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<p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月6日

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  • Sian Sloan-Dennison,
  • Kathleen M. Scullion,
  • Benjamin Clark,
  • Paul Fineran,
  • Joanne Mair,
  • Stacey Laing,
  • Neil C. Shand,
  • Cicely Rathmell,
  • David Creasey,
  • Dieter Bingemann,
  • Jonathan Faircloth,
  • Mark Zieg,
  • Elizabeth Varghese,
  • Christopher J. Weir,
  • James W. Dear,
  • Karen Faulds,
  • Duncan Graham

摘要

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.