SBIR-STTR Award

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.

Over 2 billion people are at risk of malaria infection worldwide. The availability of rapid and reliable diagnostic test will be an important tool in controlling malaria. Previously, we have developed two diagnostic tests that are based on the detection of Plasmodium Lactate Dehydrogenase. The OptiMALr dipstick test is portable, easy to run, can detect parasitemia of 50-100 parasites/ml blood and can distinguish P. falciparum from other human malarias. Furthermore, we have found that pLDH levels closely correlate with levels of parasitemia making it possible to base a quantitative test for malaria infection on the apparent level of pLDH in the blood. This Phase II SBIR will focus on improving the stability, sensitivity, specificity, and overall test format of the OptiMALr assay to produce a field ready prototype suitable for far forward conditions. We will also engineer a test strip that can indicate different levels of parasitemia as a means to monitor the progress of anti-malarial chemotherapy. The latter goal will allow a simple means for detecting drug-resistant malarial infections.

Benefits:
The OptiMALr rapid, simple, easy to interpret, diagnostic and therapeutic assay for malaria has application in the developing world; for US troops; and traveler's in malarious zones.

Keywords:
malaria lactate dehydrogenase optimal immunocapture assay immunochromatographic assay