Intended use:

For in vitro diagnostic use. The RIDASCREEN® Dengue Virus tests are enzyme immunoassays for the qualitative detection of IgG or IgM antibodies to the Dengue virus in human serum or plasma.

The tests are intended for use in cases of suspected Dengue virus infection.

General information:

Dengue viruses are enveloped, single-strand RNA viruses approximately 50 nm in diameter. They belong to the Flaviviridae family. There are four serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).

Dengue viruses are found throughout the world. Dengue fever is endemic in South and Central America, West Africa, Southeast Asia and in the Western Pacific. Its preferred host is the human being. Mosquitoes of the species Aedes aegypti transmit the virus.

Dengue has an incubation period of 3 to 14 days. Most cases are mild, similar to the flu. Symptoms include fever with chills and severe headache, muscle and joint pain. Together with exanthema, these symptoms are also known as the Dengue triad. In most patients, the illness abates after 3 to 7 days. In 2-4% of cases, however, the illness is severe, and Dengue hemorrhagic fever (DHF) or Dengue shock syndrome (DSS) can occur. In these serious cases, 1-5% end in death, but mortality rates can reach as high as 15% in individual epidemics.

Once victims recover from the infection, they are briefly immune to all serotypes and have life-long immunity to the infecting strain.  A second infection from another serotype is usually more serious. No vaccine is available.

As a result of the immune system’s response, the body produces specific antibodies to the pathogen after being infected with the Dengue virus. These antibodies can be detected in the serum or plasma with the help of immunological methods. The selection of the pathogen-specific antigen used and the applied test method are important for the validity of a test.

Test principle:

RIDASCREEN® Dengue Virus IgG

Purified antigens are bound on a microtiter plate. The antibodies in patient specimens bind to the antigens, and in a second step, they are detected with an enzyme-marked anti-human antibody Conjugate IgG   Conjugate IgG  . The enzyme changes a colorless substrate (H2O2/TMB) into a blue end product. The enzymatic reaction is stopped by the addition of sulfuric acid. This addition causes the color to change from blue to yellow. The final measurement is taken in a photometer at 450 nm (reference wavelength ≥ 620 nm).

RIDASCREEN® Dengue Virus IgM µ-capture

Anti-human IgM antibodies are bound on a microtiter plate. IgM antibodies present in patient specimens bind to the anti-human IgM antibodies. Unbound specimen material is removed by washing. A mixture of Dengue virus antigen and enzyme-marked anti-Dengue virus antibodies is then added. In positive samples, this complex binds to immobilized Dengue virus-specific antibodies. The enzyme changes a colorless substrate (H2O2/TMB) into a blue end product. The enzymatic reaction is stopped by the addition of sulfuric acid. This addition causes the color to change from blue to yellow. The final measurement is taken in a photometer at 450 nm (reference wavelength ≥ 620 nm).

Specifications
Art. No. K82**
Test format Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)

Article no. K8221
Dengue Virus IgG (96 determinations)

Article no. K8231
Dengue Virus IgM µ-capture (96 determinations)
Incubation time 60 min at 37°C
30 min at room temperature (20-25 °C) for IgG
or 30 min at 37°C for IgM
15 min at room temperature (20-25 °C)
Sensitivity 100 % (IgG)
100 % (IgM)
Specificity 98.0 % (IgG)
98.5 % (IgM)
Files
InstructionsGerman
English
French
Italian
Spanish
SDSk8221_german.zip (German)
k8231_german.zip (German)
k8221_english.zip (English)
k8231_english.zip (English)
k8221_french.zip (French)
k8231_french.zip (French)
k8221_italian.zip (Italian)
k8231_italian.zip (Italian)
k8221_spanish.zip (Spanish)
k8231_spanish.zip (Spanish)
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