A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay
Paracetamol overdose (POD) is common, with approximately 100,000 cases attending UK hospitals annually. Timely antidote administration is crucial for patients at risk of developing acute liver failure. A rapid point-of-care (POC) assay is required to identify high-risk patients with fit-for-purpose sensitivity and specificity. Here we show that by measuring a circulating biomarker, cytokeratin-18 (K18), accurate detection of drug-induced liver injury (DILI) is possible. To achieve this, we created an in vitro diagnostic medical device designed to quantitatively detect serum K18, consisting of a Lateral Flow Immunoassay (LFIA) paired with a bespoke handheld Raman Reader (HRR) to produce quantitative surface-enhanced Raman scattering (SERS). The diagnostic was assessed in 2 performance evaluation studies using 199 serum samples from individuals following POD. The device achieves diagnostic accuracy for DILI with a specificity of 94% and sensitivity of 82%. Here we show that SERS-LFIA can rapidly identify patients with DILI, allowing individualised treatment pathways.
Authors
- Christopher John Weir (ORCID: https://orcid.org/0000-0002-6494-4903)
- Neil C. Shand (ORCID: https://orcid.org/0000-0001-8655-8336)
- Jonathan Faircloth
- Karen Faulds (ORCID: https://orcid.org/0000-0002-5567-7399)
- Cicely Rathmell
- Paul Fineran (ORCID: https://orcid.org/0000-0003-0051-3482)
- Stacey Laing (ORCID: https://orcid.org/0000-0001-5781-349X)
- Benjamin Clark
- Duncan Graham (ORCID: https://orcid.org/0000-0002-6079-2105)
- Mark Zieg
- Elizabeth Varghese (ORCID: https://orcid.org/0000-0002-8012-3435)
- Dieter Bingemann
- Joanne Mair (ORCID: https://orcid.org/0000-0002-1938-9146)
- Kathleen Scullion (ORCID: https://orcid.org/0000-0002-2867-0108)
- James W. Dear (ORCID: https://orcid.org/0000-0002-8630-8625)
- Sian Sloan‐Dennison (ORCID: https://orcid.org/0000-0003-2473-1425)
- D. J. Creasey
Institutions
- Defence Science and Technology Laboratory (GB)
- University of Strathclyde (GB)
- Wasatch Photonics (United States) (US)
- Centre for Inflammation Research (GB)
- The Queen's Medical Research Institute (GB)
- University of Edinburgh (GB)
Publication Details
- Journal
- Nature Communications
- Published
- 2025-07-05
- DOI
- https://doi.org/10.1038/s41467-025-61600-9
- Citations
- 11
- Primary Topic
- Spectroscopy Techniques in Biomedical and Chemical Research
- Type
- article
- Field-Weighted Citation Impact
- 17.97
Funders
- Chief Scientist Office
- Medical Research Council
- Engineering and Physical Sciences Research Council