University of Groningen, Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
PRA Health Sciences, Bioanalytical Laboratory, Assen, The Netherlands.
Clin Chem Lab Med. 2020 Sep 25;58(10):1687-1695. doi: 10.1515/cclm-2019-1260.
Objectives Monitoring tacrolimus blood concentrations is important for preventing allograft rejection in transplant patients. Our hospital offers dried blood spot (DBS) sampling, giving patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail. In this study, both a volumetric absorptive microsampling (VAMS) device and DBS sampling were compared to venous whole blood (WB) sampling. Methods A total of 130 matched fingerprick VAMS, fingerprick DBS and venous WB samples were obtained from 107 different kidney transplant patients by trained phlebotomists for method comparison using Passing-Bablok regression. Bias was assessed using Bland-Altman. A multidisciplinary team pre-defined an acceptance limit requiring >80% of all matched samples within 15% of the mean of both samples. Sampling quality was evaluated for both VAMS and DBS samples. Results 32.3% of the VAMS samples and 6.2% of the DBS samples were of insufficient quality, leading to 88 matched samples fit for analysis. Passing-Bablok regression showed a significant difference between VAMS and WB, with a slope of 0.88 (95% CI 0.81-0.97) but not for DBS (slope 1.00; 95% CI 0.95-1.04). Both VAMS (after correction for the slope) and DBS showed no significant bias in Bland-Altman analysis. For VAMS and DBS, the acceptance limit was met for 83.0% and 96.6% of the samples, respectively. Conclusions VAMS sampling can replace WB sampling for tacrolimus trough concentration monitoring, but VAMS sampling is currently inferior to DBS sampling, both regarding sample quality and agreement with WB tacrolimus concentrations.
监测他克莫司血药浓度对于预防移植患者的移植物排斥反应非常重要。我院提供干血斑(DBS)采样,使患者有机会在家从指尖采集一滴血样,然后通过邮件将其送到实验室。在这项研究中,我们比较了容量吸收微采样(VAMS)装置和 DBS 采样与静脉全血(WB)采样。
通过训练有素的采血人员从 107 名不同的肾移植患者中采集了 130 对指尖 VAMS、指尖 DBS 和静脉 WB 样本,用于使用 Passing-Bablok 回归进行方法比较。采用 Bland-Altman 评估偏倚。一个多学科团队预先定义了一个接受标准,要求所有匹配样本中>80%的样本与两个样本平均值的 15%内一致。评估了 VAMS 和 DBS 样本的采样质量。
32.3%的 VAMS 样本和 6.2%的 DBS 样本质量不足,导致 88 个匹配样本适合分析。Passing-Bablok 回归显示 VAMS 和 WB 之间存在显著差异,斜率为 0.88(95%CI 0.81-0.97),但 DBS 无显著差异(斜率 1.00;95%CI 0.95-1.04)。VAMS(经斜率校正后)和 DBS 在 Bland-Altman 分析中均无显著偏倚。对于 VAMS 和 DBS,分别有 83.0%和 96.6%的样本符合接受标准。
VAMS 采样可替代 WB 采样用于他克莫司谷浓度监测,但 VAMS 采样在采样质量和与 WB 他克莫司浓度的一致性方面均劣于 DBS 采样。