The Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Clin Chem Lab Med. 2023 Jul 21;62(1):77-84. doi: 10.1515/cclm-2023-0532. Print 2024 Jan 26.
We report the results of glucose measurements performed during one year by the same measurement procedures (MPs) in 58 Norwegian hospital laboratories using control materials provided by external quality assessment (EQA) schemes from two different providers. The providers used materials with presumed vs. verified commutability and transfers of values using reference material vs. using a highest-order reference MP.
Data from six Labquality and three Noklus glucose EQA surveys were aggregated for each MP (Abbott Alinity, Abbott Architect, Roche Cobas, and Siemens Advia) in each scheme. For each EQA result, percent difference from target value (% bias) was calculated. Median percent bias for each MP per scheme was then calculated.
The median % biases observed for each MP in the Labquality scheme were significantly larger than those in the Noklus scheme, which uses verified commutable control materials and highest-order reference MP target values. The difference ranged from 1.2 (Roche Cobas, 2.9 vs. 1.7 %) to 4.4 percentage points (Siemens Advia, 3.2 % vs. -1.2 %). The order of bias size for the various MPs was different in the two schemes. In contrast to the Labquality scheme, the median % biases observed in the Noklus scheme for Abbott Alinity (-0.1 %), Abbott Architect (-0.5 %), and Siemens Advia (-1.2 %) were not significantly different from target value (p>0.756).
This study underlines the importance of using verified commutable EQA materials and target values traceable to reference MPs in EQA schemes designed for assessment of metrological traceability of laboratory results.
我们报告了在一年中由 58 个挪威医院实验室使用来自两个不同提供商的外部质量评估(EQA)计划提供的控制材料,通过相同的测量程序(MP)进行的葡萄糖测量结果。这些供应商使用了假定具有互换性的材料和通过参考材料进行的赋值转移,而不是使用最高阶参考 MP。
汇总了每个方案(Labquality 和 Noklus)中每个 MP(Abbott Alinity、Abbott Architect、Roche Cobas 和 Siemens Advia)的六个 Labquality 和三个 Noklus 葡萄糖 EQA 调查的数据。对于每个 EQA 结果,计算了与目标值的百分比差异(%偏差)。然后计算每个方案中每个 MP 的中位数%偏差。
在 Labquality 方案中,每个 MP 的中位数%偏差明显大于在 Noklus 方案中的%偏差,Noklus 方案使用经过验证的可互换控制材料和最高阶参考 MP 目标值。差异范围从 1.2(罗氏 Cobas,2.9%对 1.7%)到 4.4 个百分点(西门子 Advia,3.2%对-1.2%)。在两个方案中,各种 MPs 的偏差大小顺序不同。与 Labquality 方案相反,在 Noklus 方案中,Abbott Alinity(-0.1%)、Abbott Architect(-0.5%)和 Siemens Advia(-1.2%)的中位数%偏差与目标值没有显著差异(p>0.756)。
本研究强调了在设计用于评估实验室结果计量溯源性的 EQA 计划中,使用经过验证的可互换 EQA 材料和可追溯至参考 MPs 的目标值的重要性。