Strengthening its global leadership position in infectious disease testing, Ortho-Clinical Diagnostics, a Johnson & Johnson company, announces the launch of three new infectious disease assays in international markets excluding the United States.

The assays, for use on the Vitros ECi/ECiQ Immunodiagnostic system, are the Vitros Rubella IgM, the Vitros Toxoplasma IgM and the Vitros (CMV) IgG assays.

"These three new assays will provide an aid in the diagnosis of infections with rubella virus, Toxoplasma gondii and CMV," said Michael Waller, MD, vice president, Clinical and Medical Affairs for Ortho-Clinical Diagnostics. "Infections with these agents are most significant during pregnancy as they are associated with congenital defects of the newborn. Therefore, these assays provide critical information to physicians caring for women prior to and during pregnancy."

IgM antibodies are detected during an active infection and decline over time. IgG antibodies are detected soon after IgM antibodies and indicate a recent or past infection and typically remain detectable for life.

These three new assays complement the already available Vitros Rubella IgG and Vitros Toxoplasma IgG assays. To complete the congenital panel, the Vitros Cytomegalovirus (CMV) IgM assay is under development, with plans for a launch by the end of 2007.

Rubella, also known as German measles, is a viral infection that manifests itself as a mild rash on the skin and a low-grade fever. 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, mental retardation and cardiac abnormalities. The risk of fetal infection and the severity of defects are greatest during the first trimester.

Although the incidence of rubella infection is at a historic low due to the availability of a vaccine, the consequence of rubella infections during pregnancy remains an important public health problem both in the European Union and wider WHO European regions. This is due to travel to and from high incidence countries, declines and inequalities in routine vaccine coverage and the exclusion of vaccination in older age groups.