Despite being declared a global emergency in 1993, tuberculosis (TB) still claims the lives of over 1 million people each year. Additionally, approximately 2 million people who have TB are not diagnosed or put on treatment each year, stemming from challenges such as inaccessible facilities, difficulties in obtaining sputum samples, or health system inefficiencies which result in multiple visits to the facility before a diagnosis is made.
Furthermore, just over 20% of national TB testing sites are equipped with WHO-recommended rapid molecular tests (WRD) (WHO 2023). As a result, only 48% of people diagnosed with TB are initially tested with a WRD. Therefore, enhancing access to quality, timely diagnostics closer to where people first seek care is crucial to reduce the large number of people who are “missed” from care. Simple molecular tests that are battery-powered, can test swab samples (tongue or sputum swab), and provide a result within 30 – 45 minutes will soon be on the market (See Figure 1). Evaluations of two of these assays at outpatient health centers in India, Uganda and Vietnam, showed acceptable performance in line with the WHO Target Product Profiles for TB. Adopting such platforms has the potential to improve TB diagnosis for children, elderly, and people living with HIV who are unable to produce sputum and improve access to testing at lower levels of the health system.
To better understand the potential demand for such tests, the Global Fund commissioned the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), and the African Society for Laboratory Medicine (ASLM) to conduct a demand forecast across 13 countries, including 10 in Africa. ASLM worked closely with the national TB programs in Burkina Faso, the Democratic Republic of Congo, the Republic of Congo, and Zambia.
Over four months, teams reviewed strategic plans, facility lists, diagnostic network optimization and mapping reports to assess each country’s diagnostic network and identify gaps. The team also analyzed data submitted to WHO from 2021 to 2023 on WRD usage. Meetings, both virtual and in person, were held with country teams to validate data and reach consensus on the demand estimation methodology and outputs.
WRD testing varied from 9% to 100% between 2021 and 2023, with only one country on track to reach the target for universal WRD testing for all people with TB (See Figure 2). This indicates a need to improve access to WRDs to meet global testing targets. To estimate the number of tests required if countries tested all notified TB cases with a WRD, the team developed a four-year forecast of the required tests for each of these scenarios:
- volumes based on the notified cases that are currently tested with WRDs (using data submitted to WHO in 2023)
- volumes assuming all notified TB cases receive a WRD (using a forecast from the notification rate in 2023)
- volumes aligned with National TB Program (NTP) notification targets (provided by the NTP from their NSP)
- volumes required to achieve 100% WRD coverage for all incident TB (based on the forecasted TB incidence).
Results showed that, if WRD coverage remains at 2023 levels (41–98% across the four countries), just 2.3 to 3.7 million tests will be performed annually, well below the estimated 5 million needed for full coverage (see Figure 3). Achieving universal WRD testing would require a 95% increase in capacity, effectively doubling current volumes.
However, the scenario-based approach provides countries with a roadmap to scale up strategically. A realistic first step is ensuring that every diagnosed TB case is tested with a WRD. Aligning testing efforts with national notification targets will bring countries even closer to achieving global goals.
With over 90% of health facilities in these countries classified as primary care or lower, there’s enormous potential to deploy a combination of existing WRDs and the new near-point-of-care tests. But technology alone won’t solve the problem. Strengthening diagnostic networks will require sustainable financing, and investments in staffing, supply chains, sample referral systems, and data management.
Country teams welcomed this exercise, highlighting its value in supporting strategic planning. The demand estimates offer a practical tool for aligning diagnostic goals with procurement planning, budgeting, and network optimization. All project outputs were shared with country stakeholders for adaptation and use in their ongoing planning processes.
