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

Autor: Jabor A; Institute for Clinical and Experimental Medicine, Department of Laboratory Methods, Vídeňská 1958/9, 140 21, Praha 4, Czech Republic.; Third Faculty of Medicine, Charles University, Ruská 87, 100 00, Praha 10, Czech Republic., Kubíček Z; Institute for Clinical and Experimental Medicine, Department of Laboratory Methods, Vídeňská 1958/9, 140 21, Praha 4, Czech Republic., Čásenská J; Institute for Clinical and Experimental Medicine, Department of Laboratory Methods, Vídeňská 1958/9, 140 21, Praha 4, Czech Republic.; Third Faculty of Medicine, Charles University, Ruská 87, 100 00, Praha 10, Czech Republic., Vacková T; Institute for Clinical and Experimental Medicine, Department of Laboratory Methods, Vídeňská 1958/9, 140 21, Praha 4, Czech Republic.; Third Faculty of Medicine, Charles University, Ruská 87, 100 00, Praha 10, Czech Republic., Filová V; Institute for Clinical and Experimental Medicine, Department of Laboratory Methods, Vídeňská 1958/9, 140 21, Praha 4, Czech Republic., Franeková J; Institute for Clinical and Experimental Medicine, Department of Laboratory Methods, Vídeňská 1958/9, 140 21, Praha 4, Czech Republic.; Third Faculty of Medicine, Charles University, Ruská 87, 100 00, Praha 10, Czech Republic.
Jazyk: angličtina
Zdroj: Practical laboratory medicine [Pract Lab Med] 2024 Mar 19; Vol. 39, pp. e00389. Date of Electronic Publication: 2024 Mar 19 (Print Publication: 2024).
DOI: 10.1016/j.plabm.2024.e00389
Abstrakt: Background: Prothrombin/Protein Induced by Vitamin K Absence-II (PIVKA-II) is a candidate biomarker of hepatocellular cancer, recommended both for diagnostics and monitoring. The aim was to evaluate biological variation (BV) of serum PIVKA-II.
Methods: Within-subject (CV I ) and between-subject (CV G ) BV estimates were assessed in 14 healthy volunteers in a 6-week protocol. Serum concentrations of PIVKA-II were measured by a Roche Elecsys PIVKA-II diagnostic kit (cobas e8000). Precision (CV A ) was assessed from duplicate measurements of all volunteers' samples. Two methods were used for the estimation of CV I : SD-ANOVA and CV-ANOVA method. We calculated the index of individuality (II) and reference change value. The experiment was fully compliant with EFLM database checklist.
Results: The CV I of PIVKA-II in healthy persons, as calculated by two statistical methods, were 8.2% (SD-ANOVA with CV A of 3.2%) and 9.4% (CV-ANOVA) with CV A of 2.7%). The CV G was 19.5% (SD-ANOVA), and respective II and RCV were 0.42 and 24.4%.
Conclusions: CV I and CV G of PIVKA-II were 8.2% and 19.5%, respectively, with CV A below 4%. The low II and RCV below 25% enable the use of this biomarker both for diagnostics and monitoring. More data are needed before the introduction of PIVKA-II into clinical practice.
Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2024 The Authors.)
Databáze: MEDLINE
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