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

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 ev...

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Main Authors: Afranio Kritski, Maria Martha Oliveira, Isabela Neves de Almeida, Daniela Ramalho, Monica Kramer de Noronha Andrade, Monica Carvalho, Pryscila Fernandes Campino Miranda, Margareth Pretti Dalcolmo, Jose Ueleres Braga, Tania Brígido, Eliene Mesquita, Claudia Dias, Aglae Gambirasio, Joao Baptista Souza Filho, Anne Detjen, Patrick Peter John Phillips, Ivor Langley, Paula Fujiwara, Stephen Bertel Squire
Format: Article
Language:English
Published: Sociedade Brasileira de Medicina Tropical (SBMT) 2022-02-01
Series:Revista da Sociedade Brasileira de Medicina Tropical
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822022000100301&tlng=en
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author Afranio Kritski
Maria Martha Oliveira
Isabela Neves de Almeida
Daniela Ramalho
Monica Kramer de Noronha Andrade
Monica Carvalho
Pryscila Fernandes Campino Miranda
Margareth Pretti Dalcolmo
Jose Ueleres Braga
Tania Brígido
Eliene Mesquita
Claudia Dias
Aglae Gambirasio
Joao Baptista Souza Filho
Anne Detjen
Patrick Peter John Phillips
Ivor Langley
Paula Fujiwara
Stephen Bertel Squire
author_facet Afranio Kritski
Maria Martha Oliveira
Isabela Neves de Almeida
Daniela Ramalho
Monica Kramer de Noronha Andrade
Monica Carvalho
Pryscila Fernandes Campino Miranda
Margareth Pretti Dalcolmo
Jose Ueleres Braga
Tania Brígido
Eliene Mesquita
Claudia Dias
Aglae Gambirasio
Joao Baptista Souza Filho
Anne Detjen
Patrick Peter John Phillips
Ivor Langley
Paula Fujiwara
Stephen Bertel Squire
author_sort Afranio Kritski
collection DOAJ
description 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.
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spelling doaj.art-ff41475c4ec240eb99101c6e8810c6092022-12-22T03:36:01ZengSociedade Brasileira de Medicina Tropical (SBMT)Revista da Sociedade Brasileira de Medicina Tropical1678-98492022-02-015510.1590/0037-8682-0191-2021Clinical Impact of the Line Probe Assay and Xpert® MTB/RIF Assay in the Presumptive Diagnosis of Drug-Resistant Tuberculosis in Brazil: A Pragmatic Clinical TrialAfranio Kritskihttps://orcid.org/0000-0002-5900-6007Maria Martha Oliveirahttps://orcid.org/0000-0002-0064-387XIsabela Neves de Almeidahttps://orcid.org/0000-0001-6152-7648Daniela Ramalhohttps://orcid.org/0000-0003-1830-0127Monica Kramer de Noronha Andradehttps://orcid.org/0000-0002-4285-5926Monica Carvalhohttps://orcid.org/0000-0001-5861-5479Pryscila Fernandes Campino Mirandahttps://orcid.org/0000-0002-5828-4072Margareth Pretti Dalcolmohttps://orcid.org/0000-0002-6820-1082Jose Ueleres Bragahttps://orcid.org/0000-0001-5247-007XTania BrígidoEliene Mesquitahttps://orcid.org/0000-0002-0671-8211Claudia Diashttps://orcid.org/0000-0003-1552-5275Aglae Gambirasiohttps://orcid.org/0000-0001-8716-1023Joao Baptista Souza Filhohttps://orcid.org/0000-0001-6005-8480Anne Detjenhttps://orcid.org/0000-0002-9807-4045Patrick Peter John Phillipshttps://orcid.org/0000-0002-6336-7024Ivor Langleyhttps://orcid.org/0000-0002-9275-6731Paula Fujiwarahttps://orcid.org/0000-0001-6810-5202Stephen Bertel Squirehttps://orcid.org/0000-0001-7173-9038ABSTRACT 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822022000100301&tlng=enTuberculosisDiagnosticsImpact assessmentMolecular testsMDR-TB
spellingShingle Afranio Kritski
Maria Martha Oliveira
Isabela Neves de Almeida
Daniela Ramalho
Monica Kramer de Noronha Andrade
Monica Carvalho
Pryscila Fernandes Campino Miranda
Margareth Pretti Dalcolmo
Jose Ueleres Braga
Tania Brígido
Eliene Mesquita
Claudia Dias
Aglae Gambirasio
Joao Baptista Souza Filho
Anne Detjen
Patrick Peter John Phillips
Ivor Langley
Paula Fujiwara
Stephen Bertel Squire
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
Tuberculosis
Diagnostics
Impact assessment
Molecular tests
MDR-TB
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort clinical impact of the line probe assay and xpert r mtb rif assay in the presumptive diagnosis of drug resistant tuberculosis in brazil a pragmatic clinical trial
topic Tuberculosis
Diagnostics
Impact assessment
Molecular tests
MDR-TB
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822022000100301&tlng=en
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