SBIR-STTR Award

The current configuration of the OptiMAL(R) immuno-assay for malaria relies on antibodies generated to P. falciparum LDH. Some of these antibodies recognize all species of human malaria while others are more selective recognizing the falciparum pLDH isoforms specifically. These antibodies when used in combination can differentiate between P. falciparum and non-falciparum malaria. However, accurate and simple discrimination between P. vivax, P. malariae or P.ovalae is not readily available. We propose to: 1) Obtain the pLDH gene from P. vivax, P. malariae and P. ovalae. 2) Produce the corresponding pLDH proteins recombinantly in bacteria. 3) Produce monoclonal antibodies that recognize native pLDH from P. vivax P. ovalae and P. malariae that do not cross react with P. falciparum or the human LDH isoforms. 4) Assemble a prototype diagnostic immunochromatographic test strip using these new specific antibodies and test their performance under laboratory conditions. 5) Test the new prototype immunochromatographic test under laboratory/field conditions. PROPOSED COMMERCIAL APPLICATIONS: They extend the capability of the original OptiMAL(R) assay and allow introduction of new and improved products. May help better determination of antimalarial therapy, given the rise of drug resistant P. vivax but not P.ovalae or P. malariae. Antibodies may be produced that have even a better sensitivity then the ones currently used in the current version of the OptiMAL(R) diagnostic assay.

Thesaurus Terms:
Plasmodium, communicable disease diagnosis, diagnosis design /evaluation, immunologic assay /test, lactate dehydrogenase, malaria, microorganism genetics, protozoal antigen diagnostic test, immunoaffinity chromatography, monoclonal antibody

The Diagnosis of Malaria is routinely performed by microscopy of blood smears. However, in both developing countries and developed countries adequate expertise is often limited. Furthermore, this method is quite time-consuming. Flow Inc. has developed a product called the OptiMALr assay, which is an immunochromatographic test that can be used for routine malaria diagnosis without the need for an expert user or a sophisticated laboratory. This product has been successfully manufactured and masold via a commercial partnership with a larger firm. The current assay, however, has short-commings that must be surmounted to make an even more effective test. The test needs to be able to speciate all forms of human malaria species. Furthermore, it should be packaged in an individual cassette-based format to help with stability problems and make it easier to use. Finally, the test should be optimized to be more sensitive to detect very low levels of parasites in infected patients blood. The work described here will allow the development of a new test prototype that embodies these needed improvements.

Thesaurus Terms:
Plasmodium, Plasmodium falciparum, communicable disease diagnosis, diagnosis design /evaluation, immunologic assay /test, lactate dehydrogenase, malaria diagnosis quality /standard, diagnostic test, immunoaffinity chromatography, microorganism genetics, monoclonal antibody, protozoal antigen, recombinant protein, species difference clinical research, human subject, laboratory mouse