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 intra- 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® analyzer (Fujirebio, Gent, Belgium). Analytical variation (CV), within-subject biological variation (CV) and between-subject biological variation (CV) 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. CV was 2.82% while sex-independent CV and CV 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.