Development of des-gamma-carboxy prothrombin (DCP) measuring reagent using the LiBASys clinical analyzer.
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.
Yamaguchi
Isao
I
New Diagnostics Business and Technology Development Department, Wako Pure Chemical Industries Ltd., Hyogo, Japan. yamaguchi.isao@wako-chem.co.jp
Nakamura
Kenji
K
Kitano
Hiromichi
H
Masuda
Yoshie
Y
Kanke
Futoshi
F
Kobatake
Shinzo
S
Satomura
Shinji
S
D015415:Biomarkers / Q000097:blood* / Q000737:chemistry*; D006528:Carcinoma, Hepatocellular / Q000097:blood; D019963:Clinical Chemistry Tests / Q000295:instrumentation / Q000379:methods*; D007202:Indicators and Reagents; D016014:Linear Models; D011498:Protein Precursors / Q000097:blood* / Q000737:chemistry*; D011516:Prothrombin / Q000737:chemistry*; D012680:Sensitivity and Specificity; D000509:alpha-Fetoproteins / Q000032:analysis
D015415:Biomarkers; D007202:Indicators and Reagents; D011498:Protein Precursors; D000509:alpha-Fetoproteins; C008208:acarboxyprothrombin; D011516:Prothrombin