Innovate Genedrive PSD
Research type
Research Study
Full title
Clinical performance study of the Genedrive Plasma Separation Device for use in near-patient diagnosis of Hepatitis C Virus infection
IRAS ID
269842
Contact name
John Dillon
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
Research Summary:
Hepatitis C is passed from person to person through blood contact. In the UK, the most common route of transmission is through injecting drugs. It is estimated that up to 49 % of people who inject drugs in England will have hepatitis C.Testing for hepatitis C is currently performed in large laboratories attached to hospitals using complex equipment. After a positive screening test, blood is taken from a patient’s vein. This blood is sent to the laboratory, where it is tested alongside other patient samples for the virus that causes hepatitis C. It can take several weeks for results to be reported to a patient’s doctor, at which point effective medicine can be prescribed.
People Who Inject Drugs (PWID) often live transient and unpredictable lives. Contacting and arranging follow up visits to receive test results and treatment several weeks after their blood has been taken often proves very difficult or doesn’t happen at all. This results in patients not receiving treatment for their disease and potentially leading to further spread of the virus within the community. It has been shown that to effectively eliminate hepatitis C in the United Kingdom, the long wait from the patient first going to see their healthcare provider to receiving a test result must be reduced.
This study will investigate the use of a new method for collecting blood for a hepatitis C test from a patient by a pin prick from their finger. When used in combination with new, small, and fast hepatitis C test, a result could be given to a patient within 90 minutes, meaning that patients could receive their treatment on the same day. Same day treatment of hepatitis C could significantly increase the number of patients being cured of hepatitis C and reducing the spread of the disease.Summary of Results:
: This study has validated that use of the Genedrive Plasma Separation Device (PSD) in conjunction with the Genedrive HCV ID Kit provides concordant results in terms of diagnostic accuracy (once control fails and indeterminates are removed from the analysis) to use of samples derived from centrifuged venous blood and reference testing methodology. (Aptima™ HCV Quant Dx Assay, Hologic, USA) This study has also validated that the usability of the PSD is described as average or higher by the completion of System Usability Scale (SUS) questionnaires by users and subsequent analysis.
Due to incomplete data it was not possible to analyse performance of the same samples between different index tests, turnaround time of the different index tests or matrix interference (to assess whether usage of the PSD impacted peak heights for IPC or HCV within the Genedrive software and compared to centrifugation)REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
19/NW/0657
Date of REC Opinion
22 Oct 2019
REC opinion
Favourable Opinion