A sample stabilization system for HIV in Plasma and Whole Blood

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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.