Xpert MTB/RIF Ultra Assay for the Detection of Mycobacterium Tuberculosis (MTB) in Bronchoalveolar Lavage (BAL) for Pulmonary TB and Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) Samples for Mediastinal TB

This is a prospective multi-centre study across the UK including London, Birmingham, Leicester and Manchester which account for the highest proportion of TB cases in the UK. These are centres routinely investigate patients with suspected TB and routinely use Xpert Ultra in their practice.

Any patient who is suspected of having pulmonary or mediastinal TB who is routinely undergoing a bronchoscopy or EBUS-TBNA for clinical purposes will be recruited. These patients will be identified mainly by the TB services but also via Accident and Emergency, wards and clinics. Inclusion criteria include any consenting adult ≥18 years of age suspected of having pulmonary or mediastinal TB who is undergoing a routine clinical bronchoscopy for BAL or EBUS-TBNA.

Any patient identified who need a bronchoscopy or EBUS-TBNA for suspected TB will have this done in the local hospital. Patients will follow the routine follow up arrangements in line with the local trust guidelines but the researchers will review any routine follow up data up to 3 month post-procedure if available. There will be no additional procedures or visits as the researchers will merely use routinely available clinical data and follow up data if available.

The study aims to recruit a minimum of 323 participants undergoing a BAL, and 323 participants undergoing an EBUS-TBNA for a minimum of 6 months or until the recruitment targets are reached. The researchers will review any routine follow up data for a minimum of 3 months post-procedure. There will be no additional study follow up visits.

The study outcome is the diagnostic performance of Xpert Ultra in BAL and EBUS-TBNA samples in patients with suspected TB against conventional modalities available (smear microscopy, culture, cytology) using a subgroup analysis of the different clinical categories attributing to the likely TB diagnosis incorporating follow-up data and the clinician's decision to treat. A clinical expert panel will review the culture-negative cases blindly to categorise each case into a clinical diagnosis category.