Clinical Significance

Rubella is a viral illness with worldwide distribution. The infection is usually benign or even unapparent in children or adults. Clinical manifestations inculde a generalized skin rash over the entire body, a low-grade fever, headache, and sometimes a sore throat. Infections in utero, particularly during the first four months of pregnancy, can lead to congenital defects such as deafness, cardiac problems, cataracts or glaucoma, and sometime fetal death.

The detection of specific rubella antibodies is of great interest due to the teratogenic risk related to a rubella primary infection at the beginning of the pregnancy. Early methodologies used for antibody detection included serum neutralization, complement binding or immunofluorescensce. These tests are difficult to perform and presented inherent problems of reproducibility. Subsequently, hemagglutination inhibition techniques allowed a more rapid diagnosis of both the acute infected state and patient immune status.

Demonstration of rubella IgG antibody in a pregnant women prior to conception provides assurance of fetal protection from possible rubella viral infection during pregnancy. Vaccination efficiency is demonstrated by detection of rubella IgG antibody in serum following immunization. Appearance or significant rise of specific IgG concentration in two serum samples collected at least two weeks apart is indicative of rubella infection, even when typical symptoms may not be present.

_{Source: Access Rubella IgG IFU #33430, 12/17/15}