Brazilian Journal of Pulmonology

ISSN (on-line): 1806-3756 | ISSN (printed): 1806-3713

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Evaluation of the clinical utility of new diagnostic tests for tuberculosis: the role of pragmatic clinical trials

Avaliação da utilidade clínica de novos testes diagnósticos em tuberculose: o papel dos ensaios clínicos pragmáticos

Gisele Huf, Afrânio Kritski

J Bras Pneumol.2012;38(2):237-245

Abstract PDF PT PDF EN Portuguese Text

Tuberculosis is one of the major infectious diseases in developing countries, and the length of time for which the chain of transmission is maintained has been implicated as a major factor in the perpetuation of the disease. In this context, regulatory agencies in such countries have approved new diagnostic tools, which have been almost immediately incorporated into the national tuberculosis control programs. Health interventions have been increasingly investigated in clinical trials, including explanatory trials (in order to evaluate the beneficial effects of such interventions) and pragmatic trials (in order to aid in the decision-making process). We argue that the evaluation of new diagnostic techniques for the detection of tuberculosis should not escape this same logic of evaluation.

 


Keywords: Tuberculosis/diagnosis; Tuberculosis/prevention & control; Controlled clinical trial as topic.

 


Performance comparison between the mycobacteria growth indicator tube system and Löwenstein-Jensen medium in the routine detection of Mycobacterium tuberculosis at public health care facilities in Rio de Janeiro, Brazil: preliminary results of a pragmatic clinical trial

Comparação do desempenho do sistema mycobacteria growth indicator tube e meio Löwenstein-Jensen na detecção de rotina de Mycobacterium tuberculosis em unidades do sistema único de saúde no Rio de Janeiro: resultados preliminares de um ensaio clínico pragmático

Adriana da Silva Rezende Moreira, Gisele Huf, Maria Armanda Vieira, Leila Fonseca, Monica Ricks, Afrânio Lineu Kritski

J Bras Pneumol.2013;39(3):365-367

Abstract PDF PT PDF EN Portuguese Text

In view of the fact that the World Health Organization has recommended the use of the mycobacteria growth indicator tube (MGIT) 960 system for the diagnosis of tuberculosis and that there is as yet no evidence regarding the clinical impact of its use in health care systems, we conducted a pragmatic clinical trial to evaluate the clinical performance and cost-effectiveness of the use of MGIT 960 at two health care facilities in the city of Rio de Janeiro, Brazil, where the incidence of tuberculosis is high. Here, we summarize the methodology and preliminary results of the trial. (ISRCTN.org Identifier: ISRCTN79888843 [http://isrctn.org/])

 


Keywords: Controlled clinical trial; Tuberculosis; Diagnostic tests, routine.

 


Use of amplified Mycobacterium tuberculosis direct test in respiratory samples from HIV-infected patients in Brazil

Utilização do amplified Mycobacterium tuberculosis direct test em amostras respiratórias de pacientes HIV positivos no Brasil

Leonardo Bruno Paz Ferreira Barreto, Maria Cristina da Silva Lourenço, Valéria Cavalcanti Rolla, Valdiléia Gonçalves Veloso, Gisele Huf

J Bras Pneumol.2014;40(2):-

Abstract PDF PT PDF EN Portuguese Text

Objective: To compare the accuracy of the amplified Mycobacterium tuberculosis direct (AMTD) test with reference methods for the laboratory diagnosis of tuberculosis in HIV-infected patients. Methods: This was a study of diagnostic accuracy comparing AMTD test results with those obtained by culture on Löwenstein-Jensen (LJ) medium and by the BACTEC Mycobacteria Growth Indicator Tube 960 (BACTEC MGIT 960) system in respiratory samples analyzed at the Bioassay and Bacteriology Laboratory of the Oswaldo Cruz Foundation Evandro Chagas Clinical Research Institute in the city of Rio de Janeiro, Brazil. Results: We analyzed respiratory samples collected from 118 patients, of whom 88 (74.4%) were male. The mean age was 36.6 ± 10.6 years. Using the AMTD test, the BACTEC MGIT 960 system, and LJ culture, we identified M. tuberculosis complex in 31.0%, 29.7%, and 27.1% of the samples, respectively. In comparison with LJ culture, the AMTD test had a sensitivity, specificity, positive predictive value, and negative predictive value of 87.5%, 89.4%, 75.7%, and 95.0%, respectively, for LJ culture, whereas, in comparison with the BACTEC MGIT 960 system, it showed values of 88.6%, 92.4%, 83.8%, and 94.8%, respectively. Conclusions: The AMTD test showed good sensitivity and specificity in the population studied, enabling the laboratory detection of M. tuberculosis complex in paucibacillary respiratory specimens.

 


Keywords: Molecular diagnostic techniques; Tuberculosis; HIV; Molecular probe techniques.

 


 

 


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