SWITZERLAND – Access to COVID-19 Tools (ACT) Accelerator has announced a set of agreements to make available affordable, high-quality COVID-19 antigen rapid tests for low and middle-income countries.
The organizations involved in this milestone agreement include the Africa Centres for Disease Control and Prevention (Africa CDC), Bill & Melinda Gates Foundation, Clinton Health Access Initiative (CHAI), Foundation for Innovative New Diagnostics (FIND), 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 and 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 faster and cheaper than laboratory-based tests thus 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.
To scale up the Ag RDTs, the Global Fund has 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.
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.
This will bolster efforts by the African Union’s Partnership to Accelerate COVID-19 Testing (PACT) initiative launched in August 2020 to mobilize experts, community workers, supplies and other resources to minimize the impact of the pandemic on the African continent by testing, tracing and treating COVID-19 cases in a timely manner.
Testing is a critical cornerstone of the COVID-19 response enabling countries to trace and contain the virus now and to prepare for the roll-out of vaccines once available.
Effective testing strategies rely on a portfolio of test types that can be used in different settings and situations.
While molecular tests started to be rolled out within a month of the virus being sequenced, these tests are mainly laboratory based relying on infrastructure and trained personnel to conduct them.
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.
As well as supporting test-trace-isolate strategies, the tests can help identify or confirm new outbreaks, support outbreak investigations through screening; monitor disease trends and potentially test asymptomatic contacts.
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.
Overall, the ACT-Accelerator Diagnostic Pillar aims to facilitate the supply of 500 million tests to LMICs within 12 months.
Dr Tedros Adhanom Ghebreyesus, Director General of WHO, said: “High-quality rapid tests show us 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.”
On his part, 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. The beauty of antigen testing is that it is fast and gives quick results. It will allow healthcare workers to quickly isolate cases and treat them while tracing their contacts to cut the transmission chain.”
Chief Executive Officer of FIND, Dr. Catharina Boehme said: “With this Ag RDT package, the ACT-Accelerator partners have secured much-needed tools for LMICs to dramatically increase COVID-19 testing. With the financial support of several countries, we have made great progress, but to ensure we reach all those who need testing and bring the prices down, we urgently need substantial funding from public, philanthropic, and multilateral sources.”