Infectious Disease · Medical Literature
Feasibility and acceptability of pooled sputum testing for tuberculosis: a multicountry qualitative study of the Start4All project
Abstract
Objectives 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 pooled sputum testing has now been recommended by the World Health Organization in 2026, evidence on real-world feasibility and acceptability for people with TB and healthcare providers remains limited. This study explored multisectoral stakeholder perspectives on the feasibility and acceptability of pooled sputum testing for TB. Design Multicountry qualitative study using key informant interviews and focus group discussions. Data were analysed using a framework approach guided by established feasibility and acceptability models. Setting Facility and community settings across seven high-TB-burden countries: Bangladesh, Brazil, Cameroon, Kenya, Malawi, Nigeria, and Viet Nam. Participants Thirty-eight key informant interviews and 18 focus group discussions were conducted with National TB Programme (NTP) representatives, laboratory technicians, people with TB and international experts. 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. Conclusions Pooled testing was considered feasible and acceptable in settings with robust lab
Clinical relevance
Tuberculosis remains critically underdiagnosed globally, with only half of affected individuals receiving a rapid molecular test as their initial diagnostic evaluation — a gap driven largely by cost and infrastructure constraints in high-burden, resource-limited settings. Pooled sputum testing (combining specimens from multiple individuals into a single molecular assay) has recently received WHO endorsement in 2026 as a strategy to expand molecular diagnostic coverage, yet real-world evidence on its feasibility and acceptability across diverse health systems and affected communities was absent prior to this study. This multicountry qualitative investigation directly addresses that evidence gap, providing stakeholder-grounded insights essential for guiding National TB Programme (NTP) policy adaptation and implementation planning across seven high-burden countries.
Key findings
1. No quantitative effect sizes, confidence intervals, p-values, or NNT/NNH were reported in this qualitative study; findings are thematic and stakeholder-derived. 2. Pooled sputum testing was judged feasible and acceptable in both facility-based and community settings across all seven countries (Bangladesh, Brazil, Cameroon, Kenya, Malawi, Nigeria, Viet Nam), with greater confidence expressed in countries with prior implementation experience. 3. Feasibility was contingent on four key operational factors: (a) alignment with existing national diagnostic algorithms and laboratory workflows, (b) adherence to biosafety standards, (c) adequate staff training, and (d) availability of clear standard operating procedures. 4. Acceptability functioned at two distinct levels: (a) the institutional/professional level — requiring early NTP engagement to secure healthcare provider buy-in — and (b) the patient level — requiring transparent communication between providers and individuals undergoing testing to support informed understanding and consent. 5. No peer-reviewed qualitative studies focused primarily on feasibility or acceptability of pooled TB testing were identified in the prior literature, underscoring that this study fills a critical and previously unaddressed evidence gap. 6. Data were collected from 38 key informant interviews and 18 focus group discussions encompassing NTP representatives, laboratory technicians, people with TB, and international experts — a broad multisectoral participant sample supporting transferability of findings.
Practice implications
Clinicians and laboratory directors in high-TB-burden settings should advocate for early, structured engagement of NTP leadership and frontline laboratory staff when planning pooled sputum testing implementation, as professional buy-in at the institutional level is a prerequisite for sustainable adoption. Implementation should be preceded by context-specific workflow mapping to ensure compatibility with existing diagnostic algorithms, robust biosafety protocols, and standardized training programmes — particularly in settings without prior pooled testing experience. Patient-facing communication strategies must be proactively developed to explain the pooled testing process clearly, as provider–patient communication was identified as a distinct and actionable determinant of patient-level acceptability independent of system-level readiness.