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ACT-Accelerator Diagnostics Pillar Explainer Tool

What is the ACT Accelerator?

The Access to COVID-19 Tools (ACT) Accelerator was created after the outbreak of the SARS-COV-2 pandemic in 2020. 

It is a global collaboration that uses existing public health infrastructure and expertise to accelerate the development and production of Covid-19 tests, treatments, and vaccines. It also focuses on providing equitable access to diagnostics and treatment.

The ACT Accelerator was launched in April 2020. 

It has played a significant role in supporting the fasted and best coordinated global effort in history to fight a disease.

Its current focus is on scaling up access to Covid-19 tools worldwide.

Who are the convenors?

The ACT-Accelerator is co-convened by leading global health organizations.

It consists of three pillars and two or three partner agencies managing these.

What are the three pillars?

The three pillars of the ACT-Accelerator are the vaccines pillar, the diagnostics pillar, and the therapeutics pillar.

What does each pillar do?

The Vaccines Pillar has set a goal to rapidly rollout at least 2 billion vaccine doses in 2021 to high risk groups. It also has a goal to expand research and development. 

Its third task is to identify new and emerging risks from variants of the SARS-COV2 virus.

The Diagnostics Pillar aims to identify new diagnostics and devliver 900 million high-quality tests by the end of 2021 to low- and low-middle income countries.

The Therapeutics Pillar promote research for effective treatments and ensure that countries optimize clinical care including the use of corticosteroids and medical oxygen for severe and critical patients. It also seeks to introduce new therapies and distribute up to 100 million treatment courses for populations in low and middle-income countries.

What does the Health Systems Connector do?

The Health Systems Connector (HSC) works across the three product pillars to identify and address bottlenecks in health systems worldwide and to enable the rollout of Covid-19 tools. The HSC also focuses on the rollout of personal protective equipment to health workers. 

 What is the role of the Access & Allocation workstream?

This workstream focuses on ensuring global equity and the allocation of Covid-19 resources. It also ensures that civil society and community engagement are integrated across all the pillars.

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Global Partnership to Make Available 120 Million Affordable, Quality COVID-19 Rapid Tests for Low- and Middle-Income Countries

Rapid tests are a fast and accurate way to diagnose patients in a primary healthcare setting

Global partnership feeds healthy supply of rapid COVID-19 tests to low- and middle-income countries 

A set of global agreements reached in September 2020 paved the way for 120 million rapid COVID-19 tests to be distributed to low and middle-income countries.

The Access to COVID-19 Tools (ACT) Accelerator, working with other organizations, concluded these agreements to enable the manufacture, distribution and rollout of these vital diagnostic tools.

At the time, there was a huge unmet need for fast diagnostic testing globally, especially in the low and middle-income bracket.

The Africa Centres for Disease Control and Prevention (Africa CDC), the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid, and World Health Organization (WHO) all worked on this project.

There was a particular focus on making tests available to countries without extensive laboratory facilities or trained health workers to implement molecular (polymerase chain reaction or PCR) tests.

Why is testing crucial in the fight against COVID-19?

Rapid tests are a fast and accurate way to diagnose patients in a primary healthcare setting, as this is where most people access services. 

Rapid tests are also cheaper than laboratory tests. With a fast initial diagnosis, track and trace teams in more remote and rural areas can start work sooner without waiting for laboratory test results. 

Quick results can prevent the virus from spreading in communities. Rural and remote healthcare settings especially need access to rapid testing, as accessing centralized laboratory services can take a long time.

Procurement

The Global Fund made $50-million available to purchase 10 million tests per country.

Distribution

FIND and WHO supported countries in distributing these tests.

Unitaid and the Africa CDC combined resources rollout tests to countries in Africa from October 2020. 

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Project STELLAR: Supporting the COVID-19 Response

Project Stellar to help countries expand diagnostic testing for Covid-19

In Sub-Saharan Africa, COVID-19 testing rates are still low in most

Countries. One of the reasons for this is inadequate investment in laboratory capacity. There is a similar trend in testing rates for HIV, TB, and malaria.

In addition, despite the availability of rapid antigen tests, many countries have not effectively decentralized testing to a community level. 

New investment 

Since February 2022, C19RM 2021, the response arm of the Global Fund, has been investing US$800 million across 100 countries to procure COVID-19 diagnostics and commodities.

Project Stellar was created in February 2022 within the Global Fund to support countries in reaching Covid-19 testing goals and strengthen laboratory systems over the longer term. 

Goals

It aims to offer assistance with planning, mobilizing resources, and creating a targeted advocacy program to encourage testing. Countries will also receive help in developing a diagnostics strategy and algorithm.

Other goals for the project that will run up to December 2023 are to scale up testing, including training and community outreach, and the management of data and surveillance systems.

The project will also aim to improve regulatory approvals of rapid antigen tests and coverage for COVID-19 testing.

Another goal is to advocate for wastewater-based surveillance and epidemiological monitoring at a country level. Wastewater surveillance often provides an early warning system of cases rising. 

Project Stellar will also help countries to strengthen data management and surveillance systems. 

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You’re Part of Something Bigger”: Delivering Lifesaving COVID-19 Diagnostic Tests in South Africa

Getting tests into hands: delivering rapid diagnostic tests to South Africa

In June 2021, a large shipment of COVID-19 diagnostic tests procured by the Global Fund through their Pooled Procurement Mechanism arrived in South Africa.

Part of the order was 648 000 rapid antigen tests that produced results within 15 minutes for community health workers and medical personnel working on the front lines.

At the time, the country saw a rapid rise in infections caused by the Delta variant. The rollout of vaccines to the general public only started in July that year, with the elderly getting priority access.

All hands on deck
Logistics personnel interviewed by the Global Fund reported early-morning queues on average 100 metres long at testing sites, as people tried to access possible diagnoses in response to the new infection wave.

The test kits delivered in South Africa were manufactured in South Korea, flown via Ethiopia to a warehouse in Johannesburg, and sorted and distributed throughout the country. 

The supply chain also faced several problems, including a shortage of shipping containers, resulting in delays in deliveries of essential products, such as personal protective equipment. Logistics personnel also feared theft and hijacking.

By 1 July 2021, the Global Fund has procured 21.5 million diagnostic tests worldwide.

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Global Fund, United States and Unitaid Launch “Test-and-Treat” Programs at Second Global COVID-⁠19 Summit

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. 

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Vaccines Alone Won’t Defeat the Variants

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. 

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Low testing rates and constrained access to vaccines – a deadly combination?

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:

  • Germany offers a free test a week
  • England offers two free tests a week
  • Lower-income countries can only test 7 people for every 100 000
  • For every test done in lower-income countries, high-income countries test 86 people
  • According to a survey of 24 African countries, only 11% could offer rapid COVID-19 tests, and only 8% could provide PCR tests
  • Globally, there is an $8.7-billion shortfall in testing and lab capacity. Box ends

“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.

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One year into the Covid-19 pandemic, testing is as vital as ever

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. 

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The Global Fund’s COVID-19 Response Mechanism (C19RM)

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

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Global Fund’s list of diagnostic tools eligible for procuremen

Here is a list of SARS-CoV-2 Diagnostic test kits and equipment eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19. 

Why use them?

It is simpler and provides faster results than laboratory tests (PCR tests). 

How does it work?

These tests detect viral proteins from the SARS-CoV2 virus in a swab taken from the nose and other respiratory secretions. 

How fast is it?

Results are ready in around 30 minutes. 

How accurate are they?

These tests are less sensitive than PCR tests but are ideal in situations where there is a need for rapid, inexpensive, and early detection of the most infectious COVID-19 cases.

What guidance is provided by the WHO for the use of these tests?

Rapid antigen tests are ideal for primary case detection in symptomatic individuals suspected to be infected. Health workers can also use the test to ascertain the status of asymptomatic individuals at high risk of COVID-19. It is an excellent tool for contact tracing during outbreak investigations and monitoring trends of disease incidence in communities.