Evaluation of a new enzyme immunoassay based on recombinant Rubella virus-like particles for detection of immunoglobulin M antibodies to Rubella virus.

A new enzyme immunoassay for the detection of specific antibodies to rubella virus was evaluated at two different sites. This assay, the Roche Cobas Core Rubella IgM EIA recomb, uses a recombinant rubella virus-like particle and is based upon the immunoglobulin M (IgM) capture principle. It was compared to the Abbott IMx Rubella IgM test and to the Sorin ETI-RUBEK-M reverse test. The relative clinical specificities were 99.30% for the Roche test, 98.26% for the Abbott test, and 100% for the Sorin test. The relative clinical sensitivities were 100, 93.87, and 82.65%, respectively. In the case of most primary infections, IgM antibodies could be detected immediately at the onset of the disease and for up to 7 weeks. In the case of vaccinations, they could be detected between 3 and 12 weeks after vaccination.