Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000

Abstract

Background: Protein 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. Methods: We 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. Results: Repeatability (%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 (R2) was 0.9957, ranging from 11 to 69 897 mAU/mL. In comparison, the coefficient of correlation (r) was 0.9561-0.9644, agreement was 93.4%-97.6%, and the κ value was 0.855-0.945 among the three analyzers. About 99.2% of healthy individuals and 84.8% of non-HCC liver disease patients were below the cutoff value (40 mAU/mL) on HISCL-5000. Conclusions: A 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.