Abstract
In the study presented here, the performance of the BDProbeTec ET system (Becton Dickinson, USA) was compared with the Roche Cobas Amplicor-PCR (Roche, Switzerland) to detect Mycobacterium tuberculosis complex (MTB) in clinical respiratory samples. The Bactec MGIT 960 liquid culture system (Becton Dickinson) was used as a reference method. A total of 411 samples were tested. Of the 93 culture-positive samples, both the BDProbeTec ET system and the Cobas Amplicor-PCR detected 87 (sensitivity, 93.5%). When only smear-negative samples were considered, the BDProbeTec ET exhibited a sensitivity of 50% and the Cobas Amplicor-PCR 60%. Specificity was 99.7% for the BDProbeTec ET system and 100% for the Cobas Amplicor-PCR. Percent agreement between the two nucleic amplification methods was 98.7%. Inhibition occurred in three (0.7%) samples in the BDProbeTec ET system. The high sensitivity and specificity of the BDProbeTec ET system suggest it is a useful method for the rapid and direct detection of MTB in smear-positive respiratory samples.
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D'Amato RF, Wallman AA, Hochstein LH, Colaninno PM, Scardamaglia M, Ardila E, Ghouri M, Kim K, Patel RC, Miller A (1995) Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test. J Clin Microbiol 33:1832–1834
Ichiyama S, Iinuma Y, Tawada Y, Yamori S, Hasegawa Y, Shimokata K, Nakashima N (1996) Evaluation of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche PCR-microwell plate hybridization method (AMPLICOR MYCOBACTERIUM) for direct detection of mycobacteria. J Clin Microbiol 34:130–133
Scarparo C, Piccoli P, Rigon A, Ruggiero G, Scagnelli M, Piersimoni C (2000) Comparison of enhanced Mycobacterium tuberculosis amplified direct test with COBAS AMPLICOR Mycobacterium tuberculosis assay for direct detection of Mycobacterium tuberculosis complex in respiratory and extrapulmonary specimens. J Clin Microbiol 38:1559–1562
Catanzaro A, Perry S, Clarridge JE, Dunbar S, Goodnight-White S, LoBue PA, Peter C, Pfyffer GE, Sierra MF, Weber R, Woods G, Mathews G, Jonas V, Smith K, Della-Latta P (2000) The role of clinical suspicion in evaluating a new diagnostic test for active tuberculosis: results of a multicenter prospective trial. JAMA 283:639–645
Iovannisci DM, Winn-Deen ES (1993) Ligation amplification and fluorescence detection of Mycobacterium tuberculosis DNA. Mol Cell Probes 7:35–43
Lumb R, Davies K, Dawson D, Gibb R, Gottlieb T, Kershaw C, Kociuba K, Nimmo G, Sangster N, Worthington M, Bastian I (1999) Multicenter evaluation of the Abbott LCx Mycobacterium tuberculosis ligase chain reaction assay. J Clin Microbiol 37:3102–3107
Schluger NW (2001) Changing approaches to the diagnosis of tuberculosis. Am J Respir Crit Care Med 164:2020–2024
Walker GT, Nadeau JG, Spears PA, Schram JL, Nycz CM, Shank DD (1994) Multiplex strand displacement amplification (SDA) and detection of DNA sequences from Mycobacterium tuberculosis and other mycobacteria. Nucleic Acids Res 22:2670–2677
Hellyer TJ, Fletcher TW, Bates JH, Stead WW, Templeton GL, Cave MD, Eisenach KD (1996) Strand displacement amplification and the polymerase chain reaction for monitoring response to treatment in patients with pulmonary tuberculosis. J Infect Dis 173:934–941
Down JA, O'Connell MA, Dey MS, Walters AH, Howard DR, Little MC, Keating WE, Zwadyk P Jr., Haaland PD, McLaurin DA 3rd, Cole G (1996) Detection of Mycobacterium tuberculosis in respiratory specimens by strand displacement amplification of DNA. J Clin Microbiol 34:860–865
Ichiyama S, Ito Y, Sugiura F, Iinuma Y, Yamori S, Shimojima M, Hasegawa Y, Shimokata K, Nakashima N (1997) Diagnostic value of the strand displacement amplification method compared to those of Roche Amplicor PCR and culture for detecting mycobacteria in sputum samples. J Clin Microbiol 35:3082–3085
Little MC, Andrews J, Moore R, Bustos S, Jones L, Embres C, Durmowicz G, Harris J, Berger D, Yanson K, Rostkowski C, Yursis D, Price J, Fort T, Walters A, Collis M, Llorin O, Wood J, Failing F, O'Keefe C, Scrivens B, Pope B, Hansen T, Marino K, Williams K, Boenisch M (1999) Strand displacement amplification and homogeneous real-time detection incorporated in a second-generation DNA probe system, BDProbeTec ET. Clin Chem 45:777–784
Bergmann JS, Keating WE, Woods GL (2000) Clinical evaluation of the BDProbeTec ET system for rapid detection of Mycobacterium tuberculosis. J Clin Microbiol 38:863–865
Johansen IS, Thomsen VØ, Johansen A, Andersen P, Lundgren B (2002) Evaluation of a new commercial assay for diagnosis of pulmonary and nonpulmonary tuberculosis. Eur J Clin Microbiol Infect Dis 21:455–460
Metchock BG, Nolte FS, Wallace RJ Jr (1999) Mycobacterium. In: Murray PR, Baron EJ, Pfaller MA, Tenover FC, Yolken RH (eds) Manual of clinical microbiology. American Society for Microbiology, Washington DC, pp 399–437
Acknowledgements
We thank Nippon Becton Dickinson Co. Ltd. for supplying the BDProbeTec ET kits and for supporting us financially.
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Iinuma, Y., Senda, K., Fujihara, N. et al. Comparison of the BDProbeTec ET System with the Cobas Amplicor PCR for Direct Detection of Mycobacterium tuberculosis in Respiratory Samples. Eur J Clin Microbiol Infect Dis 22, 368–371 (2003). https://doi.org/10.1007/s10096-003-0913-7
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DOI: https://doi.org/10.1007/s10096-003-0913-7