Evaluation of automated serum des-gamma-carboxyprothrombin (DCP) assays for detecting hepatocellular carcinoma

Abstract

OBJECTIVES: We evaluated two new autoanalyzers, μTAS and Lumipulse for des-γ-carboxyprothrombin (DCP) assay.

MATERIAL AND METHODS: Analytical performance was evaluated, and the upper reference limit of the 97.5th percentile for DCP was re-established using sera from 140 healthy individuals. DCP levels were determined by the two autoanalyzers and EIA in a total of 239 sera from HCC patients (n=120) and those without HCC (n=119).

RESULTS: Total imprecision of the two automated assays was <5% CV. Analytical measurement ranges (AMRs) were verified to be linear. The new reference limits were 29.5 mAU/mL for μTAS and 35.0 mAU/mL for Lumipulse. There were proportional and constant biases between the results from the autoanalyzers and those from EIA.

CONCLUSION: The two newly developed DCP assays showed high analytical performance, but re-establishment of reference limits would be necessary. The new analyzers could be useful for clinical laboratories because of convenience of operation and wide AMRs