ArticleJGH open : an open access journal of gastroenterology and hepatology2022
Performance evaluation of the Elecsys PIVKA-II and Elecsys AFP assays for hepatocellular carcinoma diagnosis.
Article in JGH open : an open access journal of gastroenterology and hepatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers, 1 of them a synthesis that pooled it.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update.Hepatology international · 2026Guideline
- [APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Article
- Assay performance verification and reference interval establishment for PIVKA-II on the Roche cobas e 801.BMC gastroenterology · 2026Article
- Clinical performance of GAAD score, alpha-fetoprotein, and PIVKA-II in diagnosing hepatocellular carcinoma in the Vietnamese cohort.Discover oncology · 2025Article
- Establishing a Decision-Making Threshold for PIVKA II in the Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC): A Single Centre Experience.Asian Pacific journal of cancer prevention : APJCP · 2025Article
- Article
- Current and new strategies for hepatocellular carcinoma surveillance.Gastroenterology report · 2025Review
- Preparation and application of multiple particle binding-liposomes for electrochemiluminescent signal amplification in bioassays.Analytical and bioanalytical chemistry · 2024Article
- Article
- Disease modifiers and novel markers in hepatitis B virus-related hepatocellular carcinoma.Journal of liver cancer · 2024Article
- Biological variation of PIVKA-II in blood serum of healthy subjects measured by automated electrochemiluminescent assay.Practical laboratory medicine · 2024Article
- Battle of the biopsies: Role of tissue and liquid biopsy in hepatocellular carcinoma.Journal of hepatology · 2024Review
- Establishment and Validation of a Blood Test-based Nomogram to Diagnose Patients with AFP-negative HCC.Current cancer drug targets · 2024Article
- A pancreatic adenocarcinoma mimicking hepatoid carcinoma of uncertain histogenesis: A case report and literature review.Oncology letters · 2023Article
- Protein Induced by Vitamin K Absence or Antagonist-II Versus Alpha-Fetoprotein in the Diagnosis of Hepatocellular Carcinoma: A Systematic Review With Meta-Analysis.Journal of clinical medicine research · 2023Article
- Diagnostic Performance of Extrahepatic Protein Induced by Vitamin K Absence in the Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2023Article
- Circulating Biomarkers for the Early Diagnosis and Management of Hepatocellular Carcinoma with Potential Application in Resource-Limited Settings.Diagnostics (Basel, Switzerland) · 2023Review
- Clinical value of serum AFP and PIVKA-II for diagnosis, treatment and prognosis of hepatocellular carcinoma.Journal of clinical laboratory analysis · 2023Article
Corrections and comments
- Erratum issuedCorrigendum.2022
Authors and funding
14 authors at 12 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background and Aims: Prothrombin induced by vitamin K absence-II (PIVKA-II) is a serum biomarker linked to hepatocellular carcinoma (HCC), showing superiority to alpha-fetoprotein (AFP) for early disease detection. We aimed to assess the clinical and analytical performance of the Elecsys® PIVKA-II immunoassay in diagnosing HCC and evaluate PIVKA-II's technical performance. Methods: Serum samples from adult cases (i.e. patients with a first-time HCC diagnosis; Results: The Elecsys PIVKA-II assay compared favorably with comparator assays. Using a 28.4 ng/mL cut-off, the Elecsys PIVKA-II assay detected HCC with 86.9% sensitivity and 83.7% specificity. Clinical performance of the Elecsys PIVKA-II assay (AUC: 90.8%) was equivalent to that of comparator assays (AUC: 88.3-89.6%). Relatively high PIVKA-II concentrations were observed for cholangiocarcinoma and pancreatic cancer with the Elecsys assay in specificity panel analyses, indicating that high PIVKA-II concentrations should not be used alone in the absence of other clinical data. Conclusions: The Elecsys PIVKA-II assay showed good analytical performance under routine laboratory conditions, comparing favorably with comparator assays. These findings support the suitability of the Elecsys PIVKA-II assay as an aid in HCC diagnosis.
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