Rapid testing for Hepatitis C using finger-prick blood
Research type
Research Study
Full title
Rapid testing for Hepatitis C using finger-prick blood
IRAS ID
292998
Contact name
Brendan Healy
Contact email
Sponsor organisation
Public Health Wales
Duration of Study in the UK
0 years, 1 months, 12 days
Research summary
The aim of this research project is to develop a rapid-testing pathway for Hepatitis C using finger-prick blood. Hepatitis C can be diagnosed with a fingerprick blood sample using the Cepheid Xpert HCV VL Fingerstick system. This system can detect virus from 100 to 100,000,000 IU/mL. The system requires collection of 100μl into a Minivette. This sample can be stored at 5-35°C for up to 15 minutes. This system is suitable when a machine is present on site. Alternatively venous whole blood can be stored at 2-8°C up to 72 hours or at room temperature (max 35°C) up to 24 hours. Capillary blood collection tubes are designed to facilitate collection of small amounts of blood and to preserve that blood similar to a venous sample. These systems have not been validated for use on the Cepheid machine. This project is designed to validate the microtainer for use in the field. If successful this will allow development of highly mobile and flexible rapid testing pathways. With this system specialist nurses would be able to visit clients anywhere, collect a sample and then process it using the Cepheid machine wherever it is housed. The research will involve 20-50 participants aged over 18 that are confirmed Hepatitis C positive. The study will occur at University Hospital Wales over a 3-week data collection period. Participants will give 2 samples of blood; the first for a dried blood-spot test (which will take 2 weeks to process) and the second a finger-prick amount of blood which will be collected into a capillary tube and sent for Cepheid (laboratory machine) processing simultaneously. Results of both samples will be analysed and compared. If successful suitable pathways will be developed to optimise use of this pathway.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0096
Date of REC Opinion
8 Apr 2021
REC opinion
Favourable Opinion