定期验证多个分析器之间的结果可比性:应用EP31-A-IR指南的经验
Leonor Guiñón1,2,3, Francisco J Illana2, Biel Cuevas3
1Quality Department, Laboratories, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Clinical chemistry and laboratory medicine
|October 11, 2023
概括
临床和实验室标准研究所 (CLSI) EP31-A-IR指南对于验证分析仪可比性是有用的. 调整标准和测量确保实验室资源的可行性.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 分析科学 分析科学
背景情况:
- 定期验证分析仪之间的结果可比性对于可靠的临床实验室诊断至关重要.
- 临床和实验室标准研究所 (CLSI) EP31-A-IR指南为此验证过程提供了一个框架.
研究的目的:
- 评估CLSI EP31-A-IR指南对于定期验证多个临床化学分析仪的结果可比性的有用性.
- 评估指南在确保诊断测试一致执行方面的有效性.
主要方法:
- 在不同的分析仪上分析了24个生物化学参数.
- 根据度/活性选择了患者样本,并使用质量规格确定了接受标准.
- 计算了最大允许差异 (MAD),并与分析器之间的测量差异进行了比较.
主要成果:
- 分析仪之间的差异没有超过任何24个评估参数的最大允许差异 (MAD).
- 根据EP31-A-IR指南,可以更轻松地评估结果的可比性.
结论:
- CLSI EP31-A-IR 指南是定期验证分析仪结果可比性的有用工具.
- 实际实施可能需要根据现有技术和实验室资源对接受标准进行调整.
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