Manual Blood Sciences, Health Services Laboratories, The Halo Building, 1 Mabledon Place, London, WC1H 9AX, UK.
Laboratory Biochemistry and Molecular Biology, Inborn Errors of Metabolism Unit, Hospices Civils de Lyon, Centre de Biologie Est, 69500, Bron, France.
Urolithiasis. 2020 Dec;48(6):473-480. doi: 10.1007/s00240-020-01197-4. Epub 2020 May 29.
Measurement of oxalate in the blood is essential for monitoring primary hyperoxaluria patients with progressive renal impairment and on dialysis prior to transplantation. As no external quality assurance scheme is available for this analyte, we conducted a sample exchange scheme between six laboratories specifically involved with the investigation of primary hyperoxaluria to compare results. The methodologies compared were gas chromatography/mass spectrometry (GCMS), ion chromatography with mass spectrometry (ICMS), and enzymatic methods using oxalate oxidase and spectrophotometry. Although individual laboratories performed well in terms of reproducibility and linearity, there was poor agreement (absolute values) between centres as illustrated by a longer-term comparison of patient results from two of the participating laboratories. This situation was only partly related to differences in calibration and mainly reflected the lower recoveries seen with the ultrafiltration of samples. These findings lead us to conclude that longitudinal monitoring of primary hyperoxaluria patients with deteriorating kidney function should be performed by a single consistent laboratory and the methodology used should always be defined. In addition, plasma oxalate concentrations reported in registry studies and those associated with the risk of systemic oxalosis in published studies need to be interpreted in light of the methodology used. A reference method and external quality assurance scheme for plasma oxalate analysis would be beneficial.
血液草酸盐的测量对于监测原发性高草酸尿症患者的进展性肾功能损害以及移植前透析非常重要。由于没有针对该分析物的外部质量保证计划,我们在专门从事原发性高草酸尿症研究的六个实验室之间进行了样本交换计划,以比较结果。比较的方法有气相色谱/质谱法(GCMS)、离子色谱-质谱法(ICMS)和使用草酸氧化酶的酶法以及分光光度法。尽管各个实验室在重复性和线性方面表现良好,但中心之间的一致性(绝对值)较差,这可以通过来自两个参与实验室的患者结果的长期比较来说明。这种情况部分与校准差异有关,主要反映了样品超滤时观察到的较低回收率。这些发现使我们得出结论,对于肾功能恶化的原发性高草酸尿症患者的纵向监测,应由单个一致的实验室进行,并且应始终定义所用的方法。此外,在注册研究中报告的血浆草酸盐浓度以及在已发表的研究中与系统性草酸中毒风险相关的浓度,需要根据所用的方法进行解释。建立血浆草酸盐分析的参考方法和外部质量保证计划将是有益的。