2011-2021年来自瑞典六个县的NT-proBNP患者中位数
Morgan Lundgren1, Peter Ridefelt1, Maria K Eriksson2,3
1Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden.
概括
对于N-终端B型亲尿素 (NT-proBNP) 测试的患者中位数反映了在质量评估中发现的制造商差异. 这些患者数据为监测测定性能和确保诊断准确性提供了有价值的工具.
科学领域:
- 临床化学 临床化学
- 生物标记分析 生物标记分析
- 在诊断领域的质量保证.
背景情况:
- 在心力衰竭的诊断和管理中,N-终端亲B型性尿素 (NT-proBNP) 是至关重要的.
- 外部质量评估 (EQA) 方案突出了NT-proBNP制造商之间显著的方法差异.
- 患者结果中位数可能作为分析性能和方法可比性的指标.
研究的目的:
- 调查EQA数据中观察到的制造商之间的差异是否也在患者的中位数值中明显.
- 评估患者中位数作为NT-proBNP测试方法的质量指标的有用性.
主要方法:
- 分析了2011年至2021年间瑞典6个县的成年患者100多万个NT-proBNP结果.
- 结果按制造商方法,地理地区和临床因素分组,包括估计的淋巴细胞过率 (eGFR) 和糖尿病状况.
- 计算中位数值并与共识值进行比较.
主要成果:
- 罗氏测试在2017年之前主导着市场;其他制造商随后进入市场,导致结果更加多样化.
- 罗氏和西门子的中位数结果通常与EQA的调查结果一致,而阿伯特的结果显示出差异.
- 在2019-2021年期间,制造商的业绩不同于共识:罗氏 (+2%),西门子 (+16%),奥托 (-8%) 和阿博特 (-11%).
- 增加的NT-proBNP测试量与中位数下降相关,可能是由于指南更新.
- 降低EGFR或糖尿病患者的NT-proBNP中位数高出2-3倍,验证了整体中位数计算.
结论:
- 患者中位数在很大程度上证实了NT-proBNP测试的制造商间的差异,与EQA数据一致,而Abbott则是显著的例外.
- 在功能受损或糖尿病患者中观察到的较高中位数支持患者中位数数据的临床相关性.
- 患者中位数代表了临床上有意义的质量指标,补充了NT-proBNP测定监测的内部和外部质量控制.
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