Laboratory validation of HCV detection from DBS Samples v1.1
Research type
Research Study
Full title
Laboratory validation of baculovirus expressed proteins for detection of Hepatitis C antigen and antibody from DBS samples
IRAS ID
208004
Contact name
Benjamin Brown
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 0 months, 25 days
Research summary
Despite progress made in the last few years to increase screening for hepatitis C, hepatitis C virus infection remains a major health issue in the UK. It is estimated that 216,000 people in the UK are chronically infected with hepatitis C virus. The majority of infections (90%) are found in injecting drug users, who have proved difficult to test in the past due to their poor peripheral vein access. Progress has been made in the past few years through the use of the alternative sample types dried blood spots and oral fluids. The sample types are easy and safe to collect and with their use, testing in the IDU population has increased significantly. Despite the improvements in access to testing these sample types provide, they have several disadvantages when compared to a standard blood sample. These include:\n-\tTest sensitivity for detecting HCV infection is lower than with conventionally collected blood samples.\n-\tThe test repertoire currently available from dried blood spots or oral fluid is very limited. A HCV antigen test would significantly reduce the cost of diagnosing active HCV infection compared to the currently used HCV RNA screen.\nA new assay, taking advantage of the most advanced multi-analyte technology, and designed specifically to work with DBS and oral fluid samples, will be the ideal solution to the issues listed. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
17/NS/0087
Date of REC Opinion
29 Aug 2017
REC opinion
Favourable Opinion