Organizations involved in the milestone agreement include 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 the World Health Organization (WHO).
As part of this comprehensive, end-to-end effort, the Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with rapid diagnostic test (RDT) producers Abbott and SD Biosensor.
These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) – priced at a maximum of US$5 per unit – over a period of six months.
These tests provide results in 15–30 minutes, rather than hours or days, and will enable expansion of testing, particularly in countries that do not have extensive laboratory facilities or trained health workers to implement molecular (polymerase-chain reaction or PCR) tests.
The tests developed by Abbott and SD Biosensor are highly portable, reliable, and easy to administer, making testing possible in near-person, decentralized healthcare settings.
Both companies’ tests are faster and cheaper than laboratory-based tests, enabling countries to increase the pace of testing, tracing and treating people for COVID-19 at the point of care particularly in areas with under-resourced health systems.
Dr Tedros Adhanom Ghebreyesus, Director General of WHO, said high-quality rapid tests show them where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission.
"The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods," he said.
Mark Suzman, Chief Executive Officer of the Gates Foundation, said testing is an essential tool in the fight against COVID-19.
Dr Iain Barton, Chief Executive Officer of CHAI, said these agreements will help ensure that millions of people in low- and middle-income countries have access to high-quality rapid testing in villages and towns as well as cities.
Andrea F. Wainer, Executive Vice President of Abbott’s rapid and molecular diagnostics businesses, said Abbott is pleased to bring their Panbio COVID-19 rapid antigen test and Sympheos digital solution to people and health authorities in low- and middle-income countries through this innovative partnership.
Dr John Nkengasong, Director of the Africa CDC, said Antigen tests are an important complement to PCR testing, and are crucial to expand testing capacity throughout Africa.
Dr Carolyn Gomes, Special Advisor for the Board, ProActividad, Jamaica, and Alternate Board Member (Developing Country NGOs), The Global Fund “Ensuring equitable access to rapid diagnostic tests is essential for controlling COVID-19 in all countries and to opening up economies across the world.
To scale up the Ag RDTs, the Global Fund on Monday announced that it has made available an initial US$50 million from its COVID-19 Response Mechanism to enable countries to purchase at least 10 million of the new rapid tests for LMICs at the guaranteed price, with the first orders expected to be placed this week through the Global Fund’s pooled procurement mechanism.
FIND and WHO are working together to accelerate appropriate use by supporting implementation research that will optimize Ag RDT use in multiple LMICs, in line with WHO guidance.
Unitaid and Africa CDC will combine resources to initiate the roll out of these tests in up to 20 countries in Africa starting in October 2020.
This multi-million-dollar intervention, currently undergoing final sign-off by their Boards, is designed to engage multiple partners active in the COVID-19 response in these countries, such as CHAI, African Society for Laboratory Medicine (ASLM) and local organizations.
Rapid tests to detect the presence of the virus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19.
WHO guidance published on 11 September 2020 highlights the value of these tests in areas where community transmission is widespread and where nucleic acid amplification-based diagnostic (NAAT) testing is either unavailable or where test results are significantly delayed.
The ACT-Accelerator Diagnostics Pillar is co-convened by FIND and the Global Fund, working closely with WHO and over 30 global health expert partners to accelerate innovation and overcome the technical, financial, and political obstacles to achieving equitable access to effective and timely testing.
Such unprecedented global collaboration has enabled development and deployment of the first WHO EUL-approved Ag RDT within eight months of the first identification of the virus.