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Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

Former Soviet Union countries including the Baltic States (Latvia, Lithuania, and Estonia) are hot spots for an emerging epidemic of drug resistant tuberculosis (TB). As a part of the development of a co-ordinated network of centers for diagnostic trials across Eastern Europe we conducted a retrospective multicenter analysis of the performance of the GenoType® MTBDRPlus assay for TB identification and susceptibility to isoniazid (INH) and rifampicin (RIF) in routine settings. A total of 1,045 primary samples, 1045 TB cultures derived from these specimens and 306 separate M. tuberculosis isolates tested in 2007–2010 at four participating sites (Tartu, Estonia; Riga, Latvia; Vilnius, Lithuania; and Samara, Russian Federation) were included in the analysis. The pooled sensitivity and specificity values for RIF and INH were 95.3% and 95.5%, 89.9 and 87.1%, respectively; there were no statistically significant variations in performance across sites. The proportion of multidrug resistant (MDR) strains in the collections ranged from 21.8% (in Estonia) to 55.9% (in Russia). In a routine non-trial context, the assay reliably detected both rifampicin and isoniazid resistance. The absence of statistically significant differences between sites suggested that the comparable performance obtained using these assays has helped demonstrate the formation of a successful diagnostic trial network.

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Acknowledgements

The authors would like to thank all participating sites and laboratory staff for their helpful suggestions and support. This study was funded by EU FP7 grants TB-EURO-GEN (grant No 201483) and TB PAN-NET (grant No 223681).

Conflict of interest statement

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Samara Oblast TB Service, 154 Novo-Sadovaya Street, Samara, 443068, Russian Federation

    S. Mironova & I. Kontsevaya

  2. National Tuberculosis and Infectious Diseases University Hospital, Antakalnio str. 77, LT-10214, Vilnius, Lithuania

    E. Pimkina

  3. UK Health Protection Agency National Mycobacterium Reference Laboratory, Clinical TB and HIV Research Group, Institute for Cell and Molecular Science, Barts and the London School of Medicine, Queen Mary College University of London, 2 Newark Street, London, E1 2AT, UK

    V. Nikolayevskyy, Y. Balabanova & F. Drobniewski

  4. State Agency “Infectology Center of Latvia”, Clinic for Tuberculosis and Lung Diseases, Mycobacteriology Department, “Upeslejas” Stopinunovads, LV-2118, Riga, Latvia

    G. Skenders

  5. United Laboratory, Department of Mycobacteriology, Tartu University Hospital, Puusepa 1a, 50406, Tartu, Estonia

    T. Kummik

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  1. S. Mironova
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  2. E. Pimkina
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  3. I. Kontsevaya
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  4. V. Nikolayevskyy
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  5. Y. Balabanova
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  6. G. Skenders
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  8. F. Drobniewski
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Correspondence to V. Nikolayevskyy.

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Mironova, S., Pimkina, E., Kontsevaya, I. et al. Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study. Eur J Clin Microbiol Infect Dis 31, 1381–1387 (2012). https://doi.org/10.1007/s10096-011-1453-1

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  • DOI: https://doi.org/10.1007/s10096-011-1453-1

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