Evaluation of the Abbott ARCHITECT™ cytomegalovirus IgM/IgG, rubella IgM/IgG, and syphilis treponemal antibodies enzyme immunoassays in a mother and child health center population

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.