Rubella Virus (RV) Rapid Test

One-step Rubella Test Devices -Testing Principle

Rubella IgM test and Rubella IgG test are both based on the principle of Gold Immunochromatography Assay (GICA). With RV IgM cassette and RV IgG cassette, specific RV recombinant antigens and anti-human monoclonal antibodies are used to detect RV IgM and IgG antibodies respectively in the human serum samples with high sensitivity and specificity.

With a RV IgM screening test, if there is RV IgM antibody in the specimen added, these antibodies will react with the anti-human RV IgM monoclonal antibody in the membrane strip, chemical complexes will form. These complexes move along the strip chromatographically to the test region (T), where these complexes will be captured by the pre-coated recombinant RV antigen. Then a red or pink line will appear, indicating a positive result. The unbounded complex moves on to the control region (C), where they are captured by the anti-mouse antibody, and a red or pink line will appear, indicating the assay is a valid one. So the control line provides an internal quality control mechanism. The RV IgG screening test is of the same priciple.

Rubella Disease and Rubella Test

Rubella virus is a member of the Togaviridae family, found mainly in human populations. Although rubella can strike people of all ages, it poses the greatest danger to unborn babies. Congenital rubella syndrome (CRS) occurs when the rubella virus attacks a developing fetus. Up to 85% of infants infected during the first trimester will be born with birth defects, including deafness, blindness, heart defects, and mental retardation. Miscarriages are also common. Growth retardation and diabetes mellitus have also been associated with late complications of congenital rubella.

In an adult, IgG antibodies usually persist throughout life, while IgM appear after the rash fade but don't persisit after serveral weeks. So, the determination of rubella IgM antibody is particularly useful for the effective distinction between recent infection or vaccination, and acquired immunity. Screening for IgG antibodies to rubella virus, on the other hand, is a useful tool for diagnosis of the rubella disease, and for determination of the immune status.