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评估第二级校准器认证参考材料更换批次的可换性方面的建议

Liesbet Deprez¹, Jesper V Johansen², Thomas Keller³

¹European Commission, Joint Research Centre (JRC), Geel, Belgium.

Clinica chimica acta; international journal of clinical chemistry

|December 18, 2024

概括

确保可交换的二次认证参考材料 (CRM) 的可用性对于诊断测试至关重要. 本研究提供了一种方法来评估替换CRM批次的可交换性等价性,节省资源,同时保持结果的准确性.

科学领域:

临床化学临床化学
计量学计量学是一门学科.
在体外诊断在体外诊断.

背景情况:

可交换的二次认证参考材料 (CRM) 对于医学实验室体外诊断 (IVD) 测量程序的校准层次是必不可少的.
可持续的CRM可用性确保了临床样本结果的长期等价性.
目前评估CRM可交换性的建议可能需要生产商投入大量资源.

研究的目的:

为评估现有CRM及其替代批次之间的可换性等价性提供建议.
为了减少CRM生产商对可换性研究的资源需求.
确保二级CRM系统的持续适应性.

主要方法:

通过使用相关的测量程序,对替换CRM批次的测量结果与现有的可切换CRM批次进行评估.
评估两批测量结果之间的关系的等价性.
作为保护措施,纳入少量代表性临床样本.

主要成果:

如果测量结果的关系在替换和现有CRM批次之间是一致的,则替换批次的可交换性被认为是同等的.
这种等价性允许替代批次的声明为适合目的,利用现有批次的已被证明的可换性.
这种方法需要为CRM生产商提供先决条件和潜在的改进.

结论:

拟议的可交换性等价性评估提供了一种资源高效的方法,以维持二级CRM的供应.
成功实施将大大减少CRM生产商所需的资源.
使用防护措施确保了替换批次声明的可换性可靠性.

关键词:

经过认证的参考材料.可换性可换性是指可换性.计量学可追溯性计量学可追溯性替换批量替换批量替换批量

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