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WHO GDG | Exploring user perspectives on novel tuberculosis diagnostic tools and approaches to inform WHO policy

Novel Tuberculosis diagnostic approaches, such as tongue-swab testing, near-point-of-care molecular tools and pooled testing, are currently being evaluated for their potential to provide faster and more accessible diagnosis and treatment. Commissioned by WHO, this project aims to understand user perspectives on these innovations to support decision-making on global WHO guidelines.

Addressing Tuberculosis Through Inclusive Innovations
Despite being largely preventable and curable, Tuberculosis (TB) continues to pose a significant global public health challenge and remains the biggest infectious disease killer. People most affected by TB face systemic disadvantages related to poverty, gender, age, socio-economic position, race, ethnicity, geographical location, and migration. TB itself imposes catastrophic costs, food insecurity, revenue loss and discrimination, reinforcing cycles of vulnerability and marginalization. To address this disease of social inequity, it is essential that innovations, programs and policies include lived experiences and social science evidence alongside biomedical, clinical and public health approaches.

Over the past few decades, TB diagnostics have evolved from simple sputum smear microscopy to low-complexity molecular diagnostic tools, designed to work outside of well‐equipped, often centralized, laboratories that are difficult to access for most people. These diagnostics offer an improved diagnosis for those who reach them, but cannot overcome deficiencies in laboratory infrastructure and lack of skilled professionals to the extent it was hoped for. What is more, they rely on a sputum sample which is difficult to provide for some people including children.  

To further improve access to TB diagnosis at peripheral levels, novel near-point of care (NPOC) molecular tests, tongue swabs and pooling of respiratory samples are being developed and evaluated for their potential to support TB programs. These diagnostic innovations must be evaluated in the context of social realities, user experiences and local health-system capacities. Integrating lived experience into the design and evaluation of new tools makes them more acceptable, feasible and equitable. Additionally, these findings contribute directly to the evidence base informing the World Health Organisation's (WHO) Guideline Development Group (GDG) during their deliberations about new TB guidelines.

Informing Evidence-Based Guidelines
To provide evidence for the WHO guideline development group (GDG) meeting in November 10-14, 2025, Athena conducted a qualitative study and an evidence synthesis that together examine user perspectives on three novel interventions that the WHO will make global recommendations on: near point-of care molecular tests, tongue and sputum swabs, and pooled testing of respiratory samples to detect TB and resistance to anti-TB drugs.

The review focused on the perspectives and experiences of people receiving and providing tongue/oral swabs to diagnose non-oral infectious diseases (HIV, TB, Covid, Hepatitis). The primary qualitative study focused on user perspectives with regard to future implementation of pooled sample testing and near point-of-care tests. It comprises interviews with programme officers and lab technicians in research settings in Nigeria, Kenya, and Vietnam, a focus group discussion with TB survivors, and a survey with a broader audience of national TB program officers and laboratory managers from countries with a high TB burden.

By complementing clinical, epidemiological, and economic data with evidence representing the voices of people receiving and providing diagnostic tests, their questions and issues are included in the core of a GDG outcome and WHO recommendation, and there is accountability and an onus created for implementers to deal with them. This transdisciplinary approach to bridging technical expertise and lived experience for global guideline-making, emphasizes that the value and impact of innovation depends not only on technical performance but also on its social acceptability, feasibility and how interventions are made to work.

Project details

  • Team

    The VU Athena project team consists of:

    Additional team members include:

       Systematic review

    • Karuna Devi Sagili
    • Mercy Molaku
    • Francesca Basile
    • Gurher Sidhu
    • Lisa Were
    • Jenifer Otino
    • Ashyln Bencroft
    • Vidhi Desai
    • Hans Ket
    • Nikita Pant Pai

       Primary qualitative study

    • Karuna Devi Sagili

       Vibol Iem

    • Helene-Mari Westerhuizen
  • Funding

    This project has received funding from the World Health Organization.

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