Preparation of human GP73 immunoradiometric assay and chemiluminescence immunoassay kits and their clinical value in diagnosis of primary hepatic carcinoma and cirrhosis

Objective  To prepare human Golgi protein 73 (GP73) immunoradiometric assay (IRMA) and chemiluminescence immunoassay (CLIA) kits and explore their value in the diagnosis of primary liver cancer and liver cirrhosis.

Methods  One monoclonal antibody against GP73 was linked to the surface of carboxyl magnetic microparticles as a solid-phase carrier, and another was labeled with ¹²⁵I and acridinium ester as tracers to develop the GP73 IRMA and CLIA kits. The sensitivity, precision, and recovery rate of the kits were analyzed. Their diagnostic value for normal healthy individuals (normal group: n=60), patients with primary liver cancer (primary liver cancer group: n=52), and patients with liver cirrhosis (liver cirrhosis group: n=51) was evaluated by applying them to detect clinical serum samples. Intergroup comparisons were made using independent sample t-tests.

Results  The analytical sensitivity of IRMA and CLIA kits for GP73 was 0.91 and 0.32 ng/ml, respectively. The intrabatch variability of the IRMA and CLIA kits was 4.26% and 3.52%, respectively, and the interbatch variability was 6.84% and 6.38%, respectively. The average recovery rate of the IRMA and CLIA kits was 98.21% and 98.69%, respectively. The measured mean value of the IRMA and CLIA kits was 80.85 and 82.73 ng/ml for the liver cirrhosis group, respectively, 219.34 and 226.31 ng/ml for the primary liver cancer group, respectively, and 11.23 and 11.68 ng/ml for the normal group. Relative to the normal group, the differences for the first two groups were statistically significant (t=−11.765 to −11.539, all P<0.05).

Conclusion  The GP73 IRMA and CLIA kits prepared in this study have good technical indicators and can be used for the screening and clinical auxiliary diagnosis of primary liver cancer and liver cirrhosis.