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

• Published in: Revista da Sociedade Brasileira de Medicina Tropical
• 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 in Journal/Newspaper
• Language: English
• Published: Sociedade Brasileira de Medicina Tropical (SBMT) 2022
• Subjects: Tuberculosis; Diagnostics; Impact assessment; Molecular tests; MDR-TB; Arctic medicine. Tropical medicine; RC955-962; Arctic; Rif
• Online Access: https://doi.org/10.1590/0037-8682-0191-2021; https://doaj.org/article/ff41475c4ec240eb99101c6e8810c609

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.