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Cited by 41Tuberculosis Research and EpidemiologyDiagnosis and treatment of tuberculosisInfectious Diseases and Tuberculosis

Diagnostic accuracy of the Xpert MTB/Rif Ultra for tuberculosis adenitis

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Antel, Katherine, Oosthuizen, Jenna, Malherbe, Francois, Louw, Vernon J., Nicol, Mark P., Maartens, Gary, Verburgh, Estelle·2020·BMC Infectious Diseases
DOI 10.1186/s12879-019-4749-xPMC PMC6958753

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Abstract

BACKGROUND: The WHO recently recommended the new Xpert MTB/RIF Ultra assay (Ultra) instead of the Xpert MTB/RIF assay because Ultra has improved sensitivity. We report the diagnostic accuracy of Ultra for tuberculous adenitis in a tuberculosis and HIV endemic setting. METHODS: We obtained fine-needle aspirates (FNA) and lymph node tissue by core-needle biopsy in adult patients with peripheral lymphadenopathy of >20 mm. Ultra and mycobacterial culture were performed on FNA and tissue specimens, with histological examination of tissue specimens. We assessed the diagnostic accuracy of Ultra against a composite reference standard of 'definite tuberculosis' (microbiological criteria) or 'probable tuberculosis' (histological and clinical criteria). RESULTS: We prospectively evaluated 99 participants of whom 50 were HIV positive: 21 had 'definite tuberculosis', 15 'probable tuberculosis' and 63 did not have tuberculosis (of whom 38% had lymphoma and 19% disseminated malignancy). Using the composite reference standard the Ultra sensitivity on FNA was 70% (95% CI 51-85; 21 of 30), and on tissue was 67% (45-84; 16/24) these were far superior to the detection of acid-fast bacilli on an FNA (26%; 7/27); AFB on tissue (33%; 8/24); or tissue culture (39%; 9/23). The detection of granulomas on histology had high senstivity (83%) but the lowest specficity. When compared with culture the Ultra on FNA had a sensitvity of 78% (40-97; 7/9) and tissue 90% (55-100; 9/10). CONCLUSIONS: Ultra performed on FNA or tissue of a lymph node had good sensitivity and high specificity. Ultra had a higher yield than culture and has the advantage of being a rapid test. Ultra on FNA would be an appropriate initial investigation for lymphadenopathy in tuberculosis endemic areas followed by a core biopsy for histopathology with a repeat Ultra on tissue if granulomas are present.

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  • In lymph node biopsies, Xpert Ultra sensitivity against a composite reference standard was 73% (50 to 89).

    “In lymph node biopsies, Xpert Ultra sensitivity and specificity against a composite reference standard were 73% (50 to 89) and 96% (88 to 100) (Antel 2020), (1 study; 81 participants); Figure 14.”

    From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Antel 2020

    Table 3 in the Results reports sensitivity of 67% (95% CI 45–84; 16/24) for Ultra on lymph node tissue against the composite reference standard, not 73% (50–89). The table does match the citing sentence’s 81 participants and 96% specificity, although it gives the specificity interval as 88–99. (LLM, conf=0.90)

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  • In lymph node biopsies, Xpert Ultra specificity against a composite reference standard was 96% (88 to 100).

    “In lymph node biopsies, Xpert Ultra sensitivity and specificity against a composite reference standard were 73% (50 to 89) and 96% (88 to 100) (Antel 2020), (1 study; 81 participants); Figure 14.”

    From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Antel 2020

    Table 3 (Results) reports 96% specificity for Ultra on lymph-node tissue in 81 participants against the composite reference standard. Its confidence interval is 88–99%, not the claimed 88–100%. (LLM, conf=0.91)

    Experimental — accuracy not yet measured

  • In lymph node biopsies, Xpert Ultra sensitivity against culture in Antel 2020 was 90% (55 to 100).

    “In lymph node biopsies, Xpert Ultra sensitivity and specificity against culture were 90% (55 to 100) and 87% (77 to 94) (Antel 2020) and 100% (75 to 100) and 38% (22 to 55) (Wu 2019), (2 studies; 131 participants, 23 (17.6%) with tuberculosis); Figure 14.”

    From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Antel 2020

  • In lymph node biopsies, Xpert Ultra specificity against culture in Antel 2020 was 87% (77 to 94).

    “In lymph node biopsies, Xpert Ultra sensitivity and specificity against culture were 90% (55 to 100) and 87% (77 to 94) (Antel 2020) and 100% (75 to 100) and 38% (22 to 55) (Wu 2019), (2 studies; 131 participants, 23 (17.6%) with tuberculosis); Figure 14.”

    From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Antel 2020

  • In lymph node aspirates, Xpert Ultra specificity against culture was 78% (66 to 87).

    “In lymph node aspirates, Xpert Ultra sensitivity and specificity against culture were 78% (40 to 97) and 78% (66 to 87), (1 study; 73 participants; 9 (12.3%) with tuberculosis; Antel 2020); Figure 13.”

    From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Antel 2020

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Authors
Antel, K., Oosthuizen, J., Malherbe, F., Louw, V. J., Nicol, M. P., Maartens, G., & Verburgh, E.
Affiliations
University of Cape Town (ZA)
Corresponding author
Antel, Katherine
ORCID
Venue
BMC Infectious Diseases
Publisher
Springer Science and Business Media LLC
Published
2020-01-13
Volume
20
Issue
1
Pages
33-33
ISSN
1471-2334 (ISSN-L)
DOI
10.1186/s12879-019-4749-x
PMC
PMC6958753
OpenAlex
W3002483726
Cited by
41
References
22
Citations by year
2026: 5 · 2025: 5 · 2024: 6 · 2023: 7 · 2022: 5 · 2021: 7 · 2020: 6
FWCI
0.82
Type
journal article
Language
en
Update notices
correction (2020-03-02)
Open access
Licence
Locations
  • BMC Infectious Diseases (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • Open University of Cape Town (University of Cape Town) (submittedVersion)
  • UWA Profiles and Research Repository (UWA) (submittedVersion, cc-by)
Funders
  • Foundation for the National Institutes of Health (D43-TW010345)
  • National Institutes of Health (D43-TW010543])
  • National Research Foundation (119078)
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
Xpert MTB/RIF Ultra, tuberculous lymphadenitis, peripheral lymphadenopathy, diagnostic accuracy, sensitivity and specificity, HIV coinfection, fine-needle aspiration, core needle biopsy, mycobacterial culture, acid-fast bacilli, granuloma, tuberculosis diagnosis
MeSH terms
Data Accuracy, Adult, Diagnostic Tests, Routine, Female, HIV, HIV Seropositivity, Humans, Lymph Nodes, Male, Middle Aged, Mycobacterium tuberculosis, Probability, Prospective Studies, Sensitivity and Specificity, Tuberculosis, Lymph Node, Nucleic Acid Amplification Techniques, Biopsy, Fine-Needle

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