CJD Resource Centre, NIBSC (MHRA), United Kingdom

Key facts

• The centre was established in 2001 by the UK Department of Health and Social Care in coordination with the World Health Organisation, as part of the UK response to variant CJD.
• It is run by NIBSC at Blanche Lane, South Mimms, Potters Bar, and is registered with the Health Research Authority as a research tissue bank.
• NIBSC has been a centre of the MHRA since 1 April 2013, moving there from the Health Protection Agency, so the centre now sits within the UK medicines regulator while keeping the NIBSC name.
• Its stated purpose is to supply reference material for evaluating tests for sporadic and variant CJD and blood screening tests, so that candidate tests can be checked against common technical specifications.
• The holdings described cover human and animal material and healthy controls; the centre does not collect material itself, taking donations from clinics and archives under their own consents and holding no personal data.
• Access is managed rather than open: an oversight committee runs a stepwise evaluation of candidate tests and feeds results back to applicants, and access to the scarcest material depends on a full assessment of test performance, with European Commission Decision 2011/869/EU cited as the reference point.
• Identical blinded panels are the operating idea: the same set goes to several developing groups so results can be compared directly across different test formats.
• The centre has published under its own name since at least 2007, with three Vox Sanguinis papers from 2007, 2012 and 2013 setting out the reference material set and the evaluation route.
• That evaluation route has produced a negative verdict at least once: the 2013 paper reports a candidate test that performed well on prepared material but was judged unsuitable for blood donor screening.
• A 2019 ethics record ties the bank to an NIHR funded project, PR-R17-916-23007, with funding stated to March 2022; nothing opened says what followed.
• Research ethics approvals are on the public record twice: 6 November 2014 (IRAS 162277, REC 14/EM/1134) and 11 November 2019 (IRAS 270448, REC 19/EM/0314), both from the East Midlands Derby committee.
• The centre also states work on standardising sensitive detection methods for other neurodegenerative diseases, naming Parkinson and Alzheimer disease, so it is not prion only.
• Its material reaches work well outside the UK: the 2025 INRAE study of the human PrP E219K RT-QuIC substrate names the UK NIBSC CJD Resource Centre as the source of its sporadic MM1, MV2 and variant CJD human material.
• A Europe PMC search for the centre's name returns 15 papers from 2007 to 2025, from UK, French, Spanish and US groups, which is a small but international footprint; the search misses papers that thank the centre without using that phrase.

Timeline

1. 2001Centre established by the UK Department of Health and Social Care with the World Health Organisation.
2. 2007First Vox Sanguinis paper from the centre setting out the reference material set.
3. 2011Paper on comparing candidate variant CJD tests with identical blinded panels published online.
4. 2013NIBSC moves from the Health Protection Agency to the MHRA, becoming one of three MHRA centres.
5. 2013Paper reporting the stepwise evaluation route and a candidate test judged unsuitable for donor screening published online.
6. 2014Favourable research ethics opinion for the research tissue bank, IRAS 162277.
7. 2019Second favourable research ethics opinion, IRAS 270448, with NIHR project funding stated to March 2022.
8. 2025INRAE study of the E219K RT-QuIC substrate published, using human material from the centre.