Accu-Tell® Rubella IgG/IgM Rapid Test Cassette (Serum/Plasma)
|Product Name||Specimen||Catalog No.||Quantity per box||Certificate|
|Rubella IgG/IgM Cassette||Serum/Plasma||ABT-FT-B306||40T/20T|
Detection for: IgG/IgM antibodies to Rubella in serum or plasma
Reading time: 15 minutes
Sensitivity & Specificity & Accuracy:
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.
ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG/IgM antibodies to Rubella in serum or plasma to aid in the diagnosis of Rubella infection.
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 and draw the serum/plasma up to the Fill Line as shown in illustration below (approximately 10 µl ) and 2 drops of buffer (approx. 80µl) to the specimen well of the test cassette. Avoid trapping air bubbles in the specimen well. See the illustration above.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.
Sensitivity and Specificity
ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) was compared with leading commercial EIA Rubella tests; the results show that ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) has a high sensitivity and specificity.
|Method||Rubella EIA (IgM)||Total Results|
|ACCU-TELL® Rubella IgG/IgM Cassette for IgM||Results||Positive||Negative|
Sensitivity: 95.0% (95%CI*: 75.1%~99.9%)
Specificity: 99.0% (95%CI*: 96.4%~99.9%)
Accuracy: 98.6% (95%CI*: 96.1%~99.7%)
|Method||Rubella EIA (IgG)||Total Results|
|ACCU-TELL® Rubella IgG/IgM Cassette for IgG||Results||Positive||Negative|
Sensitivity: 99.2% (95%CI*: 97.1%~99.9%)
Specificity: 96.2% (95%CI*: 80.4%~99.9%)
Accuracy: 98.9% (95%CI*: 96.8%~99.8%)
Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive, and a high positive. The negative, low positive, and high positive values were correctly identified >99% of the time.
Between-run precision has been determined by 10 independent assays on the same three specimens: a negative, a low positive, and a high positive. Three different lots of ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) have been tested over a 3-day period using negative, low positive, and high positive specimens. The specimens were correctly identified >99% of the time.
ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, RF, Syphilis, H. Pylori, CMV, TOXO, HSV 1/2 positive specimens. The results showed no cross-reactivity.
ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) has been tested and no interference was observed in specimens containing 110 mg/ml human albumin, 1 mg/ml bilirubin, 10mg/ml hemoglobin, 0.2mg/ml cholesterol and 15 mg/ml triglycerides.
The following compounds have also been tested using ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) and no interference was observed.
1. ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of IgG/IgM antibodies to Rubella in serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG/IgM antibodies to Rubella can be determined by this qualitative test.
2. ACCU-TELL® Rubella IgG/IgM Cassette (Serum/Plasma) will only indicate the presence of IgG/IgM antibodies to Rubella in the specimen and should not be used as the sole criteria for the diagnosis of Rubella infections.
3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of Rubella infection.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.