We have generated reference reagents for evaluating assays intended to diagnose CJD – variant and sporadic – and for blood donor screening. Several commercial and research groups are developing methods to diagnose vCJD in blood.
Diagnostic assays where a positive result will have a big impact on the individual – such as Human Immunodeficiency virus (HIV), hepatitis B and C– have strict performance criteria requirements in the EU. These tests must meet the performance criteria outlined in a common technical specification and includes assessments of:
Test evaluations are normally carried out using a large number of known positive samples. For vCJD, both the volume and numbers of blood samples are small and alternative protocols are needed to establish assay performance. NIBSC has collected and prepared a bank of samples for each of these steps:
Reagents for test evaluation are sourced nationally and internationally from groups researching human and animal TSEs and from blood services. Access to rare samples of animal or human origin held at NIBSC is determined by the NIBSC CJD research and resource centre oversight committee.
Evaluation of potential tests for CJD for access to rare samples - draft1 - Microsoft Word 2000 format
Evaluation of potential tests for CJD for access to rare samples - draft1 - Adobe Acrobat 5.0 format
CJD research and resource centre oversight committee members (PDF, 54KB)
CJD research and resource centre oversight committee terms of reference (PDF, 50KB)