CE Mark Dengue IgG / IgM Antibody Rapid Test Cassette, WB / S / P
Avaliable
Introduction
Dengue virus is a mosquito-borne flavivirus, consisting of four
serotypes, it is considered as a major public health problem in
tropical / subtropical areas. 2.5-3.0 billion global population is
estimated at risk in these regions. Annually about 50 million cases
of dengue fever and more than 250,000 cases of dengue hemorrhagic
fever occur based on WHO report.
Dengue virus infection includes 1. dengue fever or simple dengue
fever usually seen with high fever, headache, myalgia, arthralgias,
rashes and leucopenia; 2. dengue haemorrhagic fever is
characterized with the acute onset, high fever, haemorrhagic
diarrhea, thrombocytopenia, haemostasis and plasma leakage with a
tendency to develop fatal shock (dengue shock syndrome).
Dengue infection can be also classified as primary and secondary
infection. Due to four serotype dengue viruses, there is no
cross-protection each other for each subtype, multiple infections
are common in the infected patients. Infants or children dengue
fever is usuauly present as primary infection;
Dengue IgM is usually detectable in primary infection between 5 to
7 days after fever, while dengue IgG appears after 7 days.
Therefore, the appearance of dengue IgM or IgM/IgG is mostly found
in the primary infection depending on the time window of test;
while dengue IgG usually appears in the secondary infection in the
early days of infection with or without dengue IgM. Based on the
tests from different geographic regions, our dengue IgG/IgM test
has the sensitivity with clear signal over 90% for all four dengue
serotypes, and equal sensitivity tested in the different geographic
region, the specifity is over 95%.
Dengue IgM/IgG rapid test cassette
Early detection of Dengue IgM and Dengue IgG in serum or plasma for
in vitro diagnostic use
Each test kit contains:
1. A sealed pouch
2. Pouch contains one cassette test device
3. One plastic pipette
4. Each 25 tests with one 3 ml dropper bottle with buffe
Stability and Storage Conditions
Dengue IgG/IgM test kit is stable at room temperature between
10-28°C for one and half year in the unopened pouches. DO NOT FREEZE the kit or expose to temperature extremes.
Limitation of the Test
This instruction should be followed carefully and performed
properly. Dengue IgM/IgG test is designed to detect antibodies
against Dengue virus in serum or plasma. Testing of any other body
fluids has not been validated and may not yield appropriate
results. For samples that test positive by Dengue IgM/IgG test,
more specific confirmatory testing may be done. A clinical
evaluation of the patient’s situation and history should also be
made before a final diagnosis is established.
