HCV seroprevalence: un-linked anonymous testing - version 1.0
Research type
Research Study
Full title
Hepatitis C virus seroprevalence among people tested for alanine aminotransferase in NHS Greater Glasgow and Clyde: unlinked anonymous testing.
IRAS ID
187381
Contact name
Eleri Wilson-Davies
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Chronic hepatitis C virus (HCV) infection can lead to progressive liver fibrosis, cirrhosis, liver failure and/or hepatocellular carcinoma. Of the estimated 37,100 people living in Scotland with chronic HCV infection, an estimated 16,800 people (45%) remain undiagnosed (including over 6,000 undiagnosed in NHS Greater Glasgow and Clyde (NHS GG&C). The aim of the study is to determine the proportion of the adult population (born 1945 -1984) with
i) HCV infection
ii) undiagnosed HCV infection
among people tested for liver function tests (in the form of alanine aminotransferase (ALT)) in primary care within NHS GG&C. The proportion of the population (prevalence) with HCV related to biochemical markers of liver fibrosis, Scottish Index of Multiple Deprivation (SIMD), age and gender will be analysed. Unlinked anonymous testing will be undertaked on 6,000 samples. The testing will be performed using residual laboratory samples which were taken for the care of patients, initiated by their general practitioners and not for research indications. The specimens once identified for inclusion will be unlinked, so that the specimen (and therefore the result) will be unable to be identified as being from an individual patient. Prior to anonymisation and HCV testing, a working list of patient identifiers with no other associated information will be held temporarily. This will avoid double testing from the same patient as a source of bias and to link the known status of previous HCV testing and treatment of patients. The outcome is intended to directly inform a business case for HCV case identification in appropriate groups in NHS GG&C. We expect the findings to inform national recommendations on HCV screening. The study is currently seeking funding from pharmacutical companies.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0550
Date of REC Opinion
18 Dec 2015
REC opinion
Favourable Opinion