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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

Kritski, Afranio, Oliveira, Maria Martha, Almeida, Isabela Neves de, Ramalho, Daniela, Andrade, Monica Kramer de Noronha, Carvalho, Monica, Miranda, Pryscila Fernandes Campino, Dalcolmo, Margareth Pretti, Braga, Jose Ueleres, Brígido, Tania, Mesquita, Eliene, Dias, Claudia, Gambirasio, Aglae, Souza Filho, Joao Baptista, Detjen, Anne, Phillips, Patrick Peter John, Langley, Ivor ORCID: https://orcid.org/0000-0002-9275-6731, Fujiwara, Paula and Squire, Bertie ORCID: https://orcid.org/0000-0001-7173-9038 (2022) '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'. Revista da Sociedade Brasileira de Medicina Tropical, Vol 55, e0191-2021.

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Abstract

Background:
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.

Methods:
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.

Results:
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).

Conclusions:
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.

Item Type: Article
Subjects: WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
WF Respiratory System > Tuberculosis > WF 360 Drug therapy
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI): https://doi.org/10.1590/0037-8682-0191-2021
SWORD Depositor: JISC Pubrouter
Depositing User: JISC Pubrouter
Date Deposited: 07 Apr 2022 12:57
Last Modified: 07 Apr 2022 12:58
URI: https://archive.lstmed.ac.uk/id/eprint/20062

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