Enzygnost™-Rubella: An Enzyme Immunoassay for Screening and Quantitation of Antibodies to Rubella Virus

Abstract

Calbiochem-Behring, Enzygnost-Rubella is an enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies to rubella virus. Two procedures, screening and quantitative, were used for the measurement of rubella antibodies in a characterized panel of sera and in random, premarital serum specimens. Using the screening procedure, no false-positive or false-negative results were observed in testing a panel of 40 sera previously characterized by human "O" cell and chick cell hemagglutination-inhibition (HI) tests. Additional testing of 323 random, premarital serum samples resulted in 99.4% agreement with HI tests in identifying positive and negative specimens. In the evaluation of the quantitative procedure, a coefficient of correlation (r) of 0.93 between ELISA titers and the geometric mean HI titers was obtained when testing the panel of 40 characterized sera. Furthermore, 100% agreement with HI test was obtained in the detection of titer rises in 20 pairs of acute and convalescent sera. The average within-run coefficients of variation for the screening and quantitative procedures were determined to be 11.2% and 15.6%, respectively. It is concluded that the Enzygnost-Rubella reagents are sensitive, specific, and provide objective means for assessing immunestatus and detecting rises in antibody titers to rubella virus.