在外部质量评估/能力测试方案中使用的样本材料的设定标准和评估可交换性的建议
Sverre Sandberg1,2,3, Pernille Fauskanger1, Jesper V Johansen4
1Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.
Clinical chemistry
|September 19, 2023
概括
外部质量评估材料 (EQAMs) 必须与临床样本可交换,以便准确的体外诊断医疗器械 (IVD-MD) 评估. 本报告提供了评估EQAM交换性和IVD-MDs之间可接受的非选择性差异的方法.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 计量学 计量学 计量学
背景情况:
- 外部质量评估材料 (EQAM) 与临床样本的可交换性对于验证体外诊断医疗器械 (IVD-MD) 至关重要.
- EQAM必须模仿最终用户实验室设置中的临床样本行为,以确保可靠的性能评估.
- 评估通用性使得在不同的IVD-MD中评估计量可追溯性和结果等价性成为可能.
研究的目的:
- 为EQAMs制定可交换性标准提供建议.
- 定义比较IVD-MDs之间的非选择性的可接受差异.
- 概述执行通用性评估的程序.
主要方法:
- 该研究定义了基于从临床样本分布得出的预测间隔的可换性评估.
- 它强调了需要可接受的IVD-MDs之间的非选择性差异.
- 提供了建议,以使用可接受的非选择性差异来修改预测间隔标准.
主要成果:
- 该报告详细说明了如何确定可接受的EQAM交换性标准.
- 它为确定IVD-MDs之间可接受的非选择性差异提供了指导.
- 包含了用于切换性评估方法的实际应用的例子.
结论:
- 为了准确的IVD-MD性能评估,制定明确的EQAM可交换性和可接受的非选择性标准是必不可少的.
- 提出的方法促进了可靠的可换性评估,提高了外部质量评估方案的可靠性.
- 这项工作通过确保结果的可比性来支持IVD-MDs的开发和验证.
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