Resources

Fact sheet for onchocerciasis rapid test diagnostic project in French.

In this Advocacy Impact Case Study, PATH and partners used the emergence of breastfeeding as a national policy priority in South Africa to demonstrate how human milk banks could provide a safe and effective solution for vulnerable infants without access to their mothers’ breast milk. Advocates from PATH, the Human Milk Banking Association of South Africa (HMBASA), South African Breastmilk Reserve, and Milk Matters provided government policymakers with evidence on the benefits of a national milk banking program throughout the late 2000s. As a result, the Tshwane Declaration, South Africa’s 2011 national policy on breastfeeding, declared the country’s support for exclusive breastfeeding and helped make human milk banking a national priority. As of early 2015, several provincial governments had also prioritized developing their own policy frameworks, adopting new technologies, and setting up milk banks to meet local needs.

In South Africa, high rates of unintended pregnancy, maternal mortality, and HIV infection make it critical for women to have access to prevention tools that meet their needs. One important tool is the female condom, which the government of South Africa has promoted through its public-sector distribution program since 1998. In 2012, the South African government launched a new National Strategic Plan on HIV, sexually transmitted infections (STIs), and tuberculosis (TB) for 2012-2016 that included ambitious female condom procurement targets. Over 18 months from 2012 to 2013, advocates from PATH and the reproductive rights advocacy group Women in Sexual and Reproductive Rights and Health (WISH) Associates implemented a series of activities to maintain a steady drumbeat of attention on female condoms, to increase accountability among South African officials for procurement and programming. As a result, the South African government released its largest-ever tender for female condoms, requesting a supply of 54 million units over three years.

Neglected tropical diseases (NTD) affect the poorest populations. Several NTDs including schistosomiasis are controlled by preventive chemotherapy (PC) in the form of periodic mass drug administration (MDA). In areas with insufficient sanitation, schistosomes and soil-transmitted helminth (STH) are transmitted by eggs excreted in human stool and/or urine that contaminates the environment. Around 200 million individuals are infected with schistosomiasis, resulting in an estimated 1.7 to 4.5 million disability-adjusted life years (DALYs) lost and 14,000 to 280,000 deaths per year.Control programs based on MDA have four designated stages: mapping disease distribution, monitoring impact of MDA interventions, stopping decisions for MDA, and post-elimination surveillance. Current diagnostics including the Kato-Katz technique are thought to be sufficient for mapping disease distribution (Appendix A: Common diagnostic tools). As the most commonly used method for schistosomiasis detection, its main strength is its extensive validation and familiarity all over the world. Requiring nothing more than a microscope and a good light source or power, the simplistic technology allows easier use at lower infrastructure levels. However, the major limitations of the Kato-Katz technique are its need for a trained microscopist and low sensitivity for detecting light intensity infections, which diminishes its utility in later disease control stages. To support schistosomiasis control programs to continue to move toward elimination, a more sensitive, field-deployable diagnostic is needed.This report proposes a target product profile (TPP) for the development of a new diagnostic technology that facilitates an accurate stopping decision for MDA. Each attribute has an “acceptable” standard that must be met and an “ideal” standard that if met would maximize the target product’s value. This TPP focuses on the development of a rapid diagnostic test that detects Schistosoma-specific antigens or nucleic acid.

Neglected tropical diseases (NTD) affect the poorest populations. Several NTDs including schistosomiasis are controlled by preventive chemotherapy in the form of periodic mass drug administration (MDA). In areas with insufficient sanitation, schistosomes and soil-transmitted helminth are transmitted by eggs excreted in human stool and/or urine that contaminates the environment. Around 200 million individuals are infected with schistosomiasis, resulting in an estimated 1.7 to 4.5 million disability-adjusted life years (DALYs) lost, and 14,000 to 280,000 deaths per year.Control programs based on MDA have four designated stages: mapping disease distribution, impactmonitoring of MDA interventions, stopping decisions for MDA, and post-elimination surveillance. Current diagnostic tools including the Kato-Katz technique are thought to be sufficient for mapping disease distribution (see Appendix A: Common diagnostic tools). As the most commonly used method for schistosomiasis detection, its main strength is its extensive validation and familiarity all over the world. Requiring nothing more than a microscope and a good light source or power, the simplistic technology allows easier use at lower infrastructure levels. However, the major limitations of the Kato-Katz technique are its need for a trained microscopist and low sensitivity for detecting light intensity infections, which diminish its utility in later disease control stages. To support schistosomiasis control programs to continue to move toward elimination, a more sensitive, field-deployable diagnostic is needed.This report proposes a target product profile (TPP) for the development of a new diagnostic technology that facilitates an accurate stopping decision for MDA. Each attribute has an “acceptable” standard that must be met and an “ideal” standard that if met would maximize the target product’s value. This TPP focuses on the development of a lateral flow rapid diagnostic test that detects a Schistosoma-specific antigen.