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Research article
He-ping Xiao
Tongji University Affiliated Shanghai Pulmonary Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-9186-6613
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Background: Tuberculous pleurisy (TBP) is the most common form of extrapulmonary tuberculosis (TB). However, rapid diagnostic methods with high accuracy for tuberculous pleurisy are urgently needed. In the present study, we evaluated the diagnostic accuracy of Xpert MTB/RIF, LAMP and SAT-TB assay with pleural fluids from from culture-positive TBP patients. Methods: We prospectively enrolled 300 patients with exudative pleural effusions used as the samples for Xpert MTB/RIF, LAMP and SAT-TB assay. Of these, 265 including 223 patients diagnosed with TP and 42 non-TB patients used as controls were analyzed. Results: The sensitivities of Xpert MTB/RIF (27.4%) , LAMP (26.5%) and SAT-TB assay (32.3%) were significantly higher than that of pleural effusion smear (14.3% , X 2 = 20.65, P < 0.001), whereas they were much lower than expected for the analysis of pleural effusion samples. Both SAT-TB assay and Xpert MTB/RIF demonstrated high specificities (100%) and PPVs (100%), but the NPVs of all of the tests were < 22%. The area under ROC curve of pleural effusionsmear, LAMP, Xpert MTB/RIF and SAT-TB assays was 0.524 (95% CI 0.431–0.617), 0.632 (95% CI 0.553–0.71), 0.637 (95% CI 0.56–0.714) and 0.673 (95% CI 0.6–0.745). SAT-TB assays had the highest AUC. Conclusion: Nucleic acid amplification tests are not the first choice in the diagnosis of tuberculous pleurisy. In this type of test, SAT-TB is recommended because of its low cost, relatively more accurate compared with the other two tests. This prospective study was approved by The Ethics Committee of the Shanghai Pulmonary Hospital (approval number: K19-148). ClinicalTrials.gov identifier: ChiCTR1900026234. Key words : Xpert MTB/RIF; AmpSure simultaneous amplification and testing; loop-mediated isothermal amplification; diagnosis; tuberculosis
Keywords
Xpert MTB/RIF; AmpSure simultaneous amplification and testing; loop-mediated isothermal amplification; diagnosis; tuberculosis
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CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
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Posted 17 Mar, 2020
No community comments so far
Editorial decision: Accept
On 13 Mar, 2020
Editor assigned
On 09 Mar, 2020
Submission checks complete
On 08 Mar, 2020
Editor invited
On 08 Mar, 2020
No comments provided
Editorial decision: Minor revision
On 05 Mar, 2020
Editor assigned
On 01 Mar, 2020
Submission checks complete
On 29 Feb, 2020
Editor invited
On 29 Feb, 2020
No comments provided
Editorial decision: Major revision
On 21 Feb, 2020
Review #2 received
Received 18 Feb, 2020
Review #1 received
Received 20 Jan, 2020
Reviewer #2 agreed
On 08 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Reviewers invited
Invitations sent on 03 Jan, 2020
Editor assigned
On 28 Dec, 2019
Submission checks complete
On 22 Dec, 2019
Editor invited
On 20 Dec, 2019
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Infectious Diseases
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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
He-ping Xiao
Tongji University Affiliated Shanghai Pulmonary Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-9186-6613
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.
Version 3
Posted 17 Mar, 2020
No community comments so far
Editorial decision: Accept
On 13 Mar, 2020
Editor assigned
On 09 Mar, 2020
Submission checks complete
On 08 Mar, 2020
Editor invited
On 08 Mar, 2020
No comments provided
Editorial decision: Minor revision
On 05 Mar, 2020
Editor assigned
On 01 Mar, 2020
Submission checks complete
On 29 Feb, 2020
Editor invited
On 29 Feb, 2020
No comments provided
Editorial decision: Major revision
On 21 Feb, 2020
Review #2 received
Received 18 Feb, 2020
Review #1 received
Received 20 Jan, 2020
Reviewer #2 agreed
On 08 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Reviewers invited
Invitations sent on 03 Jan, 2020
Editor assigned
On 28 Dec, 2019
Submission checks complete
On 22 Dec, 2019
Editor invited
On 20 Dec, 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: Tuberculous pleurisy (TBP) is the most common form of extrapulmonary tuberculosis (TB). However, rapid diagnostic methods with high accuracy for tuberculous pleurisy are urgently needed. In the present study, we evaluated the diagnostic accuracy of Xpert MTB/RIF, LAMP and SAT-TB assay with pleural fluids from from culture-positive TBP patients. Methods: We prospectively enrolled 300 patients with exudative pleural effusions used as the samples for Xpert MTB/RIF, LAMP and SAT-TB assay. Of these, 265 including 223 patients diagnosed with TP and 42 non-TB patients used as controls were analyzed. Results: The sensitivities of Xpert MTB/RIF (27.4%) , LAMP (26.5%) and SAT-TB assay (32.3%) were significantly higher than that of pleural effusion smear (14.3% , X 2 = 20.65, P < 0.001), whereas they were much lower than expected for the analysis of pleural effusion samples. Both SAT-TB assay and Xpert MTB/RIF demonstrated high specificities (100%) and PPVs (100%), but the NPVs of all of the tests were < 22%. The area under ROC curve of pleural effusionsmear, LAMP, Xpert MTB/RIF and SAT-TB assays was 0.524 (95% CI 0.431–0.617), 0.632 (95% CI 0.553–0.71), 0.637 (95% CI 0.56–0.714) and 0.673 (95% CI 0.6–0.745). SAT-TB assays had the highest AUC. Conclusion: Nucleic acid amplification tests are not the first choice in the diagnosis of tuberculous pleurisy. In this type of test, SAT-TB is recommended because of its low cost, relatively more accurate compared with the other two tests. This prospective study was approved by The Ethics Committee of the Shanghai Pulmonary Hospital (approval number: K19-148). ClinicalTrials.gov identifier: ChiCTR1900026234. Key words : Xpert MTB/RIF; AmpSure simultaneous amplification and testing; loop-mediated isothermal amplification; diagnosis; tuberculosis
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