A NEW METHOD FOR THE ANALYSIS OF VITAMIN D

描述（由申请方提供）：大多数临床试验开始时，在实验室环境中采集血液。盖茨基金会和许多其他机构已经认识到并试图解决这样一个事实，即在世界上许多地方，临床试验都是在原始环境中进行的。在许多护理点，即使在美国，也没有普遍的抽血师在实验室抽血以制备血清或血浆进行分析。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，该技术可以在没有能源或人为干预的情况下产生少量可重复的血浆。此外，以这种方式收集的2.5或6 μ L血浆样品可以通过快递或邮件在收集盘上干燥地运输到中心实验室。 为实现这一点而提出的技术是基于通过膜的微型组合的正面加载的血液分馏，其中血浆通过毛细作用被输送通过多个膜层。当血浆在大约三分钟内迁移到膜堆底部的6.4 mm直径收集盘时，通过吸附和过滤的组合去除血细胞。（分层）鞋面，来自系统的细胞承载膜层暴露血浆装载收集盘，其在大约10分钟内干燥。这些干燥的样品可以从世界上几乎任何地方运输到实验室这种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（MS）分析的组成部分。作为第一阶段提出和开发的维生素D检测的一部分，开发了一种试剂（SecoSET），可高选择性地衍生维生素D物质。SecoSET的功能是赋予维生素D物质永久的正电荷，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。

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.