对Atellica系统的精度和真实性验证研究
Alberto Vílchez Rodríguez1, Julia González Cantó1, Sara Esteve Poblador1
1Area of Biological Diagnosis, La Ribera University Hospital, Alzira, Spain.
Advances in laboratory medicine
|June 26, 2023
概括
这项研究验证了临床实验室分析仪的精度和真实性. 阿特利卡®解决方案系统符合制造商和实验室的不精确性规格,尽管可能需要进行校准调整.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 分析化学 分析化学
背景情况:
- 验证的程序对于临床实验室至关重要.
- 精度和真实性是验证新测量方法的关键指标.
- 评估诊断仪器的分析性能对于可靠的患者结果至关重要.
研究的目的:
- 为了验证不同实验室分析仪进行的生化和免疫化学分析的精度和真实性.
- 为了比较Advia 1800,Immulite 2000,CentaurXP和Atellica®Solution系统的性能,请参阅下面的图片.
- 确保测量程序符合已确定的实验室和制造商规格.
主要方法:
- 使用Advia 1800,Immulite 2000,CentaurXP和Atellica®Solution对十种分析物的生物化学和免疫化学表征.
- 使用BioRad®和西门子®控制材料在五天内 (运行内和运行间) 进行不精确性评估.
- 使用血清样本通过差异分析和线性回归评估偏差.
主要成果:
- 对于所有分析品,运行内和运行间的不精确值低于制造商声称的值.
- 在偏差评估过程中,对某些分析品检测到一个比例的,不恒定的系统错误.
- 阿特利卡®解决方案显示变化系数验证了制造商和实验室的不精确规格.
结论:
- 阿特利卡®解决方案系统成功验证了不精确的规格.
- 校准条件需要对特定参数进行修订以优化性能.
- 建议在未来的验证研究中使用更广泛的样本范围.
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