Evaluation of Commercial Immunoassays for Rubella Virus IgG Detection in Low-Antibody Sera Using a Recombinant Immunoblot as a Reference Method.

ABSTRACT: Rubella virus (RV) IgG quantification is essential for verifying immunity, particularly in prenatal care. However, substantial variability exists among commercial immunoassays, especially when testing low-antibody sera. In this study, we evaluated five commercial assays-four chemiluminescent immunoassays (CLIAs) and one Enzyme-linked Immunosorbent Assay (ELISA)-using a recombinant immunoblot (IB) as the reference method. A panel of 137 serum samples with low or undetectable IgG levels was analyzed. Sensitivity ranged from 19.6% to 70.1%, while specificity exceeded 94%. Only 18.6% of immunoblot-positive samples tested positive across all assays. Marked quantitative differences were observed, with the Atellica assay yielding the highest titers and Alinity the lowest. Reclassifying equivocal

SUBMITTER: Ortega C 

PROVIDER: S-EPMC12844522 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature