TSEs, also called prion diseases, are fatal neurodegenerative diseases that include vCJD, the human form of bovine spongiform encephalopathy (BSE), or "mad cow disease." The presentation, part of the Advisory Committee's discussion on labeling claims for TSE clearance studies for blood component filters, is a continuation of Pall Corporation's dialogue with U.S. regulatory and health authorities on protecting the blood supply from prions that can cause vCJD.
Studies Validating Filter Performance
Dr. Coker presented research results on the ability of the filter to remove all types of prions from red cells including scrapie (a TSE affecting sheep); mouse infected with human variant CJD (mvCJD) and human sporadic CJD (sCJD). Sporadic CJD is the most common form of CJD affecting people.
He provided results of bioassays to provide a quantitative method to determine log removal of infectious prion in hamsters. (Hamsters are rec
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