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
Year: 2022
Type: article
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.
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
Institutions: Universidade Federal do Rio de Janeiro, Universidade Federal de Ouro Preto, Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Universidade do Estado do Rio de Janeiro, Hospital de Messejana, Secretaria de Estado de Saúde do Rio de Janeiro, Governo do Estado do Rio Grande do Sul, Secretaria da Saúde, United Nations Children's Fund, University of California, San Francisco, MRC Clinical Trials Unit at UCL, Medical Research Council, Liverpool School of Tropical Medicine, University of California System
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4214557104
