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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F24%3A43926911" target="_blank" >RIV/00216208:11120/24:43926911 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.1016/j.plabm.2024.e00389" target="_blank" >https://doi.org/10.1016/j.plabm.2024.e00389</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.plabm.2024.e00389" target="_blank" >10.1016/j.plabm.2024.e00389</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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&apos; 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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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&apos; 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30401 - Health-related biotechnology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Practical Laboratory Medicine

ISSN

2352-5517

e-ISSN

2352-5517

Svazek periodika

39

Číslo periodika v rámci svazku

March

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

7

Strana od-do

"e00389"

Kód UT WoS článku

001221258800001

EID výsledku v databázi Scopus

2-s2.0-85188937297