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Dengue

Dengue IgA-IgG-IgM Ab Test (Triplex)

​Dengue IgA/gG/IgM (Triplex) Antibody Rapid Test

 

 

​Intended Use:

Biocan TELL ME FAST Dengue IgA/IgG/IgM (Triplex) Rapid Test is a qualitative immunochromatographic in vitro assay test for simultaneous and differential detection of IgA, IgG and IgM antibodies to all four serotypes (1,2,3 & 4) for dengue virus in human serum plasma or whole blood. The test provides a differential detection of anti-dengue IgA, IgG and IgM antibodies and can be used for the presumptive distinction between a primary, secondary and an early dengue infection. This test is for In-Vitro Diagnostic use only. This is a screening test and results should be confirmed with other qualifying assays.

⇒ Detection of Dengue IgA antibodies enhances the overall sensitivity of the test and detection of Dengue Virus by enhancing early detection of dengue virus infection and  higher detection of secondary dengue virus infection.

⇒ Ability to detect IgA for primary and secondary dengue infections enhances quality and relevance, particularly in dengue (hyper)-endemic area where the detection of dengue secondary cases at early stage of infection is especially important, because secondary cases are more frequently associated with severe outcomes.

⇒ Only Dengue Rapid test which can detect Dengue Virus IgA/IgG/IgM Antibodies in just one test.

⇒ Simple to use requiring only 10ul of patient’s finger prick whole blood, serum or plasma.

⇒ No cold chain needed as the test can be performed at room temprature (2º to 30ºC)

 

​Summary:

Dengue virus, a virus belonging to the Flavavirus group of viruses, is one of the most significant mosquito-born diseases in the world in terms of morbidity and mortality.Transmitted principally by the mosquito types Aedes aegypti and Aedes albopictus, the virus is found commonly throughout the tropic and subtropic regions of the world. There are four known serotypes of dengue. Symptoms of dengue fever include high fever, headache, muscle pain and skin rash. The complications often associated with this infection are dengue hemorrhagic fever or dengue shock syndrome. The immune response to this virus includes the production of IgM antibodies by the 5th day of symptoms, which remain in the circulatory system for 30-60 days. IgG antibodies appear by the 14th day of infection and persist for life. A secondary infection often results in high fever and, in many cases, initiates hemorrhagic events and circulatory failure. A secondary infection also induces an IgM antibody response after 20 days of infection and IgG antibodies rise within 1-2​ days after the onset of symptoms. Therefore, patients with secondary infections will have a positive IgG result, usually with a positive IgM result as well. Thus, the use of a reliable and sensitive rapid serological test that can simultaneously detect the presence of anti-dengue IgG and IgM antibodies is of great clinical utility.  Biocan TELL ME FAST Dengue IgA/IgG/IgM rapid test provides an excellent methodology for specifically detecting anti-dengue IgA, IgG and IgM antibodies. The presence of high titers of IgG antibodies does not interfere with the detection of IgM antibodies in the sample. With addition of Dengue IgA Ab detection in this novel triplex test the overall sensitivity and early detection of Dengue virus is enhanced. Dengue IgA Antibodies can be detected as early as 1-2 days on onset of Dengue fever and its detection increases after 4-5 days of infection. Due to prevalence of secondary infections in Dengue endemic regions, and the spread and circulation of dengue serotypes, secondary dengue infections stimulate the body’s immune system to produce high levels of IgA through rapid sero- conversion of memory cells derived from previous infections IgM may be undetectable in most secondary infections. By using a mixture of highly purified dengue proteins, the test is able to detect all 4 Dengue serotypes. 

​Performance Characteristics:

The overall sensitivity of Biocan Tell Me Fast Dengue IgA/IgG/IgM (Triplex) Test is 98.2% for IgG, 96.8% for IgM and 96.8% for IgA. The specificity for IgA/IgG/IgM was 98.6%. The studies and clinical evaluations were conducted in correlation with Haemagglutination (HI) Test, Elisa and other commercial rapid tests.

 

​CE APPROVED