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A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow
Sian Sloan-Dennison1, Kathleen M Scullion2, Benjamin Clark1
1Department of Pure and Applied Chemistry, Technology and Innovation Centre, University of Strathclyde, Glasgow, UK.
Nature Communications
|July 5, 2025
Summary
A new point-of-care test accurately detects drug-induced liver injury (DILI) following paracetamol overdose (POD) by measuring cytokeratin-18 (K18). This rapid SERS-LFIA assay aids in identifying high-risk patients for timely treatment.
Area of Science:
- Biomarker detection
- Point-of-care diagnostics
- Toxicology
Background:
- Paracetamol overdose (POD) is a frequent cause of hospital admissions, necessitating rapid identification of patients at risk of acute liver failure.
- Current diagnostic methods may not offer the speed required for timely intervention in POD cases.
- Accurate and sensitive point-of-care (POC) diagnostics are crucial for managing POD and preventing severe liver injury.
Purpose of the Study:
- To develop and validate a novel in vitro diagnostic medical device for the rapid, quantitative detection of serum cytokeratin-18 (K18) as a biomarker for drug-induced liver injury (DILI).
- To assess the diagnostic accuracy of the developed device in identifying patients with DILI following POD.
- To establish a fit-for-purpose POC assay for improved patient stratification and individualized treatment in POD.
Main Methods:
- Development of a Lateral Flow Immunoassay (LFIA) coupled with a handheld Raman Reader (HRR) for quantitative surface-enhanced Raman scattering (SERS) detection of serum K18.
- Evaluation of the SERS-LFIA device using 199 serum samples from individuals with a history of POD.
- Assessment of diagnostic performance metrics including sensitivity and specificity for DILI detection.
Main Results:
- The SERS-LFIA device demonstrated high diagnostic accuracy for DILI in the context of POD.
- The assay achieved a specificity of 94% and a sensitivity of 82% in identifying DILI.
- Quantitative K18 measurement using the SERS-LFIA system proved effective in detecting liver injury.
Conclusions:
- Surface-enhanced Raman scattering Lateral Flow Immunoassay (SERS-LFIA) offers a rapid and accurate method for identifying DILI in patients with POD.
- This POC diagnostic enables timely identification of high-risk individuals, facilitating personalized treatment strategies.
- The developed K18 assay holds significant potential for improving the clinical management of paracetamol overdose.
