A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay
- Sian Sloan-Dennison
- Kathleen M. Scullion
- Benjamin Clark
- Paul Fineran
- Joanne Mair
- Stacey Laing
- Neil C. Shand
- Cicely Rathmell
- David Creasey
- Dieter Bingemann
- Jonathan Faircloth
- Mark Zieg
- Elizabeth Varghese
- Christopher J. Weir
- James W. Dear
- Karen Faulds
- Duncan Graham
2025-07-05
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.