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FDA Approves First Nucleic Acid Test for HIV in Donated Plasma and Tissue

The United Kingdom’s (UK) Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) is recommending that all red blood cells given as transfusions to children under the age of 13 years old should be filtered to remove the infection that causes variant Creutzfeldt-Jakob disease (vCJD), the human form of “mad cow disease” (bovine spongiform encephalopathy, BSE).  vCJD is characterized by misshapen prion proteins that form spongelike holes in the brain tissue, causing degenerative brain disease, which results in death.


The majority of vCJD cases in humans occurred during a UK outbreak in the 1990s, when people ate beef contaminated with BSE. There have been 167 confirmed cases of vCJD in the UK; all have died. There is currently no diagnostic test for vCJD; the disease can only be confirmed via a post-mortem brain matter analysis. The virus can lie dormant for years or decades before symptoms appear, making prevalence estimates difficult.


vCJD transmissions via blood transfusions is also a growing concern. There have been five confirmed cases in the UK. The patients contracted the virus through contaminated blood or blood products.


Although the proposal by the SaBTO, an independent committee that advises the UK Department of Health (DOH), has drawn criticism for not extending the protection to patients other than children, the DOH has not changed its position. “[We are] grateful for this advice from SaBTO and are currently considering this recommendation with National Health Service (NHS) Blood and Transplant,” said a DOH spokesman. To carry out the plan, the UK government would need to purchase and employ the P-Capt (Prion Capture) prion reduction filter system, manufactured and distributed by the French company MacoPharma.


“This filter has been extensively and independently tested for three years: it works, it's safe and it's available now. Its adoption makes sense: because everyone has a right to safe blood,” said Iwona Walicka, project manager at MacoPharma. “The highest transmission risk for vCJD [now] is contaminated blood/blood products and to date there have been five confirmed cases of such transmission in the UK. Treatment of red cell concentrate with the P-Capt filter is an affordable means of removing vCJD prion and the unit cost of filters will decline sharply when they are used to treat all blood donations.”


Consumers are also advocating for broad use of the prion filter system. “As a nurse I've seen every sort of death and vCJD is horrible. It's the worst death,” said Judy Kenny. “I understand the financial pressures in the NHS, but as a wife who saw my husband die from this terrible disease I would do anything to stop it happening again ... As I see it, anything that can stop this disease occurring would be money well spent.”


Source: The Guardian (online), November 26, 2009



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