International Organization for Standardization.General Requirements for the Competence of Testing and Calibration Laboratories.ISO/IEC 17025,International Organization for Standardization,Geneva,1999.
  • 4The National Committee for Clinical Laboratory Standards.Method Comparison and Bias Estimation Using Patient Samples.Approved Guideline,Second Edition,EP9-A2,2002.
  • 5Siekmann L,Bonora R,Burtis CA,et al.IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C.International Federation of Clinical Chemistry and Laboratory Medicine.Part 7.Certification of four reference materials for the determination of enzymatic activity of gamma-glutamyltransferase,lactate dehydrogenase,alanine aminotransferase and creatine kinase accord.Clin Chem Lab Med,2002,40:739-745.
  • 6Theodore Peters,Jr.Making headway in enzyme standardization[J].Clin Chem,1988,34(2):225-226.
  • 7Shaw L M,Stromme J H,London J L,et al.IFCC methods for the measurement of catalytic concentrations of enzymes.Part 4.IFCC method for γ-glutamyltransferase[J].Clin Chem Clin Biochem,1983,21 (10):633-46.
  • 8Schumann G,Bonora R,Ceriotti F,et al.IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C.Part 6.Reference procedure for the measurement of catalytic concentration of gamma-glutamyltransferase[J].Clin Chem Lab Med,2002,40(7):734-738.
  • 9Tietz N W,Rinker A D,Shaw L M.IFCC methods for the measurement of catalytic concentrations of enzymes.Part 5.IFCC method for alkaline phosphatase[J].Clin Chim Acta,1983,135 (4):339 -367 F.
  • 10Bergmeyer H U,Horder M,Rej R.Approved recommendation on IFCC methods for the measurements of catalytic concentrations of enzymes.Part 2.IFCC method for aspartate aminotransferase[J].Clin Chem Clin Biochem,1986,24(7):497-510.

共引文献183

同被引文献4

引证文献2

二级引证文献5

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部