A Rapid Ultrasensitive Assay for Detecting Prions Based on the Seeded Polymerization of Recombinant Normal Prion Protein (rPrP-sen)
Description of Invention:
Prion diseases are neurodegenerative diseases of great public concern because humans may be infected from hoofed animals used as food, food products such as milk, or blood products. Currently available tests for disease-causing prions are either incapable of detecting low concentrations of prions and must be used post-mortem or are incapable of detecting low concentrations of prions economically or accurately. This technology enables rapid and economical detection of sub-lethal concentrations of prions by using recombinant, normal, prion protein (rPrP-sen) as a marker or indicator of infectious prions in a sample. Specifically, prions (contained in a sample) seed the polymerization of rPrP-sen, and polymerized rPrP-sen is detected as an amplified indicator of prions in the sample. This assay differs from the protein-misfolding cyclic amplification assay (PMCA) because it enables the effective use of rPrP-sen and does not require multiple amplification cycles unless a higher degree of sensitivity is required. It is anticipated that this technology can be combined with additional prion-detection technologies to further improve the sensitivity of the assay. In its current embodiment, this assay has been used to detect prions in brain tissue or cerebral spinal fluid (CSF) from humans (variant CJD), sheep (scrapie), and hamsters (scrapie).
Advantages:
Uses a consistent, concentrated source of normal prion protein (rPrP-sen)
Prions are detectable to low levels after a single amplification round
May be combined with complimentary detection technologies to improve sensitivity
Demonstrated to be effective at detecting prions from different species
May be applicable to blood products
Economical
Applications:
A test for live animals or food products
A human diagnostic for early detection of prion diseases
Monitor for effectiveness of treatments or disease progression
R Atarashi et al. Simplified ultrasensitive prion detection by recombinant PrP conversion with shaking. Nat Methods 2008 Mar;5(3):211-212. [PubMed abs]
R Atarashi et al. Ultrasensitive detection of scrapie prion protein using seeded conversion of recombinant prion protein. Nat Methods 2007 Aug;4(8):645-650. [PubMed abs]
Licensing Status: Available for exclusive and non-exclusive licensing.
Collaborative Research Opportunity:
The NIAID Laboratory of Persistent Viral Diseases, TSE/Prion Biochemistry Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Rosemary Walsh at 301-451-3528 or rcwalsh@niaid.nih.gov.
