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

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-03-01 DOI:10.1016/j.plabm.2024.e00389

Antonín Jabor , Zdenek Kubíček , Jitka Čásenská , Tereza Vacková , Vanda Filová , Janka Franeková

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Abstract

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.

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通过自动电化学发光法测定健康受试者血清中 PIVKA-II 的生物变化

背景凝血酶原/维生素 K 缺失诱导蛋白-II（PIVKA-II）是肝细胞癌的候选生物标志物，推荐用于诊断和监测。该研究旨在评估血清 PIVKA-II 的生物变异（BV）。方法在为期 6 周的方案中，对 14 名健康志愿者的受试者内（CVI）和受试者间（CVG）BV 估计值进行了评估。血清中的 PIVKA-II 浓度由罗氏 Elecsys PIVKA-II 诊断试剂盒（cobas e8000）测定。精确度（CVA）通过对所有志愿者样本的重复测量进行评估。在估算 CVI 时使用了两种方法：SD-ANOVA 法和 CV-ANOVA 法。我们计算了个体化指数（II）和参考变化值。实验完全符合 EFLM 数据库核对表的要求。结果两种统计方法计算出的健康人 PIVKA-II 的 CVI 分别为 8.2%（SD-ANOVA，CVA 为 3.2%）和 9.4%（CV-ANOVA，CVA 为 2.7%）。结论PIVKA-II的CVI和CVG分别为8.2%和19.5%，CVA低于4%。低 II 值和低于 25% 的 RCV 使该生物标记物可用于诊断和监测。在将 PIVKA-II 引入临床实践之前，还需要更多的数据。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.