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Table 4 Biomarker assays

From: Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study

Biomarker

Sample

Assay method

Laboratory

Alkaline phosphatase (ALP)

Serum

 

MLM Medical Labs (Mönchengladbach, Germany)

Bilirubin (TBL)

Serum

Albumin

Serum

Alanine transaminase (ALT)

Serum

Glutamate dehydrogenase (GLDH)

Serum

Cytokeratin-18 full length (K18)

EDTA-plasma

Commercial sandwich immunoassay (Peviva)

SIGNATOPE GmbH (Reutlingen, Germany)

Cytokeratin-18 caspase-cleaved fragment (cc-K18)

EDTA-plasma

Commercial sandwich immunoassay (Peviva)

High mobility group box 1 (HMGB1)

EDTA-plasma

Multiplex immunoprecipitation-nano-liquid chromatography + tandem mass spectrometry (IP-LC–MS/MS) with Orbitrap mass analyzer (Q-Exactive Plus, ThermoFisher)

Osteopontin (OPN)

EDTA-plasma

Glutamate dehydrogenase (GLDH)

EDTA-plasma

Macrophage colony-stimulating factor 1 receptor (MCSF1R)

EDTA-plasma

MicroRNA profile in discovery cohort of 100 DILI and 100 HV

‘Platelet-poor’ EDTA-plasma

Illumina NGS using RealSeq-biofluids serum/plasma miRNA library kit (Somagenics) [24]

TAmiRNA, Vienna, Austria

MicroRNA panel in validation cohort (identified candidate biomarkers from discovery cohort)

Commercial RT-qPCR assay

Bile acids

EDTA-plasma

Liquid chromatography mass spectrometry (Triple Quad LC/MS, Agilent technologies) [25]

University of Salamanca, Spain

Sphingolipids

EDTA-plasma

Liquid chromatography-mass spectrometry (Q-Exactive HRMS, ThermoFisher) [26]

University of Zurich, Switzerland

  1. Headings are in bold
  2. Abbreviations: LC Liquid chromatography, MS Mass spectrometry, NGS Next-generation sequencing, RT-qPCR Real-time quantitative polymerase chain reaction. Sample preparation is described in Fig. 3