Resources

Leprosy is a chronic infectious disease that results in nerve damage, muscle weakness and atrophy, and permanent disability and disfigurement, causing sufferers to be stigmatized and isolated by their communities. Provision of multidrug therapy and follow-up care has resulted in a dramatic decline in the prevalence of leprosy; however, there are close to 200,000 new cases of this curable disease each year, often diagnosed after permanent disability has already developed.The World Health Organization (WHO) 2020 goal is to eliminate leprosy as a public health problem (defined as prevalence <1 case per 10,000). The WHO set a number of goals for the Neglected Tropical Diseases (NTD) to be achieved by 2020, and the London Declaration on NTDs backed these goals with commitments from public and private institutions, notably for leprosy Novartis committed to donate antibiotic drugs to treat leprosy in endemic countries. The 3rd progress report of the London Declaration indicated that “priorities for progress” towards reaching leprosy goals include an urgent need for fieldfriendly diagnostic tests for leprosy.In support of the London Declaration goals, PATH aims to catalyze engagement of the diagnostics industry and product development efforts. As part of this work, PATH assessed needs and landscaped potential solutions to improve diagnostic tools used to support leprosy elimination efforts. We conducted literature reviews, a product development landscape, and interviews with key stakeholders in the leprosy community to identify use cases for leprosy diagnostics, understand current practices, and analyze progress toward more robust diagnostics. The findings were used to develop recommendations to improve availability, access, and adoption of leprosy diagnostic tools.PATH identified four use cases for leprosy diagnostics: diagnosing subclinical infection, diagnosing symptomatic infection including paucibacillary (PB) and multibacillary (MB) disease, and treatment monitoring. We found that current diagnostic tools and practices for leprosy are unlikely to support achievement of elimination goals. There are no POC tools commercially available for leprosy diagnosis. Tools currently in late-stage development are not applicable to all symptomatic leprosy infections and there is growing interest in new tools that can detect subclinical infections and monitor treatment outcomes. Based upon these findings, we have developed the following recommendations:Bring to market antibody-detecting rapid tests to aid health workers in the confirmation of MB infections. Prototypes are in late-stage development and would identify the most transmissible and debilitating infections. Implementation and market research may be needed to support optimal uptake and use of these tools.Develop new diagnostic tools that identify all symptomatic leprosy infections. These tools are necessary to ensure prompt treatment and cure of all leprosy cases.Support further research to understand feasibility and utility of diagnostic tools for subclinical infections and post-treatment monitoring of immunologic reactions and relapse.

Quality assurance panel for the Anti-Wb123 IgG4 SD Bioline lymphatic filariasis rapid diagnostic test

Chagas disease is a neglected tropical disease caused by the protozoan Trypanosoma cruzi and spread through the triatomine bug. The World Health Organization estimates that nearly six million people are infected with T. cruzi in Latin American and seventy million people are at risk of infection, which can cause cardiac and intestinal complications. If untreated, infection is lifelong and can be life threatening. Morbidity and mortality from Chagas disease is a critical health problem affecting poor communities throughout Latin America.The WHO has put forward goals for the interruption of transmission in the home (Latin America) and through blood transfusions (Latin America, Europe, and Western Pacific) by 2015, as well as the elimination of Chagas-carrying insects near homes in Latin America by 2020. The London Declaration on NTDs backed these goals with commitments from public and private institutions. However, according to the London Declaration 3rd Report, more concerted efforts to improve access to diagnosis and treatment are needed to achieve these goals.PATH aims to catalyze engagement of the diagnostics industry and product development efforts in support of the London Declaration goals. As part of this work, PATH examined the Chagas diagnostics landscape to identify gaps in availability, accessibility, and use of appropriate diagnostic tools for Chagas. We conducted literature reviews and interviews with key stakeholders to identify use cases for Chagas diagnostics, understand current practices, and assess progress toward more robust diagnostics. The findings were used to analyze the current diagnostic landscape for Chagas and highlight current needs to improve access to diagnostics for prioritized use cases.PATH identified four use cases for Chagas diagnostics: case diagnosis, congenital case detection, treatment monitoring, and screening of blood and organ donations. Our analysis found that access to and adoption of current tools remain a barrier to their effective use in Chagas disease control efforts in many endemic settings. This may be due in part to insufficient evidence to support their implementation. Additionally, because of the reliance on serologic tests and inadequate markers of active infection, current tools available to detect congenital infections and monitor treatment are not yet sufficient to fully support needs in these use cases. Based on these findings, we offer the following recommendations:Establish more standardized policies and practices for Chagas diagnosis and treatment by generating evidence around the efficacy of current tools in diverse settings and building consensus around standards among global and regional stakeholders.Develop a point-of-care diagnostic tool to detect congenital infections, which would enable early initiation of treatment and a clear linkage to postnatal care.Develop a diagnostic tool to monitor treatment efficacy, which would inform clinical decision-making during treatment and support the development of better drugs.

Visceral leishmaniasis (VL) is a deadly disease caused by infection with the Leishmania parasite. The majority of cases are found in South Asia, east Africa, and Brazil. As many as 310 million people are at risk of infection, and it is estimated that between 20,000 and 50,000 deaths result from VL annually. VL is spread through the bite of the sandfly vector, and it can be harbored by human and canine reservoirs. The parasite causes nonspecific symptoms such as fever and splenomegaly; if left untreated, VL typicallyleads to death.The World Health Organization (WHO) 2020 goal is to eliminate VL from the Indian subcontinent (i.e., achieve prevalence of less than 1 case per 100,000). The WHO set a number of goals for the Neglected Tropical Diseases (NTD) to be achieved by 2020, and the London Declaration on NTDs backed these goals with commitments from public and private institutions. The 3rd progress report of the London Declaration indicated that “priorities for progress” towards reaching VL goals include early detection of cases, improved access to diagnosis, and scale-up of diagnostic services.In support of the London Declaration goals, PATH aims to catalyze engagement of the diagnostics industry and product development efforts. As part of this work, PATH assessed needs and landscaped potential solutions to improve diagnostic tools used to support VL elimination efforts. We conducted literature reviews, a product development landscape, and interviews with key stakeholders to identify gaps in current human VL diagnostics as well as emerging solutions. These findings were used to identify use cases for VL diagnostics, determine which tools address specific use cases, analyze progress toward robust diagnostics in the development pipeline, and ultimately to propose recommendations on how to improve availability, access, and adoption of VL diagnostics.PATH identified four use cases for human VL diagnostics: diagnosing acute infection, diagnosing VLHIV coinfection, diagnosing post-kala-azar dermal leishmaniasis (PKDL), and treatment monitoring. We found that current tools and methods are likely sufficient for the early case detection needed to support elimination goals. However, current rapid diagnostic tests (RDTs) have limitations and new tools would benefit patients with HIV coinfection and PKDL, as well as improve treatment monitoring. We have developed the following recommendations:Support ongoing efforts to ensure full access to, and adoption of, current antibody detection RDTs. Health systems and market research may be needed to support optimal uptake of currently available antibody tests.Develop an antigen detection test to better diagnose VL-HIV coinfection and monitor treatment. There is a need for a noninvasive, field-friendly test that can identify active VL infections among HIV coinfected patients, as well as monitor for treatment failure and relapse.Support research and development needed for next generation antibody detection RDTs. A noninvasive, sensitive rapid test is needed to enable treatment monitoring and detection of PKDL.

PATH’s Center for Malaria Control and Elimination is building on our unparalleled portfolio of malaria tools and projects, encompassing a broad collection of competencies and expertise, to advance efforts toward elimination, and ultimately eradication, of both P. falciparum and P. vivax malaria.