The European Commission has set criteria to be used in the assessment of assays (that is, tests) to detect the abnormal prion protein associated

with variant Creutzfeldt-Jakob disease (vCJD), for the purposes of blood screening, diagnosis and confirmation. These are set out in the amendment made on 20 December 2011 to Directive 98/79/EC on in vitro diagnostic medical devices (the directive).

The directive sets out common technical specifications (CTS) for the analytical and diagnostic sensitivity and specificity of vCJD assays for blood screening, covering the material and the number of specimens to be tested, and performance levels to be achieved for acceptance of the assay.

The addition to the directive relating to vCJD assays, including the CTS, is published at:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:341:0063:0064:EN:PDF

The requirements of the directive are implemented in United Kingdom law by the In Vitro Diagnostic Medical Devices Regulations 2002, as amended.

Decontamination research remains a priority for the Department.

A total of £3,245,211 has been committed to funding research into decontamination of variant Creutzfeldt Jakob disease (vCJD) contaminated surfaces from 2011 to 2016. Methods of decontamination of surgical instruments, improved systems of detection of protein contamination on surgical instruments and optimisation of the function of washer disinfectors are areas that the Department currently funds. The results of these studies, which are applicable beyond vCJD, will feed into Department guidance on surgical instrument and endoscope decontamination for national health service staff and Service Commissioning groups.

In addition to surgical instruments that may be exposed to neural tissues, a high risk tissue, endoscopes may also meet lymphoid tissue infected with vCJD. Defining the level of damage and potential level of contamination and exploring novel means of sterilising the lumen of the endoscope are currently under way.

There are several tests in development for the detection of variant Creutzfeldt-Jakob disease (vCJD) in blood or plasma. The tests are in varying stages of development and the Department supports this process through funding a research group at the National Institute for Biological Standards and Control to provide independent evaluation of the parameters of the test and supplying valuable and rare test materials.

The Department supports research into test development. The research to take prototype tests to commercial endpoint for use in any large-scale screening of the population is, however, seen as the role of commercial partners and industry.

The Department sponsors both National Health Service Blood and Transplant (NHSBT), which manages the blood service in England and north Wales, and the National CJD Research and Surveillance Unit, which is collaborating with both NHSBT and the Scottish National Blood Transfusion Service with its test development. The Department has also provided funding to the MRC Prion Unit, which has helped to support the unit's core test development work, which is funded by the Medical Research Council (MRC).

On making the March 2012 decision on the importation of fresh frozen plasma, the independent scientific Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) considered all the available evidence including safety, efficacy and cost-effectiveness. SaBTO concluded that there should be no extension of the importation of fresh frozen plasma (FFP) to patients beyond those for whom it is already recommended (high-usage adult patients, and those aged 16 and under (i.e. born since 1996), who are unlikely to have been exposed to BSE through diet). SaBTO's terms of reference require consideration of cost-effectiveness evidence when making recommendations. A key consideration is the number of potential future clinical vCJD cases that might be caused by transfusion of FFP in the absence of any extension to importation. Given the continuing scientific uncertainties, a precautionary approach remains justified, and a wide range of scenarios have been considered. Nevertheless, the continuing absence to date of any known clinical cases attributable to FFP transfusion restricts the range of future possibilities, and the cost-effectiveness calculations used by SaBTO reflect this point.

Information used by SaBTO in making their recommendation is publicly available, redacted in accordance with freedom of information principles, at:

www.transparency.dh.gov.uk/2012/04/24/sabto-9-march-2012/

A copy has also been placed in the Library.

Details that could provide commercial information are not included for reasons of commercial confidentiality.

On making the March 2012 decision on the importation of fresh frozen plasma, the independent scientific Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) considered all the available evidence including safety, efficacy and cost-effectiveness. SaBTO concluded that there should be no extension of the importation of fresh frozen plasma (FFP) to patients beyond those for whom it is already recommended (high-usage adult patients, and those aged 16 and under (i.e. born since 1996), who are unlikely to have been exposed to BSE through diet). SaBTO's terms of reference require consideration of cost-effectiveness evidence when making recommendations. A key consideration is the number of potential future clinical vCJD cases that might be caused by transfusion of FFP in the absence of any extension to importation. Given the continuing scientific uncertainties, a precautionary approach remains justified, and a wide range of scenarios have been considered. Nevertheless, the continuing absence to date of any known clinical cases attributable to FFP transfusion restricts the range of future possibilities, and the cost-effectiveness calculations used by SaBTO reflect this point.

Information used by SaBTO in making their recommendation is publicly available, redacted in accordance with freedom of information principles, at:

www.transparency.dh.gov.uk/2012/04/24/sabto-9-march-2012/

A copy has also been placed in the Library.

Details that could provide commercial information are not included for reasons of commercial confidentiality.

The one in 4,000 figure relates to the potential level of unidentified asymptomatic infection

with abnormal prion protein within the population and this figure was first set out in a study published in 2004. Because of the scientific uncertainties about the potential incubation period of human prion diseases, such as variant Creutzfeldt-Jakob disease (vCJD), and the potential level of unidentified asymptomatic infection in the population, the Department's focus is to manage potential risks of person to person transmission using evidence based and cost effective measures. The following actions are among those taken with respect of the risk of anyone potentially carrying the abnormal prion protein associated with human prion diseases:

since December 1997, blood and tissues from individuals who later develop vCJD, have been withdrawn to prevent use;

since October 1999, white blood cells have been reduced in all blood used for transfusion;

since 2004 individuals who had themselves received a blood transfusion of blood since January 1980 were excluded from donating blood;

since 1999, plasma for the making clotting factors for treating patients with bleeding disorders, has been obtained from non-United Kingdom sources; and synthetic (recombinant) clotting factors have been provided to those under 16 since 1998 and for all suitable patients since 2005;

fresh frozen plasma for use in those born after 1 January 1996 is imported;

for over 10 years the independent scientific Advisory Committee on Dangerous Pathogens (ACDP) Transmissible Spongiform Encephalopathy (TSE) Risk Management Sub-Group has also issued guidance on managing potential transmission risks. This guidance is available at:

www.dh.gov.uk/ab/ACDP/TSEguidance/index.htm

since 2000 the CJD Incidents Panel has provided guidance to health services on the management of incidents involving possible CJD transmission between patients. Information on the Panel's activities can be found at:

www.hpa.org.uk/web/HPAweb&Page&HPAwebAutoList ame/Page/1204031511121

and

the Department funds studies to help ascertain the presence of abnormal prion protein present in the UK population. These include the study of appendix and tonsil tissue published in 2004, the National Anonymous Tonsil Archive and an ongoing study of appendix tissue.

The independent scientific ACDP TSE Risk Assessment Sub-Group keeps the evidence of the asymptomatic presence of abnormal prion protein associated with human prion disease under review, this work is used by the ACDP TSE Risk Management Sub-Group, the CJD Incidents Panel and the Advisory Committee on the Safety of Blood, Tissues and Organs when risk management actions.