Detection of drug resistant Mycobacterium Tuberculosis strains using kit SIRE Nitratase®: a multicenter study

This research was funded by MINAS GERAIS STATE RESEARCH SUPPORT FOUNDATION (FAPEMIG), grants numbers 65/10 and CDS-APQ-03266-13, and by NATIONAL COUNCIL FOR SCIENTIFIC AND TECHNOLOGICAL DEVELOPMENT (CNPQ) grants numbers 310174/2014-7 and 446796/2014-0.Federal University of Minas Gerais. Faculty of Medicine. Mycobacteria Research Laboratory. Belo Horizonte, MG, Brazil.Federal University of Minas Gerais. Faculty of Medicine. Mycobacteria Research Laboratory. Belo Horizonte, MG, Brazil.Federal University of Minas Gerais. Faculty of Medicine. Mycobacteria Research Laboratory. Belo Horizonte, MG, Brazil.Federal University of Minas Gerais. Faculty of Medicine. Mycobacteria Research Laboratory. Belo Horizonte, MG, Brazil.Federal University of Minas Gerais. Faculty of Pharmacy. Department of Social Pharmacy. Belo Horizonte, MG, Brazil.Federal University of Minas Gerais. Veterinary School. Department of Preventive Veterinary Medicine. Belo Horizonte, MG, Brazil.Federal University of Rio Grande. Faculty of Medicine. Laboratory of Mycobacteria. Rio Grande, RS, Brazil.Federal University of Rio Grande. Faculty of Medicine. Laboratory of Mycobacteria. Rio Grande, RS, Brazil.Federal University of Rio Grande. Faculty of Medicine. Laboratory of Mycobacteria. Rio Grande, RS, Brazil.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Ananindeua, PA, Brasil.Tropical Medicine Foundation Dr. Heitor Vieira Dourado. Manaus, AM, Brazil.Tropical Medicine Foundation Dr. Heitor Vieira Dourado. Manaus, AM, Brazil.Federal University of Rio de Janeiro. Institute of Chest Diseases. Clementino Fraga Filho University Hospital. Rio de Janeiro, RJ, Brazil.Federal University of Rio de Janeiro. Institute of Chest Diseases. Clementino Fraga Filho University Hospital. Rio de Janeiro, RJ, Brazil.Federal University of Grande Dourados. Faculty of Health Sciences. Dourados, MS, Brazil / Oswaldo Cruz Foundation. Campo Grande, Mato Grosso do Sul, MS, Brazil.Adolfo Lutz Institute. Bacteriology Center. Tuberculosis and Mycobacteriosis Center. São Paulo, SP, Brazil.Adolfo Lutz Institute. Bacteriology Center. Tuberculosis and Mycobacteriosis Center. São Paulo, SP, Brazil.Adolfo Lutz Institute. Bacteriology Center. Tuberculosis and Mycobacteriosis Center. São Paulo, SP, Brazil.State Secretariat of Health of Rio Grande do Sul. State Center for Health Surveillance. Center for Scientific and Technological Development. Porto Alegre, RS, Brazil.State Secretariat of Health of Rio Grande do Sul. State Center for Health Surveillance. Center for Scientific and Technological Development. Porto Alegre, RS, Brazil.Oswaldo Cruz Foundation. National Institute of Infectology Evandro Chagas. Laboratory of Bacteriology and Bioassays of Rio de Janeiro. Rio de Janeiro, RJ, Brazil.Sergio Arouca National Public Health School. Professor Hélio Fraga Reference Center. Rio de Janeiro, RJ, Brazil.Sergio Arouca National Public Health School. Professor Hélio Fraga Reference Center. Rio de Janeiro, RJ, Brazil.Nova University of Lisbon. Institute of Hygiene and Tropical Medicine. Medical Microbiology Unit, Global Health and Tropical Medicine. Lisboa, Portugal.Nova University of Lisbon. Institute of Hygiene and Tropical Medicine. Medical Microbiology Unit, Global Health and Tropical Medicine. Lisboa, Portugal.Federal University of Rio de Janeiro. Faculty of Medicine. Tuberculosis Research Center. Rio de Janeiro, RJ, Brazil.Background: The Commercial Kit SIRE Nitratase® PlastLabor, is a drug susceptibility test kit used to detect Mycobacterium tuberculosis resistance to first-line TB treatment drugs. The present study aimed at evaluating its performance in a multicenter study. (2) Methods: To determine its accuracy, the proportion methods in Lowenstein Jensen medium or the BACTECTMMGITTM960 system was used as a gold standard. (3) Results: The study revealed that the respective accuracies of the kit with 190 M. tuberculosis clinical isolates, using the proportion methods in Lowenstein Jensen medium or BACTECTMMGITTM960 system as a gold standard, were 93.9% and 94.6%, 96.9% and 94.6%, 98.0% and 97.8%, and 98.0% and 98.9%, for streptomycin, isoniazid, rifampicin, and ethambutol, respectively. (4) Conclusion: Thus, the kit can rapidly screen resistance to streptomycin, isoniazid, rifampicin, and ethambutol. Additionally, it does not require sophisticated equipment; hence, it can be easily used in the laboratories of low and middle income countries