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Journal of Clinical Microbiology, October 2007, p. 3387-3389, Vol. 45, No. 10
0095-1137/07/$08.00+0     doi:10.1128/JCM.00580-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Clinical Evaluation of the Microscopic Observation Drug Susceptibility Assay for Detection of Mycobacterium tuberculosis Resistance to Isoniazid or Rifampin{triangledown}

Fernanda C. Q. Mello,1,{dagger} Mayra S. Arias,2,{dagger} Senia Rosales,3 Anna Grazia Marsico,1 Ada Pavón,4 Carlos Alvarado-Gálvez,4 Carlos Leonardo Carvalho Pessôa,1 Melly Pérez,3 Monica K. Andrade,1 Afranio L. Kritski,1 Leila S. Fonseca,1 Richard E. Chaisson,5 Michael E. Kimerling,2 and Susan E. Dorman5*

Federal University of Rio de Janeiro, Rio de Janeiro, Brazil,1 University of Alabama at Birmingham, Birmingham, Alabama,2 Gorgas Tuberculosis Initiative—Honduras,3 National Thorax Institute, Tegucigalpa, Honduras,4 Johns Hopkins University School of Medicine and Bloomberg School of Public Health, Baltimore, Maryland5

Received 15 March 2007/ Returned for modification 24 June 2007/ Accepted 29 July 2007

This prospective study evaluated the performance of the microscopic observation drug susceptibility (MODS) assay for the direct detection of Mycobacterium tuberculosis drug resistance. MODS assay sensitivity, specificity, and positive and negative predictive values were 96.7% (95% confidence interval [95% CI], 92.1 to 98.8%), 78.4% (95% CI, 73.5 to 80.6%), 82.4% (95% CI, 78.4 to 84.2%), and 95.8% (95% CI, 89.9 to 98.5%), respectively, for isoniazid resistance and 96.0% (95% CI, 90.3 to 98.6%), 82.9% (95% CI, 78.8 to 84.7%), 80.0% (95% CI, 75.2 to 82.1%), and 96.7% (95% CI, 91.9 to 98.8%), respectively, for rifampin resistance. For both rifampin and isoniazid testing, the likelihood ratio for a negative test was ≤0.05, indicating that the MODS assay may be useful for ruling out drug resistance.

* Corresponding author. Mailing address: Johns Hopkins University School of Medicine, 1503 East Jefferson St., Room 105, Baltimore, MD 21231. Phone: (410) 502-2717. Fax: (410) 955-0740. E-mail: dsusan1{at}jhmi.edu

{triangledown} Published ahead of print on 15 August 2007.

{dagger} These authors contributed equally.

Journal of Clinical Microbiology, October 2007, p. 3387-3389, Vol. 45, No. 10
0095-1137/07/$08.00+0     doi:10.1128/JCM.00580-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.





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