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Journal of Clinical Microbiology, July 2003, p. 2867-2871, Vol. 41, No. 7
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.7.2867-2871.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Usefulness of a New Mycobacteriophage-Based Technique for Rapid Diagnosis of Pulmonary Tuberculosis

Servei de Microbiologia, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat,¹ Servei de Microbiologia, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain²

Received 3 January 2003/ Returned for modification 18 February 2003/ Accepted 24 March 2003

A new mycobacteriophage-based technique (PhageTek MB) was compared with standard culture and staining techniques for diagnosis of pulmonary tuberculosis. A total of 2,048 respiratory specimens from 1,466 patients collected from February 2000 to March 2001 were studied by both (i) conventional methods (direct microscopic examination [auramine-rhodamine fluorochrome], and culture in BacT/ALERT 3D and solid media) and (ii) the PhageTek MB assay. This phenotypic test utilizes specific mycobacteriophages to detect the presence of live Mycobacterium tuberculosis complex organisms within a decontaminated clinical sample. Overall, 205 (10%) specimens were positive for mycobacteria (134 patients): 144 (70.2%) M. tuberculosis isolates and 61 (29.8%) nontuberculous mycobacterium isolates (30 Mycobacterium kansasii, 12 Mycobacterium xenopi, 9 Mycobacterium gordonae, 7 Mycobacterium avium complex, 2 Mycobacterium chelonae, and 1 Mycobacterium fortuitum isolate). PhageTek MB was more likely to give a positive result with specimens in which high numbers of acid-fast bacilli were observed on the smear. The sensitivity, specificity, and positive and negative predictive values of this mycobacteriophage-based technique versus culture for M. tuberculosis were 58.3, 99.1, 83.2, and 96.9%, respectively. PhageTek MB is a rapid (48-h), specific, safe, and easy-to-perform test. According to the prevalence of the disease in the population studied, the test would require improved sensitivity in order to be used as a screening test for routine diagnosis of respiratory tuberculosis in our setting.

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