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Performance of Cepheid® Xpert MTB/RIF® and TB-Biochip® MDR in two regions of Russia with a high prevalence of drug-resistant tuberculosis

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Abstract

The purpose of this study was to assess the performance of Cepheid® Xpert MTB/RIF® (“Xpert”) and TB-Biochip® MDR (“TB-Biochip”). Sputum specimens from adults with presumptive tuberculosis (TB) were homogenized and split for: (1) direct Xpert and microscopy, and (2) concentration for Xpert, microscopy, culture [Lowenstein–Jensen (LJ) solid media and Mycobacteria Growth Indicator Tube® (MGIT)], indirect drug susceptibility testing (DST) using the absolute concentration method and MGIT, and TB-Biochip. In total, 109 of 238 (45.8 %) specimens were culture-positive for Mycobacterium tuberculosis complex (MTBC), and, of these, 67 isolates were rifampicin resistant (RIF-R) by phenotypic DST and 64/67 (95.5 %) were isoniazid resistant (INH-R). Compared to culture of the same specimen, a single direct Xpert was more sensitive for detecting MTBC [95.3 %, 95 % confidence interval (CI), 90.0–98.3 %] than direct (59.6 %, 95 % CI, 50.2–68.5 %) or concentrated smear (85.3 %, 95 % CI, 77.7–91.1 %) or LJ culture (80.8 %, 95 % CI, 72.4–87.5 %); the specificity was 86.0 % (95 % CI, 78.9–91.3 %). Compared with MGIT DST, Xpert correctly identified 98.2 % (95 % CI, 91.5–99.9 %) of RIF-R and 95.5 % (95 % CI, 85.8–99.2 %) of RIF-susceptible (RIF-S) specimens. In a subset of 104 specimens, the sensitivity of TB-Biochip for MTBC detection compared to culture was 97.3 % (95 % CI, 91.0–99.5 %); the specificity was 78.1 % (95 % CI, 61.5–89.9 %). TB-Biochip correctly identified 100 % (95 % CI, 94.2–100 %) of RIF-R, 94.7 % (95 % CI, 76.7–99.7 %) of RIF-S, 98.2 % (95 % CI, 91.4–99.9 %) of INH-R, and 78.6 % (95 % CI, 52.1–94.2 %) of INH-S specimens compared to MGIT DST. Xpert and Biochip were similar in accuracy for detecting MTBC and RIF resistance compared to conventional culture methods.

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Acknowledgments

This work was supported by the United States Agency for International Development (USAID) country mission in Russia.

Conflict of interest

No conflict of interest was reported for all authors.

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Authors and Affiliations

  1. The U.S. Centers for Disease Control and Prevention, CDC, Atlanta, GA, USA

    E. V. Kurbatova, D. A. Kaminski, J. V. Ershova & J. P. Cegielski

  2. Central TB Research Institute of the Russian Academy of Medical Sciences, Moscow, Russia

    V. V. Erokhin, S. N. Andreevskaya, L. N. Chernousova, O. V. Demikhova, E. E. Larionova, T. G. Smirnova, I. A. Vasilieva & A. V. Vorobieva

  3. Vladimir Oblast TB Dispensary, Vladimir, Russia

    G. V. Volchenkov, N. V. Kaunetis, T. A. Kuznetsova, T. R. Somova & S. S. Zolkina

  4. Global Laboratory Activity, Division of Tuberculosis Elimination, The U.S. Centers for Disease Control and Prevention, CDC, Mailstop F-08, 1600 Clifton Road, NE, Atlanta, GA, 30333, USA

    D. A. Kaminski

Authors
  1. E. V. Kurbatova
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  2. D. A. Kaminski
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  3. V. V. Erokhin
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  4. G. V. Volchenkov
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  5. S. N. Andreevskaya
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  6. L. N. Chernousova
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  7. O. V. Demikhova
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  8. J. V. Ershova
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  9. N. V. Kaunetis
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  10. T. A. Kuznetsova
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  11. E. E. Larionova
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  12. T. G. Smirnova
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  13. T. R. Somova
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  14. I. A. Vasilieva
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  15. A. V. Vorobieva
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  16. S. S. Zolkina
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  17. J. P. Cegielski
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Corresponding author

Correspondence to D. A. Kaminski.

Additional information

Disclaimer: The conclusions and interpretations of the data presented in this report are solely those of the authors and do not necessarily represent an official position of the CDC.

E.V. Kurbatova and D.A. Kaminski are joint first authors of the paper.

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Kurbatova, E.V., Kaminski, D.A., Erokhin, V.V. et al. Performance of Cepheid® Xpert MTB/RIF® and TB-Biochip® MDR in two regions of Russia with a high prevalence of drug-resistant tuberculosis. Eur J Clin Microbiol Infect Dis 32, 735–743 (2013). https://doi.org/10.1007/s10096-012-1798-0

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  • DOI: https://doi.org/10.1007/s10096-012-1798-0

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