The World Health Organisation (WHO) will make about 120 million antigen rapid diagnostic tests available to low- and middle-income countries (LMIC), a move that follows milestone agreements finalised for this purpose.

“This will enable the expansion of testing, particularly in hard-to-reach areas that do not have lab facilities or enough trained health workers to carry out PCR tests,” said WHO Director General Tedros Adhanom Ghebreyesus.

The tests are priced at a maximum of $5 per unit, substantially cheaper than PCR tests, he said, adding that it is expected to further come down. Volume guarantee agreements have been signed with rapid diagnostic test producers Abbott and SD Biosensor and the Bill and Melinda Gates Foundation (BMGF) towards this purpose.

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The tests provide reliable results in 15 to 30 minutes, as compared to a few hours or days, and at a lower price. The WHO announcement comes a week after the agency issued the first Emergency Use Listing for a quality antigen-based rapid diagnostic test, with the expectation that more would follow.

“This is a vital addition to their testing capacity and is especially important in areas of high transmission,” he said, adding the sooner Covid-19 is diagnosed, the quicker action can be taken to treat and isolate those with the virus and trace their contacts.

The BMGF has executed separate volume guarantee agreements with Abbott and SD Biosensor, said the WHO. These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) — priced at a maximum of $5 per unit — over six months.

The organisations involved in the agreements to make affordable tests more easily accessible worldwide include the Access to Covid-19 Tools (ACT) Accelerator, the Africa Centres for Disease Control and Prevention (Africa CDC), BMGF, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid, and the WHO.

Portable tests

The tests developed by Abbott and SD Biosensor are portable, reliable and easy to administer, making testing possible in near-person, decentralised healthcare settings, the WHO said.

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, it added.

To scale up the Ag RDTs, the Global Fund said it has made available an initial $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.

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FIND and WHO are working together to accelerate appropriate use by supporting implementation research that will optimise Ag RDT use in multiple LMICs, in line with WHO guidance, the note said. This includes the 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 rollout of these tests in up to 20 countries in Africa starting next month.

This multi-million-dollar intervention, currently undergoing final sign-off by their respective boards, is designed to engage multiple partners active in Covid-19 response in different countries. “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,” said Tedros. “The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”

Catharina Boehme, Chief Executive Officer of FIND, 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.”

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