Comparison of Xpert MTB/RIF with ProbeTec ET DTB and COBAS TaqMan MTB for direct detection of M. tuberculosis complex in respiratory specimens

BMC Infectious Diseases

Harald Hoffmann⁶  Tarig Alnour¹  Evgeni Sahalchyk²  Mokhonim Abdulloeva⁴  Ainura Esenalieva³  Laziz Turaev⁵  Sabine Hofmann-Thiel⁶  Uladzimir Antonenka² 

[1] Alzaeim Alazhari University, Khartoum, Sudan;IML red, Supranational Reference Laboratory of Tuberculosis, Gauting, Germany;National Reference Laboratory of Tuberculosis, Bishkek, Republic of Kyrgyzstan;National Reference Laboratory of Tuberculosis, Machiton, Republic of Tajikistan;National Institute of Tuberculosis, National Reference Laboratory of Tuberculosis, Tashkent, Republic of Uzbekistan;Synlab MVZ Gauting, Gauting, Germany

关键词: Xpert MTB/RIF;    Nucleic Acid Amplification;    Mycobacterium Tuberculosis Complex;    Tuberculosis;   

Others  :  1147725
DOI  :  10.1186/1471-2334-13-280

 received in 2012-10-01, accepted in 2013-06-10,  发布年份 2013

【 摘 要 】

Background

Nucleic acid amplification assays allow for the rapid and accurate detection of Mycobacterium tuberculosis (MTB) directly in clinical specimens thereby facilitating diagnosis of tuberculosis (TB). With the fully automated Xpert MTB/RIF system (Cepheid) an innovative solution of TB diagnostics has been launched. We performed a direct head-to-head comparison of Xpert MTB/RIF with two widely used commercial assays, ProbeTec ET DTB (DTB) (Becton-Dickinson) and COBAS TaqMan MTB (CTM-MTB) (Roche).

Methods

121 pre-characterized respiratory specimens (68 culture-positive for MTB complex, 24 culture-positive for non-tuberculous mycobacteria and 29 culture-negative) taken from our frozen specimen bank were tested for the presence of MTB complex by the three assays.

Results

Among culture-positive samples (n = 68), overall sensitivity for detection of MTB complex was 74.6%, 73.8%, and 79.1% for Xpert MTB/RIF, CTM-MTB, and DTB, respectively. Within the subgroup of smear-negative TB samples (n = 51) sensitivity was 68% for Xpert MTB/RIF and CTM-MTB and 72% for DTB. Among smear-positive TB samples (n = 17), all (100%) were detected by DTB and 94.1% and 93.3% by Xpert MTB/RIF and CTM-MTB, respectively. Specificity was best for CTM-MTB (100%) and lowest for Xpert MTB/RIF (96.2%) due to misidentification of two NTM samples as MTB complex. CTM-MTB yielded the highest rate of invalid results (4.1%) (0.8% by Xpert MTB/RIF and DTB, respectively).

Conclusions

The direct comparison of Xpert MTB/RIF with CTM-MTB and DTB yielded similar overall performance data. Whereas DTB was slightly superior to Xpert MTB/RIF in terms of sensitivity, at least in the sample collection tested here, CTM-MTB performed best in terms of specificity.

【 授权许可】

   
2013 Antonenka et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, et al.: Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010, 363(11):1005-1015.
• [2]Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, Kop J, Owens MR, Rodgers R, Banada P, et al.: Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol 2010, 48(1):229-237.
• [3]Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, Gler MT, Blakemore R, Worodria W, Gray C, et al.: Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet 2011, 377(9776):1495-1505.
• [4]Goessens WHF, de Man P, Koeleman GM, Luijendijk A, te Witt R, Endtz HP, van Belkum A: Comparison of the COBAS AMOLICOR MTB and BDProbeTec ET Assays for detection of Mycobacterium tuberculosis in respiratory specimens. J Clin Microbiol 2005, 43(6):2563-2566.
• [5]Reischl U, Lehn N, Wolf H, Naumann L: Clinical evalution of automated COBAS AMPLICOR MTB assay for testing respiratory and nonrespiratory specimens. J Clin Microbiol 1998, 36(10):2853-2860.
• [6]Lebrun L, Mathieu D, Saulnier C, Nordmann P: Limits of commercial molecular tests for diagnosis of pulmonary tuberculosis. Eur Respir J 1997, 10:874-1876.
• [7]Lumb R, Davies K, Dawson D, Gibb R, Gottlieb T, Kershaw C, Kociuba K, Nimmo G, Sangster N, Worthington M, et al.: Multicenter evaluation of the Abbott LCx Mycobacterium tuberculosis ligase chain reaction assay. J Clin Microbiol 1999, 37(10):3102-3107.
• [8]Lawn SD, Nicol MP: Xpert(R) MTB/RIF assay: development, evaluation and implementation of a new rapid molecular diagnostic for tuberculosis and rifampicin resistance. Future Microbiol 2011, 6(9):1067-1082.
• [9]Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K, Ntinginya EN, O'Grady J, Huggett J, Dheda K, et al.: Rapid and accurate detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay–a clinical validation study. PLoS One 2011, 6(6):e20458.
• [10]Marlowe EM, Novak-Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, Carlson JS, Kawamura M, Pandori M: Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. J Clin Microbiol 2011, 49(4):1621-1623.
• [11]Moure R, Munoz L, Torres M, Santin M, Martin R, Alcaide F: Rapid detection of Mycobacterium tuberculosis complex and rifampin resistance in smear-negative clinical samples by use of an integrated real-time PCR method. J Clin Microbiol 2011, 49(3):1137-1139.
• [12]Teo J, Jureen R, Chiang D, Chan D, Lin R: Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF assay and the amplified Mycobacterium Tuberculosis Direct assay, for detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. J Clin Microbiol 2011, 49(10):3659-3662.
• [13]Causse M, Ruiz P, Gutierrez-Aroca JB, Casal M: Comparison of two molecular methods for rapid diagnosis of extrapulmonary tuberculosis. J Clin Microbiol 2011, 49(8):3065-3067.
• [14]Armand S, Vanhuls P, Delcroix G, Courcol R, Lemaitre N: Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. J Clin Microbiol 2011, 49(5):1772-1776.
• [15]Miller MB, Popowitch EB, Backlund MG, Ager EP: Performance of Xpert MTB/RIF RUO assay and IS6110 real-time PCR for Mycobacterium tuberculosis detection in clinical samples. J Clin Microbiol 2011, 49(10):3458-3462.
• [16]DIN DIfNeV: Medizinische Mikrobiologie - Tuberkulosediagnostik - Teil 3: Kulturelle Methoden zum Nachweis von Mykobakterien. DIN 58943–3. Berlin: Beuth Verlag; 2011.
• [17]Moore JE, Kruijshaar ME, Ormerod LP, Drobniewski F, Abubakar I: Increasing reports of non-tuberculous mycobacteria in England, Wales and Northern Ireland, 1995–2006. BMC Publ Health 2010, 10:612. BioMed Central Full Text
• [18]Thomson RM: Changing epidemiology of pulmonary nontuberculous mycobacteria infections. Emerg Infect Dis 2010, 16(10):1576-1583.
• [19]Buijtels PC, van der Sande MA, Parkinson S, Verbrugh HA, Petit PL, van Soolingen D: Isolation of non-tuberculous mycobacteria at three rural settings in Zambia; a pilot study. Clin Microbiol Infect 2010, 16(8):1142-1148.
• [20]McHugh TD, Pope CF, Ling CL, Patel S, Billington OJ, Gosling RD, Lipman MC, Gillespie SH: Prospective evaluation of BDProbeTec strand displacement amplification (SDA) system for diagnosis of tuberculosis in non-respiratory and respiratory samples. J Med Microbiol 2004, 53(12):1215-1219.
• [21]Rüsch-Gerdes S, Richter E: Clinical evaluation of the semiautomated BDProbeTec ET system for the detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. Diagn Microbiol Infect Dis 2004, 48:265-270.