A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay

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Sloan-Dennison, Sian and Scullion, Kathleen M and Clark, Benjamin and Fineran, Paul and Mair, Joanne and Laing, Stacey and Shand, Neil and Rathmell, Cicely and Creasey, David and Bingemann, Dieter and Faircloth, Jonathan and Zeig, Mark and Weir, Christopher J. and Dear, James W. and Faulds (She/Her), Karen and Graham, Duncan (2025) A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay. Nature Communications, 16. 6223. ISSN 2041-1723 (https://doi.org/10.1038/s41467-025-61600-9)

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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.

ORCID iDs

Sloan-Dennison, Sian ORCID logoORCID: https://orcid.org/0000-0003-2473-1425, Scullion, Kathleen M, Clark, Benjamin, Fineran, Paul, Mair, Joanne, Laing, Stacey ORCID logoORCID: https://orcid.org/0000-0001-5781-349X, Shand, Neil, Rathmell, Cicely, Creasey, David, Bingemann, Dieter, Faircloth, Jonathan, Zeig, Mark, Weir, Christopher J., Dear, James W., Faulds (She/Her), Karen ORCID logoORCID: https://orcid.org/0000-0002-5567-7399 and Graham, Duncan ORCID logoORCID: https://orcid.org/0000-0002-6079-2105;
CORE (COnnecting REpositories)