用于测定血清生物药物浓度的毛细血管微量采血：米特拉微量采样器与干血斑法的比较
Capillary blood microsampling to determine serum biopharmaceutical concentration: Mitra microsampler vs dried blood spot.
作者信息
Bloem Karien, Schaap Tiny, Boshuizen Ronald, Kneepkens Eva L, Wolbink Gerrit J, Vries Annick de, Rispens Theo
机构信息
Department of Immunopathology, Sanquin Research & Landsteiner Laboratory Academic Medical Centre, 1006 CX Amsterdam, The Netherlands.
Biologics Lab, Sanquin Diagnostic Services, 1006 CX Amsterdam, The Netherlands.
出版信息
Bioanalysis. 2018 Jun 1;10(11):815-823. doi: 10.4155/bio-2018-0010. Epub 2018 Jun 4.
AIM
For assessment of concentrations of biopharmaceuticals, for example, therapeutic drug monitoring, dried blood sampling of capillary blood is a convenient alternative to traditional venepuncture sampling. We investigated an alternative to dried blood spot collection on filter paper: sampling capillary blood using the Mitra microsampler.
MATERIALS AND METHODS
Therapeutic monoclonal antibodies were spiked in whole blood, sampled using filter paper and Mitra microsampler and concentrations measured using specific ELISAs.
RESULTS
Good recoveries of adalimumab, infliximab, ustekinumab, vedolizumab, tocilizumab, natalizumab and rituximab were found up to 1 month of storage at room temperature, averaging 95.2% for the Mitra microsampler and 92.9% for Whatman paper. Both hemoglobin and potassium yield satisfactory estimates for the volume of the cellular fraction of blood samples in combination with the Mitra microsampler.
CONCLUSION
We established practical protocols for the estimation of serum/plasma concentrations of therapeutic antibodies via capillary blood microsampling.
目的
为了评估生物制药的浓度，例如治疗药物监测，毛细血管血干血样采集是传统静脉穿刺采血的一种便捷替代方法。我们研究了一种替代在滤纸上采集干血斑的方法：使用Mitra微量采样器采集毛细血管血。
材料与方法
将治疗性单克隆抗体添加到全血中，分别使用滤纸和Mitra微量采样器进行采样，并使用特定的酶联免疫吸附测定法（ELISA）测量浓度。
结果
在室温下储存长达1个月时，阿达木单抗、英夫利昔单抗、乌司奴单抗、维多珠单抗、托珠单抗、那他珠单抗和利妥昔单抗的回收率良好，使用Mitra微量采样器的平均回收率为95.2%，使用沃特曼滤纸的平均回收率为92.9%。血红蛋白和钾与Mitra微量采样器结合使用时，对血样细胞部分的体积均能给出满意的估计值。
结论
我们建立了通过毛细血管血微量采样估算治疗性抗体血清/血浆浓度的实用方案。
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