{"title":"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","authors":"Antonín Jabor , Zdenek Kubíček , Jitka Čásenská , Tereza Vacková , Vanda Filová , Janka Franeková","doi":"10.1016/j.plabm.2024.e00389","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>Within-subject (CV<sub>I</sub>) and between-subject (CV<sub>G</sub>) 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<sub>A</sub>) was assessed from duplicate measurements of all volunteers' samples. Two methods were used for the estimation of CV<sub>I</sub>: 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.</p></div><div><h3>Results</h3><p>The CV<sub>I</sub> of PIVKA-II in healthy persons, as calculated by two statistical methods, were 8.2% (SD-ANOVA with CV<sub>A</sub> of 3.2%) and 9.4% (CV-ANOVA) with CV<sub>A</sub> of 2.7%). The CV<sub>G</sub> was 19.5% (SD-ANOVA), and respective II and RCV were 0.42 and 24.4%.</p></div><div><h3>Conclusions</h3><p>CV<sub>I</sub> and CV<sub>G</sub> of PIVKA-II were 8.2% and 19.5%, respectively, with CV<sub>A</sub> 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.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00389"},"PeriodicalIF":1.7000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000350/pdfft?md5=844de81587423e7d4dbacb9cd70469dd&pid=1-s2.0-S2352551724000350-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Biological variation of PIVKA-II in blood serum of healthy subjects measured by automated electrochemiluminescent assay\",\"authors\":\"Antonín Jabor , Zdenek Kubíček , Jitka Čásenská , Tereza Vacková , Vanda Filová , Janka Franeková\",\"doi\":\"10.1016/j.plabm.2024.e00389\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>Within-subject (CV<sub>I</sub>) and between-subject (CV<sub>G</sub>) 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<sub>A</sub>) was assessed from duplicate measurements of all volunteers' samples. Two methods were used for the estimation of CV<sub>I</sub>: 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.</p></div><div><h3>Results</h3><p>The CV<sub>I</sub> of PIVKA-II in healthy persons, as calculated by two statistical methods, were 8.2% (SD-ANOVA with CV<sub>A</sub> of 3.2%) and 9.4% (CV-ANOVA) with CV<sub>A</sub> of 2.7%). The CV<sub>G</sub> was 19.5% (SD-ANOVA), and respective II and RCV were 0.42 and 24.4%.</p></div><div><h3>Conclusions</h3><p>CV<sub>I</sub> and CV<sub>G</sub> of PIVKA-II were 8.2% and 19.5%, respectively, with CV<sub>A</sub> 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.</p></div>\",\"PeriodicalId\":20421,\"journal\":{\"name\":\"Practical Laboratory Medicine\",\"volume\":\"39 \",\"pages\":\"Article e00389\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2352551724000350/pdfft?md5=844de81587423e7d4dbacb9cd70469dd&pid=1-s2.0-S2352551724000350-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Practical Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2352551724000350\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2352551724000350","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Biological variation of PIVKA-II in blood serum of healthy subjects measured by automated electrochemiluminescent assay
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 (CVI) and between-subject (CVG) 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 (CVA) was assessed from duplicate measurements of all volunteers' samples. Two methods were used for the estimation of CVI: 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 CVI of PIVKA-II in healthy persons, as calculated by two statistical methods, were 8.2% (SD-ANOVA with CVA of 3.2%) and 9.4% (CV-ANOVA) with CVA of 2.7%). The CVG was 19.5% (SD-ANOVA), and respective II and RCV were 0.42 and 24.4%.
Conclusions
CVI and CVG of PIVKA-II were 8.2% and 19.5%, respectively, with CVA 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.
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.
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