WHO reference materials for hepatitis E Virus
Research type
Research Study
Full title
Development of WHO reference materials for hepatitis E Virus (HEV) serological diagnostics
IRAS ID
198694
Contact name
Harry Dalton
Contact email
Sponsor organisation
Royal Cornwall Hospital
Clinicaltrials.gov Identifier
16/SW/0078, Cornwall and Plymouth REC
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Hepatitis E virus (HEV) has recently emerged as a threat to human health in developed countries. HEV is transmitted to humans from pigs, probably via the food chain, as 10% of UK pork sausages are contaminated with HEV. In addition, in England 1:2,848 blood donations are contaminated with HEV, and donations are not currently screened. There are approximately 100,000 infections with HEV in England every year.
The diagnosis of hepatitis E is problematic. Serological (antobody-based) tests for HEV vary enormously in their performance. To improve the quality of diagnostic tests for HEV it is vital that reference materials are made freely available. The aim of this project is to develop a World Health Authority (WHO) reference material for HEV. This will be achieved by taking large-volume blood samples from patients with past or recent HEV infectionREC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0078
Date of REC Opinion
11 May 2016
REC opinion
Further Information Favourable Opinion