The Foundation for Innovative New Diagnostics (FIND) and the Africa Centres for Disease Control and Prevention (Africa CDC) have announced a new partnership to build capacity in readiness for the introduction of new, high-quality antigen rapid diagnostic tests (RDTs) for COVID-19 that are anticipated to become available soon.

FIND is co-convener of the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar. Africa CDC is a member of the ACT-Accelerator Diagnostics Pillar and initiator of the Partnership to Accelerate COVID-19 Testing (PACT), which has led to the rapid strengthening of testing and surveillance capacity across Africa.

“Fast, smooth and efficient rollout of affordable, accurate antigen RDTs will take the COVID-19 response to the next level,” said Dr Catharina Boehme, CEO of FIND. “With over 60 partners across Africa, we are committed to supporting Africa CDC to build technical capacity so that countries are ready to implement with no delay. Testing is not just our first line of defence against this pandemic, it is also the bedrock on which strong health systems are built. We congratulate Africa CDC for providing strong and effective leadership in testing.”

Diagnosis is a driver of patient, financial and health systems impact, as well as a critical enabler of universal health coverage. Testing has emerged as a cornerstone of the COVID-19 response and fundamental to global health security. However, access to diagnostics remain the weakest link in the clinical care cascade, especially at the primary healthcare level. Even before COVID-19, diagnostic gaps threatened the achievement of the United Nations Sustainable Development Goals for major diseases including tuberculosis and malaria.

COVID-19 has dramatically widened these diagnostic gaps, precipitating major global challenges including supply chain “wars” and substantial quality issues. While accurate and reliable molecular tests became available within one month from the time COVID-19 was first reported, these tests depend on laboratory infrastructure and skilled technicians to conduct. Testing backlogs mean that results can take several days to reach patients, even in high-income countries.

“Testing is the cornerstone of response to this pandemic, without testing we will be fighting blindly. But the testing strategy must shift as countries unlock their economies. We need to scale up testing and we need to improve the turnaround time for testing so that we can quickly identify, isolate and treat positive cases. This is where the RDTs play a very important role,” said Dr John Nkengasong, Director of Africa CDC.

Simple, accurate and affordable RDTs that can be performed anywhere to reliably detect disease were identified as high priority early in the pandemic. These tests are urgently needed to expand access to testing for test-trace-isolate strategies and test-and-treat implementation, in healthcare facility and community settings, and especially in low- and middle-income countries (LMICs).

A full pipeline of potential new tests for COVID-19, streamlined processes by the World Health Organization (WHO) and regulatory bodies, and unparalleled manufacturing and supply chain collaborations have dramatically shrunk the usual time between innovation and implementation. With unprecedented speed, several new antigen RDTs have now been shown to meet WHO criteria, including sensitivity and specificity, as well as price.

FIND and other ACT-Accelerator partners are now engaging with countries to provide catalytic volumes of these tests to understand how they can best fit into health systems. Overall, the ACT-Accelerator Diagnostic Pillar aims to facilitate the supply of 500 million tests to LMICs within 12 months.

Work to ensure preparedness for the introduction of COVID-19 antigen RDTs is ongoing, and the MoU between Africa CDC and FIND will remain in effect for a period of three years.

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