Development of des-gamma-carboxy prothrombin (DCP) measuring reagent using the LiBASys clinical analyzer

Clin Chem Lab Med. 2008;46(3):411-6. doi: 10.1515/CCLM.2008.078.

Abstract

Background: Des-gamma-carboxy prothrombin (DCP), Lens culinaris agglutinin-reactive alpha-fetoprotein ratio (AFP-L3) and total alpha-fetoprotein (AFP) are tumor markers useful for diagnosing and determining the prognosis of hepatocellular carcinoma (HCC). There is a real need for measurement of these three markers on a one-assay platform.

Methods: A method of DCP measurement in human serum was developed using liquid binding assay (LBA), which enables rapid antigen-antibody reaction and bound/free separation on the LiBASys clinical analyzer.

Results: The dilution curve for DCP was linear up to 500 ng/mL. The limit of detection of DCP concentration was 0.5 ng/mL. Intra- and inter-assay coefficients of variation of DCP were 0.7%-2.4% and 2.2%-6.5%, respectively. This method was free from interference by hemoglobin, bilirubin, ditaurobilirubin, intrafat, ascorbate, galactose, glucose and rheumatoid factor. The analytical recoveries of DCP added to serum were 91.7%-108.2%. DCP concentration measured with the LBA method was linear and was significantly correlated with that measured with the ELISA method.

Conclusions: The LiBASys clinical analyzer made possible measurement of the complementary tumor markers, HCC, total AFP, AFP-L3 and DCP.

MeSH terms

  • Biomarkers / blood*
  • Biomarkers / chemistry*
  • Carcinoma, Hepatocellular / blood
  • Clinical Chemistry Tests / instrumentation
  • Clinical Chemistry Tests / methods*
  • Indicators and Reagents
  • Linear Models
  • Protein Precursors / blood*
  • Protein Precursors / chemistry*
  • Prothrombin / chemistry*
  • Sensitivity and Specificity
  • alpha-Fetoproteins / analysis

Substances

  • Biomarkers
  • Indicators and Reagents
  • Protein Precursors
  • alpha-Fetoproteins
  • acarboxyprothrombin
  • Prothrombin