J. Mitra Malaria Microlisa Kit

Malaria is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anaemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria parasite that can infect human: Plasmodium falciparum, P. vivax, P. ovale and P. malariae. The disease now occurs in more than 90 countries worldwide, and it is estimated that there are over 500 million clinical cases and 2.7 million malaria-caused deaths per year. At present, malaria is diagnosed microscopically by looking for the parasites in a drop of blood. Malaria Ag Microlisa is a microlwell ELISA test for the diagnosis of infection with all four Plasmodium Species (P. falciparum/P. vivax/ P. malariae/ P. ovale) in human whole blood. Malaria Ag Microlisa is specially designed to exluded infected blood to prevent transfusion aquired malaria and is used to monitoring of anti-malarial theraphy

Intended use
Malaria Ag Microlisa is an in-vitro qualitative enzyme immunoassay for detecting infection with plasmodium species (P. falciparum/P. vivax/ P. malariae/ P. ovale) based on pLDH antigen in human blood. It is intended for screening of blood donors or other individuals at risk for malaria infection and for clinical diagnostic testing

3. Principle of the test

Malaria Ag Microlisa test is an enzyme immunoassay based on sandwich ELISA. Anti-pLDH antibodies has been coated onto the wells of the microwell plate provided. Blood sample including controls are pipetted into these wells. During the first incubation, the plasmodium species pLDH antigen from samples and coated antibody is react and after washing the enzyme conjugate (anti-pLDH antibody HRPO) is added after incubation and washing to remove all the unbounded enzyme conjugate. A substrate solution which acts on the bound enzyme is added to induce a colured reaction product. The intensity of this coloured product is directly proportional to the concentration of pLDH present in the samples

4. Description of symbols used
The following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.