GHIT Fund Β· Grant G2024-105R1

The FLUTTE Programme

Facilitating Local Universal Tuberculosis Testing with the Lung Flute ECO

FLUTTE is a multi-country research programme funded by the GHIT Fund, bringing together five cutting-edge studies led by talented early-career researchers across Africa, Asia, and Europe. The goal: generate the high-grade evidence needed for WHO product review by 2027 and to identify manufacturers who can produce the Lung Flute ECO sustainably in high-burden regions.

FLUTTE logo
1

Generate evidence

Catalyse the production of high-grade scientific evidence by experienced trialists for key Tuberculosis use-cases to enable WHO product review in 2027.

2

Build local capacity

Identify, train, and equip candidate African and Asian businesses to sustainably produce the Lung Flute ECO in the regions where Tuberculosis burden is highest.

Ongoing research

Five studies, one mission

Each study is led by a young, talented researcher working at the frontline of Tuberculosis diagnostics. Together they cover children and adults, community and clinical settings, across three continents.

CAFETELChildren

Children's Acceptance, Fidelity, Efficacy & Tolerability of Lung Flute ECO

πŸ“ Mozambique & Uganda

A proof-of-concept study testing how well children accept and tolerate the Lung Flute ECO, and how much coaching in device use is needed. Not every child can generate sputum independently, making an accessible and well-tolerated induction method critical for pediatric Tuberculosis diagnosis.

Lead investigators

Denise Banze, Celso Khosa

FLUTTE TrialAdults

Comparators, Tolerability & Cost-Effectiveness

πŸ“ Multiple sites

This arm investigates the cost-effectiveness of a locally manufactured Lung Flute ECO. The current estimated cost of sputum induction via the device is €4.50 per sample β€” three times more expensive than spontaneous expectoration β€” largely due to device price and shipping from Japan. The study compares costs, tolerability, patient preference, and diagnostic performance across induction methods.

Lead investigator

Rian Snijders

Community ACFAdults

Community Active Case Finding with Digital Chest X-Ray

πŸ“ South Africa

A study integrating the Lung Flute ECO into community-based Tuberculosis active case finding using AI-assisted digital chest X-ray screening (Qure.ai's qXR tool). Among those flagged for molecular testing, the study compares diagnostic yield and cost per diagnosis between the Lung Flute ECO and spontaneous sputum generation.

Lead investigator

Priashni Subrayen

TUTTAdults

Targeted Universal Tuberculosis Testing in South Africa

πŸ“ South Africa

The current standard induction method for patients who cannot generate sputum independently is saline injection β€” a method that is highly unpleasant and comes with many side effects. As 31% of patients cannot produce the sputum samples required for Tuberculosis diagnosis, there is a clear need for a more comfortable alternative. This study aims to compare saline injections and the Lung Flute as induction methods, in terms of cost-per-client tested, client preference, and sample quality.

Lead investigator

Grant Theron

HCW StudyAdults

Lung Flute ECO for Active Case Finding in Sputum-Scarce High-Risk Groups

πŸ“ Mozambique

Healthcare workers in high-burden settings face elevated daily exposure to Tuberculosis, yet not all can generate sputum independently. This study compares the diagnostic yield of the Lung Flute ECO and spontaneous expectoration in vulnerable healthcare workers in Gaza province, Mozambique.

Lead investigators

Elzier Mangunyane, Sheila Mafalda Cassamo Issufo

The researchers

Meet the investigators

FLUTTE is powered by a new generation of researchers who combine clinical expertise with a passion for health equity. Here is why they do this work.

Prof Grant Theron

Prof Grant Theron

Stellenbosch University

South Africa

TUTT Study Lead

Many people dying of TB cannot make sputum β€” for too long they have been left behind.
Prof Salome Charalambous

Prof Salome Charalambous

Aurum Institute

South Africa

Co-Investigator

Finding better ways to diagnose TB will go a long way towards finally ending TB disease.
Nolundi Mshweshwe-Pakela

Nolundi Mshweshwe-Pakela

Aurum Institute

South Africa

Researcher

Low-cost approaches to sputum production are what we need – saving cost while improving diagnosis.
Rian Snijders

Rian Snijders

Institute of Tropical Medicine (ITM)

Belgium

Comparators & Cost-Effectiveness Lead

Now more than ever, we need to know if this tool is cost effective if we want resource-constrained national programs to adopt it.
Dr. Priashni Subrayen

Dr. Priashni Subrayen

Aurum Institute

South Africa

Community ACF Study Lead

Without good-quality sputum, we miss both diagnosing TB and identifying resistance β€” the Lung Flute ECO brings these patients back into reach.
Dr. Elzier Mangunyane

Dr. Elzier Mangunyane

FundaΓ§Γ£o Aurum

Mozambique

HCW Study Lead

When asymptomatic, high-risk healthcare workers cannot provide sputum, they are effectively excluded from timely Tuberculosis diagnosis β€” this must change.
Prof Satoshi Mitarai

Prof Satoshi Mitarai

Research Institute of Tuberculosis (RIT/PDP)

Japan

Principal Investigator, FLUTTE Programme

Answering the primary objective is important because it clarifies whether the Lung Flute ECO has meaningful clinical utility for sputum collection in patients with suspected pulmonary tuberculosis.
Makaita Gombe

Makaita Gombe

Aurum Institute

South Africa

Technology Transfer & Market Access Lead

Improving access to TB preventive diagnosis isn't just about optimal diagnostics β€” it's about ensuring that commodities are fit for purpose, reshaping markets, strengthening health systems, and ensuring that the most vulnerable populations are no longer left behind.
Dr. Jody Boffa

Dr. Jody Boffa

Aurum Institute

South Africa

Co-Investigator

As TB testing increasingly focuses on people in earlier stages of disease, sputum collection becomes more challenging. Client-friendly, low-cost methods to assist sputum production could be a game changer for early TB diagnosis.
Dr. Ellen M.H. Mitchell

Dr. Ellen M.H. Mitchell

Institute of Tropical Medicine (ITM)

Belgium

Co-Investigator

Sputum scarcity does not impact all people equally. It disadvantages people who are already at risk for underdiagnosis β€” such as children, women, frail elders, and hospitalised patients. We are trying to level the playing field so everyone can get treatment or preventive therapy if they need it.
Rirhandzu Makama

Rirhandzu Makama

Aurum Institute

South Africa

Market Access Lead

If we cannot make the Lung Flute ECO affordable and available where Tuberculosis burdens are highest, the clinical evidence generated by this project will not translate into lives saved. Our work converts a promising device into an accessible public health intervention β€” by building the manufacturing, regulatory, and distribution infrastructure that gets it into the hands of the health systems that need it most.

Want to build on this work?

We welcome researchers and institutions interested in replicating or expanding FLUTTE studies. Get in touch to learn about protocols, data sharing, and collaboration opportunities.

Contact us