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

The potential of PIVKA-II as a treatment response biomarker in hepatocellular carcinoma: a prospective United Kingdom cohort study

“…At the commencement of this study, all of these studies had been performed only in Asia. However, given that PIVKA-II has been shown to perform better in viral aetiologies of cirrhosis, compared to non-viral aetiology, and the 95% reference range for PIVKA-II has been shown to differ significantly between geographical regions in healthy individuals [22][23][24][25], it is therefore important to assess this in a Western population too. We therefore undertook a prospective study, at a tertiary UK centre, to evaluate the role of PIVKA-II as a treatment response biomarker and in predicting microvascular invasion.…”

Biological variation of PIVKA-II in blood serum of healthy subjects measured by automated electrochemiluminescent assay

“…Vice versa, with II bellow 0.6, RIs are of limited value and monitoring is essential. PIVKA-II had II of 0.42 in our experiment (i.e., the limited value of RI) or 0.85 in Bayart's experiment [ 18 ]. Therefore, the monitoring of PIVKA-II concentrations seems to be a reliable tool.…”

“…Therefore the power of our study is close to 1.0, as the ratio between analytical and within-person biological variation is lower than 1 ( Table 2 ). The results of the biological variation are given in Table 2 both for SD-ANOVA and CV-ANOVA method together with data by Bayart [ 18 ] for comparison. The CV G was calculated only using the SD-ANOVA method, and the resulting value of 19.5% produced an II of 0.42.…”

“…However, Bayart and coworkers in their excellent study assessed biological variation and analytical performance of PIVKA-II measured by the Lumipulse G600II analyzer (Fujirebio). This analytical method (results expressed in mAU/ml) had repeatability lower than 3% and intermediate precision lower than 4% [ 18 ]. Also, our study confirmed reliable analytical performance of Elecsys PIVKA-II electrochemiluminescent assay with CV A below 4%.…”