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 Shand; Cicely  Rathmell; David  Creasey; Dieter  Bingemann; Jonathan  Faircloth; Mark  Zeig; Christopher J. Weir; James W. Dear; Karen Faulds (She/Her); Duncan Graham

doi:10.1038/s41467-025-61600-9

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 Shand, Cicely Rathmell, David Creasey, Dieter Bingemann, Jonathan Faircloth, Mark Zeig, Christopher J. Weir, James W. Dear^*, Karen Faulds (She/Her), Duncan Graham

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	6223
Number of pages	13
Journal	Nature Communications
Volume	16
DOIs	https://doi.org/10.1038/s41467-025-61600-9
Publication status	Published - 6 Jul 2025

Funding

The study was funded by the Medical Research Council (MRC) DPFS Scheme. MICA: Point-of-care assessment of drug-induced liver injury (POC DILI) MRC Reference: MR/V038303/1 (S.S.D., K.M.S., B.C., P.F., J.M., S.L., C.J.W., J.W.D., K.F., D.G.). B.C. was supported by an EPSRC DTP studentship (EP/T517938/1) and Wasatch Photonics. K.M.S. was supported by The Centre for Precision Cell Therapy for the Liver, which was funded by the Chief Scientist Office (CSO) of the Scottish Government Health Directorates [PMAS/21/07]. The Research Electronic Data Capture (REDCap) system was used for data management. Edinburgh Clinical Trials Unit\u2014Study A database was developed by Michelle Steven, with data management undertaken by Lynsey Milne. Study A statistical analysis was performed by Robert Lee.

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10.1038/s41467-025-61600-9Licence: CC BY 4.0

Sloan-Dennison-etal-2025-NatComm-A-point-of-care-diagnostic-for-drug-induced-liver-injuryFinal published version, 1.8 MBLicence: CC BY 4.0

Cite this

Sloan-Dennison, S., Scullion, K. M., Clark, B., Fineran, P., Mair, J., Laing, S., Shand, N., Rathmell, C., Creasey, D., Bingemann, D., Faircloth, J., Zeig, M., Weir, C. J., Dear, J. W., Faulds (She/Her), K., & Graham, D. (2025). A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay. Nature Communications, 16, Article 6223. 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. ",

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Sloan-Dennison, S, Scullion, KM, Clark, B, Fineran, P, Mair, J, Laing, S , Shand, N, Rathmell, C, Creasey, D, Bingemann, D, Faircloth, J, Zeig, M, Weir, CJ, Dear, JW, Faulds (She/Her), K & Graham, D 2025, 'A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay', Nature Communications, vol. 16, 6223. https://doi.org/10.1038/s41467-025-61600-9

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AU - Sloan-Dennison, Sian

AU - Scullion, Kathleen M

AU - Clark, Benjamin

AU - Fineran, Paul

AU - Mair, Joanne

AU - Laing, Stacey

AU - Shand, Neil

AU - Rathmell, Cicely

AU - Creasey, David

AU - Bingemann, Dieter

AU - Faircloth, Jonathan

AU - Zeig, Mark

AU - Weir, Christopher J.

AU - Dear, James W.

AU - Faulds (She/Her), Karen

AU - Graham, Duncan

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N2 - 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.

AB - 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.

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JO - Nature Communications

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

Abstract

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

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

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

Abstract

Funding

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

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

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