INTENDED USE

The Rubella IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Rubella in serum or plasma to aid in the diagnosis of Rubella infection.

SUMMARY

Rubella virus is a member of the Togaviridae family, found mainly in human populations. Generally rubella is considered a mild adolescence disease. However a maternal infection could be transmitted through the placenta to the fetus, causing congenital rubella. Primary rubella infection contracted during early pregnancy, may have severe consequences as severe fetal damage, stillbirth or abortion. Children born asymptomatic may develop these abnormalities later in life.1,2 Widespread vaccination has significantly reduced the incidence of rubella in all age groups. However, 10 to 20% of young adults still appear susceptible to the virus. To reduce risk of severe complications, accurate serological methods must be performed to determine the serologic status of childbearing aged women. The Rubella IgG/IgM Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to rubella virus in serum or plasma specimens.

PRINCIPLES

The Rubella IgG/IgM Rapid Test is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to Rubella in serum or plasma specimens. In this test, anti-human IgG and anti-human IgM are coated in the test line regions of the test. During testing, the serum or plasma specimen reacts with Rubella antigen coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the anti-human IgG and/or anti-human IgM on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for Rubella infection, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.