The LabCoP management team recently sat down with Dr. Grania Brigden, Senior TB Advisor at The Global Fund, to discuss exciting updates to TB diagnostics. Near point-of-care (NPOC) tests are on the horizon that meet the WHO target product profiles, with expectations of a WHO policy update in early 2026.
ASLM: Dr. Grania, can you tell us why there is so much interest and anticipation around this new class of TB diagnostics?
Dr Grania: For me, the excitement stems from the potential of these new diagnostics to transform TB detection. Right now, over 2.5 million people go undiagnosed each year, and only 48% of those diagnosed receive an initial test with a WHO recommended rapid molecular test. That’s a huge gap, with the other 52% either being diagnosed with microscopy or clinically diagnosed, we want to be aiming to offer everyone access to the best diagnostics which is proving to be very difficult with the existing tools we have. These new NPOC tests are designed to be used closer to the patient at primary health care (PHC) levels without needing complex lab infrastructure. They offer same-day results, which means there is the potential to look at same-day treatment initiation for those with low risk of drug-resistant forms of TB. They offer the opportunity for new approaches to increase early access to accurate WHO recommended molecular diagnostics, reduce loss to follow-up and improve outcomes.
ASLM: Where are current TB diagnostics falling short, and how might these new tools fill those gaps?
Dr Grania: Current Low Complexity Automated NAAT (LCa-NAAT) diagnostics like GeneXpert and Truenat have made great strides, but they are not able to go down to the PHC level and have high costs to run and maintain. Many facilities lack the infrastructure, electricity, or trained personnel to run these tests. Plus, sputum collection can be a barrier, especially for children and people living with HIV. NPOC tests—especially those using tongue swabs—are simpler, more accessible, and better suited for peripheral settings. The early platforms in this class look like they will meet WHO’s Target Product Profile (TPP) with promising sensitivity and specificity, and they’re designed for use by health workers with basic training. The initial products in the class also are likely to be considerably cheaper than the current tests available for TB.
ASLM: What lessons have been learned from past rollouts of GeneXpert and Truenat that should inform or guide the deployment of these new tools?
Dr Grania: I think one of the key lessons we’ve learned that introducing new diagnostics isn’t just about the technology—it’s about the ecosystem required for them to operate and achieve impact. With GeneXpert and Truenat, we saw challenges around training, sample referral systems, and linkage to care. For NPOC tests, we’re emphasizing early planning, clear algorithms, and integration into existing workflows. We recognise that these are coming into existing diagnostic networks and there is unlikely to be a “one-size fits all” approach but discussions with the TB program and the Lab directorates will be key to ensure that the appropriate planning is done to ensure maximum impact. This includes considering the whole diagnostic cascade, quality assurance, especially for reflex testing for drug susceptibility testing (DST), and to consider patient preferences and diagnostic yield—not just accuracy.
ASLM: What support is available to help programs adopt these tools effectively?
Dr Grania: The Global Fund is working with many partners, including ASLM, to support countries having access to the data and evidence to start the planning for how this class can address the specific TB diagnostic challenges they have – the recent ASLM LabCoP ECHO session was an example of this. Global Fund will be working with early adopter countries to support gaining operational insights to help guide other countries in planning and scaling up this new class in the GC8 funding cycle.
WHO is holding a Guideline development group at the end of this year which will result in a guideline in 2026 and they are also developing user guides, SOPs, training materials, and M&E tools to support their guidance and the rollout of this class. Several partners including Unitaid, Gates Foundation and Stop TB partnership are supporting pilots and implementation research to provide additional data for countries. It’s a coordinated effort across partners.
ASLM: Looking ahead, what does the future of TB diagnosis look like, and how can new diagnostics help us reach the goal of ending TB?
Dr Grania: The future is an integrated diagnostic system to offer a patient-centered, and data-driven diagnosis for people with or at risk of TB. With NPOC tests, we can bring molecular diagnostics to the community level, reduce delays, and improve access—especially for key populations. We’re moving toward integrated platforms that can test for multiple diseases, which supports sustainability and domestic financing. If we get this right, we can meet the UNHLM target of 100% molecular testing by 2027 and make real progress toward ending TB.