Plasma bile acid profile as a biomarker for drug-induced liver injury

Description
Bile Acid measurements (µM) in healthy volunteers, idiosyncratic drug-induced liver injury (DILI) and nonDILI cases for TransBioLine project.
Background:
The liver maintains bile acid (BA) homeostasis; circulating BA levels are used as a biomarker in certain cholestatic conditions. BAs can initiate processes in the pathogenesis of drug-induced liver injury (DILI), an unpredictable occurrence which can lead to liver failure. As such, this study aimed to explore whether changes in plasma BA profiles can serve as useful biomarkers for diagnostic and prognostic purposes in patients presenting with suspected DILI.
Methods:
In a prospective, nested case-control observational study, adult patients presenting with acute liver injury potentially due to DILI (at secondary care centres in 6 European countries) were sampled and followed through standard clinical care with severity and outcomes monitored. After review, cases were adjudicated as DILI (n=120) or nonDILI (alternate causes; n=49). Plasma BA levels and profile were quantified by University of Salamanca and compared to those in healthy volunteers (n=25).
This is linked to publication 'Usefulness of plasma bile acid profile as a prognostic biomarker for drug-induced liver injury'.
Values reported to 4 decimal places. Mean recovery (±SEM) for samples in the DILI group (n=120) was 89.0±0.8%, which was very close to that for the NonDILI group (n=49; 87.0±1.6%). The accuracy of calibration curves was calculated at an intermediate point of the concentration range, i.e., 5 µM. The results indicated that the average value (±SEM) was 91.6±0.8% for 230 calibration curves, with no significant differences among bile acid species. Reproducibility was calculated at two concentrations of the calibration curve for each of the 22 BAs analyzed. The coefficients of variation (CVs) were lower than 15% (range 2.8-14.5%) at 1 µM, and lower than 2% (range 0.8-1.8%) at 25 µM.