Prions and blood products.

The transmission of Creutzfeldt-Jakob disease (CJD) by human pituitary-derived growth hormone has led to concerns that blood products might also provide a route for the iatrogenic transmission of CJD. A number of actions have been implemented by regulatory authorities to address such concerns, and numerous studies have been undertaken to determine whether or not there is a risk of CJD being transmitted in this manner. To date, no excess risk has been identified, leading to a growing consensus that there is little or no risk of long established forms of CJD being transmitted to recipients of blood products. This opinion does not extend to new variant CJD (vCJD) which is found predominantly in the UK and is believed to have resulted from the transmission of bovine spongiform encephalopathy (BSE) to humans. Unlike that of CJD, the prevalence of vCJD is not known. In addition, the detection of abnormal prion protein in the tonsils of vCJD-infected individuals has led to speculation that blood infectivity may be greater than in patients with CJD. A number of precautionary measures have been taken to address the possibility that vCJD may be transmissible by blood products; however, further scientific advances are needed to enable this risk to be defined. A suitable screening test is required to identify any infected blood donors, particularly where cellular blood components are being derived from populations believed to be at risk from BSE infection. Recent experimental data suggest that process operations used in the manufacture of plasma products may be capable of removing prion agents to a significant extent. However, further work is required to confirm these observations and to determine whether or not all potential vCJD infectivity would be removed by these means.