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实验室自动化的下一波创新浪潮:自动验证、质量控制和标本质量保证系统。

The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance.

机构信息

Abbott Digital Health Solutions, Macquarie Park, Sydney, NSW, Australia.

Royal College of Pathologists of Australasia Quality Assurance Programs, Sydney, QLD, Australia.

出版信息

Clin Chem Lab Med. 2022 Oct 24;61(1):37-43. doi: 10.1515/cclm-2022-0409. Print 2023 Jan 27.

DOI:10.1515/cclm-2022-0409
PMID:36282956
Abstract

Laboratory automation in clinical laboratories has made enormous differences in patient outcomes, with a wide range of tests now available that are accurate and have a rapid turnaround. Total laboratory automation (TLA) has mechanised tube handling, sample preparation and storage in general chemistry, immunoassay, haematology, and microbiology and removed most of the tedious tasks involved in those processes. However, there are still many tasks that must be performed by humans who monitor the automation lines. We are seeing an increase in the complexity of the automated laboratory through further platform consolidation and expansion of the reach of molecular genetics into the core laboratory space. This will likely require rapid implementation of enhanced real time quality control measures and these solutions will generate a significantly greater number of failure flags. To capitalise on the benefits that an improved quality control process can deliver, it will be important to ensure that an automation process is implemented simultaneously with enhanced, real time quality control measures and auto-verification of patient samples in middleware. Therefore, it appears that the best solution may be to automate those critical decisions that still require human intervention and therefore include quality control as an integral part of total laboratory automation.

摘要

临床实验室的实验室自动化在患者的治疗效果方面产生了巨大的影响,现在有广泛的准确且周转时间短的测试。全实验室自动化(TLA)已经使一般化学、免疫测定、血液学和微生物学中的管处理、样本制备和储存实现了机械化,并消除了这些过程中涉及的许多繁琐任务。然而,仍然有许多任务必须由监控自动化线的人来完成。我们通过进一步的平台整合以及将分子遗传学扩展到核心实验室空间,看到自动化实验室的复杂性在增加。这可能需要快速实施增强的实时质量控制措施,而这些解决方案将产生大量更多的故障标志。为了充分利用改进的质量控制过程所能带来的好处,重要的是要确保自动化过程与增强的实时质量控制措施同时实施,并在中间件中对患者样本进行自动验证。因此,最好的解决方案似乎是将仍然需要人工干预的关键决策自动化,并将质量控制作为全实验室自动化的一个组成部分。

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