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 se-mester of 2020 have expanded the testing capacity at SUS. However, it


Introduction
Since World Health Organization (WHO) called on all countries to ramp up their testing programs in order to slow the advance of the new coronavirus 1 , we observed some examples of success in countries with different levels of development such as South Korea, Vietnam, Thailand, and Rwanda.These nations rapidly controlled the transmission, flattening the curve of cases.The South Korean government implemented a very rigid and repressive quarantine policy and an efficient contact tracing, but the availability of tests was undoubtedly a key element in the country's response.Previous work indicated some possible reasons for the rapid increase of test production and availability: political will and coordination, preparedness, and the existence of a strong national industry able to provide reagents 2 .
Since the first recorded case of COVID-19 on February 26, 2020, in Brazil, the country has seen an exponential growth in the number of cases and deaths.This serious public health issue is as much a matter of political will and lack of national coordination, as the underinvestment of the Brazilian Unified National Health System (SUS).The austerity policies for the last four years, in particular the 95 Constitutional Amendment setting a government expenditure ceiling for the next 20 years, has left SUS extremely vulnerable to address COVID-19 epidemic 3 .
Initiatives such as biotechnological enterprises, investments in new laboratory infrastructure and fast-track regulatory measures were launched to scale-up COVID-19 testing in Brazil.These fragmented efforts have congregated a set of heterogeneous actors: from regional/local governments (states and municipalities) to the private sector.The last Brazilian National Household Sample Survey -COVID-19 (PNAD COVID19), carried out by the Brazilian Institute of Geography and Statistics (IBGE) 4 , indicates that 12,686 million PCR tests were performed by November 2020.This number represents an increase in COVID-19 testing but it is still low for a population of almost 213 million Brazilians 5 .
Considering this scenario, the project CoBRATestes -Testing Capacity for COVID-19 in Brazil: National Technological Production and Universal Access to Health in Times of Political Uncertainty funded by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) aims to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for SARS-CoV-2 in Brazil.
In this communication, we discuss the efforts to expand the offer of COVID-19 tests at SUS, as well as the major challenges to such initiatives.SUS is responsible for public health interventions and embraces more than 70% of the Brazilian population, representing a leading market for new biotechnologies on infectious diseases such as diagnostics and vaccines.

Method
This paper results from exchanges during the first months of CoBRATestes project.In this initial phase, the team has launched a platform to ease data collection, e.g., epidemiological reports, information on public purchase, gray and scientific literature, media articles.The platform also represents an effort to integrate a multidisciplinary network of Brazilian and French researchers who take part in the project team.The paper draws on this initial review of academic literature, media publication, and collection of public data on tests purchase and regulation.
The methodological approach to assess COVID-19 testing capacity in SUS is based in science and technology studies.It follows actors and action across different social worlds of science, industry, and the regulation of innovations 6 .Mixed methods are deployed, including interviews with key actors and observation in COVID-19 testing sites in Brazil.

Initiatives to enhance the molecular testing capacity
The testing strategy at SUS seems to be under continuous change.At the federal level, the government's strategy has prioritized testing in hospital and health care settings for symptomatic patients.A national testing program Diagnose to Care was launched in May with the goal to test 22% of the population 7 .
Initially, the network of central public health laboratories (LACENs) concentrated the PCR testing, with complementary support by the inclusion of laboratories from public universities and the network of HIV/AIDS viral load testing laboratories.The installation of four new PCR testing facilities further enhanced the testing capacity: two at the Oswaldo Cruz Foundation (Fiocruz) in Rio de Janeiro and Ceará; a facility in Curitiba at the Molecular Biology Institute of Paraná (IBMP) -a molecular biology institute connected to Fiocruz; and another one in a private network of laboratories (Diagnostics of America S.A. -DASA), in São Paulo.These efforts aim to increase testing capacity based on the model of public-private partnerships and the unprecedented contribution of donationbased funding.Together, these laboratories can process a million tests per month according to a public announcement 8 .Besides, some municipalities and states have developed their own testing strategies.

National production and importation of testing components
The supply of diagnostic components has affected the testing initiatives in several countries in the beginning of the pandemic.The burden was particularly high for developing countries since they need to compete with wealthier nations for reagents in the international market 9 .
The country presents a cluster of national private and public in vitro diagnostics (IVD) production.Since the 2000s, public production has been reinforced with investments to manufacture molecular kits and rapid platforms.PCR testing for COVID-19 at the LACENs has been assured by Fiocruz' biotech units (Institute of Technology in Immunobiologicals -Bio-Manguinhos -and the IBMP), by the mobilization of their molecular system, a model initially developed for blood screening.This system had already been employed during the Zika epidemics in the country 10 .Nevertheless, other biological components and platforms are outsourced from elsewhere, exposing more structural dependency in the IVD sector.

Technological development
Several research groups have announced R&D activities for COVID-19 diagnostics.These groups are essentially public universities, research institutes, and private hospitals.They are targeting rapid, cheaper, and high performing tests compared to the ones available in the market.Besides that, there are some initiatives focused on reinforcing local production of diagnostics components.

Regulatory measures
The Brazilian Health Regulatory Agency (Anvisa) has implemented some measures to fast track market authorization of COVID-19 tests.By July 14, 2020, it had authorized 275 COVID-19 tests under an emergency use authorization.Other countries and regions have also implemented a similar mechanism.Brazil put this mechanisms in force to tackle Zika epidemic, which brought to the market many arboviruses tests.Such mechanisms intend to facilitate the availability of technologies during a public health emergency.However, concerns are raised over the reliability of some tests approved under these circumstances.Granting commercial authorization of rapid tests to pharmacies in April 2020 was another mechanism deployed to facilitate widespread use of diagnostic tests 11 .We plan to study the actual significance of these mechanisms in COVID-19 outbreak control.

Discussion
We have enlisted initiatives aiming to expand the testing capacity to face COVID-19 in the SUS, as well as challenges that affect such efforts.Our analysis sheds light to the country's response to recent epidemics like HIV and Zika, and broadly to efforts in consolidating SUS in the last thirty years.
Firstly, this paper mentioned that the shortage of tests and reagents, in a first moment resulted from a lack of coordination and anticipation of reagent purchases by the country, as well as due to a simultaneous increase in the purchases at the global level.If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components.This issue was highlighted by Brazilian researchers and considered in the set of technological and industrial policies to reinforce the health care industrial complex 12 .These policies were later affected by the acute economic and political crises of the last four years and the adoption of fiscal austerity rules 13 .The lack of a consistent national strategy to fight COVID-19 only exacerbated supply problems of diagnostic components.
Secondly, the fragmented funding and distribution of tests displays the action of public health actors, universities, local health authorities, and hospitals but also of corporations and private banks in the absence of a nationally coordinated response during the first semester of 2020.This scenario may have implied health policy fragmentation and the growing importance of local governments and non-state actors in fighting the epidemics within the scope of SUS.
Finally, it is relevant to look at the Brazilian experience in fighting HIV/AIDS, even though the latter was shaped in a different political context regarding health, S&T, and foreign relations policies.The national AIDS program played a major role in assuring access, technology evaluation, standardization, laboratory training, and procurement of HIV tests.Centralized procurement procedures were critical to optimize testing, allowing price negotiation and public manufacture to regulate the market 14 .In the case of COVID-19, initiatives such as the new PCR testing facilities coordinated by Fiocruz have circumvented an initial lack of coordination.However, the expansion of the testing capacity has not been sufficient to control the progress of the epidemic in the country 15 .

Contributors
K. Kameda contributed to the study conception and design; data collection, analysis and interpretation; manuscript writing and review; and approved the final version of the manuscript, including the guarantee of its accuracy and integrity.M. M. Barbeitas contributed to the data collection, analysis and interpretation; manuscript writing and review; and approved the final version of the manuscript, including the guarantee of its accuracy and integrity.R. Caetano, I. Löwy, and A. C. D. Oliveira contributed to the data collection and interpretation and manuscript review; and approved the final version of the manuscript, including the guarantee of its accuracy and integrity.M. C. D. V. Corrêa and M. Cassier contributed to the study conception and design; data collection, analysis and interpretation; manuscript review; and approved the final version of the manuscript, including the guarantee of its accuracy and integrity.