ArticleJournal of clinical laboratory analysis2019
Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000.
Article in Journal of clinical laboratory analysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 14 citations in OpenAlex.
- PIVKA-II: A biomarker for diagnosing and monitoring patients with pancreatic adenocarcinoma.PloS one · 2021Trial
- Characterization of PIVKA-II Molecular Forms via Size Exclusion Chromatography and Hydrophobic Interaction Chromatography in HCC Patients.Journal of clinical laboratory analysis · 2025Article
- Development and Validation of a PIVKA-II-Based Model for HCC Risk Stratification in Patients With HCV-Related Cirrhosis Successfully Treated With DAA.Alimentary pharmacology & therapeutics · 2025Article
- Review
- Tumor biomarkers for diagnosis, prognosis and targeted therapy.Signal transduction and targeted therapy · 2024Review
- Article
- A performance evaluation of chemiluminescence enzyme immunoassays on the Sysmex CN-6500 haemostasis analyser.International journal of laboratory hematology · 2021Article
- The clinical application of PIVKA-II in hepatocellular carcinoma and chronic liver diseases: A multi-center study in China.Journal of clinical laboratory analysis · 2021Article
- Vitamin K Status in Adherent and Non-Adherent Patients with Phenylketonuria: A Cross-Sectional Study.Nutrients · 2020Article
- Evaluation of the clinical performance of the HISCL-5000 analyzer in the detection of Krebs von den Lungen-6 antigen and its diagnostic value in interstitial lung disease.Journal of clinical laboratory analysis · 2020Article
- Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000.Journal of clinical laboratory analysis · 2019Article
- Article
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProtein induced by vitamin K antagonist-II (PIVKA-II), in addition to alpha-fetoprotein, is a useful tumor marker for diagnosis of hepatocellular carcinoma (HCC). We evaluated the analytical performance of the HISCL-5000 analyzer (Sysmex Corporation) in the measurement of serum PIVKA-II.
methodsWe evaluated the precision and linearity of PIVKA-II assays using the HISCL-5000 analyzer. Methods using HISCL-5000, LUMIPULSE G1200 (Fujirebio Diagnostics), and ARCHITECT i2000 (Abbott Diagnostics) were compared according to the guidelines of the Clinical and Laboratory Standards Institute. A total of 501 subjects (median age 59 years, age range 24-90 years) were enrolled. Among them, 335 were HCC patients, 46 were patients with non-HCC liver disease, and 120 were healthy individuals. Non-HCC liver disease included liver cirrhosis, chronic hepatitis, HBV or HCV carrier, hepatic adenoma, and intrahepatic cholangiocarcinoma.
resultsRepeatability (%CV) in low- and high-level controls and pooled serum was 2.81%-10.30%, and within-laboratory precision was 4.24%-8.86%. In a linearity test, the coefficient of determination (R
conclusionsA PIVKA-II assay using HISCL-5000 showed acceptable analytical performance including precision, linearity, and method comparison. This indicates that HISCL-5000 can be potentially helpful in clinical laboratories.
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