Rubella IgG Assay Launched

An assay has been launched that aids in the determination of immunity to rubella infection, commonly known as German measles.

The Vitros Rubella IgG assay1 determines if IgG antibodies to the rubella virus are in the blood. The presence of IgG antibodies may indicate a recent or past rubella infection or that a rubella vaccine has been given and is providing adequate protection. The Vitros ECi/ECiQ immunodiagnostic system is a simple-to-use, flexible, and fully-automated
laboratory testing system that provides true continuous STAT, random access capabilities for routine and specialty immunodiagnostic testing. The system uses proprietary enhanced chemiluminescence detection.

Rubella is a viral infection that manifests itself as a mild rash on the skin and a low-grade fever. It is primarily transmitted via droplets from the nose or throat that others inhale. It is also transmitted from a pregnant woman's bloodstream to the unborn child. It is generally a mild disease in children and healthy adults. However, there can be significant medical danger if a pregnant woman has an active infection and the developing unborn child becomes infected. This can lead to death of the unborn child or birth defects such as blindness, deafness, metal retardation, and cardiac abnormalities. The risk of fetal infection and the severity of defects are greatest during the first trimester.

Ortho-Clinical Diagnostics (Raritan, NJ, USA), a Johnson & Johnson company, announced U.S. Food and Drug Administration (FDA) clearance and availability of the Vitros rubella IgG assay1. The Vitros ECi/ECiQ immunodiagnostic system uses Intellicheck technology, a technology designed to verify diagnostic checks throughout automated sample and assay processing. Intellicheck serves to increase the integrity and security of reported patient results while helping to ensure greater confidence and productivity for laboratories that generate these results.

"Even though the incidence of rubella infections [is at a] record low, routine rubella IgG testing is a vital part of pre-natal screening to determine the immune status of females planning pregnancy” said Michael Waller, M.D., vice president, clinical and medical affairs for Ortho-Clinical Diagnostics. "Once the results are known, appropriate vaccination or precautions can be made.”


Related Links:
Ortho-Clinical Diagnostics