A rapid test for the qualitative detection of IgG and IgM
antibodies to Rubella in human serum or plasma CE certified
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE0123 |
| Reading Time | 15 minutes |
| Pack | 25 T/40 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 93.40% |
| Specificity | 99.00% |
| Accuracy | 98.10% |
| Cut-Off | / |
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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| IRG-302 | Rubella IgG Rapid Test Cassette | S / P | 40 T |
| IRG-402 | Rubella IgG Rapid Test Cassette | WB/S/P | 40 T |
| IRM-302 | Rubella IgM Rapid Test Cassette | S / P | 40 T |
| IRM-402 | Rubella IgM Rapid Test Cassette | WB/S/P | 40 T |
| IRGM-302 | Rubella IgG/IgM Rapid Test Cassette | S / P | 40 T |
| IRGM-325 | Rubella IgG/IgM Combo Rapid Test Cassette | S / P | 25 T |
| IRGM-402 | Rubella IgG/IgM Rapid Test Cassette | WB/S/P | 40 T |
| IRGM-425 | Rubella IgG/IgM Combo Rapid Test Cassette | WB/S/P | 25 T |
