Abstract
Most diagnostic tests for tuberculosis (TB) rely on sputum samples, which are difficult to obtain and have low sensitivity in immunocompromised patients, patients with disseminated TB, and children, delaying treatment initiation. The World Health Organization (WHO) calls for the development of a rapid, biomarker-based, non-sputum test capable of detecting all forms of TB at the point-of-care to enable immediate treatment initiation. Lipoarabinomannan (LAM) is the only WHO-endorsed TB biomarker that can be detected in urine, an easily collected sample. This status update discusses the characteristics of LAM as a biomarker, describes the performance of first-generation urine LAM tests and reasons for slow uptake, and presents considerations for developing the next generation of more sensitive and impactful tests. Next-generation urine LAM tests have the potential to reach adult and pediatric patients regardless of HIV status or site of infection and facilitate global TB control. Implementation and scale-up of existing LAM tests and development of next-generation assays should be prioritized.
Highlights
Tuberculosis (TB) has infected one-quarter of the world’s population and is the leading infectious cause of mortality worldwide [1]
Most conventional diagnostic tests for microbiological confirmation rely on sputum samples, which can be difficult to obtain and have low diagnostic sensitivity in children, patients with extrapulmonary TB (EPTB), and people living with HIV (PLHIV) [2]
Active Mycobacterium tuberculosis (Mtb) infection begins when Mtb enters the lungs via inhalation and invades the lung interstitial tissue where the process of infection evolves (Figure 1)
Summary
Tuberculosis (TB) has infected one-quarter of the world’s population and is the leading infectious cause of mortality worldwide [1]. Ten million people develop active TB each year, one million of whom are children [1]. An estimated 36% of new TB cases remain undiagnosed or unreported, partly due to the major limitations of current diagnostic tools [1]. Most conventional diagnostic tests for microbiological confirmation rely on sputum samples, which can be difficult to obtain and have low diagnostic sensitivity in children, patients with extrapulmonary TB (EPTB), and people living with HIV (PLHIV) [2]. EPTB occurs in one fifth of all incident TB cases, and the majority (60%) of EPTB patients do not have traceable TB in the lungs and sputum [3]. A point of care (POC) test that readily detects active TB would reduce diagnostic delays, interrupt transmission with appropriate therapy, and address many of the current gaps in global TB control
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