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不同检测系统测定血糖结果的可比性分析 被引量:14

Comparability research on blood glucose results among different kinds of detection systems
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摘要 目的通过对不同检测系统进行方法对比分析,探讨各系统之间检测血糖(Glu)结果是否具有可比性。方法参照NCCLS《EP9A文件》的要求,以可溯源的检测系统为目标检测系统,采用电极法或干化学法或己糖激酶法或葡萄糖氧化酶法测定Glu,应用该院6个不同检测系统对朗道质控物(水平2和水平3)各测定20次和测定新鲜血浆标本48例。结果朗道质控物和新鲜血浆标本Glu测定经随机区组设计资料的方差分析,各检测系统间的总体差异有统计学意义(P<0.001)。各检测系统新鲜血浆标本Glu测定可靠性系数α为0.9993,各系统间的相关系数均大于0.975;各检测系统测定Glu的精密度变异系数均小于T±3.3%。以可溯源的检测系统1为目标检测系统,临床可接受性能评价除检测系统2和检测系统3外,其他系统均未超过T±5%范围。结论6个不同检测系统测定Glu结果存在不可比性,应对其实施整改措施,使结果具有可比性。 Objective To discuss the comparability of blood glucose(Glu)results with different detection systems. Methods Six different kinds of biochemistry detection systems were used to detect plasma Glu concentrations at 2 levels of Randox quality controls and 48 clinical plasma according to EPg-A file. The collected data were treated with statistical analysis. Results Analysis of variance showed Glu results from different control and patients plasma had significant difference between various detection systems (P〈0. 001). The correlation coefficiency of each detection system was above 0. 975 and their reliability coefficiency was 0. 999 3. The CV value of all detection systems did not excell T±3.3% by precise assessment, Target system 1 was regarded as standard detection system and evaluated the acceptability of other detection systems, As a result,all detection systems except detection system 2 and detection system 3 did not excel T±5% according to clinical assessment, Conclusion The precision of Glu results in the 6 kinds of detection systems accords with clinical requirement, However, incomparability exists in the evaluation of clinical acceptability.
出处 《国际检验医学杂志》 CAS 2006年第2期97-99,共3页 International Journal of Laboratory Medicine
基金 国家高技术研究发展计划(863计划)课题资助(2002AA2Z341B)
关键词 实验室技术和方法 血糖 比对研究 Labratory techniques and procedures Blood glucose Comparative study
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参考文献3

  • 1朱忠勇.实用医学检验学[M].北京:人民军医出版社,1997.243-353.
  • 2李影林.中华医学检验全书[M].北京:人民卫生出版社,1997.458-459.
  • 3Anonymous.Medicare,Medicaid and CLIA programs,regulations implementing the Clinical Laboratory Improvement Amendments of1988 (CLIA)--HCFA.Final rule with comment period.Fed Regist,1992,57(40):7002-7186.

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