血斑干燥时间对6种免疫抑制剂回收率的影响

R. Koster, Rixt Botma, B. Greijdanus, D. Uges, J. Kosterink, J. Alffenaar, D. Touw
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引用次数: 13

摘要

DBS取样的主要优点之一是患者可以在家中取样,并将DBS样本邮寄到实验室[1-4]。这种采样被认为是对患者友好的,因为它侵入性较小,节省了患者的运输成本和时间。DBS采样也具有较低的生物危害风险,并且比静脉采样所需的血量更少[2,4]。实体器官移植受者需要终生使用免疫抑制药物,如他克莫司(TaC)、西罗莫司(SiR)、依维莫司(EvE)和环孢素a (CyA),以防止同种异体移植排斥反应。这些药物的生物分析和治疗药物监测是必要的,因为疗效和毒性与血药浓度和/或药代动力学参数有关。因此,这些患者可以从免疫抑制剂DBS分析中获益。自从将干血斑(DBS)分析用于治疗药物监测(TDM)以来,为了提高分析结果的质量,已经提出了更广泛的验证程序。红细胞压积值、斑点体积和DBS稳定性的变化是方法验证过程中应该研究的参数[1,5]。一个可能未被重视的可变性来源可能是干燥的血斑样本的干燥时间。DBS卡片上的血液采集后应在常温下干燥。欧洲生物分析论坛(EBF)已经提出,所需的干燥时间可能会受到红细胞压积(HT)的影响,这可能会影响检测的稳稳性和可重复性[5]。因此,建议将这些参数作为验证的一部分进行研究[5]。虽然DBS在3小时后可能会出现干燥,但DBS中物质的提取回收率,应用生物分析杂志,2015年10月,第116-122页。http://dx.doi.org/10.17145/jab.15.019 (ISSN 2405-710X)第一卷,第4期
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The influence of the dried blood spot drying time on the recoveries of six immunosuppressants
One of the main advantages of DBS sampling is that it allows the patient to sample at home and send the DBS sample to the laboratory by mail [1-4]. This sampling is considered to be patient friendly because it is less invasive and saves patients transportation costs and time. DBS sampling also has a lower biohazard risk and requires a smaller amount of blood than venous sampling [2,4]. Solid organ transplant recipients are required to use a lifetime of immunosuppressant medications like tacrolimus (TaC), sirolimus (SiR), everolimus (EvE) and cyclosporin A (CyA) to prevent allograft rejection. Bioanalysis and Therapeutic Drug Monitoring of these drugs are necessary because efficacy and toxicity is associated with blood concentrations and/or pharmacokinetic parameters. Therefore, these patients could greatly benefit from immunosuppressant DBS analysis. Since the use of dried blood spot (DBS) analysis for therapeutic drug monitoring (TDM), more extensive validation procedures have been proposed in order to improve the quality of the analysis results. Variations of the hematocrit value, spot volume and DBS stability are among the parameters that should be investigated during method validation [1,5]. A perhaps unappreciated source of variability may be the drying time of a dried blood spot sample. After collection of the blood on the DBS card it should be dried dried at ambient temperature. It is already suggested by the European Bioanalysis Forum (EBF) that the required drying time may be influenced by the hematocrit (HT) and that this may affect the robustness and reproducibility of the assay [5]. Consequently it is recommended to investigate these parameters as part of the validation [5]. Although the DBS may appear dry after 3 hours, the extraction recoveries of the substances within the DBS JOURNAL OF APPLIED BIOANALYSIS, October 2015, p. 116-122. http://dx.doi.org/10.17145/jab.15.019 (ISSN 2405-710X) Vol. 1, No. 4
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