ABEI-Based Automated Immunoassays for PIVKA-II Testing.
(2025) Annals of clinical and laboratory science — Vol. 55, n° 5, p. 802-805 (2025)
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- (en) 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.
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Gruson, D., & Raguz, J. (2025). ABEI-Based Automated Immunoassays for PIVKA-II Testing. Annals of clinical and laboratory science, 55(5), 802-805. https://hdl.handle.net/2078.5/278000 (Original work published 2025)