Performance of an automated Q-beta replicase amplification assay for Mycobacterium tuberculosis in a clinical trial.

Journal of Clinical Microbiology
J H SmithJ D Klinger

Abstract

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 <10 to 300 CFU. The assay was tested for cross-hybridization by using large numbers (e.g., 10(5)to 10(10) CFU/assay) of 133 other organisms commonly found in respiratory tract samples, including non-M. tuberculosis Mycobacterium spp., other bacteria, fungi, and viruses. All of these competitors tested negative by the assay. Automated assay results for 780 respiratory tract samples (sputum or bronchoalveolar lavage specimens) collected and tested at three trial sites in the United States) were compared with the results of culture and acid-fast microscopy. Aliquots of conventionally digested and decontaminated sputum pellets were heated at 100 degrees C and mechanically disrupted prior to hybridization and background reduction, amplificat...Continue Reading

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Citations

Jan 25, 2002·Annals of the New York Academy of Sciences·M Caws, F A Drobniewski
Dec 17, 1997·Journal of Clinical Microbiology·J P CegielskiL B Reller
Aug 31, 2002·Journal of Clinical Microbiology·Jacqueline LachnikFranz-Christoph Bange

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