建立意大利法医血液酒精分析的国家决策规则:一个包含测量不确定性和实验室间性能的动态框架
Luca Zamengo1, Gianpaola Tedeschi1, Giampietro Frison1
1Laboratory of Clinical and Forensic Toxicology, DMPO Department, AULSS 3, Venice, Italy.
Forensic science international
|September 23, 2025
概括
报告血液中酒精度 (BAC) 的新框架整合了测量不确定性和实验室变化. 这通过标准化结果和通过分级分类提高实验室性能来确保更公平的法律决策.
科学领域:
- 法医科学 法医科学 法医科学
- 分析化学 分析化学
- 生物统计学 生物统计学
背景情况:
- 血液中酒精度 (BAC) 分析对于法律环境至关重要,但面临测量不确定性和实验室间变化的挑战.
- 由于实验室性能和方法的变化,BAC结果的现有决策规则缺乏一致性.
- 需要一个标准化,可靠的框架来报告BAC结果,在不同国家适应.
研究的目的:
- 引入BAC报告的动态框架,包括测量不确定性和实验室间变化.
- 在法律环境中为BAC结果制定标准化决策规则.
- 为应对实验室性能变化和方法不确定性所带来的挑战.
主要方法:
- 利用了自2017年以来涉及多达50家实验室的国家实验室间熟练程度计划的数据.
- 应用了可靠的统计方法来确定共识值和结合不确定性.
- 将实验室分为四个绩效级别 (Q1-Q4),根据防护带 (GB) 分布四分位数和不确定性值来设定标准化的决策限值.
主要成果:
- 在实验室之间观察到显著的性能差异,GB值的广泛变化导致了分散的决策边界.
- 拟议的框架将实验室分成四分之一组,减少碎片化和协调评估.
- 制定了标准化的决策限值,确保所有参与实验室的最大假阳性风险在5%以内.
结论:
- 开发的框架提高了BAC评估在法律环境中的可靠性,准确性和公平性.
- 它提供了一种科学严格的方法,用于统一报告法医实验室的结果.
- 通过有针对性的培训和定期重新校准,促进了持续改进,使实验室能够提升性能水平.
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