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Evaluation of the Xpert MTB/RIF Ultra Assay for Direct Detection of Mycobacterium tuberculosis Complex in Smear-Negative Extrapulmonary Samples
Open accessAbstract
complex (MTUBC) in clinical samples is essential for successful treatment. New techniques such as real-time PCR have been developed in order to facilitate rapid diagnosis, but their sensitivity is low in extrapulmonary specimens, due to the low bacillary load in such samples. A next-generation assay has recently been developed to try to overcome this limitation. The aim of this study was to analyze the effectiveness of the Xpert MTB/RIF Ultra (GX-Ultra) for the detection of MTUBC DNA in 108 smear-negative extrapulmonary specimens that were MTUBC culture positive. In addition, 40 extrapulmonary culture-negative samples and 20 samples with nontuberculous mycobacteria were tested to evaluate the specificity of the assay. All samples were collected between May 1999 and May 2017. The GX-Ultra detected DNA of MTUBC in 82 extrapulmonary specimens that were MTUBC culture positive (75.9% sensitivity; 95% confidence interval [CI], 66.6 to 83.4%). The assay was negative for all clinical specimens that were MTUBC culture negative and the samples with nontuberculous mycobacteria (100% specificity). Furthermore, two (1.8%) samples presented mutations related to rifampin resistance. The highest sensitivity was obtained in samples of lymph nodes (94.1%) and nonsterile fluids (93.7%), followed by tissue specimens (86.6%), stool material (80%), abscess aspirates (64.7%), and sterile fluids (60.5%). Pleural fluids, one of the least optimal samples for detecting DNA of MTUBC, were GX-Ultra positive in 10/21 (47.6%) of cases. In summary, GX-Ultra showed excellent specificity and high sensitivity in paubacillary specimens, making it a useful tool for rapid diagnosis of extrapulmonary tuberculosis.
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“In urine, Xpert Ultra sensitivity and specificity against culture were 100% (74 to 100) and 100% (74 to 100), (1 study; 24 participants, 12 (50%) with tuberculosis) (Perez‐Risco 2018); Figure 15.”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Perez‐Risco 2018
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In the citing paper
“Perez‐Risco 2018 assessed Xpert Ultra specificity using 20 culture‐positive NTM specimens (covering a total of 18 species) and found that Xpert Ultra was negative for all specimens.”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Perez‐Risco 2018
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In the citing paper
“In urine, Xpert Ultra sensitivity and specificity against culture were 100% (74 to 100) and 100% (74 to 100), (1 study; 24 participants, 12 (50%) with tuberculosis) (Perez‐Risco 2018); Figure 15.”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Perez‐Risco 2018
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“In bone or joint aspirate, Xpert Ultra sensitivity and specificity against culture were 88% (47 to 100) (specificity was not estimable) (Perez‐Risco 2018), and 96% (87 to 100) and 97% (85 to 100) (Sun 2019) (2 studies; 94 participants, 60 (63.8%) with tuberculosis); Appendix 9.”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Perez‐Risco 2018
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“In peritoneal fluid, Xpert Ultra sensitivity against culture was 33% (1 to 91) and specificity was not estimable (Perez‐Risco 2018) (1 study; 3 participants); Appendix 10.”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Perez‐Risco 2018
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Cites
Global tuberculosis report (2014)
Gabbasova, L. A., & Who, E. R. E. (2014) · Cited by 12,702
Rapid Molecular Detection of Tuberculosis and Rifampin Resistance
Boehme, C. C., Nabeta, P., Hillemann, D., Nicol, M. P., Shenai, S., Krapp, F., Allen, J., Tahirli, R., Blakemore, R., Rustomjee, R., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0907847 · Cited by 2,309
Lewinsohn, D. M., Leonard, M. K., LoBue, P. A., Cohn, D. L., Daley, C. L., Desmond, E., Keane, J., Lewinsohn, D. A., Loeffler, A. M., Mazurek, G. H., et al. (2017) · Clinical Infectious Diseases · doi:10.1093/cid/ciw694 · Cited by 992
Helb, D., Jones, M., Story, E., Boehme, C., Wallace, E., Ho, K., Kop, J., Owens, M. R., Rodgers, R., Banada, P., et al. (2010) · Journal of Clinical Microbiology · doi:10.1128/jcm.01463-09 · Cited by 914
Lewinsohn, D. M., Leonard, M. K., Jr., LoBue, P. A., Cohn, D. L., Daley, C. L., Desmond, E., Keane, J., Lewinsohn, D. A., Loeffler, A. M., Mazurek, G. H., et al. (2017) · Clinical Infectious Diseases · doi:10.1093/cid/ciw778 · Cited by 776
Dorman, S. E., Schumacher, S. G., Alland, D., Nabeta, P., Armstrong, D. T., King, B., Hall, S. L., Chakravorty, S., Cirillo, D. M., Tukvadze, N., et al. (2017) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(17)30691-6 · Cited by 705
Chakravorty, S., Simmons, A. M., Rowneki, M., Parmar, H., Cao, Y., Ryan, J., Banada, P. P., Deshpande, S., Shenai, S., Gall, A., et al. (2017) · mBio · doi:10.1128/mbio.00812-17 · Cited by 668
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Zeka, A. N., Tasbakan, S., & Cavusoglu, C. (2011) · Journal of Clinical Microbiology · doi:10.1128/jcm.05434-11 · Cited by 362
Xpert MTB/RIF: a New Pillar in Diagnosis of Extrapulmonary Tuberculosis?
Vadwai, V., Boehme, C., Nabeta, P., Shetty, A., Alland, D., & Rodrigues, C. (2011) · Journal of Clinical Microbiology · doi:10.1128/jcm.02319-10 · Cited by 357
Flagged first, then by citations
Research works printed but not linked: 5
- World Health Organization. 2017. Global tuberculosis report 2017. World Health Organization, Geneva, Switzerland.
- World Health Organization. 2011. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. World Health Organization, Geneva, Switzerland.
- World Health Organization. 2017. WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTB/RIF Ultra compared to Xpert MTB/RIF. World Health Organization, Geneva, Switzerland.
- Cepheid. 2017. Xpert MTB/RIF Ultra: instruction manual. Cepheid, Sunnyvale, CA.
- Zar HJ, Workman L, Nicol MP. 2017. Diagnosis of pulmonary tuberculosis in HIV-infected and uninfected children using Xpert MTB/RIF Ultra, abstr A7610. ATS 2017 International Conference. American Thoracic Society, Washington, DC.
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Items 101–102 of 102
Wong, H. S. C., Shing, K. K. D., Cho, W. F., Shum, R., & Wong, W. Y. (2026) · Infectious Medicine · doi:10.1016/j.imj.2026.100275
Metadata
- Authors
- Perez-Risco, D., Rodriguez-Temporal, D., Valledor-Sanchez, I., & Alcaide, F.
- Affiliations
- Bellvitge University Hospital (ES)
- Department of Microbiology, Hospital Universitari de Bellvitge-IDIBELL, Hospitalet de Llobregat, Spain
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2018-09
- Volume
- 56
- Issue
- 9
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC6113499
- OpenAlex
- W2808815524
- Cited by
- 103
- References
- 28
- Citations by year
- 2026: 2 · 2025: 8 · 2024: 11 · 2023: 12 · 2022: 9 · 2021: 14 · 2020: 25 · 2019: 21 · 2018: 1
- FWCI
- 11.52
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
- Health Sciences › Medicine › Infectious Diseases › Infectious Diseases and Tuberculosis
- Keywords
- Xpert MTB/RIF Ultra, Mycobacterium tuberculosis complex, extrapulmonary tuberculosis, nucleic acid amplification tests, sensitivity and specificity, nontuberculous mycobacteria, pleural fluid, rapid diagnosis
- MeSH terms
- Adult, Antibiotics, Antitubercular, Diagnostic Tests, Routine, Humans, Mycobacterium tuberculosis, Nontuberculous Mycobacteria, Rifampin, Sensitivity and Specificity, Time Factors, Tuberculosis, Drug Resistance, Bacterial, Molecular Diagnostic Techniques
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