Result Laboratorium, Amphia, Breda, The Netherlands.
SKML, Nijmegen, The Netherlands.
Clin Chem Lab Med. 2023 Jul 4;61(12):2167-2177. doi: 10.1515/cclm-2023-0463. Print 2023 Nov 27.
Measurement of plasma albumin is pivotal for clinical decision-making in patients with chronic kidney disease (CKD). Routinely used methods as bromocresol green (BCG) and bromocresol purple (BCP) can suffer from aselectivity, but the impact of aselectivity on the accuracy of plasma albumin results of CKD-patients is still unknown. Therefore, we evaluated the performance of BCG-, BCP- and JCTLM-endorsed immunological methods in patients with various stages of CKD.
We evaluated the performance of commonly used albumin methods in patients with CKD stages G1 through G5, the latter divided in two groups based on whether they received hemodialysis treatment. In total, 163 patient plasma samples were measured at 14 laboratories, on six different BCG and BCP-platforms, and four different immunological platforms. The results were compared with an ERM-DA-470k-corrected nephelometric assay. The implications on outcome is evaluated by the proportion of patient results <38 g/L for the diagnosis of protein energy wasting.
Albumin results determined with BCP- and immunological methods showed the best agreement with the target value (92.7 and 86.2 %, respectively vs. 66.7 % for BCG, namely due to overestimation). The relative agreement of each method with the target value was platform-dependent, with larger variability in agreement between platforms noted for BCG and immunological methods (3.2-4.6 and 2.6-5.3 %) as opposed to BCP (0.7-1.5 %). The stage of CKD had similar effects on the variability in agreement for the three method-groups (0.6-1.8 % vs. 0.7-1.5 % vs. 0.4-1.6 %). The differences between methods cause discrepancies in clinical decision-making, as structurally fewer patients were diagnosed with protein energy wasting upon using BCG-based albumin results.
Our study shows that BCP is fit for the intended use to measure plasma albumin levels in CKD patients from all stages, including patients on hemodialysis. In contrast, most BCG-based platforms falsely overestimate the plasma albumin concentration.
在慢性肾脏病(CKD)患者的临床决策中,血浆白蛋白的测量至关重要。常规使用的溴甲酚绿(BCG)和溴甲酚紫(BCP)方法可能存在选择性问题,但选择性对 CKD 患者血浆白蛋白结果准确性的影响尚不清楚。因此,我们评估了各种 CKD 阶段患者中常用的 BCG、BCP 和 JCTLM 认可的免疫方法的性能。
我们评估了 G1 至 G5 期 CKD 患者中常用白蛋白方法的性能,后者根据是否接受血液透析治疗分为两组。共有 163 名患者的血浆样本在 14 个实验室中使用六种不同的 BCG 和 BCP 平台和四种不同的免疫平台进行测量。结果与 ERM-DA-470k 校正的散射比浊法进行比较。通过诊断蛋白质能量消耗的患者结果<38g/L 的比例来评估对结果的影响。
BCP 和免疫方法测定的白蛋白结果与靶值的一致性最好(分别为 92.7%和 86.2%,而 BCG 为 66.7%,即存在高估)。每种方法与靶值的相对一致性取决于平台,BCG 和免疫方法之间的平台一致性变化较大(3.2-4.6%和 2.6-5.3%),而 BCP 则较小(0.7-1.5%)。CKD 阶段对三种方法组的一致性变化具有相似的影响(0.6-1.8%比 0.7-1.5%比 0.4-1.6%)。方法之间的差异导致临床决策的差异,因为使用基于 BCG 的白蛋白结果,结构上较少的患者被诊断为蛋白质能量消耗。
我们的研究表明,BCP 适合用于测量所有阶段的 CKD 患者,包括血液透析患者的血浆白蛋白水平。相比之下,大多数基于 BCG 的平台会错误地高估血浆白蛋白浓度。