A NEW METHOD FOR THE ANALYSIS OF VITAMIN D

维生素 D 分析的新方法

• 批准号: 8781294
• 负责人: Fred E Regnier
• 金额: $ 48.99万
• 依托单位: NOVILYTIC, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8781294
• 关键词: Adsorption; Aliquot; Alkylation; Americas; Antibodies; Biological Assay; Biological Products; Blood; Blood Cells; Blood Tests; Blood capillaries; Blood specimen; Caliber; Carrier Proteins; Cell membrane; Cells; Charge; Clinical; Collection; Data; Development; Digestion; Dimensions; Drops; Drug Formulations; Energy-Generating Resources; Filtration; Fingers; Foundations; Healthcare; Heart; Human; Immune; Individual; Intervention; Laboratories; Mails; Marketing; Mass Spectrum Analysis; Membrane; Methods; Microfluidics; Monitor; Monoclonal Antibodies; Peptides; Pharmaceutical Preparations; Phase; Physicians; Plasma; Preparation; Process; Process Assessment; Production; Proteins; Proteomics; Reagent; Sales; Sampling; Serum; Shipping; Ships; Site; Spectrometry, Mass, Electrospray Ionization; Speed; Stream; Structure; System; Technology; Temperature; Testing; Text; Therapeutic Agents; Time; Trypsin; Validation; Venipunctures; Vitamin D; Vitamin D Analog; Work; Writing; base; blood fractionation; capillary; cost; ionization; new technology; operation; point of care; public health relevance; quality assurance; research clinical testing; therapeutic protein

DESCRIPTION (provided by applicant): Most clinical assays begin with blood collection in a laboratory setting. The Gates foundation and many others have recognized and attempted to deal with the fact that in much of the world clinical testing is done in a primitive setting. The luxury of having a phlebotomist to draw blood with a laboratory to prepare serum or plasma for analysis is not universal at many points-of-care, even in America. The most significant component of this proposal is that the world will obtain a plasma extraction technology that produces a small, reproducible aliquot of plasma without an energy source or human intervention. Moreover, 2.5 or 6 ¿L plasma samples collected in this manner can be transported dry on a collection disc to a central laboratory by courier or mail. The technology proposed to accomplish this is based on blood fractionation by frontal loading of a miniature assemblage of membranes where plasma is transported through multiple membrane layers by capillary action. Blood cells are removed via a combination of adsorption and filtration as plasma migrates to a 6.4 mm diameter collection disc at the bottom of the membrane stack during roughly three min. Stripping (delaminating) the upper, cell bearing membrane layers from the system exposes the plasma loaded collection disc which dries in roughly 10 min. These dried samples can be transported from almost anywhere in to world to a laboratory for analysis within 24 hr. This plasma extraction technology is being developed and validated as component of a mass spectrometry (MS) analysis of vitamin D analogues. As part of the vitamin D test proposed and developed in Phase I, a reagent was developed (SecoSET) that derivatizes vitamin D species with high selectivity. The function of SecoSET is to impart a permanent positive charge to vitamin D species that increases their ionization efficiency in electrospray ionization MS and concomitantly reduces their LOQ.

描述（由申请人提供）：大多数临床测定都是从实验室环境中的血液采集开始的。盖茨基金会和许多其他基金会已经认识到并试图解决这样一个事实：在世界许多地方，临床测试是在原始环境中进行的。在许多护理点，即使在美国，由抽血师在实验室抽血来制备血清或血浆进行分析的奢侈情况并不普遍。该提案最重要的组成部分是，世界将获得一种血浆提取技术，无需能源或人工干预即可产生少量、可重复的等分血浆。此外，以这种方式收集的 2.5 或 6 L 血浆样本可以通过快递或邮件将干燥的收集盘运输到中心实验室。 为实现这一目标而提出的技术是基于通过正面加载微型膜组合来进行血液分级，其中血浆通过毛细管作用穿过多个膜层。当血浆在大约三分钟内迁移到膜堆叠底部的直径 6.4 毫米的收集盘时，通过吸附和过滤的结合去除血细胞。从系统中剥离（分层）上部的细胞承载膜层，暴露出装载血浆的收集盘，该盘在大约 10 分钟内干燥。这些干燥的样品可以在 24 小时内从世界上几乎任何地方运输到实验室进行分析。 这种血浆提取技术正在开发和验证，作为维生素 D 类似物质谱 (MS) 分析的组成部分。作为第一阶段提出和开发的维生素 D 测试的一部分，开发了一种试剂 (SecoSET)，可以高选择性地衍生维生素 D 种类。 SecoSET 的功能是为维生素 D 物质赋予永久正电荷，从而提高其在电喷雾电离 MS 中的电离效率，同时降低其 LOQ。