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Diagnostic Tools to Support the Elimination and Control of Neglected Tropical Diseases

Background
Neglected tropical diseases (NTDs) are bacterial, parasitic, and viral infections that disproportionately affect poor and underserved populations around the world, and are primarily associated with high levels of morbidity due to the chronic nature of the infections. Adults affected by NTDs often have decreased productivity. School aged children are also affected by NTDs, resulting in decreased physical and scholastic performance.  A subset of NTDs, including lymphatic filariasis (1 billion people at risk in 73 countries), onchocerciasis (120 M people at risk in 37 countries), schistosomiasis (700 M at risk in 74 countries), trachoma (540 M at risk in 55 countries) and soil transmitted helminth (STH) infections (4 billion at risk, 1 billion infected, worldwide), can be targeted effectively through mass drug administration (MDA). In recent years, there have been significant increases in the number of countries implementing public health programs to combat NTDs, and in the number of persons being treated for NTDs. This progress is the direct result of generous donations of drugs from pharmaceutical manufacturers as well as funding support from the U.S. Agency for International Development (USAID) and the UK Department for International Development (DFID), among others. Reducing the morbidity caused by NTDs is an objective of the U.S. Government Global Health Initiative (GHI) with specific targets for the global elimination of lymphatic filariasis and trachoma.
Currently available laboratory and epidemiological tools to achieve the new elimination goals set for several NTDs require improvement. For example, there is significant geographic overlap in the distribution of most NTDs, but programs continue to use disease-specific and labor intensive clinical or parasitologic exams for mapping and surveillance.  This approach does not maximize the limited resources available to these programs.  Treatment drugs for some NTDs can cause serious adverse events if other infections are also present. For example, serious neurologic adverse events can result when MDA takes place with the use of ivermectin in regions where onchocerciasis and Loa loa overlap (i.e., Central and West Africa).  An integrated diagnostic platform for NTDs could produce significant cost-savings for mapping and surveillance and improved safety for MDA programs.
 Project Goal 
Field-compatible antibody and antigen (as appropriate for the particular disease, as delineated in the table below) tests can be used to define treatment areas, guide MDA program implementation and to conduct post-treatment surveillance. Development of multiplexed strip tests would facilitate integrated, cost-effective surveillance and mapping activities.
 

NTD

Antigen

Antibody

Lymphatic filariasis (LF)

+

Onchocerciasis

+

+

Loa loa

+

+

LF/onchocerciasis

+

+

Schistosomiasis

+

Soil Transmitted Helminth (STH)

+

+

(+) = test is needed
 
The specific project goal is to have prototype field-compatible tests that can address the following issues currently faced by national NTD programs
?       the need  for rapid  determination of infection prevalence in support of micro mapping;
?       the detection of co-infections that hamper MDA activities (for example lymphatic filariasis endemicity in areas where ivermectin has been previously used for onchocerciasis MDA,  Loa loa infections in areas endemic for onchocerciasis);
?       epidemiological surveillance, evaluation of program impact through serological monitoring, and surveillance for infection or exposure following apparent interruption of transmission.
The proposed assays should be developed towards use of a standard platform, therefore opening opportunities for integrated surveillance for NTDs.
Phase I Activities and Expected Deliverables 
1)     Prototype device or methodology for point of care application (field compatible) for simultaneous or consecutive detection of one or more NTDs. A rapid diagnostic, field compatible serological assay is highly desirable.  Such a device will help identify infected persons in specific areas, therefore facilitating fast mapping could be the basis of program monitoring and evaluation activities. A desirable prototype should include either two or more of the NTDs listed above, including but not limited to:
?  Schistosomiasis and lymphatic filariasis
?  Loa loa and onchocerciasis
?  Loa loa and LF
?  Schistosomiasis and intestinal helminth infections (e.g. Strongyloides stercoralis)
2)     Determination of basic assay performance characteristics: preliminary sensitivity and specificity desired but not required.
3)     Field compatibility characteristics: performance outside a fully equipped laboratory and the stability, shelf life, and storage requirements of the tests.
Projected Phase II activities
Phase II activities for a successful Phase I prototype will include expanded testing for sensitivity and specificity, and small-scale production of beta prototypes for field testing. Following this, modifications of the beta prototypes towards a final field-compatible test will be done. Finally, data will be generated to further characterize the test performance characteristics and assay compatibility with NTD program needs for mapping and program monitoring and evaluation, including post-treatment surveillance.
Impact
Development of improved diagnostic tools supports CDC?s efforts to address lymphatic filariasis in the Americas and the NTD GHI targets. These tools would also encourage the commitment of donors and policy makers to NTD control and elimination programs by allowing program integration across diseases and enhanced efficiency. New devices or assays may provide more reliable detection of infection rates, which would lead to increased confidence towards meeting public health goals. Significant savings in human and financial resources could be obtained through the development of improved diagnostic tools.
Commercialization Potential
NTDs are by definition neglected and diagnostic tests for NTDS are not necessarily compatible with standard commercialization strategies.  However, there is a need for new diagnostic methods. Small businesses are the frontrunners on developing novel technologies and approaches for addressing unmet needs. Market opportunities arise from the presence of donors and policy makers already committed in NTD elimination and control efforts, who could encourage manufacturers to promote production and commercial availability of these devices.
National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
The mission of the National Center for Emerging and Zoonotic Infectious Diseases aims to prevent disease, disability, and death caused by a wide range of infectious diseases. NCEZID focuses on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). NCEZID?s work is guided in part by a holistic ?One Health? strategy, which recognizes the vital interconnectedness of microbes and the environment. Through a comprehensive approach involving many scientific disciplines, NCEZID can attain better health for humans and animals and improve our environment.
NCEZID?s Web site:  https://www.cdc.gov/ncezid
 
For this solicitation NCEZID invites Phase I proposals in the following areas:

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