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The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) has embarked on a pivotal collaboration with a foundation through a cooperative research and development agreement (CRADA). This partnership aims to create standards and testing protocols for a new generation of breathalysers to diagnose malaria and tuberculosis (TB). This initiative represents a significant step forward in leveraging digital technology to address critical global health challenges.
This is crucial for their potential deployment across the developing world. The development of these breathalysers involves several manufacturers and universities, reflecting a broad, collaborative effort to tackle two of the leading causes of death worldwide. NIST materials research engineer Kavita Jeerage emphasised the broader potential of breath-based diagnostics, noting that these technologies may soon be applicable for identifying or monitoring various conditions and diseases, including liver disease, multiple sclerosis, and cancer.
Malaria and TB are responsible for the deaths of approximately 2 million people each year. Current diagnostic methods for malaria typically involve blood tests, while TB is diagnosed through sputum (cough mucus) samples. These costly procedures require access to technical equipment and laboratory facilities, often scarce in developing regions. Additionally, certain strains of the malaria parasite have evolved mechanisms to escape detection, complicating diagnosis and treatment efforts.
In recent years, scientific advancements have led to identifying biomarkers in human breath – referred to as a “breathprint” – that can indicate infection by malaria or TB. Developing sensors capable of detecting these biomarkers promises to create low-cost, easily deployable breathalysers that could be used globally. However, for these breathalysers to gain widespread acceptance, they must deliver accurate and reliable results. These objectives include developing specially designed testing equipment to benchmark the performance of breathalysers and ensure measurement accuracy, and creating gas mixtures to test the accuracy of the breathalysers. Some of these gas mixtures will simulate the breath of individuals infected with malaria or TB, while others will replicate the breath of infection-free individuals.
Identifying certain volatile organic compounds (VOCs) in human breath, which signal the presence of illness or health conditions, has been a key advancement in this field. Unlike the breathalysers used by law enforcement to detect alcohol, which measures a single compound (ethanol), disease-diagnosing breathalysers must be technologically advanced enough to detect multiple VOCs simultaneously. This complexity necessitates sophisticated digital technology to ensure precise and reliable detection.
Kavita highlighted the progress made in recent years towards developing more advanced breathalysers. The measurement standards NIST works on for malaria and TB breathalysers could serve as a foundation for further advancements in clinical breath analysis. NIST’s extensive experience in measuring trace compounds in gases and creating reference materials to calibrate alcohol breathalysers is instrumental in this endeavour.
The integration of digital technology in the development of these breathalysers is crucial. It involves sophisticated sensor technologies, advanced data analytics, and rigorous standardisation processes. Accurately detecting and diagnosing diseases through breath analysis could revolutionise healthcare, especially in resource-limited settings where traditional diagnostic methods are impractical or unavailable.
Moreover, the collaboration between NIST, the foundation, and other stakeholders underscores the importance of public-private partnerships in advancing digital health technologies. These collaborations can accelerate the development and deployment of innovative solutions to global health challenges by pooling resources and expertise.
The CRADA between NIST and the foundation represents a significant stride towards harnessing digital technology to improve global health outcomes. Developing accurate and reliable breathalysers for diagnosing malaria and TB can save millions of lives and pave the way for further advancements in breath-based diagnostics. As this technology continues to evolve, it promises to play a pivotal role in the future of healthcare, particularly in underserved regions worldwide.
