For in vitro diagnostic use. The RIDASCREEN® Malaria Ab-Screening test is an enzyme immunoassay for the qualitative detection of IgG and IgM antibodies to Plasmodium spp. in human serum or plasma. The test is intended for use in cases of a suspected Plasmodium infection.
Malaria is a life-threatening disease caused by the protozoan Plasmodium spp. It is transmitted mainly by the Anopheles mosquito. Infections can also occur via a blood transfusion. Four parasite species can infect humans: P. falciparum, P. vivax, P. ovale and P. malariae. Plasmodium falciparum causes potentially deadly cases of malaria infection and is the most common type, along with P. vivax. The disease occurs primarily in tropical and subtropical regions.
As a result of the immune system’s response, the body produces specific antibodies to the pathogen after being infected with plasmodia. 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. Antibody detection is more sensitive than the direct detection of the pathogen, e.g., via microscopy, and is independent of the status of the parasitemia. Recombinant antigens of P. falciparum and P. vivax are used for detection. Due to the antigenic similarity between the plasmodia species, P. ovale and P. malariae should also be detectable through cross-reactivity.
Recombinant 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. 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)
|Test format||Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)|
|Incubation time||60 min at 37°C|
30 min at room temperature (20-25 °C)
15 min at room temperature (20-25 °C)