根据CLSI C37-A准备的参考材料是否可以在不进行交换性评估的情况下使用? 基于脂质测量的前景
Jong Do Seo1, Gye Cheol Kwon2, Jeong-Ho Kim3
1Department of Laboratory Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
Annals of laboratory medicine
|September 3, 2025
概括
根据CLSI C37-A指导方针编制的参考材料 (RMs) 通常可以用于总胆固醇和甘油三. 然而,RM中高甘油水平可能会影响HDL-C和LDL-C测量的可变性.
科学领域:
- 临床化学
- 实验室医学
- 参考资料
背景情况:
- 参考材料的可交换性对于测量可追溯性和标准化实验室测试至关重要.
- 对RM可换性进行评估并不一致.
- 本研究使用已确定的方案评估了脂质测量的RM可换性.
研究的目的:
- 根据CLSI C37-A指南编制的RM是否可以在没有明确的可换性评估的情况下使用.
- 评估四个主要脂质测量的RM可换性.
- 调查甘油三度对RM可变性的影响.
主要方法:
- 在11个RM和20个单个血清中分析了总胆固醇 (TC),甘油三 (TGs),HDL- C和LDL- C.
- 使用了六种常规测量程序 (MP) 和CLSI EP14协议.
- 使用IFCC协议来评估MP之间的偏差以及TG度对可换性的影响.
主要成果:
- 对于TC和TG,RM显示了大多数MP对的交换性.
- 对于HDL- C和LDL- C的可交换性在RM之间有所不同,更高的TG水平 (RM10,RM11) 显示了可交换性的减少.
- 在TG度较高的RM中观察到偏差百分比增加.
结论:
- 根据CLSI C37-A准则编制的RM显示了TC和TG的良好交换性.
- 在RM中提升的TG水平会对HDL- C和LDL- C的可换性产生负面影响.
- 考虑TG度和交换性评估对于RM标准化至关重要.
相关概念视频
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
300
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
300
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
259
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
259