Patent ID: 7045297

Claim:
An assaying method for detecting a prion disease in an animal or a human, the method comprising the steps of: (a) homogenizing a biological sample from an animal or a human suspected of containing a pathogenic prior protein with a buffer comprising: (i) at least one surfactant or emulsifier; (ii) at least one polysaccharide; (iii) casein; and (iv) albumin; (b) providing a test device comprising: (i) a digestive pad comprising immobilized proteinase-K; (ii) a membrane through which the homogenized sample of pathogenic prion protein migrates by capillary action, the membrane being in fluid communication with the proteinase-K support; and (iii) a pair of antibodies to the pathogenic prion protein, one of the antibodies being immobilized on the membrane, and the other of the antibodies being labeled for forming a complex with the pathogenic prion protein such that the complex migrates toward the immobilized antibody; (c) applying the homogenized biological sample to the test device wherein: (i) the proteinase-K removes interfering constituents, and (ii) the pathogenic prion protein in the sample binds with both antibodies to produce a response; and (d) interpreting the response to indicate the presence or concentration of the pathogenic prion protein in the sample.