Prevalence of Xpert MTB/RIF Ultra Trace Call Results and Associated Risk Factors During Active Tuberculosis Case Finding in Viet Nam: A Programmatic Evaluation.

The Xpert MTB/RIF Ultra assay (Ultra) is a second-generation molecular diagnostic test for tuberculosis (TB). The "Trace Call" result was added as a semi-quantitative category for extremely low bacillary loads. The prevalence and interpretation of Trace Call results remains insufficiently elucidated in the context of community-based active case finding (ACF). We organized 56 days of mobile chest X-ray (CXR) screening events in Ho Chi Minh City, Viet Nam, between October 2020 and March 2021. Participants were screened verbally and by CXR and tested by Ultra, if eligible. Persons with a Trace Call were re-tested on Ultra per national guidelines. qXRv3 computer-aided detection software was used for post hoc quality control of CXR interpretation. We calculated descriptive statistics and fitted mixed-effect multivariate regression models to identify factors associated with Trace Call results and confirmatory diagnosis. A total of 16,698 people were screened by CXR to detect 185 Ultra-positive participants, including 142 persons with a confirmed TB diagnosis. Among Ultra-positive participants, 38.4% (71/185) had Trace Call results. Of these, 85.9% (61/71) were re-tested, and 45.9% (28/61) were bacteriologically-confirmed, comprising 19.7% (28/142) of the final number of confirmed diagnoses. Having a low qXR abnormality score (<0.5) (aOR = 4.97; 95%CI: [1.88, 13.14]; = 0.001) and a history of TB within 5 recent years (aOR = 3.53; 95%CI: [1.69, 7.35]; = 0.001) were associated with an initial Trace Call. The Trace Call can improve ACF detection, particularly in earlier stages of disease with limited pulmonary deterioration. However, participants with a history of TB had higher rates of Trace Call, reinforcing the need to interpret test results in this group with caution.