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Journal of Clinical Microbiology, October 2004, p. 4432-4437, Vol. 42, No. 10
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.10.4432-4437.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Microscopic Observation Drug Susceptibility Assay, a Rapid, Reliable Diagnostic Test for Multidrug-Resistant Tuberculosis Suitable for Use in Resource-Poor Settings

David A. J. Moore,1,2,3* Daniel Mendoza,1 Robert H Gilman,1,3,4 Carlton A. W. Evans,1,2,3 María-Graciela Hollm Delgado,1 Jose Guerra,1 Luz Caviedes,1 Daniel Vargas,3 Eduardo Ticona,5 Jaime Ortiz,6 Giselle Soto,3 Jose Serpa,1 and the Tuberculosis Working Group in Perú{dagger}

Department of Microbiology and Pathology, Universidad Peruana Cayetano Heredia,1 Asociación Benéfica PRISMA,3 Hospital Nacional Dos De Mayo,5 Hospital María Auxiliadora, Lima, Perú,6 Wellcome Trust Centre for Clinical Tropical Medicine, Imperial College London, London, United Kingdom,2 Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland4

Received 1 December 2003/ Returned for modification 27 January 2004/ Accepted 14 May 2004

There is an urgent need for new tools to improve our ability to diagnose tuberculosis (TB) and multidrug-resistant TB (MDR-TB) in resource-poor settings. In a retrospective analysis undertaken in a region with a high incidence of TB, we evaluated the performance of the microscopic observation drug susceptibility assay (MODS), a novel assay developed in Perú which uses an inverted light microscope and culture in Middlebrook 7H9 broth to detect mycobacterial growth. MODS detected 94.0% of 1,908 positive sputum cultures, whereas Löwenstein-Jensen (LJ) culture detected only 86.9% (P < 0.001). The median time to culture positivity was 8 days (compared to 16 days for the same 208 samples by LJ culture; P < 0.001, Wilcoxon signed rank test). The results obtained by direct susceptibility testing using MODS demonstrated excellent concordance for isoniazid and rifampin and the detection of multidrug resistance with those obtained by indirect colorimetric methods: the microplate Alamar Blue assay (MABA) and the tetrazolium microplate assay (TEMA) (agreement, 95, 98, and 94%; kappa values, 0.8, 0.7, and 0.7, respectively). The concordance of the susceptibility testing results for ethambutol and streptomycin was poor. MODS is a novel assay which can detect the organisms responsible for TB and MDR-TB directly from sputum inexpensively, rapidly, and effectively. A comprehensive prospective evaluation of MODS is under way in Perú, and independent validation in nonresearch laboratories should be undertaken at the earliest opportunity.

* Corresponding author. Mailing address: Laboratorio de Investigación de Enfermedades Infecciosas, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, San Martín de Porras, Lima 31, Perú. Phone: 00511 382 3398. Fax: 00511 464 0781. E-mail: dajmoore{at}imperial.ac.uk.

{dagger} Contributing members of the Tuberculosis Working Group in Perú are listed in Acknowledgments.

Journal of Clinical Microbiology, October 2004, p. 4432-4437, Vol. 42, No. 10
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.10.4432-4437.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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