HCV microfluidic diagnostics
Research type
Research Study
Full title
Development of point-of-care and wearable sensors for Hepatitis C diagnostics
IRAS ID
323660
Contact name
John Greenman
Contact email
Sponsor organisation
University of Hull
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Hepatitis C diagnostic devices have been developed at the University of Hull to detect and quantify the Hepatitis C virus in patients’ plasma and serum samples. This study aims to test the new point-of-care devices that are designed to be low cost and user-friendly. Point-of-care testing encompasses any tests that are performed at, or near, a patient and at the site where care or treatment is provided; for instance the home pregnancy test, COVID-19 lateral flow test and portable glucose meters are good examples. Consequently, results are typically available relatively quickly so that they can be acted upon without delay. The proposed devices for detecting Hepatitis C would be more accessible than the standard method that involves genetic analysis, and hence would hopefully provide earlier diagnosis of a disease which infects 1.5 million people/year and killed about 290 000 people in 2019 according to World Health Organisation (WHO). The study will assess the levels of sensitivity and specificity of the device compared with the standard genetic (Polymerase Chain Reaction, PCR) method. Excess, stored, HCV patients’ plasma, serum and blood samples will be supplied by the Virology laboratory (Hull University Teaching Hospital's Trust; HUTH). These samples were taken and analysed as part of patients' clinical monitoring, and are stored prior to disposal in the Virology laboratory. The proposed study will use the samples in a fully anonymised manner. It is proposed to take the new test device to the Virology laboratory and be tested in collaboration with HUTH NHS staff.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0149
Date of REC Opinion
16 May 2023
REC opinion
Further Information Favourable Opinion