Comparison of Five Methods for the Determination of Rubella Immunity

OBJECTIVE The purpose of this study was to compare the accuracy of commonly used methods for the detection of rubella immunity, especially the fully automated IMx assay. METHODS A total of 190 sera (101 immune and 89 non-immune) submitted to Harrisburg Hospital or Polyclinic Medical Center for the determination of rubella immunity were tested by enzyme immunoassay (IMx and Rubazyme, Abbott Diagnostic Laboratories, North Chicago, IL), indirect immunofluorescence (FIAX, Whittaker Bioproducts, Walkersville, MD), and latex agglutination (Rubascan, Becton Dickinson Microbiology Systems, Cockeysville, MD, and Rubalex, Wellcome Diagnostics, Research Triangle Park, NC). Specimens were frozen at -30 until the study was initiated. Each of the assays was performed according to the manufacturers' specifications. Sensitivity, specificity, accuracy, and positive and negative predictive values for each assay were calculated using a consensus result of the 5 methods tested. RESULTS The sensitivity, specificity, and accuracy, respectively, of the test systems were as follows: IMx, 96%, 97%, and 96%; Rubazyme, 100%, 99%, and 99%; Rubascan, 100%, 98%, and 99%; Rubalex, 99%, 97%, and 98%; and FIAX 90%, 100%, and 95%. False negative reactions were seen with the FIAX system. CONCLUSIONS The IMx system, a new "walk away" system from Abbott Diagnostic Laboratories and the Rubazyme systems performed well; however the latex agglutination tests proved to be the most rapid and convenient methods for screening sera for the presence of rubella immunity.