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 specificity against culture was 100% (74 to 100).
“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
The Results report 100% Xpert Ultra specificity for the culture-negative and nontuberculous-mycobacteria specimens overall. Our copy does not give a urine-specific specificity estimate or the stated 74–100 confidence interval, so it supports the overall result but not the urine-specific figure. (LLM, conf=0.78)
Experimental — accuracy not yet measuredPerez-Risco 2018 found Xpert Ultra negative for all 20 culture-positive NTM specimens covering 18 species.
“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
In urine, Xpert Ultra sensitivity against culture was 100% (74 to 100).
“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
The Results report sensitivity by specimen group and refer to Table 1, but the passages in our copy do not give a urine-specific result. Searches for urine, the reported 100% sensitivity, and the sample counts did not locate the claimed urine estimate or its 74–100 interval. (LLM, conf=0.72)
Experimental — accuracy not yet measuredIn bone or joint aspirate, Xpert Ultra sensitivity against culture in Perez-Risco 2018 was 88% (47 to 100).
“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
The Results section reports sensitivity by broad specimen group, including tissue specimens and abscess aspirates, but gives no bone-or-joint aspirate estimate. Searches of our copy for bone, joint, and the claimed figure found no matching passage, so the 88% sensitivity and its interval cannot be verified. (LLM, conf=0.70)
Experimental — accuracy not yet measuredIn peritoneal fluid, Xpert Ultra sensitivity against culture was 33% (1 to 91).
“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
The Results (page unavailable) report Xpert Ultra sensitivity for broad specimen groups and pleural fluid, but no passage in our copy gives a peritoneal-fluid result. Searches for peritoneal or ascitic fluid, one positive result among three samples, and 33.3% did not establish the claimed 33% sensitivity or 1–91 interval. (LLM, conf=0.70)
Experimental — accuracy not yet measured
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- 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 › Surgery › 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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