Introduction and Background of the Project

Introduction

Tuberculosis (TB) remains one of the world’s deadliest infectious diseases, yet many at-risk people cannot produce sputum for testing. The Lung Flute ECO (LFE) is a simple, paper-based acoustic device that helps people generate sputum safely and affordably through a short breathing exercise. Building on the successful GHIT-sponsored 3V Trial (2021-2023), which demonstrated a 12.1 % increase in diagnostic yield, the FLUTTE project expands evaluation of the LFE in vulnerable populations and diverse epidemiological contexts.

Project objective

The goal is to generate robust scientific evidence for WHO endorsement of the Lung Flute ECO by 2027. The project will assess LFE performance in:

  1.Targeted Universal TB Testing (TUTT) among health-care workers and PLHIV unable to expectorate;

  2.Paediatric TB diagnosis comparing LFE with saline induction, nasopharyngeal aspirates, and tongue swabs; and

  3.Community screening combined with digital chest X-ray and computer-aided detection (CAD).
    The project also aims to establish sustainable local manufacturing in Africa and Asia.

Project design

A network of clinical trials in South Africa, Mozambique, and Uganda will enroll over 8,000 participants using randomized or crossover designs with molecular and culture-based TB diagnostics as references. Data on diagnostic yield, safety, acceptability, and cost-effectiveness will be harmonized for pooled analysis to meet WHO guideline review criteria. Parallel activities include technology transfer, manufacturer training, and market-entry preparation for LMICs.

How can your partnership (project) address global health challenges?

By enabling sputum production for those who cannot expectorate, LFE tackles a critical bottleneck in TB diagnosis. It promotes equitable access to molecular testing, accelerates case detection in high-burden settings, and supports WHO goals for universal testing and drug-resistance surveillance. The low-cost, biodegradable design allows decentralized use in primary and community care, directly benefiting women, children, and PLHIV.

What sort of innovation are you bringing in your project?

LFE is the world’s first biodegradable acoustic sputum-induction device that requires no electricity, medication, or clinical infrastructure. It bridges the gap between emerging molecular tests and field realities, providing a low-cost, scalable solution that complements non-sputum diagnostics. Its combination of simplicity, affordability, and regulatory readiness positions it as a transformative enabling tool for universal TB testing.

Role and Responsibility of Each Partner

• RIT-JATA (Japan): Designated Development Partner; overall coordination, protocol governance, and GHIT reporting.
• Acoustic Innovation (Japan): Device optimization, technology transfer, and manufacturing training.
• ITM (Belgium): Scientific oversight, health-economic analysis, and evidence synthesis.
• Aurum Institute (South Africa, Mozambique): Leads FLUTTE implementation and Lung Flute ECO trials among health care workers and PLHIV in South Africa. Coordinates with SAHPRA on regulation and supports local manufacturing through technology transfer.
• Stellenbosch University (South Africa): Clinical trials in PLHIV and targeted testing cohorts.
• INS (Mozambique): Paediatric evaluation, site implementation.
• WALIMU (Uganda): Paediatric evaluation and community engagement.

Others (including references if necessary)

Phase 1 results: Mbuli C et al., ERJ Open Res 2024 10(3):00902-2023.
Two U.S. patents (6702769B1, 6984214B2) have expired, allowing unrestricted global access.
WHO Coordination Scientific Advice (CSA) submission in progress for regulatory alignment.