分析性能规范在国际指导方针和标准中的作用,这些指导方针和标准涉及实验室医学中的计量可追溯性
1Department of Pathology, 6889 Virginia Commonwealth University , Richmond, VA, USA.
Clinical chemistry and laboratory medicine
|April 5, 2024
概括
确保准确的临床测量需要在体外诊断医疗器械 (IVD-MDs) 强大的计量可追溯性. 目前的方法往往低估了测量不确定性,这可能会影响患者的护理.
科学领域:
- 临床化学和诊断 临床化学和诊断
- 计量学和测量科学 计量学和测量科学
- 生物医学工程 生物医学工程
背景情况:
- 计量可追溯性旨在在不同临床样品 (CS) 的体外诊断医疗器械 (IVD-MD) 中获得一致的结果.
- 国际标准17511概述了IVD-MD中计量可追溯性的要求,涉及每个校准步骤的不确定性.
- 综合不确定性必须符合CS结果的分析性能规范 (APS),具有最大允许的不确定性 (umax).
研究的目的:
- 为了解决评估IVD-MD的计量可追溯性的挑战,特别是重复性不确定性 (uRw) 的估计.
- 突出目前从内部质量控制数据中估计Rw的方法不足.
- 强调需要准确的不确定性评估,以确保IVD-MD满足临床护理要求.
主要方法:
- 从内部质量控制数据中评估可重复性不确定性 (uRw) 的现有建议的审查.
- 在当前估计方法中分析时间区间的代表性.
- 讨论低估uRw对计量可追溯性评估的影响.
主要成果:
- 目前用于估计uRw的建议经常使用不够代表的时间间隔.
- 这导致Rw的低估,损害了测量不确定性的评估.
- 不准确的Rw可以导致未能满足最大允许不确定性 (umax) 标准.
结论:
- 准确估计可重复性不确定性 (uRw) 对于验证IVD-MDs的计量可追溯性至关重要.
- 需要改进的方法来捕捉所有变异源,以获得更具代表性的Rw估计.
- 确保准确的不确定性预算对于可靠的诊断测量和有效的临床护理至关重要.
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