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Journal of Clinical Microbiology, January 1999, p. 137-140, Vol. 37, No. 1
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Performance Characteristics of the BDProbeTec System for Direct Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens

Gaby E. Pfyffer,1,* Pascale Funke-Kissling,1 Eva Rundler,1 and Rainer Weber2

Swiss National Center for Mycobacteria, Department of Medical Microbiology, University of Zurich, CH-8028 Zurich,1 and Division of Infectious Disease, Department of Internal Medicine, University Hospital, CH-8091 Zurich,2 Switzerland

Received 2 July 1998/Returned for modification 30 September 1998/Accepted 13 October 1998

Strand displacement amplification (SDA) technology has been established in a fully automated system known as BDProbeTec. Target sequences of the insertion sequence IS6110 and the 16S rRNA gene are simultaneously amplified, which thus allows the detection of Mycobacterium tuberculosis complex and, as an additional option, of most Mycobacterium species. Detection occurs via a chemiluminescent microwell assay that employs the simultaneous hybridization and capture of SDA products with a biotinylated capture probe and an alkaline phosphatase detector probe. We have evaluated the performance of the BDProbeTec system in detecting M. tuberculosis complex by testing 799 respiratory specimens and comparing the results to those obtained by conventional diagnostic techniques, i.e., microscopy and culture (solid and radiometric media). M. tuberculosis was cultivated from 41 specimens, of which 28 (68.4%) were smear positive and 13 (31.6%) were smear negative. The overall sensitivity of the SDA assay was 97.6% (for smear-positive specimens, 100%; for smear-negative specimens, 92.3%), and specificity was 95.0%. After resolution of the discrepancies by studying the patients' clinical data, sensitivity and specificity were 97.9 and 96.5%, respectively, and positive and negative predictive values were 63.9 and 99.9%, respectively. These preliminary data demonstrate that the BDProbeTec system has promising performance characteristics with respiratory specimens and that it allows the detection of M. tuberculosis complex within hours.

* Corresponding author. Mailing address: Swiss National Center for Mycobacteria, Department of Medical Microbiology, University of Zurich, Gloriastrasse 30, 8028 Zurich, Switzerland. Phone: 41 1 634 27 86. Fax: 41 1 634 49 18. E-mail: pfyffer{at}immv.unizh.ch.

Journal of Clinical Microbiology, January 1999, p. 137-140, Vol. 37, No. 1
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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