Global partnership to make available 120 million affordable, quality COVID-19 rapid tests for low- and middle-income countries

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2020-09-29

A full access package includes WHO policy guidance on the use of antigen-based rapid diagnostic tests, manufacturer volume guarantees for low and middle-income countries, catalytic funding to assist governments to deploy the tests and an initial US$50 million procurement fund

Several rapid, point-of-care antigen tests are being assessed by WHO for Emergency Use Listing (EUL)

Agreements between the Bill & Melinda Gates Foundation and test manufacturers Abbott and SD Biosensor make available innovative tests priced at a maximum of US$5 for low- and middle-income countries (LMICs)

The Global Fund commits an initial US$50 million to enable countries to purchase the new tests, with the first orders expected to be placed this week

Expedited market introduction of these tests in multiple LMICs is being supported through the Africa Centres for Disease Control and Prevention (Africa CDC), Unitaid, FIND, CHAI, and their partners

This is the latest move from the Access to COVID-19 Tools (ACT) Accelerator to develop, procure and distribute critical new tools to fight the pandemic; new tests are urgently needed to meet the huge unmet needs for testing worldwide

A set of agreements to make available, for low and middle-income countries, affordable, high-quality COVID-19 antigen rapid tests were announced on Sept.28 by the Access to COVID-19 Tools (ACT) Accelerator. 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. A number of other Ag RDTs are at various stages of development and assessment.

To scale up the Ag RDTs, the Global Fund 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. This includes provision of catalytic volumes of tests to understand how Ag RDTs can best fit into health systems.

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.

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.

Source: World Health Organization