Development and Validation of Assay Protocols for use with Dried Blood Spot Samples
Development and Validation of Assay Protocols for use with Dried Blood Spot Samples
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DOI：
10.1002/ajhb.22463
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发表时间：
2014-01-01
影响因子：
2.9
通讯作者：
McDade, Thomas W.
中科院分区：
文献类型：
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作者：
McDade, Thomas W.
从指尖采血采集的毛细血管全血的干血斑 (DBS) 滴代表了静脉穿刺的一种微创替代方案，有助于在自然、基于现场的研究环境中从研究参与者那里采集血液样本。但与血清或血浆相比，用于量化 DBS 样本中生物标志物的经过验证的检测数量相对较少。本综述的目的是讨论 DBS 采样的优点和缺点，并概述开发和验证应用于 DBS 样品的免疫测定法所涉及的步骤。这些步骤包括决定试剂、准备校准和质量控制材料、评估洗脱方案、优化样品数量以及评估测定性能的多个方面，包括测定内和测定间变异、检测下限、准确性、稳定性以及匹配的 DBS 和血浆样品结果之间的一致性。该方法的更广泛目标是鼓励研究人员验证、实施和传播 DBS 样本的检测方案，以推进人类生物学的实地研究。是。 J.哼。生物。 26:1-9, 2014 年。(c) 2013 年 Wiley 期刊公司。
Dried blood spots (DBS)drops of capillary whole blood collected from finger stickrepresent a minimally invasive alternative to venipuncture that facilitates the collection of blood samples from research participants in naturalistic, field-based research settings. But the number of validated assays for quantifying biomarkers in DBS samples is relatively low in comparison with serum or plasma. The objective of this review is to discuss the advantages and disadvantages of DBS sampling, and to outline the steps involved in developing and validating an immunoassay for application to DBS samples. These steps include deciding on reagents, preparing calibration and quality control material, evaluating elution protocols, optimizing sample quantity, and assessing multiple aspects of assay performance, including intra- and interassay variation, lower limit of detection, accuracy, stability, and agreement between results from matched DBS and plasma samples. The broader goal of this how-to approach is to encourage investigators to validate, implement, and disseminate assay protocols for DBS samples in order to advance field-based research on human biology. Am. J. Hum. Biol. 26:1-9, 2014. (c) 2013 Wiley Periodicals, Inc.