The hep C fingerprick study v1
Research type
Research Study
Full title
Validation of the use of capillary blood collected by fingerprick for the detection on hepatitis C virus (HCV) RNA on the GeneXpert molecular diagnostic system
IRAS ID
187854
Contact name
Anna Maria Geretti
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
In the North-West of England, HCV infection is common but often remains undiagnosed until significant liver disease develops. We are researching ways to improve access to HCV testing in the general population. One strategy is to provide rapid testing at points where patients may present for general care, including GP practices and A&E.
Point-of-care testing (POCT) is already well established in the UK for a number of infections, most commonly HIV. For this purpose, HIV tests have been developed that return a result within a short time (usually one hour), so that patients may be informed immediately and promptly directed to appropriate care. As a way to improve patients’ acceptance and return rapid results, HIV POCT commonly uses a few drops of capillary blood collected by fingerprick, a practice that many patients prefer to blood collection by venupuncture.
First-generation POCT devices relied on the detection of antibodies or virus proteins as a way to diagnose an infection. Next-generation POCT instruments target viral nucleic acids, and offer greater diagnostic sensitivity. The GeneXpert (GX) Instrument performs automated detection of nucleic acids within self-contained, single-use disposable cartridges. This innovative system is easy to use and ideal for next-generation POCT. The GX Instrument is approved in the EU for detecting HIV in both venous and fingerprick blood. It is also approved for HCV detection in venous blood. Here we propose to study its performance for the detection of HCV in fingerprick blood. We will compare fingerprick and venupuncture results in patients who are already known to have HCV and in patients without HCV (as a control group). If the results show that fingerprick blood can be used reliably, we will set up a separate study to offer HCV POCT to undiagnosed patients attending A&E and a local GP practice (subjected to a separate application).
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0715
Date of REC Opinion
9 Feb 2016
REC opinion
Further Information Favourable Opinion