血液溶解指数. 血解指数. 我们是否可以不顾一切地相信制造商的声明?
Alen Vrtaric1,2, Marijana Miler1,2, Nora Nikolac Gabaj1,2,3
1Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia.
Clinical chemistry and laboratory medicine
|October 23, 2025
概括
制造商的血液溶解干扰数据不一致,往往缺乏关键细节. 临床实验室必须独立验证这些值,以确保准确的患者结果并保持质量标准.
科学领域:
- 临床生物化学 临床生物化学
- 预分析变量 预分析变量
- 实验室医学 实验室医学
背景情况:
- 血液溶解是临床生物化学中常见的预分析干扰,影响高达3.3%的样本,导致~60%的样本被排斥.
- 这种干扰是由于红细胞膜损伤导致的血红蛋白和等细胞内成分的释放引起的.
- 当前来自体外诊断 (IVD) 分析仪的血液溶解指数 (HI) 值可能与临床需求或生物可变性不一致.
研究的目的:
- 评估主要IVD制造商提供的血液溶解干扰数据的一致性和完整性.
- 将制造商数据与临床和实验室标准研究所 (CLSI) C56-A指南进行比较.
- 为了确定血液溶解干扰报告和验证标准中的差异.
主要方法:
- 一项描述性研究分析了来自五家制造商 (Abbott,Beckman Coulter,BioSystems,Roche,Siemens) 的72种临床化学分析物的血液溶解干扰数据.
- 检查了制造商的包装插件,并与CLSI C56-A指南进行了比较.
- 数据点包括报告的分析剂水平,干扰标准和偏差值.
主要成果:
- 制造商对CLSI指南的遵守程度有很大差异;西门子的遵守程度高于其他制造商.
- 对于测试的参数,BioSystems没有提供分析物的度.
- 对干扰标准的不一致报告,任意偏差门 (例如,10%) 和缺失的偏差数据在制造商中很常见,只有阿博特和西门子提供了详细的偏差信息.
结论:
- 制造商关于血液溶解干扰的说明经常不完整和不一致.
- 临床实验室必须独立验证血解值,以确保准确性和可靠性.
- 结合制造商数据,研究和本地验证的协调方法对于提高实验室质量和监管合规性至关重要.
相关概念视频
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