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...

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Bibliographic Details
Published in:Nature communications Vol. 16; no. 1; pp. 6223 - 13
Main Authors: Sloan-Dennison, Sian, Scullion, Kathleen M., Clark, Benjamin, Fineran, Paul, Mair, Joanne, Laing, Stacey, Shand, Neil C., Rathmell, Cicely, Creasey, David, Bingemann, Dieter, Faircloth, Jonathan, Zieg, Mark, Varghese, Elizabeth, Weir, Christopher J., Dear, James W., Faulds, Karen, Graham, Duncan
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 06.07.2025
Nature Publishing Group
Nature Portfolio
Subjects:
140/133
631/1647/527/1821
631/61/32
692/4020/4021/1607/2749
692/53/2421
82/1
Acetaminophen - adverse effects
Analgesics
Antibodies
Biomarkers
Biomarkers - blood
Chemical and Drug Induced Liver Injury - blood
Chemical and Drug Induced Liver Injury - diagnosis
Cytokeratin
Emergency medical care
Female
Gold
Humanities and Social Sciences
Humans
Immunoassay
Immunoassay - instrumentation
Immunoassay - methods
Keratin-18 - blood
Lasers
Liver
Liver failure
Male
Medical devices
multidisciplinary
Nanoparticles
Overdose
Paracetamol
Patients
Performance evaluation
Point-of-Care Systems
Point-of-Care Testing
Raman spectra
Risk
Risk groups
Science
Science (multidisciplinary)
Sensitivity
Sensitivity and Specificity
Spectrum analysis
Spectrum Analysis, Raman - instrumentation
Spectrum Analysis, Raman - methods
Transplants & implants
United Kingdom > UK
United States > US
ISSN:2041-1723, 2041-1723
Online Access:Get full text
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Description
Summary: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. There is an unmet clinical need for a rapid point-of-care tests to identify patients at high-risk of developing acute liver failure following a paracetamol overdose. Here, authors assess a diagnostic test, consisting of a lateral flow immunoassay paired with a handheld Raman reader, in performance evaluation studies.
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ISSN:2041-1723
2041-1723
DOI:10.1038/s41467-025-61600-9