Related Experiment Video
Updated: Jan 11, 2026
Use of Capillary Electrophoresis Immunoassay to Search for Potential Biomarkers of Amyotrophic Lateral Sclerosis in Human Platelets
Published on: February 10, 2020
ABEI-Based Automated Immunoassays for PIVKA-II Testing
Damien Gruson1,2, Josipa Raguz3
1Department of Clinical Biochemistry, Cliniques Universitaires St-Lux, Brussels, Belgium and Université Catholique de Louvain, Brussels, Belgium damien.gruson@uclouvain.be.
Objective:
To evaluate the analytical performance of the Maglumi® X6 ABEI-based automated immunoassay for quantifying PIVKA-II, a clinically relevant biomarker for hepatocellular carcinoma (HCC), and to compare its performance with the Lumipulse® assay.
Methods:
Imprecision was assessed following CLSI EP15-A3 guidelines using internal quality controls (IQCs) at low and high concentrations, measured three times daily for five days. Method comparison was performed on 63 patient serum samples, and reference values were assessed in 25 healthy individuals.
Results:
Within-run coefficients of variation (CVs) for the Maglumi® assay were 17.19% and 3.65% at 56 and 5026 mAU/mL, respectively. Between-run CVs were 1.47% and 2.14% for the same IQCs. Accuracy showed biases of 13.51% and 0.53% at low and high IQC, respectively. Comparison with Lumipulse® showed strong correlation (r=0.95) with a mean bias of 49.9 mAU/mL. Among healthy subjects, the 95th percentile was 45 mAU/mL.
Conclusion:
The Maglumi® X6 ABEI-based immunoassay demonstrated good analytical performance. Further studies with larger cohorts are warranted to confirm clinical performance.
