Clinical Evaluation of a Newly Developed Chemiluminescent Enzyme Immunoassay for Hepatitis C Virus Core Antigen in Japan.

An advanced and fully automated chemiluminescent enzyme immunoassay for the hepatitis C virus core antigen (HCVcAg) was recently developed in Japan. We aimed to evaluate its clinical utility. The new Fujirebio assay (Lumipulse Presto HCVcAg [LP-Presto]) was compared with 2 conventional assays (Lumipulse Ortho HCVcAg [LP-Ortho] and Abbott's Architect HCVcAg). Basic assessments of LP-Presto (reproducibility, stability, range of quantitation, and specificity) were performed on 220 frozen sera (83 positive and 137 negative by LP-Ortho) and 206 fresh sera (all negative by LP-Ortho). Correlation analysis was performed and the rates of concordance for each assay were determined. Additionally, the frozen sera of 42 hyperimmunoglobulinemia patients, including 3 unmeasurable by LP-Ortho, were tested by LP-Presto. All the basic assessments of LP-Presto were consistent with the results of LP-Ortho and Architect. The concordance rate between LP-Presto and LP-Ortho for the 220 frozen sera was 99.5% (219/220), and that between LP-Presto and Architect was 99.1% (218/220). LP-Presto (HCVcAg cut-off value; 20 fmol/L) was fully consistent with LP-Ortho (100%), which found 343 sera negative for HCVcAg. All 42 hyperimmunoglobulinemic sera were measurable using LP-Presto. In conclusion, the performance of LP-Presto was rapid and reliable, and nonspecific test results due to hyperimmunoglobulinemia were reduced when LP-Presto was used. Therefore, LP-Presto is a high-quality HCVcAg assay that shows promising applications.