1. 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
- Author
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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, and Stephen Bertel Squire
- Subjects
Microbiology (medical) ,Impact assessment ,MDR-TB ,Microbial Sensitivity Tests ,Antitubercular ,Sensitivity and Specificity ,Vaccine Related ,Rare Diseases ,Antibiotics ,Clinical Research ,Tropical Medicine ,Tuberculosis, Multidrug-Resistant ,Humans ,Tuberculosis ,Antibiotics, Antitubercular ,Diagnostics ,Evaluation of treatments and therapeutic interventions ,Mycobacterium tuberculosis ,Multidrug-Resistant ,Emerging Infectious Diseases ,Orphan Drug ,Good Health and Well Being ,Infectious Diseases ,Molecular tests ,6.1 Pharmaceuticals ,wf_360 ,HIV/AIDS ,wf_220 ,Parasitology ,Antimicrobial Resistance ,wf_200 ,Rifampin ,Infection ,Brazil - Abstract
Background:\ud 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.\ud \ud Methods:\ud 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.\ud \ud Results:\ud 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
- Published
- 2022
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