The Indian Council of Medical Research (ICMR) will soon commercialise its newly developed immunodiagnostic reagent for the detection of malaria caused by Plasmodium vivax in patient’s blood. An Indian Patent application (application no.1606/DEL/2008) has been filed by the ICMR for this new technology.

There are several salient features to this technology developed by the National Institute for Malaria Research, New Delhi (an ICMR institute). Hybridoma cell lines producing antibody probe against P. vivax. This monoclonal antibody is specific for detection of P. vivax non-secretory erythrocytic stage antigen in patient’s blood and it is based on immunodiagnostic antibody probe. The monoclonal antibody is unique and the fusion of spleen cells takes place with mouse myeloma cells. It has high specificity towards non-secretary antigens of P. vivax. The monoclonal antibody has been validated.

Senior officials in the ICMR said that the development of this new immunodiagnostic reagent for the detection of P. vivax antigen is of significance as the parasite Plasmodium vivax is the most frequent and widely distributed cause of malaria in India. It is one of four species of parasite that commonly cause malaria infection in humans. P. vivax can reproduce both asexually and sexually, depending on its life cycle stage. P. vivax differs from other species in its life cycle particularly for the latent liver stage termed hypnozoites.

Officials said that some of the sporozoites do not immediately start to grow and divide after entering the hepatocyte, but remain in a dormant hypnozoite stage for weeks or months. The duration of latency is variable from one hypnozoite to another and the factors that will eventually trigger growth are not known. In this way a single infection can be responsible for a series of relapses in the patient. Treatment to reduce the chance of such relapses is available and should follow treatment of the first attack.

Therefore, it becomes important to identify the particular species responsible for malarial infection before deciding the appropriate course of treatment or prophylaxis to check relapse of disease. Colorimetric immunoassays have been employed for the diagnosis of erythrocyte secreted P. vivax antigens. However no such diagnostic assays are available for P.vivax specific erythrocytic stage antigens. Therefore there is a need for an antibody based diagnostic assay for the detection of P. vivax specific erythrocytic stage antigens in malaria patients, officials said.

The premier research organisation has invited proposals from potential agencies/ companies interested in manufacturing of monoclonal antibody diagnostic kit for diagnosis of malaria, caused by Plasmodium vivax (P. vivax) in patient’s blood. However, only those with GLP/GMP certificate are eligible to apply.