Dried Blood Spot Testing for Blood Borne Virus Infection v1.0

  • Research type

    Research Study

  • Full title

    Dried Blood Spot Testing for Blood Borne Virus Infection:- Quantitative HCV PCR and whole genome sequencing.

  • IRAS ID

    290445

  • Contact name

    Paul Klapper

  • Contact email

    paul.klapper-2@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Clinicaltrials.gov Identifier

    NHS001875,

  • Duration of Study in the UK

    2 years, 11 months, 10 days

  • Research summary

    Hepatitis C virus infection (HCV) is a major cause of liver inflammation (hepatitis), infection with this virus can cause liver failure and death many years after an initial infection. Yet hepatitis C infection can be cured if it is diagnosed and treated. In the United Kingdom the majority of infections (90%) are found in injecting drug users, who have proved difficult to test because of difficulty in drawing blood from their veins damaged through prolonged intravenous drug usage. Using a simple finger prick test (the dried blood spot test; DBS) which collects a spot of blood onto paper that is then dried and transported to the laboratory, diagnosis can now be easily made in individuals with poor veins. We aim to develop a method to precisely measure the amount of virus in these DBS samples to allow us to show how the amount changes in response to treatment. Also by examining the genetic make up of the virus, determine the optimum antiviral drug treatment for the individual infected and at the same time enable study how different strains of virus spread in the community as an aid to public health control of infection. Information gathered would also aid development of new methods of control of spread including vaccination. The simplicity of collection of DBS allows extension of diagnosis, monitoring and treatment outside the traditional healthcare environment and would have clear potential for use in healthcare resource poor regions throughout the world. This initial study will, within 2 years, demonstrate the feasibility of the approach which, if successful, will allow development of clinical trials to determine the feasibility and utility of the new techniques and their introduction into routine practice.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    21/PR/1245

  • Date of REC Opinion

    9 Sep 2021

  • REC opinion

    Favourable Opinion