TB PCR in BAL and EBUS-TBNA samples for the diagnosis of pulmonary and mediastinal lymph node TB: retrospective TRiBE study.

Autor:	Park M; Department of Respiratory Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK onn.kon@imperial.ac.uk mirae.park@nhs.net.; National Heart and Lung Institute, Imperial College London, London, UK., Kumar K; Department of Respiratory Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.; National Heart and Lung Institute, Imperial College London, London, UK., Coleman M; Department of Respiratory Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK., Martin L; Department of Respiratory Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK., Russell G; Department of Respiratory Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK., Scheelbeek P; London School of Hygiene and Tropical Medicine, London, UK., Lalvani A; Tuberculosis Research Unit, Imperial College London, London, UK., Satta G; University College Hospitals London NHS Foundation Trust, London, UK., Kon OM; Department of Respiratory Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK onn.kon@imperial.ac.uk mirae.park@nhs.net.; National Heart and Lung Institute, Imperial College London, London, UK.
Jazyk:	angličtina
Zdroj:	Thorax [Thorax] 2024 Aug 19; Vol. 79 (9), pp. 870-877. Date of Electronic Publication: 2024 Aug 19.
DOI:	10.1136/thorax-2023-220647
Abstrakt:	Introduction: The role of Xpert Ultra in bronchoalveolar lavage (BAL) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples for pulmonary and mediastinal lymph node tuberculosis (TB) remains unclear. Methods: This was a retrospective observational service evaluation at a tertiary TB centre in a low-incidence setting. The diagnostic indices of Xpert Ultra, smear and culture (with cytology for EBUS-TBNA samples) were compared with culture positivity or a composite reference standard of clinical TB diagnosis. Trace readouts, a new category of results for Xpert Ultra indicating low bacillary load, were analysed in two ways as a true positive or true negative result. 282 BAL and 139 EBUS-TBNA samples were included in the analysis. Results: BAL: sensitivity with 95% CI against culture-confirmed pulmonary TB from BAL samples for Xpert Ultra (trace as positive) was 0.91 (0.82 to 0.98), Xpert Ultra (trace as negative) was 0.76 (0.69 to 0.83), smear was 0.38 (p=0.0009) and culture was 1.00 (0.91 to 1.00). Specificities for all the tests were ≥0.99 (0.98 to 1.00). The addition of smear to Xpert Ultra did not improve the diagnostic accuracy.EBUS-TBNA: sensitivity against culture-confirmed TB from EBUS-TBNA samples for Xpert Ultra (trace as positive) was 0.71 (0.63 to 0.78), Xpert Ultra (trace as negative) was 0.59 (0.54 to 0.63), smear was 0.12 (p=0.002), culture was 1.00 (0.89 to 1.00), cytology was 0.87 (0.76 to 0.98) and rapid on-site evaluation of cytology (ROSE) was 0.92 (0.78 to 1.00). Specificities were 0.99 (0.97 to 1.00), 0.99 (0.97 to 1.00), 1.00 (0.98 to 1.00), 1.00 (0.98 to 1.00), 0.67 (0.67 to 0.68) and 0.42, respectively. Conclusion: Xpert Ultra had a significantly higher sensitivity compared with smear in both BAL and EBUS-TBNA samples. Xpert Ultra had a lower sensitivity compared with culture but comparable specificity with results being available within <24 hours. Trace readings in our low-incidence setting were associated with culture positivity in all BAL samples. Competing Interests: Competing interests: MP, GS, KK, GR, LM and PS have no declaration of interests. OMK has received speaking fees and an educational grant from Cepheid (Sunnyvale, USA) to evaluate GeneXpert Ultra in bronchoscopic samples. AL reports issued patents underpinning IGRA and next-generation IGRA, some of which were assigned by the University of Oxford to Oxford Immunotec, resulting in royalty entitlements for the University of Oxford and AL. AL is a named inventor on the following patents: EP05729257.5, EP1735623[B1], US8,105,797[B2], EP2069792, EP2069792[B1], EP2005182, EP2005182[B1], US8,765,336[B2], EP10716313.1, EP2417456[B1], US9,377,460[B2], US9360480[B2], EP0941478[B2], EP1152012[B1], EP1735623[B1], US8105797[B2], EP1144447[B1] and US9005902[B2]. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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