REF:

C1304 (Cassette)

INTENDED PURPOSE:

NOVAtest® Rubella Virus IgG/IgM Antibody Joint Test is an immunochromatographic assay that use immuno-capture method for qualitative detection of anti-rubella virus IgG/IgM antibodies from serum, plasma and whole blood specimens of human. It’s used as an aid in the diagnosis of the rubella virus infection. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Rubella is a single positive strand RNA virus, usually causing a systemic illness known as German measles. The infection is characterized by rash, fever and lymphadenopathy. Up to 70% of infected adult women develop arthritis. If, however, infection occurs in the first weeks of pregnancy, up to 85% of neonates are born with a pattern of growth restriction and major birth defects known as congenital rubella syndrome (CRS). Later-onset sequelae of rubella in early pregnancy include autism and diabetes.

Up to 60% of women of childbearing age worldwide remain susceptible to rubella and the CRS. In poorer countries, CRS is a major cause of developmental anomalies, especially blindness and deafness. Worldwide, about 100,000 infants are born annually with CRS. Fetal damage associated with rubella tends to result only when infection occurs in the first 16 weeks of gestation. In general, the earlier the onset of infection, the more severe are the observed malformations.