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

摘要

This study evaluated the concordance of Architect (TM) chemiluminescent microparticle immunoassays with Captia (TM) ELISA for cytomegalovirus (CMV) IgM and IgG, with Enzygnost (TM) and Captia (TM) ELISA for rubella IgM and IgG and with Trep-Sure (TM) 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% Cl: 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 (TM) chemiluminescent microparticle immunoassays correlate well with other FDA-approved ELISA a ssays in this specific population. (C) 2019 Elsevier Inc. All rights reserved.