A sample stabilization system for HIV in Plasma and Whole Blood

血浆和全血中 HIV 样品稳定系统

• 批准号: 8410535
• 负责人: HAYNES W SHEPPARD
• 金额: $ 16.15万
• 依托单位: ACXEND
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8410535
• 关键词: Bacterial RNA; Biomedical Research; Blood; Blood specimen; Chemicals; Chemistry; Clinical; Collection; Complex; DNA; DNA Viruses; Dependence; Detection; Developing Countries; Development; Device Designs; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Drug Formulations; Enzymes; Fingers; Foundations; Gel; Goals; HIV; HIV Seropositivity; Healed; Laboratories; Life; Liquid substance; Membrane; Methods; Molecular; Molecular Diagnostic Techniques; Movement; Mucous body substance; Nucleic Acids; Patients; Performance; Plasma; Procedures; Process; RNA; RNA Viruses; Reagent; Recovery; Research; Research Methodology; Risk; Sampling; Shipping; Ships; Skin; Solid; Source; Spottings; Sputum; Structure; System; Temperature; Testing; Time; Transport Process; Urine; Viral; Water; Whole Blood; Work; absorption; aqueous; base; design; healing; improved; macromolecule; nuclease; nucleic acid purification; prototype; research study; sample collection; seal; tool; user-friendly; viral DNA; viral RNA; water solution

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.

描述(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。定量分子诊断方法在很大程度上依赖于在纯化前稳定采集样本的能力和 分析。虽然传统的侵入性抽血方法已经存在，但发达国家和不发达国家都希望和推动更少侵入性的样本采集和运输程序。例如，虽然使用侵入性较小的程序，如手指治疗棒是可取的，但收集、稳定、运输和处理样本的能力并未优化。这些现行程序在这些样品的稳定性(需要温度控制的运输或运输)以及促进可能的样品交叉污染的工作流程方面存在众所周知的问题。为了解决这一挑战，我们提出了一系列研究，以确定替代方法的可行性，该方法将保持简化的收集程序(与DBS样本一样)，但允许显著提高样本稳定性。该系统还简化了实验室的工作流程，不再需要用工具直接接触样品，从采集材料中取出样品，或者使用水重新悬浮稳定的样品。拟议的系统，如果在一系列分析物浓度范围内确定是可行的，可能代表着在诊断艾滋病毒阳性患者的能力方面向前迈出了一大步，提高了分析灵敏度。 公共卫生相关性：样本稳定性仍然是从全血和血浆来源准确检测和定量检测艾滋病毒的能力的关键组成部分。目前的提议旨在减少在诊断实验室收集、运输、储存和处理样本的费用和劳动密集型方式。能够将样本收集到在不受控制的环境条件下长期稳定的固体形式因素中，将能够更有力地提纯和检测艾滋病毒RNA和亲病毒DNA。该系统大大减少了用户步骤，可以降低样品与常用方法(如干血迹)的交叉污染风险，因为稳定的样品只需在纯化前用水溶解。