Analytical performances and biological variation of PIVKA-II (des-y-carboxy-prothrombin) in European healthy adults

Background: PIVKA-II (DCP) is increasingly used for the diagnosis and the surveillance of hepatocellular carcinoma (HCC) in at-risk populations. However, to date, few data are available concerning the infra- and inter-individual variability of this marker, which makes the interpretation of serial measurements difficult in the context of monitoring. Methods: 19 European healthy volunteers (HVs) were taken each week during five consecutive weeks. Samples were analyzed in duplicate on the Lumipulse (R) analyzer (Fujirebio, Gent, Belgium). Analytical variation (CVA), within-subject biological variation (CVI) and between-subject biological variation (CVG) were calculated using nested ANOVA following normality assessment, outlier exclusion, and homogeneity of variance analysis. Results: No significant difference was observed for the mean values (p = 0.23) between men (mean: 30.66 mAU/mL) and women (mean: 33.90 mAU/mL) subgroups. CVA was 2.82% while sex-independent CVI and CVG were 13.35% and 16.05%, respectively. Taking these values, the calculated reference change value (RCV) and index of individuality were 37.70% and 0.85, respectively. Conclusion: We reported for the first-time biological variation data for PIVKA-II in a cohort of European HVs. We believe that our results can be used to set analytical specification goals as well as to improve the interpretation of serial measurements of PIVKA-II for monitoring purposes.