Use of serum PIVKA-II (DCP) determination for differentiation between benign and malignant liver diseases.
BACKGROUND
The concentration of Des-gamma-carboxy-prothrombin (DCP) or PIVKA-II has been described to be increased in patients with hepatocellular cancer, along with its elevation in vitamin K deficient states by warfarin or dicoumarol treatment. The aim of the study was to investigate its clinical value in HCC in comparison with alpha-fetoprotein.


METHODS
Measurements were performed in duplicate in serum of 87 patients with benign (acute/chronic hepatitis B/C/autoimmune, liver cirrhosis B/C/alcoholic) and 154 patients with highly probable (CT, MRT imaging) or histologically proven HCC. Two commercial or research ELISA tests (1: Eitest MonoP-II, Eisai, Tokyo, Japan; 2: Asserachrom PIVKA-II, Stago, France) using murine monoclonal anti-PIVKA-II antibodies were used comparatively and compared with a laboratory-developed conventional AFP-RIA.


RESULTS
By ROC analysis, a highly significant discrimination (p < 0.0001) was found at cutoffs of 0.09 AU/ml (Eisai) or 0.8 ng/ml (Stago) at a specificity of about 90% (Eisai: s = 78.6%, ppv = 0.92, npv = 0.70; Stago: s = 77.9%, ppv = 0.93, npv = 0.70) compared with the AFP-test at a cutoff of 45 ng/ml (sp = 91%, s = 58.4%, ppv = 0.92, npv = 0.55). A higher significant correlation was seen between both DCP tests in malignant (rS = 0.89, p < 0.0001) than benign groups (rS = 0.41, p < 0.001) and a lower correlation between the AFP and Eisai (rS = 0.27/0.36, p < 0.01) and Stago test for the malignant group (0.16; p < 0.05).


CONCLUSIONS
DCP determination in serum/plasma adds significantly in the discrimination between benign and malignant liver diseases.
Lamerz
R
R
Department of Internal Medicine II, Ludwig-Maximilians-University, Munich, Germany. lamerz@med2.med.uni-muenchen.de
Runge
M
M
Stieber
P
P
Meissner
E
E
D000328:Adult; D000368:Aged; D015415:Biomarkers; D014408:Biomarkers, Tumor / Q000097:blood*; D006528:Carcinoma, Hepatocellular / Q000097:blood* / Q000175:diagnosis*; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008107:Liver Diseases / Q000097:blood / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000097:blood* / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000032:analysis*; D011516:Prothrombin / Q000032:analysis*; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014057:Tomography, X-Ray Computed; D000509:alpha-Fetoproteins / Q000032:analysis
D015415:Biomarkers; D014408:Biomarkers, Tumor; D011498:Protein Precursors; D011933:Reagent Kits, Diagnostic; D000509:alpha-Fetoproteins; C008208:acarboxyprothrombin; D011516:Prothrombin