Rapid diagnostics of tuberculosis using the Xpert MTB/Rif Ultra test
https://doi.org/10.54921/2413-0346-2025-13-1-22-29
Abstract
The aim of the study was evaluation of the diagnostic efficiency of the Xpert MTB/RIF Ultra test for detection of M. tuberculosis DNA and determination of drug susceptibility to rifampicin in various diagnostic samples of patients examined for disease verification.
Materials and methods. We analyzed 427 respiratory and extrapulmonary diagnostic samples obtained from 378 patients (including HIV-infected ones) requiring rapid TB diagnostics. The study was conducted from one portion of the sediment of the diagnostic sample using bacteriological methods (luminescent microscopy, cultivation on Middlebrook 7H9 medium in the Bactec MGIT 960 system and on a Lowenstein-Jensen medium) and Xpert MTB/RIF Ultra test.
Results. High efficiency of the Xpert MTB/RIF Ultra test-system was demonstrated in verifying of TB in HIV-positive and HIV-negative patients with suspected disease or relapse. Xpert MTB/RIF Ultra demonstrated high efficiency of M. tuberculosis DNA detection (39.2%, 95%CI 32.6–46.2%) in various diagnostic samples that were smear-negative and had no growth on nutrient media and obtained from TB patients. The use of the WHO-recommended QC of 0.5 μg/ml for M. tuberculosis drug susceptibility testing to rifampicin in the Bactec MGIT 960 system would improve the estimated concordance of 97.4% (95% CI: 86.8 – 99.5) with Xpert MTB/Rif Ultra.
About the Authors
E. Yu. Nosova
Moscow Research and Clinical Center for Tuberculosis Control of the Moscow City Health Department
Russian Federation
Russian Federation
Moscow
M. A. Sviridenko
Moscow Research and Clinical Center for Tuberculosis Control of the Moscow City Health Department
Russian Federation
Russian Federation
Moscow
A. A. Khakhalina
Moscow Research and Clinical Center for Tuberculosis Control of the Moscow City Health Department
Russian Federation
Russian Federation
Moscow
K. Yu. Galkina
Moscow Research and Clinical Center for Tuberculosis Control of the Moscow City Health Department
Russian Federation
Russian Federation
Moscow
Yu. D. Mikhailova
Moscow Research and Clinical Center for Tuberculosis Control of the Moscow City Health Department
Russian Federation
Russian Federation
Moscow
S. G. Safonova
Moscow Research and Clinical Center for Tuberculosis Control of the Moscow City Health Department
Russian Federation
Russian Federation
Moscow
References
1. Бородулина Е.А., Пискун В.В., Ураксина М.В, Шубина А.Т. Молекулярно-генетические тесты GENEXPERT MTB/RIF и XPERT MTB/RIF (ULTRA) в диагностике туберкулеза: обзор литературы // Клиническая лабораторная диагностика. – 2022. – № 2. 67(9). – С. 544-549.
2. Приказ Минздрава России от 21.03.2003 № 109 (ред. от 05.06.2017) «О совершенствовании противотуберкулезных мероприятий в Российской Федерации». – Электронный ресурс: https://www.consultant.ru/document/cons_doc_LAW_100829/
3. Чункаева Д.Д., Чингисова Л.Т., Коптлеуова А.Б. и др. Эффективность XPERT MTB/RIF ULTRA для диагностики туберкулеза: обзор литературы) // Фтизиопульмонология. – 2022. – № 1(39) – С. 163-168.
4. Эпидемиологические показатели по туберкулезу в г. Москве по итогам 2023 года. – Электронный ресурс https://mnpcbt.ru/epidSituation/epid-pokazateli-po-tb-itog-2023/
5. Andama A., Jaganath D. et al. The transition to Xpert MTB/RIF ultra: diagnostic accuracy for pulmonary tuberculosis in Kampala, Uganda // BMC Infect. Dis. – 2021. – Vol. 21, No 49. – P. 1-7. https://doi.org/10.1186/s12879-020-05727-8doi:10.1186/s12879-020-05727-8.
6. Boehme C.C., Nabeta P., Hillemann D. et al. Rapid molecular detection of tuberculosis and rifampin resistance // N. Engl. J. Med. – 2010. – Vol. 363. – P. 1005-1015.
7. Chakravorty S., Simmons A.M., Rowneki M. et al. The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable forPoint-of-Care testing // mBio. – 2017. – Vol. 8, No 4. – P. e00812. – e00817. doi:10.1128/mBio.00812-17.
8. Chilukutu L., Mwanza W., Kerkhoff A.D. et al. Prevalence and interpretation of Xpert® Ultra trace results among presumptive TB patients // Public Health Action. – 2022 – Vol. 12, No 1 – P. 28-33.
9. Denkinger C.M., Schumacher S.G., Boehme C.C. et al. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis // Eur. Respir. J. – 2014. – Vol. 44. – P. 435-446. https://doi.org/10.1183/09031936.00007814
10. Huang T.-S., Chen C.S., Lee S.S. et al. Comparison of the BACTEC MGIT 960 and BACTEC 460TB Systems for Detection of mycobacteria in Clinical Specimens // Ann. Clin. Lab. Sci. – 2001. – Vol. 31, No 3. – P. 279-283.
11. Marlowe E., Novak-Weekley S.M., Cumpio J. et al. Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens // J. Clin. Microbiol. – 2011. – Vol. 49. – P. 1621-1623.
12. Rigouts L., Gumusboga M., Bram de Rijk W. et al. Rifampin resistance missed in automated liquid culture system for Mycobacterium tuberculosis isolates with specific rpoB mutations // J. Clinical Microbiol. – 2013. – Vol. 51, No 8. – P. 2641-2645.
13. Siddiqi S. MGIT Procedure Manual for BactecTM MGITTM 960 TB System (also applicable for Manual MGIT) Mycobacteria Growth Indicator Tube (MGIT) Culture and Drug Susceptibility Demonstration Projects. - 2007.
14. Steingart K.R., Schiller I., Horne D.J. et al. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults // Cochrane Database Syst. Rev. – 2014. – No 1. – CD009593. https://doi.org/10 .1002/14651858.CD009593.pub3.
15. Тheron G., Peter J., Calligaro G. et al. Determinants of PCR performance (Xpert MTB/RIF), including bacterial load and inhibition, for TB diagnosis using specimens from different body compartments // Sci. Rep. – 2014. – No 4. – P. 1-10. doi: 10.1038/srep05658.
16. Williams-Bouyer N., Yorke R., Lee H.I., Woods G.L. Comparison of the BACTEC MGIT 960 and ESP culture system II for growth and detection of mycobacteria // J. Clin. Microbiol. – 2000. – Vol. 38, No 11. – P. 4167-4170.
17. WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTF/RIF Ultra compared to Xpert MTB/RIF / WHO/HTM/TB/2017.04. Licence: CC BY-NCSA 3. – Geneva: World Health Organization, 2017.
18. World Health Organization. Technical Report on critical concentrations for drug susceptibility testing of isoniazid and the rifamycins (rifampicin, rifabutin and rifapentine) – Geneva: WHO, 2021.
19. World Health Organization. Global tuberculosis report. – Geneva: WHO, 2023. – 57 р. Электронный ресурс: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023.
20. Zeka A.N., Tasbakan S., Cavusoglu C. Evaluation of the GeneXpert MTB/RIF assay for rapid diagnosis of tuberculosis and detection of rifampin resistance in pulmonary and extrapulmonary specimens // J. Clin. Microbiol. – 2014. – Vol. 49. – P. 4138-414.
Review
For citations:
Nosova E.Yu., Sviridenko M.A., Khakhalina A.A., Galkina K.Yu., Mikhailova Yu.D., Safonova S.G. Rapid diagnostics of tuberculosis using the Xpert MTB/Rif Ultra test. Tuberculosis and socially significant diseases. 2025;13(1):22-29. (In Russ.) https://doi.org/10.54921/2413-0346-2025-13-1-22-29
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