Protein products isolated from human plasma are an important class of therapeutics that are
used to treat patients afflicted with hereditary deficiencies, trauma, and severe infections …

Background The variant C reutzfeldt‐J akob disease incidence peaked a decade ago and
has since declined. Based on epidemiologic evidence, the causative agent, pathogenic …

Infectious prion diseases have very long incubation periods, and the role that subclinical
infections play in transmission, persistence and re-emergence of these diseases is unclear …

Protein products prepared from pooled human plasma are an essential class of therapeutics
used mostly to control bleeding and/or immunological disorders. Because of the human …

Concerns over the potential for infectious prion proteins to contaminate human biologics and
biotherapeutics have been raised from time to time. Transmission of the pathogenic form of …

BACKGROUND: Experimental evidence from rodent models indicates that blood can
contain transmissible spongiform encephalopathy (TSE) infectivity, which suggests a …

BACKGROUND: Therapeutic proteins derived from human plasma and other biologic
sources have demonstrated an excellent safety record relative to the potential threat of …

Background and Objectives The outbreak of vCJD in the UK leads to concern regarding the
potential for human‐to‐human transmission of this agent. Plasma‐derived products such as …

Blood products prepared from human blood theoretically risk contamination with infectious
pathogens. Since recent reports now confirm the likely transmission of pathogenic prions …

Determining the risk of transmissible spongiform encephalopathy (TSE) transmission by
blood or plasma-derived products requires sensitive and specific assays for the detection of …