120 Million COVID-19 Rapid Tests to Be Made Available for Low and Middle Income Countries

It was set up in response to a call from G20 leaders in March 2020 and launched by the World Health Organization (WHO), the European Commission, France and the Bill & Melinda Gates Foundation in April 2020. 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.

As part of the latest comprehensive, end-to-end effort by ACT Accelerator to develop, procure and distribute critical new tools to fight the pandemic, the Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with rapid diagnostic test (RDT) producers Abbott (Lake Forest, IL, USA) and SD Biosensor (Korea). These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) – priced at a maximum of USD 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, which is one of the organizations involved in the milestone agreement, has made available an initial USD 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. Meanwhile, the Foundation for Innovative New Diagnostics (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.

“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,” said Dr. Tedros Adhanom Ghebreyesus, Director General of WHO.

“Testing is an essential tool in the fight against COVID-19. We are delighted to join a partnership that will help ensure that the latest, high-quality diagnostics do not just go to the highest bidder but will be available at an affordable price to the world’s lower income countries. In addition, all of the actions announced today point to the growing success of the ACT-Accelerator in catalyzing global cooperation for a fair and effective response to this global crisis,” said Mark Suzman, Chief Executive Officer of the Gates Foundation.
“Abbott is pleased to bring our 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. We have long been committed to making sure our life-changing technologies are affordable and accessible, and for decades have been supporting many of these countries with our rapid tests for malaria, HIV, hepatitis, and other deadly infectious diseases,” said Andrea F. Wainer, Executive Vice President of Abbott’s rapid and molecular diagnostics businesses.

“We, SD Biosensor, are pleased to supply our STANDARD Q COVID-19 rapid antigen tests for people who really need fast and accurate COVID-19 diagnosis. Through this partnership, we will keep striving do our best to provide the best quality of COVID-19 antigen rapid kits for fighting COVID-19,” said Hyo-Keun Lee, Chief Executive Officer of SD Biosensor.