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即时检验中的质量控制问题。

Quality control issues in point of care testing.

作者信息

Martin Cameron L

机构信息

Pathology Queensland, Clinical and State Wide Services, Royal Brisbane & Women's Hospital, Herston, Qld 4006, Australia.

出版信息

Clin Biochem Rev. 2008 Aug;29 Suppl 1(Suppl 1):S79-82.

Abstract
  • Quality Control (QC) in Point of Care Testing (PoCT) is often thought of as a complex issue; however intelligent system analysis can simplify matters and greatly increase the chances of a well controlled system. What we want to achieve is a QC program which adequately controls the PoCT system, but does not excessively contribute to the operating costs or complexity of maintaining a PoCT instrument, or network of instruments. * Don't neglect effective pre-analytical work: good documentation, operator training, monitoring, and analyser maintenance programs are essential, as for any analyser. * Look closely at your analyser: Is it a "laboratory type" instrument or cartridge or strip based? Can it perform multiple test types or a single test only? How is it calibrated? Does it have built in self-check capabilities or an electronic check cartridge? Is the sample in contact with the instrument? What are the cartridge/strip/reagent storage requirements? * Establish where the analysis is taking place and which system component is involved. * Tailor your QC program to target this component, but still check the system as a whole. * A common approach is to check cartridges/strips on delivery and run a QA sample at least monthly to check storage conditions and operator performance. If there is no independent electronic instrument check, daily QC checks are also recommended. * Don't be afraid to stray beyond conventional QC models if necessary. Some PoCT systems are not adequately controlled by the application of conventional QC alone.
摘要
  • 即时检验(PoCT)中的质量控制(QC)通常被认为是一个复杂的问题;然而,智能系统分析可以简化问题,并大大增加系统得到良好控制的机会。我们想要实现的是一个能充分控制PoCT系统的质量控制程序,但又不会过度增加维护PoCT仪器或仪器网络的运营成本或复杂性。

  • 不要忽视有效的分析前工作:良好的文档记录、操作人员培训、监测以及分析仪维护程序对于任何分析仪来说都是必不可少的。

  • 仔细查看你的分析仪:它是“实验室型”仪器,还是基于试剂盒或试纸条的?它能进行多种测试类型,还是只能进行单一测试?它是如何校准的?它有内置的自检功能还是电子检测试剂盒?样本与仪器是否接触?试剂盒/试纸条/试剂的储存要求是什么?

  • 确定分析在何处进行以及涉及哪些系统组件。

  • 根据这个组件调整你的质量控制程序,但仍要对整个系统进行检查。

  • 一种常见的方法是在试剂盒/试纸条到货时进行检查,并至少每月运行一次质量保证样本,以检查储存条件和操作人员的表现。如果没有独立的电子仪器检查,也建议进行每日质量控制检查。

  • 如有必要,不要害怕偏离传统的质量控制模式。有些PoCT系统仅应用传统质量控制无法得到充分控制。

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