ABSTRACT
This study evaluated the concordance of Architect™ chemiluminescent microparticle immunoassays with Captia™ ELISA for cytomegalovirus (CMV) IgM and IgG, with Enzygnost™ and Captia™ ELISA for rubella IgM and IgG and with Trep-Sure™ ELISA for syphilis treponemal antibodies in a mixed pediatric and obstetrical population. Total agreement between assays and Kappa statistic value were 82.5% (95% CI: 75.6-87.7) and 0.65 (95% CI: 0.54-0.77) for CMV IgM, 82.8% (95% CI: 76.7-87.6) and 0.65 (95% CI: 0.55-0.75) for CMV IgG, 89.2% (95% CI: 82.9-93.4) and 0.56 (95% CI: 0.36-0.75) for rubella IgM, 88.6% (95% CI: 82.9-92.6) and 0.74 (95% CI: 0.63-0.84) for rubella IgG, and 97.9% (95% CI: 94.5-99.4) and 0.89 (95% CI: 0.79-1.00) for syphilis treponemal antibodies. This study demonstrates that the Architect™ chemiluminescent microparticle immunoassays correlate well with other FDA-approved ELISA assays in this specific population.
Subject(s)
Antibodies, Bacterial/blood , Antibodies, Viral/blood , Cytomegalovirus Infections/diagnosis , Diagnostic Tests, Routine/methods , Immunoenzyme Techniques/methods , Rubella/diagnosis , Syphilis/diagnosis , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Female , Humans , Immunoglobulin G/blood , Immunoglobulin M/blood , Infant , Infant, Newborn , Luminescent Measurements , Male , Middle Aged , Young AdultABSTRACT
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.
