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Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens

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Abstract

The automated high-throughput Abbott RealTime MTB real-time PCR assay has been recently launched for Mycobacterium tuberculosis complex (MTBC) clinical diagnosis. This study would like to evaluate its performance. We first compared its diagnostic performance with the Roche Cobas TaqMan MTB assay on 214 clinical respiratory specimens. Prospective analysis of a total 520 specimens was then performed to further evaluate the Abbott assay. The Abbott assay showed a lower limit of detection at 22.5 AFB/ml, which was more sensitive than the Cobas assay (167.5 AFB/ml). The two assays demonstrated a significant difference in diagnostic performance (McNemar’s test; P = 0.0034), in which the Abbott assay presented significantly higher area under curve (AUC) than the Cobas assay (1.000 vs 0.880; P = 0.0002). The Abbott assay demonstrated extremely low PCR inhibition on clinical respiratory specimens. The automated Abbott assay required only very short manual handling time (0.5 h), which could help to improve the laboratory management. In the prospective analysis, the overall estimates for sensitivity and specificity of the Abbott assay were both 100 % among smear-positive specimens, whereas the smear-negative specimens were 96.7 and 96.1 %, respectively. No cross-reactivity with non-tuberculosis mycobacterial species was observed. The superiority in sensitivity of the Abbott assay for detecting MTBC in smear-negative specimens could further minimize the risk in MTBC false-negative detection. The new Abbott RealTime MTB assay has good diagnostic performance which can be a useful diagnostic tool for rapid MTBC detection in clinical laboratories.

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Authors and Affiliations

  1. Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Queen, Pokfulam, Hong Kong Special Administrative Region, China

    J. H. K. Chen, K. K. K. She, T.-C. Kwong, O.-Y. Wong, P.-L. Ho, V. C. C. Cheng, K.-Y. Yuen & W.-C. Yam

  2. Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region, China

    G. K. H. Siu

  3. Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region, China

    P.-L. Ho, V. C. C. Cheng, K.-Y. Yuen & W.-C. Yam

  4. Tuberculosis and Chest Service, Centre for Health Protection, Department of Health, Hong Kong, China

    C.-C. Leung, K.-C. Chang & C.-M. Tam

Authors
  1. J. H. K. Chen
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  2. K. K. K. She
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  3. T.-C. Kwong
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  4. O.-Y. Wong
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  5. G. K. H. Siu
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  6. C.-C. Leung
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  7. K.-C. Chang
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  8. C.-M. Tam
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  9. P.-L. Ho
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  10. V. C. C. Cheng
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  11. K.-Y. Yuen
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  12. W.-C. Yam
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Corresponding author

Correspondence to W.-C. Yam.

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Chen, J.H.K., She, K.K.K., Kwong, TC. et al. Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens. Eur J Clin Microbiol Infect Dis 34, 1827–1832 (2015). https://doi.org/10.1007/s10096-015-2419-5

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  • DOI: https://doi.org/10.1007/s10096-015-2419-5

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