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

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 (R (2)) 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.