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).