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Research article
Katherine Antel
University of Cape Town Department of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-9000-5504
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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 the samples from tissue and FNA were pooled and compared to culture the sensitivity was 84% (60-97; 16/19). 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.
Keywords
Tuberculosis, Xpert MTB/RIF Ultra, HIV, fine-needle aspiration, core needle biopsy
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CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
No community comments so far
Editorial decision: Accept
On 27 Dec, 2019
Editor assigned
On 26 Dec, 2019
Submission checks complete
On 25 Dec, 2019
Editor invited
On 25 Dec, 2019
Version 2
Posted 27 Nov, 2019
No comments provided
Editorial decision: Minor revision
On 19 Dec, 2019
Review #2 received
Received 11 Dec, 2019
Reviewers invited
Invitations sent on 05 Dec, 2019
Reviewer #1 agreed
On 05 Dec, 2019
Reviewer #2 agreed
On 05 Dec, 2019
Review #1 received
Received 05 Dec, 2019
Editor assigned
On 25 Nov, 2019
Submission checks complete
On 24 Nov, 2019
Editor invited
On 24 Nov, 2019
No comments provided
Review #2 received
Received 05 Nov, 2019
Editorial decision: Major revision
On 05 Nov, 2019
Reviewer #2 agreed
On 28 Oct, 2019
Review #1 received
Received 18 Sep, 2019
Reviewers invited
Invitations sent on 06 Sep, 2019
Reviewer #1 agreed
On 06 Sep, 2019
Editor assigned
On 19 Aug, 2019
Submission checks complete
On 18 Aug, 2019
Editor invited
On 14 Aug, 2019
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Subject Areas
Infectious Diseases
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A new preprint design is coming!
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See the published version of this preprint at BMC Infectious Diseases.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Katherine Antel
University of Cape Town Department of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-9000-5504
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
No community comments so far
Editorial decision: Accept
On 27 Dec, 2019
Editor assigned
On 26 Dec, 2019
Submission checks complete
On 25 Dec, 2019
Editor invited
On 25 Dec, 2019
Version 2
Posted 27 Nov, 2019
No comments provided
Editorial decision: Minor revision
On 19 Dec, 2019
Review #2 received
Received 11 Dec, 2019
Reviewers invited
Invitations sent on 05 Dec, 2019
Reviewer #1 agreed
On 05 Dec, 2019
Reviewer #2 agreed
On 05 Dec, 2019
Review #1 received
Received 05 Dec, 2019
Editor assigned
On 25 Nov, 2019
Submission checks complete
On 24 Nov, 2019
Editor invited
On 24 Nov, 2019
No comments provided
Review #2 received
Received 05 Nov, 2019
Editorial decision: Major revision
On 05 Nov, 2019
Reviewer #2 agreed
On 28 Oct, 2019
Review #1 received
Received 18 Sep, 2019
Reviewers invited
Invitations sent on 06 Sep, 2019
Reviewer #1 agreed
On 06 Sep, 2019
Editor assigned
On 19 Aug, 2019
Submission checks complete
On 18 Aug, 2019
Editor invited
On 14 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Infectious Diseases.
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 the samples from tissue and FNA were pooled and compared to culture the sensitivity was 84% (60-97; 16/19). 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.
Figure 1
Figure 2
Figure 3
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