看不见的桥梁:协调如何缩小不可能的标准化和临床必要性之间的差距
Kaiduo Xu1, Xuanchang Bai1, Yunmiao Sun2
1National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
标准化临床实验室试验提高了准确性,但在标准化不可能时,需要协调. 工作重点是改善全球多样化测试平台的可比性.
科学领域:
- 临床实验室科学 临床实验室科学
- 医学诊断 医学诊断 医学诊断
- 在医疗保健中的计量学.
背景情况:
- 临床实验室测试在医学中至关重要,但方法间结果的变化构成了重大挑战.
- 标准化和协调对于不同实验室方法和平台的可靠和可比的诊断结果至关重要.
研究的目的:
- 审查目前标准化和协调临床实验室试验结果的方法.
- 检查ISO 17511和ISO 21151在实现计量可追溯性和协调方面的作用.
- 讨论基础设施和国际组织 (如IFCC,JCTLM和ICCHLR) 的努力.
主要方法:
- 对国际标准 (ISO 17511,ISO 21151) 进行校准层次和协调协议的审查.
- 分析国际组织 (IFCC,JCTLM,ICCHLR) 开发的基础设施.
- 检查成功的应用程序和在方法间可比性方面的剩余挑战.
主要成果:
- 通过计量学可追溯性的标准化是理想的,但在没有参考材料/方法的情况下,协调是必要的.
- 国际合作改善了各种临床试验的方法间可比性.
- 仍然存在重大挑战,特别是在平台多样性较高的市场.
结论:
- 为了实现广泛的协调,需要开发可交换的参考材料,先进的校准算法和质量监测系统.
- 未来的努力必须集中在可扩展的解决方案上,以保持全球可比性,同时适应区域测试差异.
- 持续的国际合作对于推动临床实验室测试的标准化和协调至关重要.
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