Sysmex Journal International

2018Vol.28 No.1


Fundamental Study of HISCL™ PIVKA-II Reagent for Fully Automated Immunoassay Analyzer HISCL™


Yuji HORIUCHI*, Mayumi IKEDA*, Shinji OIKAWA*, Kenji ABE* and Akira HISHINUMA*1,3

*1 Clinical Laboratory Center, Dokkyo Medical University Hospital
*2 Clinical Research Department, EDIA Co., Ltd.
*3 Department of Infection Control and Clinical Laboratory Medicine, Dokkyo Medical University


Proteins induced by vitamin K absence or antagonists (PIVKAs) are a result of the abnormal synthesis of γ-carboxyglutamic acid (Gla) residues near the N-terminus of a vitamin K-dependent blood coagulation protein, where all or part of the Gla residues appear in the blood as glutamic acid residues. PIVKA-II is the PIVKA form of blood coagulation factor II (prothrombin), which is found in high concentration in the blood of patients with hepatocellular carcinoma.

PIVKA-II is measured using the MU-3 antibody, a monoclonal antibody that recognizes PIVKA-II. The MU-3 antibody has strong reactivity to PIVKA-II with a small number of Gla residues. A large amount of accumulated clinical data shows that PIVKA-II specifically increases in patients with hepatocellular carcinoma and is thus useful for assessing response to treatment or assisting in diagnosing the recurrence of the disease.

HISCL™ PIVKA-II Reagent was developed for the fully automated immunoassay analyzer HISCL™ (Sysmex Corporation, Kobe, Japan), which employs chemiluminescent enzyme immunoassay. In this paper, we report the results of a fundamental study of HISCL and its correlation with other assays using human serum samples.


PIVKA-II, CLEIA Method, Hepatocellular Carcinoma


This article is translated and republished from Japanese Journal of Medicine and Pharmaceutical Science Vol.72 No.9, 2015. (issued in Japan) (Acceptable secondary publication)