A NEW METHOD FOR THE ANALYSIS OF VITAMIN D

维生素 D 分析的新方法

• 批准号: 8934122
• 负责人: Fred E Regnier
• 金额: $ 48.04万
• 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 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8934122
• 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; Health; Healthcare; Heart; Human; Immune; Individual; Intervention; Laboratories; 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; 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（由适用提供）：大多数临床阿萨斯始于实验室环境中的血液收集。盖茨基金会（Gates Foundation）和许多其他基金会已经认识并试图处理这样一个事实，即在世界上的许多地方，临床测试都是在原始环境中进行的。拥有静脉血化的人用实验室抽血来准备血清或血浆进行分析的奢侈品在许多护理点也不是普遍的，即使在美国也是如此。该提案的最重要组成部分是，世界将获得一种血浆提取技术，该技术在没有能源或人类干预的情况下产生小血浆等分试样。此外，以这种方式收集的2.5或6 l等离子体样品可以通过快递或邮件将收集光盘干燥到中央实验室。提出实现此目的的技术是基于血液分馏，是通过膜的微型组合的额叶负载来基于膜的额叶负载，在该组合中，血浆通过毛细管作用通过多个​​膜层运输。随着血浆在大约三分钟内迁移到膜堆栈底部的6.4 mm收集盘时，血细胞通过添加吸收和过滤的组合去除。从系统中剥离（分式）上部的细胞轴承膜层，暴露了血浆载荷的收集盘，该圆盘大约在10分钟内饮用。这些干样品可以在24小时内从几乎任何地方传输到世界的任何地方，以进行分析。该血浆提取技术正在开发和验证，作为维生素D类似物的质谱分析的组成部分。作为在I期提出和开发的维生素D检验的一部分，开发了一种试剂（SECOSET），该试剂以高选择性衍生了维生素D物种。 SECOSET的功能是向维生素D物种赋予永久性阳性电荷，从而提高其在电喷雾电离MS中的电离效率并同时降低其LOQ。