Tuberculosis (TB) remains a significant global health concern, affecting millions of people annually and causing substantial mortality. Early diagnosis and treatment are crucial for effective management and preventing disease transmission, especially in underdeveloped regions with limited healthcare access. Current diagnostic methods for TB are complex, expensive, and often inaccessible to those most in need.

NOZE® aims to revolutionize TB diagnosis by utilizing advanced odor detection technology to analyze breath odors. Research suggests that people with TB emit distinct chemicals in their breath, which NOZE® technology can potentially detect. However, before implementing this technology on a larger scale, a proof-of-concept study is required that will evaluate the feasibility of differentiating between exhaled breath of TB and non-TB patients using Noze® ’s breathalyzer. To achieve this, a study will be conducted in Kericho, Kenya, involving 100 individuals with TB and 100 without TB. Participation in this study is voluntary, and each participant will provide five breath samples using the DiagNoze® breathalyzer. Additional data on lifestyle, medical history, diet, and co-infections like HIV will also be collected to analyze potential factors that may affect breath odors.

The study will also involve blood, urine and sputum sample collection for traditional TB and HIV diagnosis, as well as screening for latent TB. While there are minimal risks associated with breathalyzer use, blood and sputum collection procedures carry some discomfort and associated risks.

Although participants won't directly benefit from the study, its potential societal impact may be significant. If successful, the DiagNoze® breathalyzer could offer a rapid, noninvasive, and cost-effective method for TB detection, particularly in rural areas where TB prevalence is high and healthcare resources are limited.

Tuberculosis (TB) is a major cause of death worldwide. In 2021, 10.6 million people contracted tuberculosis, with 1.6 million dying from the disease. It disproportionally affects marginalized communities, particularly in the developing world. The main tests for the detection of TB in sputum and tissue samples are culture (the gold standard), microscopy, and nucleic acid amplification tests. However, these tests can be slow, exhibit low sensitivity or specificity, and require access to costly healthcare facilities. Rapid diagnosis and targeted treatment are essential for treatment and preventing TB transmission. A rapid inexpensive screening tool, which can diagnose TB and monitor its progress would be invaluable.

There have been many reports regarding the Volatile Organic Compounds (“VOCs”) found in the exhaled breath of tuberculosis participants. However, the breath capture and analysis methods in these studies are heavily reliant on standard exploratory approaches such as Gas Chromatography–Mass Spectrometry (“GC-MS”), which is clunky and expensive. However, NOZE® has built an advanced digital odor perception platform to diagnose/screen disease states, using breath as the odor source.      

This cross-sectional study seeks to implement a first-in-human proof-of-concept study of this breathalyzer for the detection of TB using data clustering methods. At least N=200 adult study participants (100 controls and 100 TB cases) will be recruited at KEMRI/WRP Clinic, Kericho, Kenya. A questionnaire on participants’ demographic, lifestyle, and medical information will also be completed. The study will also involve sputum and urine collection for TB diagnosis using GenXpert and TB-LAM respectively. Blood sample will also be collected for HIV diagnosis, as well as screening for latent TB. The findings/data from this study will be provided to the study sponsor. NOZE® is the study sponsor, and the findings are intended to inform the continuing development of a NOZE® diagnostic device for the eventual diagnosis of TB. With the agreement of the sponsor and the principal investigators, the findings will be published in peer-reviewed journals and presented at conferences.