title: Development and evaluation of analytical performance of a fully automated chemiluminescent immunoassay for protein induced by vitamin K absence or antagonist II.
abstract: OBJECTIVE
  Protein induced by vitamin K absence or antagonist II (PIVKA-II), an abnormal form of prothrombin, has been used as an aid in the diagnosis of hepatocellular cancer (HCC) as a tumor marker. We developed a fully automated quantitative immunoassay for PIVKA-II on the ARCHITECT® i systems. The aim of this study was to evaluate the analytical performance of this assay.
  
  
  METHODS
  Assay imprecision, sensitivity, dilution linearity, high dose hook effect, sample type equivalency, assay interferences of potential interfering materials and correlation with Picolumi PIVKA-II (Eidia, Tokyo, Japan) were evaluated.
  
  
  RESULTS
  The percentage coefficient of variation (%CV) of total imprecision ranged from 2.8% to 5.4% with 10 levels of samples. The limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) were less than 0.63 mAU/mL, 1.62 mAU/mL, and 8.25 mAU/mL, respectively. Linearity up to 30,000 mAU/mL, no high dose hook effect, no difference among sample types and no interference of common drugs and endogenous substances were observed. Correlation study with the Picolumi PIVKA-II gave a correlation coefficient of 0.93 and a regression slope of 1.07.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Research and Development, Abbott Japan Co., Ltd., Chiba, Japan. Electronic address: Kenju.fujita@abbott.com.
authors.forename: Kenju
authors.initials: K
authors.lastname: Fujita
authors.affiliation: Research and Development, Abbott Japan Co., Ltd., Chiba, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Kinukawa
authors.affiliation: R&D Center for Diagnostic Reagents, Denka Seiken Co., Ltd., Niigata, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Ohno
authors.affiliation: R&D Center for Diagnostic Reagents, Denka Seiken Co., Ltd., Niigata, Japan.
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Ito
authors.affiliation: R&D Center for Diagnostic Reagents, Denka Seiken Co., Ltd., Niigata, Japan.
authors.forename: Haruhisa
authors.initials: H
authors.lastname: Saegusa
authors.affiliation: Research and Development, Abbott Japan Co., Ltd., Chiba, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Yoshimura
mesh_terms: D057205:Automation, Laboratory / Q000592:standards*; D015415:Biomarkers / Q000097:blood; D014408:Biomarkers, Tumor / Q000097:blood / Q000235:genetics*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis / Q000235:genetics; D015870:Gene Expression; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000592:standards*; D057230:Limit of Detection; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis / Q000235:genetics; D008163:Luminescent Measurements / Q000295:instrumentation / Q000592:standards*; D011498:Protein Precursors / Q000097:blood / Q000235:genetics*; D011516:Prothrombin / Q000235:genetics*
chemical_list: D015415:Biomarkers; D014408:Biomarkers, Tumor; D011498:Protein Precursors; C008208:acarboxyprothrombin; D011516:Prothrombin
keywords: ARCHITECT; Chemiluminescent microparticle immunoassay; DCP; Hepatocellular carcinoma; PIVKA-II; Tumor marker