Description

The Diagnostic Automation, Inc. Rubella IgM is intended for use in the detection of IgM antibody to the
rubella virus.

Rubella is a herpes virus. Generally rubella is considered a mild adolescence disease. However a maternal infection could be transmitted through the placenta to the fetus, causing congenital rubella.
Congenital rubella may result in chronic cardiac disease, growth retardation, hepatosplenomegaly,
malformations and other severe anomalies. Children born asymptomatic may develop these abnormalities later in life. To reduce risk of such severe complications, accurate serological methods must be performed to determine the serologic status of childbearing aged women.

Purified rubella antigen is coated on the surface of microwells. Diluted patient serum is added to wells,
and the rubella IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody-antigen complex. Excess enzyme conjugate is washed off and TMB Chromogenic substrate is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of IgM specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.