WHO Collaborating Centre

Tuberculosis (TB) remains one of the most significant global public health challenges and continues to be the leading cause of death from a single infectious agent worldwide. Despite being both preventable and curable, TB causes disease in more than 10 million individuals each year and is responsible for over one million deaths annually. Although substantial international efforts have been implemented to achieve the targets of the global TB control strategies for 2030, progress remains insufficient in many regions, particularly in settings with limited resources and high disease burden. 

Transmission of Mycobacterium tuberculosis (MTB), the causative agent of tuberculosis, remains inadequately controlled in many countries. Although considerable advances have been made in TB research, important gaps persist in the understanding of TB pathogenesis and of the biological mechanisms governing the progression from infection toward TB disease. This incomplete understanding hampers the development of predictive tools capable of identifying individuals at highest risk of disease progression and therefore limits the ability to effectively target preventive therapy. 

Despite significant improvements in diagnostic technologies, important limitations remain. Sputum continues to be the primary sample used for TB diagnosis, which substantially restricts diagnostic performance in populations that are often unable to produce sputum, including children and people living with HIV. In addition, extrapulmonary TB represents a major diagnostic challenge due to the paucibacillary nature of the disease and the frequent difficulty in obtaining appropriate clinical specimens. These limitations contribute to delayed diagnosis and under-detection of cases in vulnerable populations. 

While drug-susceptible TB can generally be cured with a multidrug regimen lasting four to six months, the increasing emergence and spread of drug-resistant TB represents a major threat to global TB control. Multidrug-resistant TB (MDR-TB), defined as TB caused by strains resistant to at least rifampicin and isoniazid, the two cornerstone first-line anti-TB drugs, is substantially more difficult to diagnose and treat and is associated with significantly higher mortality rates. Until recently, treatment of MDR-TB required prolonged regimens lasting up to two years, often associated with severe adverse effects, poor treatment adherence, and suboptimal treatment outcomes. In recent years, the introduction of novel and repurposed anti-TB drugs has enabled the development of shorter and more effective treatment regimens, reducing treatment duration to approximately 6–9 months in many cases. However, the emergence of resistance to these new drugs, including bedaquiline, is increasingly reported and threatens to undermine recent therapeutic progress. The limited availability of diagnostic tools capable of detecting resistance to newer drugs has contributed to the silent dissemination of resistant strains, highlighting the urgent need for improved molecular diagnostics, comprehensive drug susceptibility testing, and strengthened surveillance systems. 

Taken together, these challenges emphasize the critical need for continued research aimed at improving the understanding of TB pathogenesis, enhancing diagnostic capabilities, particularly for vulnerable populations and extrapulmonary disease, and developing robust strategies to detect and manage drug-resistant TB. Strengthening these areas will be essential to accelerate progress toward global TB elimination targets. 

The Emerging Bacterial Pathogens Unit headed by Dr Daniela Maria Cirillo was established in 2003 and was awarded international funds to perform basic and translational research in the field of TB, non tubercular mycobacteria and antimicrobial resistance (AMR). Since 2013, the Unit has been designated a WHO Collaborating Centre for Tuberculosis Laboratory Strengthening, and since 2006 it has hosted a Tuberculosis Supranational Reference Laboratory.  A molecular program for surveillance of multidrug-resistant pathogens including M. tuberculosis was established in 2010. 

The overall mission of ITA-125 is to support WHO in reducing the global burden of TB to meet the global targets of the UN Sustainable Development Goals and the post-2030 agenda.  

The Centre’s primary mandate is to collaborate with the WHO directly or through other international partners including the European Center of Disease Control, in strengthening TB laboratory capacity, advancing innovative diagnostics, and expanding access to high-quality drug susceptibility testing. Through translational research in the field of diagnostics and drug resistance detection, technical support to implement new tools, training, quality assurance, and surveillance activities, the Centre contributes to improving the capacity to detect TB and other relevant drug-resistant pathogens, monitoring drug resistance, and accelerating progress toward global health goals. 

The activities carried out by the WHO CC ITA-125 are organized into five thematic areas under the guidance of WHO: 

1. Technical assistance and capacity building to strengthen TB laboratory networks in the framework of WHO End TB strategy 
2. Support WHO to provide capacity building through training and mentoring activities to accelerate the use of genotypic and phenotypic drug susceptibility testing for Mycobacterium tuberculosis and other relevant pathogens for diagnosis and clinical management. 
3. Support WHO to review and evaluate novel diagnostic tests that predict progression from tuberculosis infection to asymptomatic and symptomatic disease 
4. Support WHO to conduct operational and translational research and policy supportive activities to improve tuberculosis care and control 
5. Support monitoring of TB rates and MTB drug resistant rates