Rubella Rapid Diagnostic Cassette to detect IgM antibody of Rubella
in human blood, easiy and quick
Rubella Rapid Diagnostic test
The Rubella Rapid Test Device is a panel of rapid qualitative
lateral flow test designed for the quantitive detection of IgM
antibodies to Rubella in human serum/plasma samples.
The Rubella Rapid Test Cassette (Serum/Plasma) is a qualitative,
lateral flow immunoassay for the detection of antibodies to Rubella
in serum or plasma specimens. In this test, mouse anti-human IgG
and mouse 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 mouse anti-human IgG or mouse 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
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
1. Bring the pouched test device to room temperature(15-30℃) prior
to testing. Do not open the pouch until ready to begin testing.
2. Remove the device from the sealed pouch and lay it on a flat and
3. Using the provided pipette, add one drop of fresh specimen to
the sample well.
4. Hold the buffer bottle vertically and add 1 drop to the sample
well. /If using a pipette, change a new one to avoid
cross-contamination. Draw and transfer 2-3 drops of buffer to the
5. Read the result between 15-20minutes. Do not read results after
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the control line
region (C) and another apparent colored line should be in the test
line region (T).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of TP antibodies present in the
specimen. Therefore, any shade of color in the test line region (T)
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line
appears in the test line region (T).
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.
A clinical evaluation was conducted comparing the results obtained
using the Rubella Rapid Test Cassette to Rubella ELISA Testing.
Table: Clinical Study from
|Rapid Test Cassette||Positive||68||2||70|
|Relative Sensitivity: 97.1% (95%CI*: 90.1%-99.7%)||*Confidence Interval|
|Relative Specificity: 99.3% (95%CI*: 97.6%-99.9%)|
|Accuracy: 98.9% (95%CI*: 97.3%-99.7%)|
|ORIENT NEW LIFE MEDICAL CO., LTD.|
|Email:||Jerry @ newlifebiotest .com|