Turn off MathJax
Article Contents
CUI Hongen, ZHANG Chao, Zhao Li, SI Qiyi. Formulation of Calibration Specification for Dry Biochemistry Analyzers[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2021.0559
Citation: CUI Hongen, ZHANG Chao, Zhao Li, SI Qiyi. Formulation of Calibration Specification for Dry Biochemistry Analyzers[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2021.0559

Formulation of Calibration Specification for Dry Biochemistry Analyzers

doi: 10.12338/j.issn.2096-9015.2021.0559
  • Available Online: 2022-03-16
  • The accuracy of the dry biochemistry analyzer has a direct impact on the clinical diagnosis results. In view of the lack of its calibration specifications, the calibration specifications are formulated. Through the analysis of the technical principles and calibration methods of the dry biochemistry analyzers, the main measurement characteristics and specific calibration methods were determined, and a representative dry biochemistry analyzer model was selected for experimental verification. According to the calibration method, the verification result of the dry biochemistry analyzer meets the requirements of the determined measurement characteristics. The "Calibration Specification of Dry Biochemistry Analyzers" was successfully formulated, which promoted the standardization and standardization of the traceability of the dry biochemistry analyzers.
  • loading
  • [1]
    黄昊, 陈卫彬. 普通湿式生化分析仪与干式生化分析仪的比较分析[J]. 中国医学装备, 2005(12): 35-36. doi: 10.3969/j.issn.1672-8270.2005.12.015
    [2]
    谭为, 周卫东. 标本溶血对干化学生化分析仪测定结果的影响[J]. 实验与检验医学, 2010, 28(2): 180-180. doi: 10.3969/j.issn.1674-1129.2010.02.033
    [3]
    刘丹. 干式生化分析方法的建立及其方法学评价[D]. 长春: 长春理工大学, 2014.
    [4]
    Greyson J. Problems and possibilities of chemistry on dry reagent carriers[J]. Journal of Automated Methods & Management in Chemistry, 1981, 3(2): 66-71.
    [5]
    杨树德. 当代临床检验中的固相化学[J]. 国际检验医学杂志, 1995, 16(3): 98-102.
    [6]
    黄旭峰. 浅谈全自动生化分析仪的实验参数设置及调试[J]. 中国医药指南, 2013(5): 692-694.
    [7]
    张宜文, 李韬, 甄啸啸, 等. 快速C-反应蛋白分析仪性能评价方法研究[J]. 计量技术, 2019, 543(11): 24-26.
    [8]
    宋彩侨. 固态离子选择性电极检测血清钾离子[D]. 大连: 大连理工大学, 2020.
    [9]
    Beastall G H, Brouwer N, Quiroga S, et al. Traceability in laboratory medicine: a global driver for accurate results for patient care[J]. Clinical Chemistry & Laboratory Medicine, 2017, 55(8): 1100-1108.
    [10]
    周伟燕, 刘庆香, 刘珍妮, 等. 计量溯源性和临床检验参考系统[J]. 临床检验杂志, 2020, 38(10): 7-14.
    [11]
    中国合格评定国家认可委员会. 医学实验室质量和能力认可准则的应用要求: CNAS-CL02-A0012021 [S]. 北京: 中国合格评定国家认可委员会, 2021.
    [12]
    ISO. Medical laboratories-Particular requirements for quality and competence: ISO 15189: 2012[S]. Geneva, Switzerland: ISO, 2012.
    [13]
    王建平, 张梅香, 王笔金, 等. SP-4430干式生化分析仪部分急诊项目测定结果分析[J]. 检验医学与临床, 2009, 6(1): 26-27. doi: 10.3969/j.issn.1672-9455.2009.01.014
    [14]
    国家食品药品监督管理局. 干式化学分析仪: YY/T 0655-2008[S]. 北京: 中国标准出版社, 2008.
    [15]
    徐阳, 傅燕翔, 马玉容, 等. 干式生化分析仪的校准方法[J]. 中国计量, 2014(11): 80-81.
    [16]
    赵迎晨, 毛森, 刘斌杰, 等. 全自动生化分析仪校准方法的探讨[J]. 计量技术, 2016(11): 45-47.
    [17]
    崔宏恩, 姚绍卫, 封志明, 等. 电解质分析仪检定过程中的基质效应变化规律研究[J]. 计量学报, 2018, 39(1): 130-134. doi: 10.3969/j.issn.1000-1158.2018.01.27
    [18]
    刘波, 王蕾, 王国平, 等. 丙氨酸氨基转移酶在干、湿化学检测系统测定结果中的比对和偏倚评估[J]. 国际检验医学杂志, 2011, 32(20): 2387-2388. doi: 10.3969/j.issn.1673-4130.2011.20.041
    [19]
    国家质量监督检验检疫总局. 测量不确定度评定与表示: JJF 1059.1-2012 [S]. 北京: 中国质检出版社, 2012.
    [20]
    国家质量监督检验检疫总局. 测量仪器特性评定: JJF 1094-2002 [S]. 北京: 中国计量出版社, 2002.
    [21]
    国家质量监督检验检疫总局. 半自动生化分析仪检定规程: JJG 464-2011 [S]. 北京: 中国质检出版社, 2011.
    [22]
    国家市场监督管理总局. 全自动生化分析仪校准规范: JJF 1720-2018 [S]. 北京: 中国质检出版社, 2018.
    [23]
    Regist F. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)-HCFA. Final rule with comment period[J]. Federal Register, 2019, 84(23): 1536-1567.
    [24]
    杨宗兵, 王瑞霞, 张国军, 等. 丙氨酸氨基转移酶催化活性浓度参考测量中磷酸吡哆醛对测量结果的影响[J]. 检验医学与临床, 2017, 14(Z1): 24-27.
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Tables(5)

    Article Metrics

    Article views (73) PDF downloads(7) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return