title: Evaluation of automated serum des-gamma-carboxyprothrombin (DCP) assays for detecting hepatocellular carcinoma.
abstract: OBJECTIVE
  We evaluated two new autoanalyzers, μTAS and Lumipulse for des-γ-carboxyprothrombin (DCP) assay.
  
  
  METHODS
  Analytical performance was evaluated, and the upper reference limit of the 97.5th percentile for DCP was re-established using sera from 140 healthy individuals. DCP levels were determined by the two autoanalyzers and EIA in a total of 239 sera from HCC patients (n=120) and those without HCC (n=119).
  
  
  RESULTS
  Total imprecision of the two automated assays was <5% CV. Analytical measurement ranges (AMRs) were verified to be linear. The new reference limits were 29.5 mAU/mL for μTAS and 35.0 mAU/mL for Lumipulse. There were proportional and constant biases between the results from the autoanalyzers and those from EIA.
  
  
  CONCLUSIONS
  The two newly developed DCP assays showed high analytical performance, but re-establishment of reference limits would be necessary. The new analyzers could be useful for clinical laboratories because of convenience of operation and wide AMRs.
authors.affiliation: Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jonghyeon
authors.initials: J
authors.lastname: Choi
authors.forename: Yongjung
authors.initials: Y
authors.lastname: Park
authors.forename: Jeong-Ho
authors.initials: JH
authors.lastname: Kim
authors.forename: Hyon-Suk
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D057205:Automation, Laboratory; D015415:Biomarkers / Q000097:blood*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis*; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000097:blood*; D011516:Prothrombin; D011786:Quality Control; D012372:ROC Curve; D012015:Reference Standards; D012016:Reference Values
chemical_list: D015415:Biomarkers; D011498:Protein Precursors; C008208:acarboxyprothrombin; D011516:Prothrombin