2017 Volume 66 Issue 2 Pages 125-132
Protein induced by vitamin K absence or antagonist-II (PIVKA-II), a tumor marker of hepatocellular carcinoma, is the abnormal variant of pro-thrombin produced in the absence of vitamin K. In this study, we evaluated the basic performance of a new assay kit, ARCHITECT PIVKA-II, in measuring PIVKA-II. The coefficients of variation (C.V.) of within-run and between-day precisions with quality control samples for ARCHITECT PIVKA-II were 2.2 to 3.0% and 2.8 to 4.9%, respectively. Using pooled sera of patients, we determined the C.V. to be 2.0 to 2.7% and 3.2 to 4.9%, respectively. It showed good linearity from 0 to 30,000 mAU/mL, and the limit of quantitation was 3.45 mAU/mL. No interference by endogenous substances was observed. The correlations between Picolumi or Lumipulse Presto and ARCHITECT PIVKA-II assay were good. The differences in the values of the samples prepared using plain serum tubes, serum separator tubes, and rapid serum tubes, which include thrombin, were not significant. These results indicate that ARCHITECT PIVKA-II has high basic performance and greatly contributes to routine tests in laboratories.
