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关于制定评估二级校准器认证参考材料可换性标准的建议

W Greg Miller1, Thomas Keller2, Jeffrey Budd3

  • 1Department of Pathology, Virginia Commonwealth University, Richmond, VA, United States.

Clinical chemistry
|August 11, 2023
PubMed
概括

建立可交换性评估的定量标准,确保认证的参考材料 (CRM) 是适合用于体外诊断医疗器械 (IVD-MDs) 的校准器. 这涉及定义相对于测量不确定性的最大允许的非可交换性偏差 (MANCB).

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