Integrated diagnostics context
Access to diagnostics and testing tools and services is critical to ensure health outcomes across many diseases. Screening, early detection, and diagnosis can help people link to prevention and treatment services, but access to diagnostics remains very low in LMICs, with less than half of the global population having little to no access to diagnostics. The consequences are profound: delayed or missed diagnoses, inappropriate treatment, and preventable deaths from both infectious and noncommunicable diseases. This is further exacerbated by recent shifts in global health financing, with many countries relying on funding for diagnostics linked to vertical programs.
While integrating diagnostics (through tools or service delivery approaches) has significant potential for impact and some countries are adapting testing strategies to reflect integration, there is limited evidence or documented experience on optimized use. As a result, adoption of new tools, and development of new multi-disease technologies, have been hindered, with benefits not yet translating into widespread implementation. Considerable investments over the last two decades by Unitaid and partners working to advance HIV and TB responses through introduction of technologies and supportive programmatic services has led to significant diagnostic infrastructure available across countries. Furthermore, an expanded pipeline of multi-disease diagnostics, including those supported by Unitaid and other partners during the COVID-19 pandemic, are now entering the market. These recent innovations have emerged with a high potential for closing the diagnostic gap in LMICs, notably at the point-of-care. This provides an opportunity to leverage diagnostic infrastructure and advance integration across diseases and programs, with a significant benefit at various levels of care – patient, community facility, laboratory, health system and globally.
The vision for integrated diagnostics is grounded in evidence demonstrating that approaches to diagnostic integration can both improve access to testing tools and services, while optimizing the use of limited resources. Leveraging integrated systems has the potential to help break down long standing “silos” between disease programs, and address the increasing co-occurrences of diseases and conditions. Care is often delivered to the same person, through the same healthcare facilities, overseen by the same clinical staff, offering opportunities for more integrated service delivery. Put more simply, integration relates to sharing devices and/or sharing services across programmes for people affected by one or more illness or condition, which can improve access to and uptake of testing services, as well facilitate programme efficiencies in effective diagnostic delivery.
Integration should be driven by country priorities and be implemented in collaboration with national programs, affected communities, partners and other funders. This may include different aspects of integration, such as:
- Integrated products: Technologies that address multiple diseases or conditions in a single tool. These include multiplex tests that detect several pathogens from one sample and in a single run; multi-disease platforms that can run different assays either simultaneously or sequentially; and multi-modal platforms capable of analyzing more than one biological marker such as nucleic acids, proteins, or metabolites. Since COVID-19, innovations in this space have accelerated, offering high-quality, affordable, and portable solutions better suited to LMIC needs. Examples include new triplex rapid diagnostic tests for mother-to-child transmission prevention, fever panels for differential diagnosis, near point-of-care molecular tests for TB with capacity to expand to other diseases compact dry biochemistry analyzers for liver function testing, and high throughput molecular platforms. Self-testing and self-collection approaches can also be considered where relevant or complementary.
- Integrated service delivery: Approaches that use one program or clinical interaction to address multiple health issues. For example, leveraging child health visits to diagnose malaria, or using antenatal care to screen for hepatitis B, HIV, and syphilis. Put simply, sharing devices and services across programs enables people affected by more than one condition to access the testing they need, while generating efficiencies for health systems.
- Integrated systems: A critical element of advancing integrated diagnostics is addressing fragmentation particularly across resources and infrastructure and supply chain networks. Many components of sample transportation and supply chain and human resources can be streamlined and shared across health areas—including forecasting (for procurement planning and supplier negotiations), product selection, quantification, procurement, storage, transport, and distribution. This integration not only reduces inefficiencies but also strengthens system resilience. For both point-of-care and near point-of-care tools, as well as laboratory-based technologies, it is important to ensure that data management systems and connectivity solutions are interoperable with national dashboards, databases, and laboratory information management systems (LIMS).
To address these opportunities, catalytic action is needed to drive adoption of integrated diagnostic technologies and approaches. This begins with working closely with country stakeholders to determine how integrated diagnostics can meet national needs – by mapping patient journeys, identifying opportunities for integration, and using these to identify use-cases for the roll out of integrated diagnostics. This foundational step is essential for guiding implementation and scaling efforts. It is an important time to intervene as countries now have access to a pipeline of new and existing tools, while working against a backdrop of increasingly constrained resources. Strong leadership and political will has also been reinforced by national governments and programs, as well as the World Health Organization, responding to the World Health Assembly Resolution WHA76.5 (2023), which urges Member States to strengthen diagnostic capacity as a cornerstone of primary health care and universal health coverage. While integration is now possible across a variety of diseases and programs, we expect that diagnostics that test for TB and other pathogens may be among the most advanced in the timeframe of this proposal, and that TB may therefore be the most relevant ‘anchor’ program. This does not preclude work in other key programs of interest. Proposed efforts should dovetail with and complement investments from other funders such as CIFF, the Gates Foundation, and Global Fund, strengthening scalability pathways for integrated diagnostics.
Objectives of this Call
The objective of this call for proposals is to increase access to diagnostics through the optimal introduction, placement and delivery of effective, affordable, and innovative diagnostic solutions that support integrated, multi-disease detection and diagnosis. This can be achieved through:
- Supporting countries and affected communities in designing and deploying integrated diagnostic strategieswithin specific settings or programs. In service of national diagnostic strategies, efforts on integration should optimize resources, expand access to testing in line with national health priorities, and demonstrate effective, scalable implementation models across diverse contexts. Priority programs include HIV, TB, hepatitis, cervical cancer, sexually transmitted infections women’s health, and emerging global threats to complement Unitaid’s strategic investment priorities.
- Accelerating the deployment and adoption of integrated diagnostic tools—particularly at or near the point of care—that expand testing capacity at the lowest levels of the health system. A priority focus is on molecular diagnostic tools, which have demonstrated high performance and promise for TB detection, but also hold significant potential for additional diseases. These tools should be considered within a comprehensive network of tests needed for definitive diagnosis and linkage to treatment and care.
Through this Call, Unitaid seeks to accelerate progress toward equitable, sustainable diagnostic access and to strengthen the resilience of routine health program needs, but also to a broader range of future health threats.
