Rapid Malaria Test for Diagnosis and Treatment

Malaria infects over 200 million people and is responsible for 2 million deaths annually. Flow Inc. has developed diagnostic procedures based upon the fact that the parasite contains an enzyme lactate dehydrogenase (pLDH) (US patent 5,124,141). Recently, Flow Inc. has increased the sensitivity of its diagnostic procedures to detect 50 parasites/ul with the use of monoclonal antibodies (US Patent Pending) Flow Inc,has developed a wet (immunocapture) assay , and a dry (immuno-chromatographic) assay, which are able to differentiate Plasmodium falciparum and Plasmodium vivax, and to monitor the effectiveness of in vivo and in vitro drug therapy. These rapid assays have potential application for malaria diagnosis; epidemological surveillance; and to monitor the effectiveness of flew anti-malarial therapy. This proposal will further increase the level of sensitivity and specificity of these immunoassays using laboratory-derived and anonymous patient samples undergoing anti-malarial therapy in order to prepare these assays for application under stringent field conditions. The development of rapid simple to perform, easy to interpret, diagnostic, and in vitro and in vivo therapeutic assays for the malaria parasite has extensive application in the developing world; and for US troops stationed in malarious zones The rapid assays have significant global commercial potential.