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Research Article
Wakjira Kebede
Jimma University
Corresponding Author
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Introduction: The value of Lateral Flow urine Lipoarabinomannan (LF-LAM) assay and the role of empiric tuberculosis (TB) treatment in the era of the highly sensitive Xpert MTB/RIF Ultra (Xpert Ultra) assay is unclear. This study aimed to assess the additional yield of Xpert Ultra compared to Xpert MTB/RIF, the yield of LF-LAM assay when used in combination with Xpert Ultra, and the role of empiric TB treatment in the Xpert Ultra era among patients with symptoms of TB admitted to a tertiary hospital in Ethiopia.
Methods: We performed a secondary analysis of a cohort of hospitalized Xpert MTB/RIF-negative patients. Sputum samples were examined for Mycobacterium tuberculosis by culture and Xpert Ultra. In HIV positive and severely ill patients, a urine sample was collected for the LF-LAM assay. Treatment outcome was assessed six months after enrollment. Logistic regression was used to identify factors predictive of deaths among Xpert Ultra negative patients.
Results: Of the 250 hospitalized Xpert MTB/RIF-negative patients, 35 (14.0%) had culture-confirmed TB. The Xpert Ultra assay diagnosed 31 of the 35 culture positive cases that had been missed by Xpert MTB/RIF. The LF-LAM assay did not identify any case that was not detected by Xpert Ultra. Empiric treatment did not improve survival among Xpert Ultra negative patients (OR 1.28, 95% CI: 0.3-5.3). Low body mass index (< 18.5kg/m2) was the only significant predictor of death in Xpert Ultra negative patients (OR 4.0, 95% CI: 1.12-16.5).
Conclusions: In this prospective cohort, we observed that LF-LAM did not improve the diagnostic yield when used in combination with Xpert Ultra and did not find a survival benefit of empiric treatment among Xpert Ultra negative individuals. Research is needed to determine the optimal management of patients with presumptive TB and a negative Xpert Ultra assay in high TB burden settings.
Keywords
tuberculosis, molecular diagnostics, LF-LAM, Xpert MTB/RIF Ultra, rifampicin, empiric treatment, sputum, urine, Ethiopia
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No competing interests reported.
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On 11 Oct, 2021
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Received 29 Jun, 2021
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On 17 Jun, 2021
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On 10 Jun, 2021
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This preprint is under consideration at Scientific Reports. A preprint is 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
Wakjira Kebede
Jimma University
Corresponding Author
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: Under Review
Version 1
Posted 02 Jun, 2021
Community comments: 3
Editorial decision: Major revision
On 11 Oct, 2021
Reviews received
Received 27 Sep, 2021
Reviews received
Received 09 Jul, 2021
Reviews received
Received 29 Jun, 2021
Reviewers agreed
On 17 Jun, 2021
Reviewers agreed
On 10 Jun, 2021
Reviewers invited
Invitations sent on 10 Jun, 2021
Editor assigned
On 10 Jun, 2021
Editor invited
On 01 Jun, 2021
Submission checks complete
On 31 May, 2021
First submitted
On 27 May, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Medical Genetics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Introduction: The value of Lateral Flow urine Lipoarabinomannan (LF-LAM) assay and the role of empiric tuberculosis (TB) treatment in the era of the highly sensitive Xpert MTB/RIF Ultra (Xpert Ultra) assay is unclear. This study aimed to assess the additional yield of Xpert Ultra compared to Xpert MTB/RIF, the yield of LF-LAM assay when used in combination with Xpert Ultra, and the role of empiric TB treatment in the Xpert Ultra era among patients with symptoms of TB admitted to a tertiary hospital in Ethiopia.
Methods: We performed a secondary analysis of a cohort of hospitalized Xpert MTB/RIF-negative patients. Sputum samples were examined for Mycobacterium tuberculosis by culture and Xpert Ultra. In HIV positive and severely ill patients, a urine sample was collected for the LF-LAM assay. Treatment outcome was assessed six months after enrollment. Logistic regression was used to identify factors predictive of deaths among Xpert Ultra negative patients.
Results: Of the 250 hospitalized Xpert MTB/RIF-negative patients, 35 (14.0%) had culture-confirmed TB. The Xpert Ultra assay diagnosed 31 of the 35 culture positive cases that had been missed by Xpert MTB/RIF. The LF-LAM assay did not identify any case that was not detected by Xpert Ultra. Empiric treatment did not improve survival among Xpert Ultra negative patients (OR 1.28, 95% CI: 0.3-5.3). Low body mass index (< 18.5kg/m2) was the only significant predictor of death in Xpert Ultra negative patients (OR 4.0, 95% CI: 1.12-16.5).
Conclusions: In this prospective cohort, we observed that LF-LAM did not improve the diagnostic yield when used in combination with Xpert Ultra and did not find a survival benefit of empiric treatment among Xpert Ultra negative individuals. Research is needed to determine the optimal management of patients with presumptive TB and a negative Xpert Ultra assay in high TB burden settings.
Figure 1
Figure 2
No competing interests reported.
This is a list of supplementary files associated with this preprint. Click to download.
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