Manufacturing

ACT-A Dx Knowledge Hub

The Diagnostic Journey

Once in-vitro diagnostics (IVDs) are quality assured and countries have policies in place to deploy diagnostic tools and technologies, products must be made available for purchase. Availability is critical for consumption and commercialization. For optimal diagnostic impact, products need to be in widespread use. Products thus need to be manufactured and produced in volumes based on global and national requirements.

Challenge

The onset of the COVID-19 pandemic was a watershed moment in global health as it spurred extraordinary development and deployment of IVD tools and technologies. Initially, molecular testing was the only option available, and many countries were overwhelmed by unprecedented demands on laboratories and testing facilities. Molecular testing requires central laboratory systems, a high level of expertise, well-developed infrastructure, additional equipment, robust specimens, and results referral networks. As a consequence, turnaround times to receive results often lagged, taking days or even weeks in certain settings.

To address the need for faster results return and relieve the burden on the healthcare system through decentralized access to testing, antigen-detection rapid diagnostic tests or AgRDTs were developed for both professional and self-test use. However, the lack of diversity in test manufacturers, particularly in low- and middle-income settings, and limited competition in the market meant that these countries were often left without access to timely tests needed to protect their populations effectively in the fight against the COVID-19 pandemic.

Approach

Without the ability to produce COVID-19 IVD tools and technologies, countries were unable to access regulatory approved tests. To address the manufacturing challenge, the ACT-A Diagnostics Pillar launched a worldwide call for expressions of interest to drive equitable access and global supply of fit-for-purpose antigen-detecting rapid diagnostic tests for COVID-19.

With the support of partners, the following key activities were prioritized to support manufacturing efforts:

Funding to support manufacturing capacity expansion in exchange for access pricing
Building and expanding local manufacturing capacity in low and middle-income settings through technology transfer agreements between diagnostic developers and local manufacturers
Ensuring high-volume commitment and distribution regardless of demand volatility for low and middle-income countries through manufacturing capacity expansion
Technical assistance for manufacturing, regulatory procedures, and market entry. This specifically includes investments in knowledge and technology transfer as well as licensing to cultivate trust in local products and ensure they are quality-assured
Support provided by the WHO COVID-19 Technology Access Pool (C-TAP) to enable developers of diagnostics and other health products to share their intellectual property with quality-assured manufacturers worldwide

Making an impact

Manufacturing investments for COVID-19 IVD tools and technologies supported the scaling of manufacturing capacity and technology transfer projects across multiple manufacturers and countries. This has increased equitable access and purchase of COVID-19 products. Notable manufacturing achievements are highlighted. To learn more about the manufacturing achievements and work, refer to the key learnings and resource section below.

partner manufacturers across various product classes

countries engaged in local manufacturing and technology transfer projects

LMIC manufacturers selected for technology transfer for C-TAP licenses

licenses via COVID-19 Technology Access Pool (C-TAP)

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COVID-19 professional use antigen RDTs available to LMICs

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COVID-19 self test antigen RDTs available to LMICs

Key Learnings & Featured Work

Reflections on Manufacturing

Leveraging the ACT-Accelerator experience, there are key lessons to expand the use of diagnostic tools and technologies for COVID-19 as well as other diseases of endemic and pandemic potential.