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 and Duncan Graham
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Sian Sloan-Dennison: University of Strathclyde
Kathleen M. Scullion: University of Edinburgh
Benjamin Clark: University of Strathclyde
Paul Fineran: Institute for Regeneration and Repair
Joanne Mair: Institute for Regeneration and Repair
Stacey Laing: University of Strathclyde
Neil C. Shand: Defence Science and Technology Laboratory (DSTL), Porton Down
Cicely Rathmell: Wasatch Photonics
David Creasey: Wasatch Photonics
Dieter Bingemann: Wasatch Photonics
Jonathan Faircloth: Wasatch Photonics
Mark Zieg: Wasatch Photonics
Elizabeth Varghese: University of Edinburgh
Christopher J. Weir: University of Edinburgh
James W. Dear: University of Edinburgh
Karen Faulds: University of Strathclyde
Duncan Graham: University of Strathclyde

Nature Communications, 2025, vol. 16, issue 1, 1-13

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-61600-9

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