A Method For Detecting Transmissible Spongiform Encephalopathies
Description of Invention:
This invention provides improved assays for the detection of transmissible spongiform encephalopathies (TSEs). TSEs are believed to be caused by prions, which are essentially infectious proteins and thus represent a new class of infectious agent. Examples of TSE diseases are scrapie in sheep, "mad cow disease" in bovines and Creutzfeldt-Jacob disease (CJD) in humans. The assays involve detecting the presence or absence of 14-3-3 proteins in cerebrospinal fluid from the tested organism. Elevated levels of 14-3-3 are indicative of TSE-related disease. The immunoassay formats described include Western blot and antigen capture tests.
Potential Area of Application:
Clinical immunoassays developed using this invention could be used to rule out CJD in dementia patients or to support a CJD diagnosis in patients with rapid dementia accompanied by myoclonus or ataxia. Veterinary immunoassays resulting from this invention might be used for ruling out "mad cow disease" in beef and dairy herds, as well as in slaughterhouses. Such tests would also be valuable in helping disease eradication programs to target for slaughter only those animals that test positive.
Main Advantage of Invention:
The invention describes the only known premortem test for TSEs in animals and humans. In addition, the test can be formatted as an ELISA antigen capture assay, making it simple to use in reference laboratories and field testing.
Stage of Development:
A Western blot version of the test has been developed and extensively tested in the laboratory. A prototype antigen capture ELISA has been developed.
Further Development Required:
Additional work required to develop a commercial antigen capture assay would involve preparation and selection of appropriate antibodies and detection format, assay optimization using appropriate infected and uninfected samples and regulatory approval.
Inventors:
Gary Hsich Kimbra Kenney Clarence Gibbs (NINDS) and Michael Harrington (Caltech)
Patent Status:
DHHS Reference No. E-055-1996/0
Relevant Publication:
Hsich, G. et al. (1996): The 14-3-3 Brain Protein in Cerebrospinal Fluid as a Marker for Transmissible Spongiform Encephalopathies, New Eng. J. Med. 335, 924-930
Licensing Status: This technology is no longer available for licensing.
For Additional Information Please Contact: Peter A. Soukas J.D.
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301) 435-4646
Email: soukasp@mail.nih.gov
Fax: (301) 402-0220
