A sample stabilization system for HIV in Plasma and Whole Blood

描述（由申请人提供）：核酸分析是许多生物医学研究和诊断方法的重要基础。定量分子诊断方法严重依赖于在纯化之前稳定收集的样品的能力， 分析.虽然存在用于侵入性抽血程序的常规方法，但是在发达国家和不发达国家中都存在对用于样本收集和运输的侵入性较小的程序的期望和运动。例如，虽然希望使用侵入性较小的程序，例如手指愈合棒，但收集、稳定、运输和处理样品的能力并未优化。这些当前程序在这些样品的稳定性方面存在众所周知的问题（需要温度控制的装运或运输）以及促进可能的样品交叉污染的工作流程。为了解决这一挑战，我们提出了一组研究，以确定一种替代方法的可行性，该方法将保持简化的采集程序（与DBS样本一样），但允许显着提高样本稳定性。该系统还简化了实验室的工作流程，无需直接接触样品与工具，以将其从收集材料中切除，或者使用水重新悬浮稳定的样品。所提出的系统，如果确定可行的范围内的分析物浓度，可能代表了一个显着的进步，在诊断患者的能力是HIV阳性，提高分析灵敏度。 公共卫生相关性：样品稳定化仍然是从全血和血浆来源准确检测和定量检测HIV的能力的关键组成部分。目前的建议旨在减少诊断实验室中收集、运输、储存和处理样本的费用和劳动密集型方式。将样品收集到在不受控制的环境条件下长时间稳定的固体形状因子中的能力将使得能够更稳健地纯化和检测HIV RNA和前病毒DNA。显著减少用户步骤的系统可以降低样品交叉污染的风险，超过常用的方法，例如干燥的血斑，因为稳定的样品仅需要在纯化之前用水溶剂化。

DESCRIPTION (provided by applicant): Nucleic acid analysis is the essential foundation of many biomedical research and diagnostic methods. Quantitative molecular diagnostic methods are critically dependent on the ability to stabilize the collected sample prior to purification and analysis. While conventional methods for invasive blood draw procedures exist, there is a desire and movement in both developed and un-developed countries for less invasive procedures for sample collection and transport. For example, while the use of less invasive procedures such as a finger heal stick are desirable, the ability to collect, stabilize, transport and process the samle is not optimized. These current procedures have well known issues with the stability of these samples (that require temperature controlled shipping or transport) as well as workflows that promote possible sample cross contamination. To solve this challenge, we have proposed a set of studies to determine the feasibility of an alternative approach that would maintain the streamlined collection procedure (as with DBS samples), but allows for significantly increased sample stabilization. The system also streamlines the workflow in the laboratory by eliminating the need to directly contact the sample with tools to excise them from the collection material, alternatively using water to re-suspend the stabilized sample. The proposed system, if determined feasible over a range of analyte concentrations, may represent a dramatic step forward in the ability to diagnose patients that are HIV positive with improved analytical sensitivity. PUBLIC HEALTH RELEVANCE: Sample stabilization remains a critical component to the ability to accurately detect and quantitative detect HIV from whole blood and plasma sources. The current proposal is aimed at the reduction of the expense and labor intensive manner in which samples are collected, transported, stored and processed in diagnostic laboratories. The ability to collect samples into a solid form factor that is stable in uncontrolled environmental conditions for long periods of time will enable more robust purification and detection of HIV RNA and pro-viral DNA. The system which significantly minimizes user steps may reduce the risk of sample cross contamination over methods commonly used such as dried blood spots as the stabilized samples are only required to be solvated with water prior to purification.