临床化学测量不确定性的评估及其与分析性能规格的比较
Nishtha Wadhwa1, Kiran Bhat1, Mansi Kalsi1
1Biochemistry, Himalayan Institute of Medical Sciences, Dehradun, IND.
Cureus
|March 18, 2025
概括
临床实验室必须根据分析性能规范 (APS) 评估测量不确定性 (MU). 这项研究发现,一些测量值超过了APS,突出了对患者安全和诊断准确性的潜在风险.
科学领域:
- 临床生物化学 临床生物化学
- 测量科学 测量科学 测量科学
- 实验室医学 实验室医学
背景情况:
- 准确的临床实验室结果取决于理解测量不确定性 (MU).
- 之前的研究显示了MU估计的变化及其与分析性能规范 (APS) 的调整.
- 在MU的差异可能会影响临床决策和患者安全.
研究的目的:
- 在临床生物化学实验室中确定31个测量项的MU.
- 将估计的MU值与已确定的APS进行比较.
- 评估实验室测量系统满足APS的能力.
主要方法:
- 使用"自上而下的"方法来估计MU,利用内部质量控制数据和校准器信息.
- 应用了公式u结果 =√(ucal 2 + uRw 2+ ubias 2) 的结果.
- 从文献中客观地获得的APS被用作允许的MU的基准.
主要成果:
- 在31个测量项中,有24个测量项的不确定性估计低于最低APS.
- 血清乳酸脱酶 (LD),肌酸激酶 (CK),性酸酶 (ALP),,化物,葡萄糖和铁素显示MU超过最低APS.
- 高校准不确定性 (ucal) 导致ALP,LD,CK和费里丁的MU升高. 血清化物和的严格APS没有达到.
结论:
- MU评估为测量系统质量提供了关键的见解.
- 如果未能满足某些测量标准的APS,可能会导致误诊,治疗错误和患者安全问题.
- 不遵守APS可能会阻碍ISO 15189认证,并增加实验室成本.
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