Evaluation of a commercial antibody capture enzyme immunoassay for the detection of rubella specific IgM.

A commercial M antibody capture ELISA kit ( Rubenz M) for the detection of rubella specific IgM was evaluated in comparison with M antibody capture radioimmunoassay. A total of 248 sera were evaluated, including sera from cases of primary postnatal rubella, congenital rubella, infectious mononucleosis, and sera which contained rheumatoid factor. No false positive results were obtained but two high positive sera gave Rubenz M values which were below the value recommended as indicative of a positive result. We therefore propose changes in the criteria used for assessing the significance of the results obtained. These changes improve the accuracy of the assay without loss of specificity.