EClinicalMedicine
Diagnostic testing for pulmonary tuberculosis in low and middle-income countries: innovations to achieve universal access—a narrative review
By Nazir A. Ismail, Rebecca H. Berhanu, Nina von Knorring and 8 others.
Abstract
Summary: Though rapid molecular diagnostics for tuberculosis (TB) have substantially improved diagnostic accuracy and turnaround times, implementation and impact has been constrained by cost, infrastructure requirements, and continued reliance on sputum. This review examines advances in diagnostic technologies and sampling strategies that could overcome these barriers and accelerate universal access to TB diagnostics. We conducted a narrative review of studies published between Jan 1, 2020, and April 30, 2026, focusing on near-point-of-care molecular (NPOC) platforms, next-generation lipoarabinomannan (LAM) assays, and non-sputum sampling approaches. Emerging NPOC molecular platforms, demonstrate high sensitivity using both sputum and tongue-swab specimens while substantially reducing equipment and testing costs compared with existing nucleic acid amplification test platforms. Next-generation urine LAM assays offer improved sensitivity and potential for use beyond people living with HIV. In addition, parallel testing approaches with multiple sample types, including sputum, tongue swab, stool for children, and urine testing, can substantially increase diagnostic yield in specific populations. Integrating low-cost technologies with non-sputum sampling strategies could provide a scalable pathway towards universal access to TB diagnostics. Realizing this potential will require streamlined regulatory pathways, sustainable financing, and integration of these tools into primary healthcare systems. Funding: None.



