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Dengue

Dengue IgG-IgM Ab & NS1 Ag Combo

Dengue IgG/IgM Ab & NS1 Ag Combo Rapid Test

 

Intended Use:

TELL ME FAST Dengue IgG/IgM antibody & NS1 antigen Combo Rapid Test is a qualitative immunochromatographic in vitro assay for simultaneous and differential detection of IgG and IgM antibodies and NS1 Antigen to all four serotypes (1,2,3 & 4) of dengue virus in human serum plasma or whole blood. The test provides a differential detection of anti-dengue IgG, anti-dengue IgM antibodies and NS1 Antigen 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.

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 IgG/IgM rapid test proteins, the test is able to detect all 4 Dengue serotypes. During the early phase of Dengue infection NS1 is found in high concentration in sera ofprovides an excellent methodology for specifically detecting anti-dengue IgG and IgM antibodies. The presence of high titers of IgG antibodies does not interfere with the detection of IgM antibodies in the sample. By using a mixture of highly purified dengue

​Peformance Characteristics:

The overall sensitivity of Biocan Tell Me Fast Dengue NS1 Antigen Test is 94.5% and specificity is 98.9%. The studies and clinical evaluations were conducted in correlation with PCR and Viral Culture Tests.   The overall sensitivity of Biocan Tell Me Fast Dengue IgG/IgM Antibody Test is 96.9% and specificity is 99.2%. The studies and clinical evaluations were conducted in correlation with Haemagglutination (HI) Test, Elisa and other commercial rapid tests.

 

​CE APPROVED