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

ObjectivesWe evaluated two new autoanalyzers, μTAS and Lumipulse for des-γ-carboxyprothrombin (DCP) assay.Material and methodsAnalytical 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).ResultsTotal 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.ConclusionThe 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.

► We evaluated new analyzers, μTAS and Lumipulse for des-γ-carboxyprothrombin assay.
► Total imprecision of the automated assays was < 5% CV.
► Analytical measurement ranges of the analyzers were far wider than the EIA.
► There were proportional and constant biases between the analyzers and EIA.
► Re-established cutoffs were 29.5 mAU/mL for μTAS and 35.0 mAU/mL for Lumipulse.