2019 Volume 68 Issue 1 Pages 56-60
PIVKA-II is released from hepatocytes during vitamin K deficiency, vitamin K antagonist administration, or hepatocellular injury. It is used as a tumor marker since it is highly expressed in patients with hepatocellular carcinoma. In this study, we examined the basic performance of the newly improved “Lumipulse Presto PIVKAII-N Eisai” reagent. For this reagent, the anti-MU-3 antibody is used as the primary antibody and a monoclonal antibody is used as the secondary antibody (previously, a polyclonal antibody was used). Moreover, the measurement of PIVKAII in plasma and also in serum became possible. The coefficients of variation of repeatability and reproducibility were 1.8–6.3% and 2.9–5.4%, respectively. A satisfactory linearity was obtained for the dilution test. The correlation with the current reagent was good (r = 0.99). When the measurement range was from 0 to 75,000 mAU/mL, the correlation between the serum and the plasma was strong (r = 1.00). However, the regression formula was y = 0.78x + 231.4, and the slope was slightly lower. The slope was 1.04 at 10,000 mAU/mL or less. In conclusion, this new reagent should be useful for routine examination.
