QUANTUM DOTS AND MAGNETIC NANOPARTICLES FOR ANTE-MORTEM DIAGNOSIS OF PRION INFECT -
DESCRIPTION (provided by applicant): NIH Phase I Quantum dots and Magnetic nano-particles for Ante-mortem Diagnostics of m Prion Infection Ocean Nano Tech proposes to develop a portable, rapid, sensitive, high throughput, inexpensive, and easy to use system for the ante-mortem diagnosis of prion infection using high emission intensity quantum dots and magnetic nanoparticles in a disposable lab-on-a-chip (dLOAC) format. The proposed system consists of a fully automated equipment consisting of a miniaturized fluorimeter that uses dLOAC and miniaturized pumps for automated delivery of reagents. The dLOAC is configured for ante-mortem diagnosis of 1 x 10-15 molar (possibly 1 x 10-18molar) concentrations of PrPSc in a rapid assay d 60 min, high throughput allowing > 50 samples/h per instrument, high sensitivity with > 95% reliability (eliminating false positives and false negatives), and minimizing the hazard of handling infected biological fluids. This system will diagnose prion infection before the appearance of clinical symptoms and is anticipated to replace post mortem diagnostic methods that are useful only in the advanced stage of the disease that is always fatal. The proposed system will lead to products used for: 1) diagnosis of PrPSc levels in asymptomatic cows (and for humans with additional development), 2) monitor PrPSc levels in donated blood (with additional development on the dLOAC and using the same instrument), 3) monitor PrPSc levels in beef and cow parts at slaughter houses to eliminate contaminated meat and meat products from entering the market, 4) monitor PrPSc levels in industrial products that use cow-derived raw materials, 5) monitor drug and vaccine development, and 6) monitor the efficacy of drugs, vaccine, and therapeutic agents during medication. In addition, the products are also usable for post-mortem diagnosis. These products have enormous commercial and societal impact. Ante-mortem diagnosis in beef that brings >$ 9 billion income will protect beef industry in the US. With additional development, the instruments and dLOAC will have use in stationary or mobile clinics or hospitals as diagnostic tool for early detection, ante- and post-mortem detection of prion disease in humans. PUBLIC HEALTH RELEVANCE: The products resulting from this project for ante-mortem detection of prion infection have various urgent commercial applications with enormous societal impact. Its applications include the >$10 billion beef industry in the US and worldwide, monitoring of donated blood amounting to 12-14 million units of whole blood collected annually in the US and 80 million units worldwide, and detection of prions in tissues for transplant, for grafting, and for use as raw materials for various food, cosmetic, and medical products because of the fatal nature of the infection. The products can also be used to monitor drug and vaccine development and to monitor the efficacy of drugs, vaccine, or other therapeutic agents during medication.