POC-DILI

  • Research type

    Research Study

  • Full title

    Point-of-care assessment of drug-induced liver injury (POC-DILI)

  • IRAS ID

    317414

  • Contact name

    James Dear

  • Contact email

    james.dear@ed.ac.uk

  • Sponsor organisation

    University of Edinburgh

  • Duration of Study in the UK

    1 years, 3 months, 31 days

  • Research summary

    Paracetamol overdose (POD) is common (approximately 100,000 cases per year, around 50,000 of these are treated and around 5,000 develop liver injury). The most common treatment used is called N-acetylcysteine (NAC).The sooner treatment with NAC is started post-POD the greater the likelihood that liver injury (Drug Induced Liver Injury - DILI) will be prevented.

    The current biomarker (molecule in the blood) that shows us the extent of DILI is called ALT and it is a reliable gold standard for established liver injury. However, ALT increases too slowly post-POD for the diagnosis of liver injury to occur so that treatment with NAC can have the best possible outcome. There is a need for an assay (a quick test) capable of telling us quicker that patients are likely to develop liver injury post-POD to improve treatment knowledge and hopefully a better outcome.

    K18 is another biomarker that is seen in liver injury, it is seen earlier on than ALT. To try and improve patient care we have created a capillary blood (taken from a fingerpick), quantitative (can be measured), K18 Lateral Flow Assay/test (K18-LFA) that is low-cost, rapid and reliable. These look the same as the covid-19 tests and can be read by the naked eye. We also plan to test a device that uses a low powered laser to read the strip and give us a value (called a Raman Reader).

  • REC name

    Yorkshire & The Humber - Sheffield Research Ethics Committee

  • REC reference

    23/YH/0062

  • Date of REC Opinion

    11 Apr 2023

  • REC opinion

    Favourable Opinion