For the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection.
Diluted samples are incubated in antigen-coated wells. Absorbents have been included in the Diluent to neutralize the affects of rheumatoid factor and anti-rubella IgG antibody. Rubella antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to rubella are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme-labeled substrate is added and incubated. In the Presence of the enzyme, the substrate is converted to a yellow end product which is read photometrically.