# Xpert MTB/RIF Ultra performance on bronchial specimens in diagnosing pulmonary tuberculosis in Vancouver, Canada

## TL;DR

This study shows that the Xpert Ultra test works well for diagnosing tuberculosis using bronchoscopy samples, offering fast and accurate results compared to traditional culture methods.

## Contribution

The study evaluates Xpert Ultra's performance on bronchoscopy samples in a low-TB incidence setting, filling a gap in its application beyond sputum.

## Key findings

- Xpert Ultra had 93.6% positive agreement and 98.7% negative agreement with culture results.
- Xpert Ultra results were available in 24 hours, compared to 15.2 days for culture.
- Xpert Ultra performed well in both smear-positive and smear-negative cases.

## Abstract

Introduction. In cases where sputum is non-diagnostic or unavailable, bronchoscopy can yield high-value respiratory samples for tuberculosis (TB) diagnosis. Whilst Mycobacterium tuberculosis (MTB) complex culture remains the gold standard, molecular assays such as Xpert MTB/RIF Ultra (Xpert Ultra) are increasingly being used for rapid diagnosis.

Gap Statement. Xpert Ultra is increasingly used for TB diagnosis and has been extensively evaluated on sputum specimens, but assessment of performance on bronchoscopy samples is more limited.

Aim. To retrospectively evaluate the performance of Xpert Ultra on bronchoscopy specimens in comparison to culture in a low-incidence, high-resource setting.

Methodology. Patients with a clinical suspicion of TB, who had non-diagnostic sputum or limited sputum production and underwent bronchoscopy between March 2019 and October 2023, were included in the study. Bronchoscopy specimens comprised bronchoalveolar lavages, bronchial washings and endobronchial ultrasound lymph node tissue biopsies. All included specimens underwent acid-fast bacilli (AFB) smear, mycobacterial culture and Xpert Ultra. Positive MTB culture was considered the reference standard for TB diagnosis.

Results. One hundred thirty-five bronchoscopy samples from 126 patients were included. Cultures were positive for MTB in 47 out of 126 (37.3%) of included patients. Overall, positive percent agreement (PPA) and negative percent agreement (NPA) of Xpert Ultra to MTB culture were 93.6% and 98.7%, respectively. In 19 AFB smear-positive cases, Xpert Ultra had 100% PPA and NPA, whilst in 28 smear-negative cases, PPA and NPA were 89.3% and 98.6%, respectively. On average, positive culture results were available after 15.2 days of incubation (range, 5–42 days) versus 24 h for Xpert Ultra. Xpert Ultra PCR cycle threshold values correlated strongly with AFB-smear grade and time-to-culture positivity.

Conclusion. Xpert Ultra performed on specimens collected via bronchoscopy demonstrated excellent agreement with culture, even in smear-negative cases. Our results support the use of the Ultra on bronchoscopy specimens for accurate and rapid TB diagnosis in a low-incidence setting.