【INTENDED USE】

The Rubella IgM Rapid Test Device (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to Rubella in serum,plasma to aid in the diagnosis of Rubella infection.

【SUMMARY】

Rubella 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 feral damage, stillbirth or abortion.Children born asymptomatic may develop these abnormalities later in life. 1,2 wide spread 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 IgM Rapid Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to rubella virus in serum or plasma specimens.

【DIRECTIONS FOR USE】

Bring the pouch to room temperature before opening it.Remove the test Device from the sealed pouch and use it as soon as possible.Best results will be obtained if the assay is performed within on hour.

Place the test device on a clean and level surface.

Hold the dropped vertically,draw the specimen up to the Fill Line,and transfer 10ul serum/plasma and 2 drop of buffer (Approx 80µl) to the specimen well of the test device.

Avoid trapping air bubbles in the specimen well.

Wait for the colored line(s) to appear.The result should be read at 15 minutes.Do not interpret result after 20minutes.