临床实验室中补充功能测试的挑战:从测试验证到临床解释
Vijayalakshmi Nandakumar1, Karin M P Braun2, Maria Alice V Willrich2
1Exsera BioLabs, Division of Rheumatology, University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America.
Journal of immunological methods
|January 25, 2025
概括
补充功能测定对于诊断免疫疾病至关重要,但由于蛋白质不稳定性而面临挑战. 为了准确的实验室评估和个性化治疗,需要标准化.
科学领域:
- 临床免疫学 临床免疫学
- 实验室医学 实验室医学
- 补充系统生物学
背景情况:
- 补充功能测定对于诊断各种疾病至关重要,包括免疫缺陷,自身免疫性疾病和血栓性微血管病变.
- 这些测定评估补充路径和组件,有助于诊断和疾病监测.
- 补充剂抑制剂的使用越来越多,需要对治疗疗效进行可靠的实验室评估.
研究的目的:
- 讨论当前补充功能分析的挑战和局限性.
- 突出临床实验室标准化和改进实践的需要.
- 通过准确的补充评估来满足个性化治疗计划的需求.
主要方法:
- 审查当前的补充功能测试方法.
- 讨论预分析和分析方面的挑战.
- 对实验室开发的测试 (LDT) 的监管状态和验证要求的分析.
主要成果:
- 补充蛋白质是不稳定的,需要严格的处理协议 (快速处理,冷离心,-80°C的储存).
- 只有一个FDA批准的补充功能测试存在;其他是LDT,需要严格的验证.
- 实验室之间的协调受到不同的方法和校准器的阻碍.
结论:
- 补充功能测试是必不可少的,但在技术上要求很高.
- 标准化和改进的实验室实践对于可靠的补充测试至关重要.
- 需要进一步开发和验证测试,以支持个性化医疗和补充抑制剂治疗.
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