Development and evaluation of analytical performance of a fully automated chemiluminescent immunoassay for protein induced by vitamin K absence or antagonist II

Abstract

The results demonstrate that the fully automated prototype ARCHITECT PIVKA-II assay is an accurate, highly sensitive and precise assay for the measurement of PIVKA-II levels in human sera and plasmas.

Diagnostic accuracy of des‐gamma‐carboxy prothrombin for hepatocellular carcinoma in a French cohort using the Lumipulse® G600 analyzer

“…These assays use a monoclonal antibody MU‐3 reacting with an epitope located within the amino acid residues 17‐27 in the γ‐carboxyglutamic domain. The most recent immunoassay is marketed by Abbott Laboratories on the Architect analyzer and uses two monoclonal antibodies, 3C10 and MCA 1‐8, which both recognize an epitope within the γ‐carboxyglutamic domain (amino acid 13‐27 and 33‐46, respectively) making the assay independent of the cleavage of the molecule by proteases . It is noteworthy that the Japanese manufacturers have been particularly interested in the development of this marker on clinical analysers over the past three decades, despite the fact that viral hepatitis leading to HCC is a worldwide burden.…”

Validation of a novel model for the early detection of hepatocellular carcinoma

“…US-approved AFP and ex-US‒approved PIVKA-II were measured using the ARCHITECT i 2000 immunoassay analyzer (Abbott Laboratories, North Chicago, IL) per the manufacturer’s instructions [22, 23]. Each two-step sandwich immunoassay utilizes paramagnetic microparticles coated with either anti-AFP [24] or anti-PIVKA-II [25] antibodies and a chemiluminescent signal for the quantitative measurement of AFP or PIVKA-II in human serum and plasma. The performance characteristics for the ARCHITECT AFP and PIVKA-II assays are described in Table 1.…”

Persistent Elevation of Serum Prothrombin Induced by Vitamin K Deficiency or Antagonist Despite Discontinuation of Warfarin Administration in Alcoholic Cirrhosis in The Absence of Hepatocellular Carcinoma: A Case Report

“…More recently, an automated chemiluminescent immunoassay using a new monoclonal antibody (3C10) as a primary antibody and a monoclonal antibody as a secondary antibody has been developed (AR-CHITECT PIVKA-II assay and Lumipulse Presto PIVKA-II Eisai, respectively) [23,24]. The values of serum PIVKA-II obtained using these methods showed positive correlations [24].…”

“…More recently, an automated chemiluminescent immunoassay using a new monoclonal antibody (3C10) as a primary antibody and a monoclonal antibody as a secondary antibody has been developed (AR-CHITECT PIVKA-II assay and Lumipulse Presto PIVKA-II Eisai, respectively) [23,24]. The values of serum PIVKA-II obtained using these methods showed positive correlations [24]. In the present case, since serum PIVKA-II levels were measured by the ARCHITECT PIVKA-II assay using the monoclonal antibody 3C10, a different result may have been obtained than had measurement been done using the monoclonal antibody MU-3.…”