Summary
Background: Tuberculosis (TB) remains underdiagnosed in many high-burden countries due to high costs and limited availability of rapid molecular tests. Globally, only half of people with TB receive a molecular test as their initial diagnostic test. Pooled testing combines sputum samples from multiple individuals into a single molecular assay, offering cost savings by optimising existing resources, particularly in resource-constrained health systems. Although diagnostic performance has been demonstrated and was reviewed by the WHO Guideline Development Group in November 2025, evidence on real-world feasibility and acceptability for people with TB and healthcare providers remains limited.
Methods: This qualitative study explored multisectoral stakeholder perspectives on pooled testing across seven high-TB-burden countries: Bangladesh, Brazil, Cameroon, Kenya, Malawi, Nigeria, and Viet Nam. Thirty-eight key informant interviews and eighteen focus group discussions were conducted with National TB Programme (NTP) representatives, laboratory technicians, people with TB, and international experts. Data were analysed using a framework approach guided by established feasibility and acceptability models.
Results: Pooled testing was considered feasible and acceptable in facility and community settings, with greater confidence in countries with prior implementation experience. Feasibility depended on alignment with diagnostic algorithms and laboratory workflows, biosafety, training, and clear standard operating procedures.
Acceptability operated at two levels: early NTP engagement with healthcare providers to secure professional buy-in, and clear communication between healthcare providers and people undergoing testing to support understanding.
Health system readiness and strengthening were seen as prerequisites, with regular on-site mentoring, procedural oversight, and monitoring systems crucial for maintaining quality and consistency.
Conclusions: Pooled testing was considered feasible and acceptable in settings with robust laboratory systems and routine practices. Readiness varied across countries, with some suitable for rapid implementation and scale-up, while others required system strengthening. In settings perceived as having suitable infrastructure and readiness, pooled testing was viewed as a pragmatic strategy to optimise molecular TB testing.
