Performance of an Automated Q-Beta Replicase Amplification Assay ...

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the first report of a clinical study with a fully automated amplification probe ... replicase amplification and detection system (37). ... E-mail: [email protected].
JOURNAL OF CLINICAL MICROBIOLOGY, June 1997, p. 1484–1491 0095-1137/97/$04.0010 Copyright © 1997, American Society for Microbiology

Vol. 35, No. 6

Performance of an Automated Q-Beta Replicase Amplification Assay for Mycobacterium tuberculosis in a Clinical Trial J. H. SMITH,† G. RADCLIFFE,‡ S. RIGBY,§ D. MAHAN,¶ D. J. LANE,*

AND

J. D. KLINGER#

Vysis Inc., Downers Grove, Illinois 60515 Received 9 September 1996/Returned for modification 17 October 1996/Accepted 4 March 1997

We present data from a clinical trial study in which an automated version (Galileo) of a previously described Q-Beta replicase-amplified probe assay (J. S. Shah et al., J. Clin. Microbiol. 33:1435–1441, 1995) was used for the direct detection of Mycobacterium tuberculosis complex in sputum. The assay was designed to target specific regions of 23S rRNA found in M. tuberculosis, Mycobacterium bovis, Mycobacterium africanum, and Mycobacterium microti and had a sensitivity ranging from approximately

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