Xpert MTB/RIF Ultra versus mycobacterial growth indicator tube liquid culture for detection of Mycobacterium tuberculosis in symptomatic adults: a diagnostic accuracy study.

Autor:	Xie YL; Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA., Eichberg C; Medical University of South Carolina, Charleston, SC, USA., Hapeela N; Division of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Nakabugo E; Infectious Diseases Institute, Makerere University, Kampala, Uganda., Anyango I; Kenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya., Arora K; Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA., Korte JE; Medical University of South Carolina, Charleston, SC, USA., Odero R; Kenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya., van Heerden J; Division of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Zemanay W; Division of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Kennedy S; Medical University of South Carolina, Charleston, SC, USA., Nabeta P; FIND, Geneva, Switzerland., Hanif M; State TB Training and Demonstration Centre, New Delhi, India., Rodrigues C; PD Hinduja Hospital and Medical Research Centre, Mumbai, India., Skrahina A; National Reference Laboratory, Republican Scientific and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus., Stevens W; Department of Molecular Medicine and Hematology, Faculty of Health Science, School of Pathology, and the National Priority Program of the National Health Laboratory Service, Johannesburg, South Africa., Dietze R; Universidade Federal do Espirito Santo, Vitoria, Brazil., Liu X; Henan Provincial Chest Hospital, Zhengzhou, China., Ellner JJ; Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA., Alland D; Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA., Joloba ML; Mycobacteriology Laboratory, Department of Microbiology, School of Biomedical Sciences, Makerere University, Kampala, Uganda., Schumacher SG; FIND, Geneva, Switzerland., McCarthy KD; US Centers for Disease Control and Prevention, Kisumu, Kenya., Nakiyingi L; Infectious Diseases Institute, Makerere University, Kampala, Uganda., Dorman SE; Medical University of South Carolina, Charleston, SC, USA. Electronic address: dorman@musc.edu.
Jazyk:	angličtina
Zdroj:	The Lancet. Microbe [Lancet Microbe] 2024 Jun; Vol. 5 (6), pp. e520-e528. Date of Electronic Publication: 2024 Apr 09.
DOI:	10.1016/S2666-5247(24)00001-6
Abstrakt:	Background: Xpert MTB/RIF Ultra (Ultra) is an automated molecular test for the detection of Mycobacterium tuberculosis in sputum. We compared the sensitivity of Ultra to that of mycobacterial growth indicator tube (MGIT) liquid culture, considered the most sensitive assay in routine clinical use. Methods: In this prospective, multicentre, cross-sectional diagnostic accuracy study, we used a non-inferiority design to assess whether the sensitivity of a single Ultra test was non-inferior to that of a single liquid culture for detection of M tuberculosis in sputum. We enrolled adults (age ≥18 years) with pulmonary tuberculosis symptoms in 11 countries and each adult provided three sputum specimens with a minimum volume of 2 mL over 2 days. Ultra was done directly on sputum 1, and Ultra and MGIT liquid culture were done on resuspended pellet from sputum 2. Results of MGIT and solid media cultures done on sputum 3 were considered the reference standard. The pre-defined non-inferiority margin was 5·0%. Findings: Between Feb 18, 2016, and Dec 4, 2019, we enrolled 2906 participants. 2600 (89%) participants were analysed, including 639 (25%) of 2600 who were positive for tuberculosis by the reference standard. Of the 2357 included in the non-inferiority analysis, 877 (37%) were HIV-positive and 984 (42%) were female. Sensitivity of Ultra performed directly on sputum 1 was non-inferior to that of sputum 2 MGIT culture (MGIT 91·1% vs Ultra 91·9%; difference -0·8 percentage points; 95% CI -2·8 to 1·1). Sensitivity of Ultra performed on sputum 2 pellet was also non-inferior to that of sputum 2 MGIT (MGIT 91·1% vs Ultra 91·9%; difference -0·8 percentage points; -2·7 to 1·0). Interpretation: For the detection of M tuberculosis in sputum from adults with respiratory symptoms, there was no difference in sensitivity of a single Ultra test to that of a single MGIT culture. Highly sensitive, rapid molecular approaches for M tuberculosis detection, combined with advances in genotypic methods for drug resistance detection, have potential to replace culture. Funding: US National Institute of Allergy and Infectious Diseases. Competing Interests: Declaration of interests SGS was employed by FIND during conduct of the study. FIND is a not-for-profit foundation that supports the evaluation of publicly prioritised tuberculosis assays and the implementation of WHO-approved (guidance and prequalification) assays using donor grants. FIND has product evaluation agreements with several private sector companies that design diagnostics and related products for treatment of tuberculosis and other diseases. These agreements strictly define FIND’s independence and neutrality with regard to the companies whose products get evaluated and describe roles and responsibilities. DA receives income from licence payments from Cepheid to Rutgers University and reports receiving research contracts and research support from Cepheid. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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