Dengue IgG/IgM Ab Rapid Test
For the qualitative detection of Dengue ( IgG & IgM ) in
serum/plasma and whole blood
Dengue Rapid Test Kit Dengue Fever IgG/IgM Combo Home Use
Mosquito-Borne Infectious Disease
Main Features
☀ High Sensitivity: 100%
☀ Specificity: 100%
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Reliable: Accuracy higher than 97.5%, early detection of the
presence of Dengue Antibody
☀ Simple: No Instrument Required
☀ Convenient: Room Temperature Storage, Built-In Control
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
Intended Use
The Dengue IgG and IgM Combo Rapid Test is a qualitative test for
the detection of IgG and IgM Antibodies to dengue virus in human
serum plasma ,or whole blood.
The test provides a differential detection of anti-dengue IgG and
anti-dengue-IgM antibodies and can be used for the presumptive
distinction between a primary and secondary dengue infection.
This test is for In-Vitro Diagnostic use only.
Interpretation of Results
Negative:The control line is the only line visible in the test zone. No IgG
or IgM antibodies were detected. The result does not exclude dengue
infection. A new sample should be drawn from the patient in 3-5
days and then should be retested.
IgG Positive: The control line and G line are visible in the test zone. The test
is positive for IgG antibodies. This is indicative of a past dengue
infection.
IgM Positive: The control line and M line are visible in the test zone. The test
is positive for IgM antibodies. This is indicative of a primary
dengue infection.
IgM and IgG Positive: The control line, M and G lines are visible in the test zone. The
test is positive for IgM and IgG antibodies. This is indicative of
a secondary dengue infection (see limitation).
Invalid: The test results are INVALID, if no control line is visible,
regardless of the presence or absence of lines in the IgG or IgM
test zone of the strip. Repeat the test using a new cassette.
Storage
Store the kit between 4°C and 30°C. Do not store the kit in direct
sunlight. Only remove and open the number of cassettes to be
immediately used. The test kit should be used until the expiration
date of the kit. Please refer to the package label for the
expiration date.
Reagents and Materials Provided
☀ 40 pouched cassettes with desiccant.
☀ Dropper bottle of sample diluent buffer.
☀ One operating instruction.
Materials Required But Not Provided
☀ Stop watch.
☀ Adjustable 0.5 - 10μl pipette (adjustable)
Expected Value
Primary dengue is characterized by the presence of detectable IgM
antibodies 5 days after the onset of infection. Secondary dengue is
characterized by the elevation of specific IgM antibodies and the
evaluation of specific IgG antibodies.
