The Prionics®-Check WESTERN is the test of choice for the diagnosis of variant Creutzfeldt-Jakob Disease (vCJD) in post mortem human tissues. This is the result of a pilot study by Gary Mallinson and colleagues of the National Health Service Blood & Transplant (NHSBT), UK. The group showed that a modification of the Prionics®-Check WESTERN protocol developed by Prionics was the most sensitive of the tests evaluated for detecting the presence of vCJD in human tissues.
Transplantation of human tissues harbours the risk of disease transmission. Consequently, donor selection and testing are critical to ensure the safety of tissues for transplantation. The European Commission (EC) directive 2006/86/EC, has regulated stricter rules for the safety of tissues for transplantation and the directive will come in to effect for European Union (EU) member states in September, 2007.
Risk of vCJD transmission through transplantation
The new EC directive has implications for tests being performed for the admission of transplantation donors. This was one the focal points for discussion at the annual meeting of the European Eye Bank Association (EEBA) held January, 2007 in Bratislava. One of the risks with transplantation of tissues such as the dura mater, cornea, or transplants containing lymphoreticular tissue, is the transmission of the human prion disease, vCJD. At the EEBA meeting the results of a pilot study by Gary Mallinson and colleagues of the NHSBT which began in April, 2006 were presented. The pilot study involves the testing of tonsils from deceased tissue donors for the presence of the malignant prion protein. Several different tests were evaluated before the actual testing on tissue donors began. The most sensitive test was the Prionics®-Check WESTERN which had been adapted by Prionics for testing of tonsil tissue. The study is ongoing and to date no positive tissue samples have been identified. Currently, there is no blood test available for the diagnosis of vCJD in humans. The availability of a reliable ante mortem test would further improve the safety of transplantation tissues and cells. The development of a sensitive and specific vCJD ante mortem test for donor screening is one of the major focal points of Prionics' research and development.
Prionics®-Check WESTERN: completely reliable
The Prionics®-Check WESTERN is the first rapid post-mortem test for the diagnosis of prion disease in animal brain tissues. The test has proven its sensitivity and specificity in over 20 million tests world-wide. The key reagent of the Prionics®-Check WESTERN is the monoclonal antibody 6H4. This antibody recognizes the prion protein of many species with high specificity, among which are the human, cattle, sheep and mouse prion protein.
