High Performance Rubella IgM Assay on Superparamagnetic Beads with a Novel Recombinant Rubella Antigen

Virion\Serion presents a novel recombinant Rubella spike ectodomain (E1-E2) antigen in comparison with established IVD Rubella IgM assays. The IgM antibodies are detected on magnetic beads coated with the new recombinant Rubella antigen and a fluorescent read-out system.

Rubella is a contagious viral infection typically occurring in childhood and mostly causing mild symptoms only. Rubella virus infection during pregnancy, however, can cause congenital Rubella syndrome with serious damage to unborn babies. The global incidence of Rubella is approximately 100,000 cases per year, manifesting mainly in Southeastern Asia, India, China and Africa. Detection of Rubella IgM specific antibodies is used for monitoring infectious diseases associated with Rubella virus. Here, a new recombinant Rubella antigen based on spike E1-E2 ectodomain (patent pending) is used for the detection of Rubella IgM antibodies. The E1-E2 heterodimers on the viral surface are the major target for neutralizing antibodies during infection. So far two types of Rubella antigens are used in diagnostics - purified and inactivated Rubella virus lysates or recombinant Rubella-like particles (RLPs). Both antigens are costly in production and difficult in standardization. Also modifications of these Rubella antigens for optimization or adaption to specific diagnostic platforms, e.g. special coating or coupling strategies, are not feasible due to the nature of these antigens. In contrast the novel recombinant Rubella spike ectodomain (E1-E2) antigen can be produced in high yields in cell culture and can be genetically modified according to any specific need. That makes the novel antigen an excellent choice for advanced diagnostic systems for serology, like micro arrays, multiplex tests (beads/POCT) or chemiluminescent tests (CLIA). But the new Rubella antigen can also be used in conventional ELISA systems to replace the conventional antigens.