Clinical Impact of the Line Probe Assay and Xpert® MTB/RIF Assay in the Presumptive Diagnosis of Drug-Resistant Tuberculosis in Brazil: A Pragmatic Clinical Trial
Rapid molecular methods such as the line probe assay (LPA) and Xpert® MTB/RIF assay (Xpert) have been recommended by the World Health Organization for drug-resistant tuberculosis (DR-TB) diagnosis. We conducted an interventional trial in DR-TB reference centers in Brazil to evaluate the impact of th...
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| Published in: | Revista da Sociedade Brasileira de Medicina Tropical Vol. 55; p. e0191 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Brazil
Sociedade Brasileira de Medicina Tropical - SBMT
01-01-2022
Sociedade Brasileira de Medicina Tropical (SBMT) |
| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Rapid molecular methods such as the line probe assay (LPA) and Xpert® MTB/RIF assay (Xpert) have been recommended by the World Health Organization for drug-resistant tuberculosis (DR-TB) diagnosis. We conducted an interventional trial in DR-TB reference centers in Brazil to evaluate the impact of the use of LPA and Xpert.
Patients with DR-TB were eligible if their drug susceptibility testing results were available to the treating physician at the time of consultation. The standard reference MGITTM 960 was compared with Xpert (arm 1) and LPA (arm 2). Effectiveness was considered as the start of the appropriate TB regimen that matched drug susceptibility testing (DST) and the proportions of culture conversion and favorable treatment outcomes after 6 months.
A higher rate of empirical treatment was observed with MGIT alone than with the Xpert assay (97.0% vs. 45.0%) and LPA (98.2% vs. 67.5%). Patients started appropriate TB treatment more quickly than those in the MGIT group (median 15.0 vs. 40.5 days; p<0.01) in arm 1. Compared to the MGIT group, culture conversion after 6 months was higher for Xpert in arm 1 (90.9% vs. 79.3%, p=0.39) and LPA in arm 2 (80.0% vs. 83.0%, p=0.81).
In the Xpert arm, there was a significant reduction in days to the start of appropriate anti-TB treatment and a trend towards greater culture conversion in the sixth month. |
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| Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Conflict of Interest: The authors declare that there are no conflicts of interest. Authors’ contribution: ALK: Conception and design of the study, Lead the data curation, Lead the Funding acquisition, Analysis and interpretation of data, design the methodology of the study, validation of data, supervision and administration of the project, Drafting the article, Final approval of the version to be submitted. MMO: Conceptualization of the study, validation of data, lead the investigation, wrote the original draft of the article, final approval of the version to be submitted. INA: Supporting the data curation, validation of data, supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted and coordination of submission. DR: Conceptualization of the study, validation of data, analysis and interpretation of data, supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. MKA: Design the methodology of the study, analysis and interpretation of data, supporting the investigation, final approval of the version to be submitted.MC: Supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. PM: Validation of data, analysis and interpretation of data, supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. MPD: Design the methodology of the study, wrote the original draft of the article, final approval of the version to be submitted. JUB: Design the methodology of the study, analysis and interpretation of data, final approval of the version to be submitted. TB: Design the methodology of the study, supporting the investigation, final approval of the version to be submitted. EM: Supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. CD: Supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. AG: Validation of data, supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. JBSF: Validation of data, supporting the investigation, wrote the original draft of the article, final approval of the version to be submitted. AD: Conceptualization of the study, validation of data, analysis and interpretation of data, wrote the original draft of the article, final approval of the version to be submitted. PPJP: Design the methodology of the study, validation of data, analysis and interpretation of data, wrote the original draft of the article, final approval of the version to be submitted. IL: Design the methodology of the study, wrote the original draft of the article, final approval of the version to be submitted. PIF: Design the methodology of the study, analysis and interpretation of data, wrote the original draft of the article, final approval of the version to be submitted. SBS: Conceptualization of the study, design the methodology of the study, validation of data, supervision and administration of the project, analysis and interpretation of data, wrote the original draft of the article, final approval of the version to be submitted. |
| ISSN: | 0037-8682 1678-9849 1678-9849 |
| DOI: | 10.1590/0037-8682-0191-2021 |