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首页> 外文期刊>Journal of Pharmacological and Toxicological Methods >Evaluation of dry blood spot technique for quantification of an Anti-CD20 monoclonal antibody drug in human blood samples
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Evaluation of dry blood spot technique for quantification of an Anti-CD20 monoclonal antibody drug in human blood samples

机译：人血样中抗CD20单克隆抗体药物定量的干血斑技术评价

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Introduction: To evaluate the dried blood spot (DBS) technique in ELISA quantification of larger biomolecular drugs, an anti-CD20 monoclonal antibody drug was used as an example. A method for the quantification of the anti-CD20 drug in human DBS was developed and validated. Methods: The drug standard and quality control samples prepared in fresh human blood were spotted on DBS cards and then extracted. A luminescent ELISA was used for quantification of the drug from DBS samples. Results: The assay range of the anti-CD20 drug standards in DBS was 100-2500. ng/mL. The intra-assay precision (%CV) ranged from 0.4% to 10.1%, and the accuracy (%Recovery) ranged from 77.9% to 113.9%. The inter assay precision (%CV) ranged from 5.9% to 17.4%, and the accuracy ranged from 81.5% to 110.5%. The DBS samples diluted 500 and 50-fold yielded recovery of 88.7% and 90.7%, respectively. The preparation of DBS in higher and lower hematocrit (53% and 35%) conditions did not affect the recovery of the drug. Furthermore, the storage stability of the anti-CD20 drug on DBS cards was tested at various conditions. It was found that the anti-CD20 drug was stable for one week in DBS stored at room temperature. However, it was determined that the stability was compro]mised in DBS stored at high humidity, high temperature (55°C), and exposed to direct daylight for a week, as well as for samples stored at room temperature and high humidity conditions for a month. Stability did not change significantly in samples that underwent 3 freeze/thaw cycles. Discussion: Our results demonstrated a successful use of DBS technique in ELISA quantification of an anti-CD20 monoclonal antibody drug in human blood. The stability data provides information regarding sample storage and shipping for future clinical studies. It is, therefore, concluded that the DBS technique is applicable in the quantification of other large biomolecule drugs or biomarkers.
机译：简介：为了评估较大生物分子药物的ELISA定量中的干血斑（DBS）技术，用抗CD20单克隆抗体药物作为示例。开发并验证了用于定量人体DBS中抗CD20药物的方法。方法：在新鲜人体血液中制备的药物标准和质量控制样品在DBS卡上发现，然后提取。发光ELISA用于量化来自DBS样品的药物。结果：DBS中抗CD20药物标准的测定范围为100-2500。 ng / ml。测定内精度（％CV）的范围为0.4％至10.1％，精度（恢复）的准确性范围为77.9％至113.9％。测定型精度（％CV）的范围为5.9％至17.4％，准确度为81.5％至110.5％。 DBS样品稀释500和50倍，分别恢复为88.7％和90.7％。在较高和下血细胞比容（53％和35％）条件下的DBS的制备不影响药物的回收率。此外，在各种条件下测试抗CD20药物上的抗CD20药物的储存稳定性。发现抗CD20药物在室温下储存的DBS稳定一周。然而，确定在高湿度，高温（55℃）下储存的DBS中的稳定性是COLO]，并暴露于一周的直接日光，以及用于在室温和高湿度条件下储存的样品一个月。在冻结/解冻循环的样品中，稳定性在显着变化。讨论：我们的结果表明，在人类血液中的抗CD20单克隆抗体药物的ELISA定量中成功地使用DBS技术。稳定性数据提供有关样品存储和运输的信息，以备将来临床研究。因此，结论是DBS技术适用于其他大型生物分子或生物标志物的定量。

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