RECOMBINANT EXPRESSION OF RUBELLA E1 ENVELOPE PROTEIN VARIANTS AS CHAPERONE FUSION-PROTEINS, THEIR REFOLDING INTO A SOLUBLE, NATIVE-LIKEAND IMMUNOREACTIVE ANTIGENIC CONFORMATION AND THEIR USE IN THE DETECTION OFANTI-RUBELLA ANTIBODIES

摘要

The invention relates to a soluble Rubella E1 antigen and variants lacking a t the C--terminal end at least the transmembran region and the anchor segment as well as at least the amino acids 143 to 164 and containing at least the region spanning the disulfid-bridges Cys 349 - Cys 352 and Cys 368 - 401 whereas the N-terminus of this region contains additionally at least 15 amino acids and/or the C- terminus of this region contains additionally at least 8 amino acids of the adjacent Rubella E1 antigen sequence. The region spanning the disulfid-bridges Cys 349 - Cys 352 and Cys 368 - 40 1 contains at the N-terminus of this region additionally at least 25, 30, 34 amino acids and/or at the C-terminus of this region additionally at least 10, 11, 15, 25 , 35 amino acids of the adjacent Rubella E1 antigen sequence. Furthermore, the invention relates to a recombinant DNA molecule encoding a Rubella E1 antigen and variants, methods for the detection, determination an d quantification of anti-Rubella antibodies, and a diagnostic test and reagent kit for the detection of anti-Rubella antibodies.