A rapid test for the qualitative detection of IgG and IgM antibodies to Rubella in human serum or plasma CE certified

Applications:

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

Description:

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.

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.

How to use?

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

2. Place the test cassette on a clean and level surface. Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 10 μl). Transfer the specimen to the specimen well, then add 2 drops of buffer (approximately 80 μl) and start the timer. See the illustration below.

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

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two or three lines appear. One colored line should always appear in the control line region (C) and another one or two apparent colored line(s) should be in the test line region(s) (IgM and/or IgG).

IgM Positive: Along with line in Control region (C), a line appears in IgM region. It indicates a IgM positive Test result for antibodies to Rubella.

IgG Positive: Along with line in Control region (C), a line appears in IgG region. It indicates a IgG positive Test result for antibodies to Rubella

*NOTE: The intensity of the color in the test line regions (IgM and IgG) may vary depending on the concentration of Rubella antibodies present in the specimen. Therefore, any shade of color in the test line region (IgM and/or IgG) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions (IgM and IgG).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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