Intended Use

The LIAISON® Rubella IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to rubella virus in human serum specimens. It is intended for use as an aid in the determination of immune status to rubella in individuals including pregnant women. The performance of this device has not been established for cord blood, neonatal samples, or for any matrices other than human serum. Likewise, performance has not been established for population(s) of immunocompromised or immunosuppressed individuals.