title: Clinical application of an enzyme-linked immunosorbent assay detecting hepatoma-specific gamma-glutamyltransferase.
abstract: OBJECTIVE
  To develop a sandwich enzyme-linked immunosorbent assay (ELISA) measuring hepatoma-specific datura stramonium agglutinin-tightly bounding gamma-glutamyltransferase (DSA-GGT) and evaluate its clinical application for hepatocellular carcinoma (HCC) diagnosis.
  
  
  METHODS
  Serum DSA-GGT concentrations were measured with the sandwich ELISA system in 96 patients with HCC, 240 patients with chronic liver diseases and 119 healthy subjects. The diagnostic performance of DSA-GGT for HCC was assessed using receiver operating characteristic (ROC) curves. The diagnostic accuracy of DSA-GGT was compared with serum alpha-fetoprotein (AFP).
  
  
  RESULTS
  The area under the ROC curve of DSA-GGT in discriminating patients with HCC from non-HCC was 0.865 (95% confidence interval: 0.818-0.915, P < 0.001). Serum DSA-GGT was positive in 67 out of 96 patients with HCC and 23 out of 240 patients with non-HCC diseases. The sensitivity and specificity of DSA-GGT and AFP for the diagnosis of HCC were 69.8% and 90.5%, and 72.9% and 89.1%, respectively. A higher sensitivity (93.8%) in the identification of HCC was observed by combining DSA-GGT and AFP.
  
  
  CONCLUSIONS
  The sandwich ELISA system showed good reliability and reproducibility, and using the measurement, we found that serum DSA-GGT was a valuable marker of HCC, as a usable complementary to AFP. The sensitivity for identifying HCC could be significantly improved by combining DSA-GGT and AFP, and the combination could be used in large-scale screening for HCC in susceptible individuals.
authors.affiliation: Department of Clinical Laboratory, Nanjing Second Hospital Affiliated to Medical College, Southeast University, Nanjing, China.
authors.forename: Nian-Yue
authors.initials: NY
authors.lastname: Wang
authors.forename: Dai
authors.initials: D
authors.lastname: Zhang
authors.forename: Wei
authors.initials: W
authors.lastname: Zhao
authors.forename: Guo-Xiang
authors.initials: GX
authors.lastname: Fang
authors.forename: Yu-Ling
authors.initials: YL
authors.lastname: Shi
authors.forename: Mu-Hao
authors.initials: MH
authors.lastname: Duan