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Cited by 322Tuberculosis Research and EpidemiologyDiagnosis and treatment of tuberculosisInfectious Diseases and Tuberculosis

Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis

Open access
Tortoli, Enrico, Russo, Cristina, Piersimoni, Claudio, Mazzola, Ester, Dal Monte, Paola, Pascarella, Michela, Borroni, Emanuele, Mondo, Alessandra +5 more·2012·European Respiratory Journal
DOI 10.1183/09031936.00176311
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Abstract

Extrapulmonary tuberculosis (EPTB) accounts for more than 20% of tuberculosis (TB) cases. Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, CA, USA) is a fully automated amplification system, for which excellent results in the diagnosis of pulmonary TB in highly endemic countries have been recently reported. We aimed to assess the performance of the Xpert system in diagnosing EPTB in a low incidence setting. We investigated with Xpert a large number of consecutive extrapulmonary clinical specimens (1,476, corresponding to 1,068 patients) including both paediatric (494) and adult samples. We found, in comparison with a reference standard consisting of combination of culture and clinical diagnosis of TB, an overall sensitivity and specificity of 81.3% and 99.8% for Xpert, while the sensitivity of microscopy was 48%. For biopsies, urines, pus and cerebrospinal fluids the sensitivity exceeded 85%, while it was slightly under 80% for gastric aspirates. It was, in contrast, lower than 50% for cavitary fluids. High sensitivity and specificity (86.9% and 99.7%, respectively) were also obtained for paediatric specimens. Although the role of culture remains central in the microbiological diagnosis of EPTB, the sensitivity of Xpert in rapidly diagnosing the disease makes it a much better choice compared to smear microscopy. The ability to rule out the disease still remains suboptimal.

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  • Noninterpretable results for Xpert were reported in three studies, with only one study [28] having >2% (3.6%).

    “Noninterpretable results for Xpert were reported in three studies, with only one study [28] having .2%(i.e.3.6%).”

    From Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis (2014) · cites this paper as [28]

    The Results section reports 17 indeterminate Xpert results, or 1.1% of samples—not the attributed 3.6% or a rate above 2%. This paper cannot establish how many other studies reported noninterpretable results. (LLM, conf=0.90)

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Research works printed but not linked: 1

  1. [3]3. Centers for Disease Control and Prevention. Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. MMWR 2009; 58: 7-10.

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Authors
Tortoli, E., Russo, C., Piersimoni, C., Mazzola, E., Dal Monte, P., Pascarella, M., Borroni, E., Mondo, A., Piana, F., Scarparo, C., Coltella, L., Lombardi, G., & Cirillo, D. M.
Affiliations
  • Bambino Gesù Children's Hospital (IT)
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT)
  • Ospedale San Bortolo (IT)
  • Ospedale Amedeo di Savoia (IT)
  • Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo (IT)
  • Ospedale Santa Maria della Misericordia di Udine (IT)
  • IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
ORCID
Venue
European Respiratory Journal
Publisher
European Respiratory Society (ERS)
Published
2012-01-12
Volume
40
Issue
2
Pages
442-447
ISSN
  • 0903-1936 (ISSN-L)
  • 1399-3003
DOI
10.1183/09031936.00176311
OpenAlex
W2098719497
Semantic Scholar
b1b1ee37fb8c822f1e8ddbb557df577754385ac8
Cited by
322
References
19
Citations by year
2026: 6 · 2025: 7 · 2024: 8 · 2023: 19 · 2022: 16 · 2021: 26 · 2020: 27 · 2019: 22 · 2018: 32 · 2017: 16 · 2016: 27 · 2015: 30 · 2014: 43 · 2013: 28 · 2012: 15
FWCI
25.73
Type
journal article
Language
en
Open access
Locations
  • European Respiratory Journal (publishedVersion)
  • PubMed (publishedVersion)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Funders
European Commission (223681)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
  • Health Sciences › Medicine › Surgery › Diagnosis and treatment of tuberculosis
  • Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
Keywords
extrapulmonary tuberculosis, Xpert MTB/RIF, nucleic acid amplification tests, sensitivity and specificity, pediatric tuberculosis, cerebrospinal fluid, urine, gastric aspirate, low-incidence settings, tuberculosis diagnosis
MeSH terms
Adolescent, Adult, Automation, Biopsy, Child, Child, Preschool, Humans, Infant, Infant, Newborn, Nucleic Acids, Sensitivity and Specificity, Sputum, Tuberculosis, Reproducibility of Results, Tuberculosis, Multidrug-Resistant, Diagnostic Techniques and Procedures

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