Evaluation of the abbot Architect™ epstein-barr virus viral capsid antigen IgM, viral capsid antigen IgG and nuclear antigen IgG assays in a pediatric and adult population

Background The detection of antibodies against Epstein-Barr viral capsid (VCA) and nuclear (EBNA) antigens is routinely performed with different commercially available immunoassays. Objectives In this study, we evaluated the concordance and performance of the Architect™ chemiluminescent microparticle immunoassays (CMIAs) using Captia™ enzyme linked immunosorbent assays (ELISA) for VCA IgM, and standard immunofluorescence (IF) assays for VCA IgG and EBNA IgG as comparative techniques. Study design Sera were selected from a heterogeneous population including pediatric and adult patients. Results Concordance between CMIAs and comparative assays was high with total agreement percentages of 84,1% (95% CI: 77.8–88.9) for VCA IgM, 90,6% (95% CI: 84.2–94.7) for EBNA IgG and 98,0% (95% CI: 93.9–99.6) for VCA IgG. Moreover, kappa statistic values showed good to excellent correlation with values of 0.68 (95% CI: 0.57–0.79) for VCA IgM, 0.73 (95% CI: 0.58–0.87) for EBNA IgG and 0.95 (95% CI: 0.89–1.00) for VCA IgG. A correlation was observed between positivity levels on CMIAs and semi-quantitative fluorescence intensity on IF for VCA IgG and EBNA IgG assays. With regard to an accepted gold standard IF assays, CMIA was 98,1% (95% CI: 93.3–99.8) sensitive and 97,4% (95% CI: 86.5–99.9) specific for the detection of VCA IgG. For the detection of EBNA IgG, it was 92,2% (95% CI: 85.1–96.6) sensitive and 84,6% (95% CI: 65.1–95.6) specific. Conclusion In summary, we demonstrated that the CMIA EBV antibody detection panel has high performance and high concordance with other commercially available immunoassays.