Category: Featured Work – Manufacturing

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Featured Work - Manufacturing

COVID-19 diagnostics: preserving manufacturing capacity for future pandemics

Manufacturing capacity for diagnostics increased at a rapid rate during the COVID-19 pandemic. It is estimated to have grown by 200% since the onset of the pandemic. Sustaining this expanded capacity over the long term will require coordinated strategies to ensure the progress made in recent years is not lost. 


The authors of this commentary piece, representing the ACT-A Diagnostics Partnership, suggest strategies which could be implemented to preserve manufacturing capacity in the face of future pandemic threats.

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Global Partnership to Make Available 120 Million Affordable, Quality COVID-19 Rapid Tests for Low- and Middle-Income Countries

Street scene outside the Lok Nayak Jai Prakash Narayan Hospital, Delhi.December 2017Photo credit: FIND / Ben Phillips

Rapid tests are a fast and accurate way to diagnose patients in a primary healthcare setting

Global partnership feeds healthy supply of rapid COVID-19 tests to low- and middle-income countries 

A set of global agreements reached in September 2020 paved the way for 120 million rapid COVID-19 tests to be distributed to low and middle-income countries.

The Access to COVID-19 Tools (ACT) Accelerator, working with other organizations, concluded these agreements to enable the manufacture, distribution and rollout of these vital diagnostic tools.

At the time, there was a huge unmet need for fast diagnostic testing globally, especially in the low and middle-income bracket.

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 World Health Organization (WHO) all worked on this project.

There was a particular focus on making tests available to countries without extensive laboratory facilities or trained health workers to implement molecular (polymerase chain reaction or PCR) tests.

Why is testing crucial in the fight against COVID-19?

Rapid tests are a fast and accurate way to diagnose patients in a primary healthcare setting, as this is where most people access services. 

Rapid tests are also cheaper than laboratory tests. With a fast initial diagnosis, track and trace teams in more remote and rural areas can start work sooner without waiting for laboratory test results. 

Quick results can prevent the virus from spreading in communities. Rural and remote healthcare settings especially need access to rapid testing, as accessing centralized laboratory services can take a long time.

Procurement

The Global Fund made $50-million available to purchase 10 million tests per country.

Distribution

FIND and WHO supported countries in distributing these tests.

Unitaid and the Africa CDC combined resources rollout tests to countries in Africa from October 2020. 

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US$7 million investment accelerates availability COVID-19 self-tests in low- and middle-income countries

Key takeaway: Successful applicants to manufacture 240 million low-priced tests a month.

On March 31 2021, FIND launched a request for proposals (RFP) to develop, manufacture, and launch to market COVID-19 self-tests in low- and middle-income countries (LMIC). 

The RFP called for quality-assured and easy-to-use self-tests that were accurate and affordable. It was prepared in the context of the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, co-convened by FIND and the Global Fund.

Innovators, developers and manufacturers of in vitro diagnostics, and LMIC-based diagnostic stakeholders, were invited to submit proposals.

A package of US$7 million was offered in support, funded via grants to FIND from the German Federal Ministry of Education and through KfW and other donors.

International expertiseFrom 80 applicants, contracts were signed with four companies, and their names announced in February 2022:

Each has committed to manufacturing up to 60 million tests per month, priced from US$1–2 per test.FIND will conduct independent clinical evaluations of test performance, with support dependent on meeting project milestones.

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Featured Work - Manufacturing

Outline of WHO’s C-TAP platform

The COVID-19 Technology Access Pool (C-TAP) provides a platform for developers of COVID-19 therapeutics, diagnostics, vaccines and other health products to voluntarily share their intellectual property, knowledge, and data, with quality-assured manufacturers. 

It was launched in May 2020 by WHO, the Government of Costa Rica and other partners to facilitate faster equitable and affordable access to COVID-19 health products for all countries.

Currently endorsed by 45 WHO Member States, it is a response to the global Solidarity Call to Action. Its implementing partners include UNDP, the Medicines Patent Pool, the UN Technology Bank and Unitaid.

C-TAP provides a single global platform that includes public health-driven, transparent, voluntary, non-exclusive and transparent licences. 

Read more on C-TAP here