Intended use:

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

The tests are intended to be used in cases of suspected Zika virus infection.

General Information:

The Zika virus is a single-stranded RNA virus of the Flaviviridae family, genus Flavivirus.

Zika viruses are primarily transmitted by mosquitoes belonging to the species A. aegypti and A. albopictus. There are, however, reports of less common types of transmission, including blood transfusions, perinatal transmission, and sexual contact.

The precise incubation period of Zika fever is not known, but is probably around a few days.

It is estimated that only one of five people infected with the Zika virus will develop symptoms. Clinical manifestations are similar to those of dengue virus or chikungunya virus infection, but normally have a milder course.

The most common symptoms are maculopapular rash, mild fever, arthralgia, myalgia, headache, and conjunctivitis. Less common symptoms are edemas, neck pain, cough, vomiting, and hematospermia. Infections in humans are usually mild and self-limiting, and the symptoms disappear spontaneously usually within three to seven days. Arthralgia can last up to one month. In rare cases, Guillain-Barré syndrome (GBS), a disease of the peripheral nervous system, can also develop following infection with the Zika virus.

A correlation between Zika virus infection in pregnancy and brain defects in the unborn child is now considered to be likely.

As a result of the immune system’s response, the body produces specific antibodies to the pathogen after being infected with the Zika virus. These antibodies can be detected in the serum 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

Anti-human IgG and anti-human IgM antibodies are bound on a microtiter plate. IgG or IgM antibodies present in patient specimens bind to the anti-human IgG or IgM antibodies. Unbound specimen material is removed by washing. Next the enzyme-marked Zika virus antigens are added. This antigen conjugate binds to the specific bound IgG or IgM antibodies. In a second wash step, unbound conjugate  Conjugate  is removed. 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. K84**
Test format Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)

Article no. K8421
Zika Virus IgG capture (96 determinations)

Article no. K8431
Zika Virus IgM µ-capture (96 determinations)
Incubation time 60 min at 37 °C
30 min at 37 °C
15 min at room temperature (20-25 °C)
Sensitivity 96 % (IgG)
100 % (IgM)
Specificity 99.6 % (IgG)
98.6 % (IgM)
Files
InstructionsGerman
English
French
Italian
Spain
Portuguese
SDSk8421_german.zip (German)
k8431_german-1.zip (German)
k8421_english.zip (English)
k8431_english.zip (English)
k8421_french.zip (French)
k8431_french.zip (French)
k8421_italian.zip (Italian)
k8431_italian.zip (Italian)
k8421_spanish.zip (Spanish)
k8431_spanish.zip (Spanish)
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