Cumulative TB disease burden following sputum Xpert Ultra 'Trace' results in clinical settings: Results from a multi-site observational clinical study.

ABSTRACT:

Background

Highly sensitive molecular tests, like Xpert Ultra, are reshaping TB diagnosis-detecting paucibacillary TB but sometimes creating uncertainty when they detect DNA in extremely low quantities that may not signal disease. This ambiguity also complicates the evaluation of novel diagnostic strategies. We sought to monitor adults with a 'Trace' result on an Xpert Ultra test to estimate the risk of tuberculosis disease up to 24 months later.

Methods

We conducted a multi-site clinical observational study in South Africa and Uganda, where we enrolled ambulatory participants aged >=15 years with a sputum Xpert Ultra Trace result who had not yet initiated TB treatment. All participants underwent comprehensive clinical evaluation and repeated, standard sputum TB testing. Cli

SUBMITTER: Dalmat RR 

PROVIDER: S-EPMC12338891 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature