Is qualitative social research in global health fulfilling its potential?: a systematic evidence mapping of research on point-of-care testing in low- and middle-income contexts.

BACKGROUND: Qualitative social research has made valuable contributions to understanding technology-based interventions in global health. However, we have little evidence of who is carrying out this research, where, how, for what purpose, or the overall scope of this body of work. To address these questions, we undertook a systematic evidence mapping of one area of technology-focused research in global health, related to the development, deployment and use of point-of-care tests (POCTs) for low-and middle-income countries (LMICs). METHODS: We conducted an exhaustive search to identify papers reporting on primary qualitative studies that explore the development, deployment, and use of POCTs in LMICs and screened results to identify studies meeting the inclusion criteria. Data were extracted from included studies and descriptive analyses were conducted. RESULTS: One hundred thirty-eight studies met our inclusion criteria, with numbers increasing year by year. Funding of studies was primarily credited to high income country (HIC)-based institutions (95%) and 64% of first authors were affiliated with HIC-based institutions. Study sites, in contrast, were concentrated in a small number of LMICs. Relatively few studies examined social phenomena related to POCTs that take place in HICs. Seventy-one percent of papers reported on studies conducted within the context of a trial or intervention. Eighty percent reported on studies considering POCTs for HIV and/or malaria. Studies overwhelmingly reported on POCT use (91%) within primary-level health facilities (60%) or in hospitals (30%) and explored the perspectives of the health workforce (70%). CONCLUSIONS: A reflexive approach to the role, status, and contribution of qualitative and social science research is crucial to identifying the contributions it can make to the production of global health knowledge and understanding the roles technology can play in achieving global health goals. The body of qualitative social research on POCTs for LMICs is highly concentrated in scope, overwhelmingly focuses on testing in the context of a narrow number of donor-supported initiatives and is driven by HIC resources and expertise. To optimise the full potential of qualitative social research requires the promotion of open and just research ecosystems that broaden the scope of inquiry beyond established public health paradigms and build social science capacity in LMICs.

Needs-driven versus market-driven pharmaceutical innovation: the consortium for the development of a new medicine against malaria in Brazil.

The prevailing model for encouraging innovation based on patents and market-oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction to the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed-Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed-dose combinations recommended by the WHO - artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm - needs-driven instead of market-driven -, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs-driven pharmaceutical innovation.

Imperfect diagnosis: The truncated legacies of Zika testing.

When the Zika virus burst onto the international scene in the second half of 2015, the development of diagnostic tools was seen as an urgent global health priority. Diagnostic capacity was restricted to a small number of reference laboratories, and none of the few available molecular or serological tests had been validated for extensive use in an outbreak setting. In the early weeks of the crisis, key funders stepped in to accelerate research and development efforts, and the WHO took responsibility for steering diagnostic standardization, a role it had successfully played during the West Africa Ebola virus outbreak. Yet when the WHO declared the end of the Zika Public Health Emergency of International Concern in November 2016, diagnostic capacity remained patchy, and few tools were available at the scale required in the countries that bore the brunt of the epidemic, particularly Brazil. This article analyses the limited impact of global R&D efforts on the availability of Zika diagnostic options where they were most needed and for those most vulnerable: women who might have been exposed to the virus during their pregnancy and children born with suspected congenital Zika syndrome. The truncated legacies of testing during the Zika crisis reveal some of the fault lines in the global health enterprise, particularly the limits of 'emergency R&D' to operate in geopolitical contexts that do not conform to the ideal type of a humanitarian crisis, or to tackle technical issues that are inextricably linked to domestic struggles over the scope and distribution of biological citizenship. Diagnostic shortcomings, we argue, lie at the heart of the stunning transformation, in less than two years, in the status of Zika: from international public health emergency to neglected disease.

Testing COVID-19 in Brazil: fragmented efforts and challenges to expand diagnostic capacity at the Brazilian Unified National Health System.

Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

Testing COVID-19 in Brazil: fragmented efforts and challenges to expand diagnostic capacity at the Brazilian Unified National Health System / A testagem para COVID-19 no Brasil: esforços fragmentados e desafios para ampliar a capacidade diagnóstica no Sistema Único de Saúde / Testar para COVID-19 en Brasil: esfuerzos fragmentados y desafíos para expandir la capacidad diagnóstica en el Sistema Único de Salud

Abstract: Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

Resumo: Desde que o primeiro caso de COVID-19 no Brasil foi notificado, em 26 de fevereiro de 2020, o país assiste a um crescimento exponencial no número de casos e mortes. A estratégia nacional de testagem tem sido insuficiente para usar essa ferramenta corretamente no apoio à contenção da epidemia no país. O artigo discute os esforços e desafios para escalonar a testagem para COVID-19 no Sistema Único de Saúde (SUS). O texto apresenta os resultados iniciais de um projeto de pesquisa sobre os aspectos políticos, industriais, tecnológicos e regulatórios que podem afetar a capacidade diagnóstica e de testagem para COVID-19 no Brasil. O estudo se apoia em revisão da literatura cientifica, artigos publicados na mídia e coleta de dados públicos sobre a compra e regulamentação de testes. O texto faz referência a iniciativas para ampliar a testagem de PCR, a produção nacional e o desenvolvimento de tecnologias, além de medidas regulatórias fast-track para novos testes. Nossa análise sugere alguns pontos para reflexão. Primeiro, a falta de uma estratégia nacional consistente para combater a COVID-19 agravou os problemas de fornecimento de reagentes de diagnostico num primeiro momento. Esta situação foi posteriormente resolvida, embora coloque novamente em pauta a dependência estrutural do país na importação de insumos de saúde estratégicos. Em segundo lugar, financiamento e a distribuição de testes, que ocorreram de forma descontinuada, podem indicar a fragmentação da política sanitária, assim como o papel de governos estaduais, municipais e atores não estatais no combate à epidemia no âmbito do SUS. Por último, iniciativas estabelecidas no segundo semestre de 2020 contribuíram para ampliar a capacidade de testagem molecular no SUS. Contudo, essa capacidade não foi suficiente para controlar a epidemia no Brasil.

Resumen: Desde que se registró el primer caso de COVID-19 el 26 de febrero de 2020, Brasil ha visto un crecimiento exponencial en el número de casos y muertes. La estrategia nacional para preconizar el test de diagnóstico ha sido insuficiente en el uso correcto de esta herramienta, con el fin de ayudar a contener la epidemia en el país. Se presentó los esfuerzos y los desafíos para ampliar la realización de pruebas de COVID-19 en el Sistema Único de Salud brasileño (SUS). Este artículo presenta los resultados iniciales del proyecto de investigación sobre los aspectos políticos, industriales, tecnológicos y regulatorios que pueden afectar la capacidad de diagnóstico para la COVID-19 en Brasil. El grupo de investigación realizó una revisión de la literatura académica, medios de comunicación y recogida de datos públicos respecto a la adquisición de tests y su regulación. Se haz referencia a iniciativas para promover la realización de pruebas de PCR, la producción nacional y el desarrollo de tecnologías, así como las medidas regulatorias fast-track para nuevas pruebas. Nuestro análisis indica algunos puntos de reflexión. Primero, la falta de una estrategia nacional consistente para luchar contra la COVID-19 que exacerbó los problemas de sumistro de los componentes de diagnóstico en un primer momento. Se solucionó posteriormente esta situación, aunque se coloque nuevamente en pauta la dependencia estructural del país en la importación de insumos de salud estratégicos. Segundo, la financiación y la distribución de tests de forma descontinuada pueden indicar la fragmentación de la política de salud, así como los gobiernos estaduales, municipales, y atores no estatales asumiendo un rol preponderante en acciones de combate a la epidemia en el SUS. En último, las iniciativas establecidas en el segundo semestre del 2020 contribuyeron para ampliar la capacidad de realización de tests moleculares en el SUS. Sin embargo, esa capacidad no fue suficiente para controlar la epidemia en Brasil.

A incorporação do teste diagnóstico baseado na amplificação de ácidos nucleicos (NAT) para triagem de sangue no SUS: arranjos tecnológicos para a nacionalização do "NAT brasileiro" / The introduction of nucleic acid tests (NAT) for blood screening in the Brazilian public healthcare system: technological arrangements for the nationalization of the "Brazilian NAT"

Resumo Os testes de ácidos nucleicos (NAT) são ferramentas complementares aos testes sorológicos para controle da transmissão de doenças infecciosas por meio de produtos obtidos a partir do sangue. Em 2002, um decreto do Ministério da Saúde tornou obrigatória a realização do NAT por todos os bancos de sangue, medida dificultada por razões como os custos necessários para a sua implantação. Como estratégia para a sua incorporação nos bancos de sangue ligados ao SUS, um consórcio público foi criado para desenvolver uma versão local do kit. A partir de métodos de pesquisa qualitativa, os autores analisam essa iniciativa, visando esmiuçar os detalhes da "nacionalização tecnológica" de um teste diagnóstico in vitro. O artigo descreve como o consórcio compreende o kit e como cada uma das tecnologias que o compõem são obtidas e reunidas no teste brasileiro. A relevância dessa análise é identificar quais os desafios e os limites à produção de testes in vitro para doenças infecciosas no Brasil, assim como a repercussão desse tipo de iniciativa para o sistema nacional de inovação em saúde.

Abstract Nucleic acid based amplification tests (NAT) are employed as complementary tools to control the transmission of infectious diseases through contaminated blood. In 2002, a decree from the Brazilian Ministry of Health made compulsory the use of NAT by all the blood services in the country, a measure that was challenged by costs related to the test incorporation. As the strategy to introduce the test in the blood banks serving the public healthcare system (Sistema Único de Saúde), a public Consortium was constituted to develop a local version of the kit. On the basis of qualitative fieldwork, the authors investigate the strategies used by the Brazilian laboratories and universities to nationalize the kit through capturing and assembling its various components. The paper contributes to revealing the challenges and limits to the production of in vitro tests for infectious diseases in Brazil, as well as the repercussion of such an initiative to the national healthcare innovation system.