On this episode of the Global Health Matters podcast, FIND CEO Bill Rodriguez and Sikhulile Moyo, who led the team that helped discover the Omicron variant in Botswana, to discuss key questions such as “how available are essential diagnostics in low- and middle-income countries (LMICs)?” in an effort to understand the state of diagnostic testing in LMICs and how to achieve equity in access to testing in all countries.
“Diagnostics constitutes the most significant funding gap within the ACT Accelerator”
Low testing rates and constrained access to vaccines – a deadly combination?
In this opinion piece Peter Sands, Director of the Global Fund to Fight AIDS, tuberculosis, and malaria, and Emma Hannay, Find’s Chief Access Officer, argue for a global refocus on testing to fight the COVID-19 pandemic.
They highlight the stark inequalities in COVID-19 testing between high-, middle- and low-income countries, saying that this can create conditions for a more severe and contagious mutation of SARS-COV-2 to emerge unnoticed.
The authors add that diagnostics constitutes the most significant funding gap within the ACT Accelerator.
The statistics:
“The low availability of testing, coupled with constrained access to vaccines, create a perfect environment for new, more contagious, and perhaps more deadly strains of the COVID-19 virus to emerge without initial notice, putting even vaccinated populations at risk” – Peter Sands and Emma Hannay.
Why do we not use antibody tests to diagnose COVID-19 infections?
Checking for antibodies is not the most accurate indicator of the presence of a SARS-COV-2 infection.
What are antibody tests?
This article explains the role antibody tests are playing in fighting the pandemic.
Antibodies neutralize foreign cells the body sees as a threat. Most COVID-19 vaccines trigger the body to produce antibodies against the spike protein in the SARS-COV-2 virus.
The spike protein is a molecule found on the surface of the virus, and it helps the virus to enter the host cells and spread from there.
Why can’t we use antibody testing to measure vaccine efficacy?
COVID-19 serology tests were designed early in the pandemic to detect only a few antibodies generated by natural infection, not vaccine-induced immunity.
They detect antibodies produced to fight the protein capsule around the virus and not the spike protein, while most COVID-19 vaccines introduce the body to small amounts of the genetic material in the spike protein to elicit an immune reaction.
Can antibody testing determine if a vaccine worked?
Not precisely. It takes around two weeks for the body to generate antibodies after COVID-19 vaccination, so even tests to detect the “right” antibody could be negative in the first few weeks after vaccination.
Can antibody tests be wrong?
The United States Food and Drug Administration (FDA) has recommended that antibody testing not be used to evaluate either immunity levels or protection levels from SARS-COV-2.
Why still do antibody tests?
Data from antibody tests are helpful for surveillance studies. In these studies, large numbers of people in a community are tested. These studies estimate how many people were infected in the past and how fast the virus spreads.
First established in April 2020, the Global Fund’s COVID-19 Response Mechanism (C19RM) was designed to rapidly respond to the global health emergency created by SARS-CoV-2. Building on 20 years of experience in fighting three of the deadliest infectious diseases, and using its comparative advantages in procurement, deployment at scale and existing relationships with implementing countries and communities, the Global Fund was swiftly able to step up its COVID-19 response.
Since first establishing C19RM, the Global Fund has been able to expand, refine and develop the mechanism. It learned lessons and responded as the pandemic evolved and adapted to changing country needs and the availability of new tools such as self-testing and oral antivirals.
Through C19RM, the Global Fund has been the primary source of funding for all COVID-19 tools, except vaccines. Thanks to the generous backing of donors, the Global Fund has awarded over US$4.9 billion since March 2020 to 109 low- and middle-income countries (LMICs) and 22 multi-country programs, to support health and community health workers and communities fight and recover from COVID-19.
The Global Fund has been able to support LMICs in responding to the new virus, mitigating the knock-on impact on HIV, TB and malaria programs and protecting the health services. C19RM support included providing access to diagnostics, oxygen, therapeutics, and personal protective equipment (PPE) at a time of unprecedented global demand, as well as adapting lifesaving HIV, TB and malaria services and investing to reinforce overstretched health systems, including supporting community health workers.
In addition to provision of COVID-19 tools, countries were encouraged to invest in crucial Community interventions, such as responding to human rights and gender related barriers to services, community-led monitoring, community-led advocacy and research, social mobilization, building community linkages and coordination, institutional capacity building, planning and leadership development, and gender-based violence (GBV) prevention. Working through the community engagement strategic initiative partners, communities and civil society were able to access technical support to engage in the process.
C19RM on Diagnostics
From the start of the pandemic, the Global Fund took a leading role in supporting LMICs to scale up testing for the new virus, based on 20 years of experience in procuring diagnostics and investing in laboratory capacities.
C19RM investments have backed countries’ efforts to address the acute difficulties in sourcing PCR and rapid antigen diagnostic tests (Ag-RDT) and scaling-up testing in response to COVID-19 – including supply-side constraints, high costs, quality issues, long delivery times and delays in the issuance of guidance on testing strategies. C19RM procured PCR tests and Ag-RDTs, strengthened laboratory systems and network capacities, and reinforced national testing strategies and governance. In the first phase of the pandemic, the Global Fund worked closely with ACT-Accelerator partners to ensure equitable allocation of the extremely limited volume of PCR diagnostics then available to LMICs, while working to secure greater production capacity, negotiate pricing and tackle implementation bottlenecks. Following the introduction of WHO-approved Ag-RDTs in September 2020, the Global Fund encouraged their deployment and the introduction of community-based testing and self-testing.
Alongside large-scale procurement and deployment of diagnostics, the Global Fund has also been supporting technical capacity building through Project STELLAR, supporting a group of 23 African countries in scaling-up COVID-19 testing, including wastewater testing, improving diagnostic governance and data management, and galvanizing longer term strengthening of laboratory systems, a key component of resilient and sustainable health systems.
In 2023, as the acute phase of the disease had passed and COVID-19 is becoming endemic in many countries, the priorities of implementing countries have shifted towards longer-term investments in health infrastructure and capacities for pandemic preparedness. To respond to counties’ needs, C19RM priorities have shifted to strengthening key components of an effective health system, especially laboratory systems, surveillance, human resources (including community health workers), supply chain management, oxygen and respiratory care, infection prevention and control (IPC), pandemic preparedness and response (PPR) and sustainable waste management. In addition, the Global Fund continues to work towards limiting the impact of COVID-19 on high-risk populations in LMICs through Test and Treat integrated service delivery models. Key activities include facilitating access to novel treatments and providing technical assistance to integrate treatment into existing public health infrastructure.
To learn more, visit the Global Fund’s C19RM page
Diagnostics are an essential part of a well functioning and high-quality health system. Yet, almost half of the global population has little or no access to diagnostics. The COVID-19 pandemic has shown acutely that diagnostic capacity in a country is directly linked to the ability to respond to the pandemic with appropriate public health measures and to monitor emerging variants. There is an urgent need to strengthen diagnostics for future pandemic preparedness but also beyond pandemics. Diagnostics are central to an accurate diagnosis of communicable and non-communicable diseases, to guide therapy, monitor progress, and assess response to treatment. The Commission puts forward recommendations to accelerate and transform access to diagnostics globally.