SBIR Phase II: Broad-based Urine Test for the Diagnosis of Plasmodium falciparum and P. vivax Malaria In Febrile Patients

This Small Business Innovation Research (SBIR) Phase II project will develop and validate a broad-based non-invasive, single-step Urine Malaria Test (UMT-Pf/Pv) for the clinical diagnosis of Plasmodium falciparum (Pf) and P. vivax (Pv) malaria, which account for ~800,000 deaths a year. Since malaria deaths occur within 48 hours of onset of symptoms, the ability to manage malaria at home or in village settings where most cases occur would (i) facilitate prompt access to antimalarial treatment, (ii) target treatment to those who need it, and (iii) reduce malaria mortality. In this project, monoclonal antibodies (MAbs) to novel poly-asparagine protein fragments identified in the urine of febrile malaria patients will be used to develop a UMT-Pf/Pv dipstick. The four overlapping specific aims are to (1) perform a detailed characterization of the diagnostic utility of MAbs developed in Phase I; (2) develop, test and optimize a prototype to meet design input specifications; (3) implement preliminary performance evaluation studies to evaluate sensitivity/specificity, and; (4)undertake preliminary clinical testing. As a non-invasive alternative to blood-based tests, the UMT-Pf/Pv could facilitate the delivery of rapid malaria diagnosis in settings across all geographical areas where malaria is endemic, markedly impacting the way malaria is diagnosed and treated worldwide. The broader impact/commercial potential of this project is the development of a broad-based one-step urine test for the home-based or point-of-care diagnosis of clinical Pf and/or Pv malaria in persons with fever. With the UMT-Pf/Pv dipstick, the number of steps that the operator is required to perform is significantly reduced, permitting greater utility, convenience and reliability in primary care settings. The test will also facilitate the effective integration of malaria RDTs into private sector malaria case management and encourage wider acceptability of clinical malaria diagnosis in endemic regions, especially in rural areas and in places where mixed infections frequently occur. Overall, the test has the potential to markedly impact the way over 95% of all clinical malaria is diagnosed and treated, and drive current global efforts toward home-based or point-of-care testing for malaria prior to treatment in all cases of fever, as mandated by the World Health Organization. Since it is based on the same platform as current RDTs, this test can be easily integrated into current healthcare structures to provide significant benefits to public health in most endemic countries. No such test is currently available.