A new point of care diagnostic for the sensitive and specific diagnosis of drug-induced liver injury using a surface enhanced Raman scattering lateral flow immunoassay (SERS-LFIA)

Paracetamol overdose (POD) is common, with approximately 100,000 cases attending hospital emergency departments in the UK annually. Early treatment with the antidote N -acetylcysteine (NAC) is crucial for patients who are at risk of developing life-threatening acute liver failure. A rapid point-of-care (POC) assay is required to identify high-risk patients with fit-for-purpose sensitivity and specificity to facilitate early targeted NAC treatment. Here we demonstrate that measuring a circulating biomarker, cytokeratin-18 (K18), using a novel POC assay facilitates the rapid and accurate detection of drug-induced liver injury (DILI). To achieve this, a novel in vitro diagnostic medical device was developed to quantitatively detect serum K18. The device combines a Lateral Flow Immunoassay (LFIA) with a bespoke handheld Raman Reader (HRR) to produce quantitative surface-enhanced Raman scattering (SERS). The accuracy of the novel diagnostic was assessed in 2 performance evaluation studies using a total 199 serum samples from individuals following a POD. The device achieved diagnostic accuracy for DILI with a specificity of 94% and sensitivity of 82%. These data demonstrate that SERS-LFIA can rapidly identify patients who have DILI which potentially allows for individualised treatment pathways.